GC, 9th chamber, December 12, 2018, No T-679/14

THE GENERAL COURT (Ninth Chamber),

I. Background to the dispute

A. Perindopril and its patents

1 The Servier group, composed of Servier SAS and several subsidiaries (individually or jointly, 'Servier'), developed perindopril, a medicinal product used in cardiovascular medicine, primarily intended for the treatment of hypertension and heart failure, by inhibiting the angiotensin converting enzyme.

2 The active pharmaceutical ingredient of perindopril ('API'), that is to say, the biologically active chemical substance which produces the desired therapeutic effects, takes the form of a salt. The salt used initially was erbumine (or tert butylamine), which is in its crystalline form on account of the synthesis process applied by Servier.

1. Compound patent

3 The perindopril compound patent (patent EP0049658, 'the 658 patent') was filed with the European Patent Office (EPO) on 29 September 1981. The 658 patent was due to expire on 29 September 2001, but protection was prolonged in a number of EU Member States, including the United Kingdom, until 22 June 2003, in accordance with Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1).

2. Secondary patents

4 In 1988, Servier also filed a number of patents before the EPO relating to processes for the manufacture of the perindopril compound with an expiry date of 16 September 2008: patents EP0308339, EP0308340, EP0308341 and EP0309324 (respectively, 'the 339 patent', 'the 340 patent', 'the 341 patent' and 'the 324 patent').

5 Servier filed new patents relating to erbumine and its manufacturing processes with the EPO between 2001 and 2005, including patent EP1294689 (known as 'the beta patent' - 'the 689 patent'), patent EP1296948 (known as 'the gamma patent' - 'the 948 patent'), and patent EP1296947 (known as 'the alpha patent' - 'the 947 patent'). The 947 patent application relating to the alpha crystalline form of erbumine and the process for its preparation was filed on 6 July 2001 and granted by the EPO on 4 February 2004.

3. Second generation perindopril

6 From 2002, Servier began developing a second generation perindopril product, manufactured using another salt, arginine, instead of erbumine. Perindopril arginine showed improvements in terms of shelf life, which increased from two to three years; stability, enabling the use of a single type of packaging for all climatic zones; and storage, since it required no particular storage conditions.

7 Servier applied for a European patent for perindopril arginine (patent EP1354873B, 'the 873 patent') on 17 February 2003. The 873 patent was granted to Servier on 17 July 2004 with an expiry date of 17 February 2023. The introduction of perindopril arginine in the European Union markets started in 2006. Servier launched perindopril arginine on the United Kingdom market in April 2008, whereas generic perindopril had already been on the market for several months.

B. The applicants

8 Teva Pharmaceutical Industries Ltd is a multinational pharmaceutical company that develops, produces and markets generic medicines for all major medical treatment categories. It also produces APIs for its own pharmaceutical production and for other manufacturers. Teva UK Ltd is a wholly owned subsidiary of Teva Pharmaceuticals Europe BV, which itself is a wholly owned subsidiary of Teva Pharmaceutical Industries (together or individually, 'Teva' or 'the applicants'). Teva is one of the largest pharmaceutical companies in the world operating in the generic medicinal products sector.

9 On 26 January 2006, Teva merged with Ivax Europe ('Ivax'), a multinational pharmaceutical company which manufactures generic medicines and which therefore became a wholly owned subsidiary of Teva.

C. Teva's perindopril activities

10 Before their merger, Teva and Ivax each developed their own perindopril project.

11 Accordingly, between 1999 and 2005, Teva tried, without success, to source perindopril API from a number of suppliers.

12 In 2003, following its failed negotiations with Servier concerning the conclusion of an agreement to market and supply Servier's generic perindopril, Ivax started to develop its own perindopril. Accordingly, on 24 September 2003, it concluded a contract to supply perindopril API with Hetero Drugs Ltd and, on 21 December 2005, it concluded a manufacturing and supply agreement with Alembic Pharmaceuticals Ltd for the manufacture of perindopril as an end product from that API.

13 In 2003, Ivax also started discussions with Krka Tovarna Zdravil d.d. ('Krka') which, at that time, was developing its own perindopril. Negotiations intensified in May 2006 following the merger of Ivax and Teva, but were ultimately unsuccessful and, on 18 May 2006, Teva announced to Krka its decision not to pursue their cooperation on perindopril in the United Kingdom.

D. Disputes relating to perindopril

1. Disputes before the EPO

14 In 2004, 10 generic companies, including Norton Healthcare Ltd, a subsidiary of Ivax, filed opposition proceedings against the 947 patent before the EPO seeking the revocation of that patent on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.

15 On 27 July 2006, the Opposition Division of the EPO confirmed the validity of the 947 patent after Servier made some minor amendments to its original claims. Seven companies brought an appeal against that decision. By decision of 6 May 2009, the EPO's Technical Board of Appeal annulled the decision of the EPO's Opposition Division of 27 July 2006 and revoked the 947 patent. Servier's request for a revision of that decision was rejected on 19 March 2010.

16 On 13 April 2005, Teva filed opposition proceedings against the 873 patent. The Opposition Division rejected that opposition on the ground, in particular, that Teva had not demonstrated that that patent had insufficient inventive step. On 22 December 2008, Teva filed an appeal against that decision, before withdrawing the appeal on 8 May 2012.

2. Disputes before the national courts

17 The validity of the 947 patent has also been disputed by generic companies before the courts of certain Member States, notably in the United Kingdom.

(a) Dispute between Servier and Ivax

18 On 9 August 2005, Ivax requested the revocation of the 947 patent, as validated in the United Kingdom ('the UK 947 patent'), before the High Court of Justice (England & Wales), Chancery Division (Patents Court). In October 2005, Servier and Ivax decided, however, to stay the proceedings until the adoption of the final decision in the opposition proceedings before the EPO. In return, Servier gave Ivax, its licensees and its customers an undertaking that, for the period of the stay and in the United Kingdom, it would not commence proceedings, seek an account of profits or any financial relief other than a reasonable royalty in respect of any acts of infringement of the UK 947 patent, or seek injunctive relief or delivery up. Servier also undertook to continue proceedings before the EPO diligently and not to seek an interim injunction in any infringement action brought once the proceedings before the EPO had been concluded.

(b) Dispute between Servier and Apotex

19 On 1 August 2006, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court) against Apotex Inc, claiming infringement of the UK 947 patent, since the latter had launched a generic version of perindopril in the United Kingdom on 28 July 2006. Apotex brought a counterclaim for annulment of the UK 947 patent. An interim injunction prohibiting Apotex from importing, offering to sell or selling perindopril was obtained on 8 August 2006. On 6 July 2007, the High Court of Justice (England & Wales), Chancery Division (Patents Court) ruled that the UK 947 patent was invalid because it lacked novelty and inventive step over another patent held by Servier. Consequently, the injunction was lifted immediately and Apotex was able to resume selling its generic version of perindopril on the United Kingdom market. On 9 May 2008, the Court of Appeal (England & Wales) (Civil Division) dismissed Servier's appeal against the judgment of the High Court of Justice (England & Wales), Chancery Division (Patents Court). On 9 October 2008, the High Court of Justice (England & Wales), Chancery Division (Patents Court) awarded damages to Apotex in the amount of 17.5 million pounds sterling (GBP) on account of the loss of revenue suffered during the period when the injunction was in force.

E. The Agreement

20 Servier entered into a series of settlement agreements with a number of generic companies with which it was involved in patent disputes.

21 On 13 June 2006, Servier concluded a settlement and exclusive purchasing agreement ('the Agreement') with Teva. The perindopril referred to in the Agreement was perindopril erbumine (Clause 1.12 of the Agreement).

22 Under the clauses concerning the settlement agreement, Teva undertook to destroy all perindopril owned or controlled by it and intended for sale in the United Kingdom (Clause 2.2 of the Agreement). Moreover, Teva was to refrain, in the United Kingdom, from making, having made, keeping, importing, supplying, offering to supply or disposing of generic perindopril either manufactured in accordance with the process it had developed, which was considered by Servier to infringe the UK 947 patent, and the 339, 340 and 341 patents, as validated in the United Kingdom (respectively, 'the UK 339 patent', 'the UK 340 patent' and 'the UK 341 patent'), or infringing those patents until the termination or expiration of the Agreement or the expiration of those patents (Clause 2.3 of the Agreement) ('the non-marketing clause'). Furthermore, Teva undertook not to challenge the abovementioned patents in the United Kingdom for the duration of the Agreement, it being stipulated that Teva was not prevented from continuing opposition proceedings against the disputed patents before the EPO (Clause 2.4 of the Agreement) ('the non-challenge clause').

23 In return for Teva's undertakings, Servier undertook to waive any claims against Teva in respect of any infringement of the disputed patents in the United Kingdom prior to the entry into force of the Agreement (Clause 2.1 of the Agreement).

24 Under the clauses concerning the exclusive purchasing obligation, Teva undertook to purchase exclusively from Servier all of its requirements for generic perindopril intended for distribution in the United Kingdom for the duration of the Agreement (Clause 1.14 and 3.1 of the Agreement; 'the exclusive purchasing clause'). In the case of failure to supply by Servier, Teva had no other right of remedy or termination ('the non-termination clause'), but the right to payment of liquidated damages of GBP 500 000 per month (Clauses 1.8 and 3.8.3 of the Agreement).

25 Under the general provisions of the Agreement, the agreement had a duration of three years and was renewable for an additional two year period (Clauses 8.1 and 8 of the Agreement). Moreover, on signature of the Agreement, upon presentation of an 'appropriate invoice', Servier had to pay Teva GBP 5 million as a 'contribution towards the costs incurred by Teva in preparing to enter into this Agreement, including, without limitation, the costs of terminating its existing supply arrangements for the United Kingdom' (Clause 10 of the Agreement).

26 On 23 February 2007, Servier and Teva concluded an amendment to the Agreement ('the amendment to the Agreement'), confirming the actual implementation of the exclusive purchasing obligation by setting a date on which Teva could start to distribute the generic perindopril supplied by Servier. That date either had to be set unilaterally by Servier, or it had to correspond to the date of revocation or expiry of the 947 patent, or be the date on which Apotex commenced distribution of generic perindopril in the United Kingdom following the settlement of its dispute with Servier.

F. Developments after the conclusion of the Agreement

27 Servier did not make the first delivery of perindopril, expected by Teva on 28 July 2006 and also refused to honour all subsequent orders by Teva until February 2007, when deliveries started but continued to be supplied on a consignment basis until July 2007. As a result of that non-compliance with the Agreement, Servier paid Teva liquidated damages of GBP 5.5 million.

28 Following the invalidation of the UK 947 patent by the High Court of Justice (England & Wales), Chancery Division (Patents Court) (see paragraph 19 above), Servier authorised Teva, in accordance with the provisions in the amendment to the Agreement, to market the generic perindopril it had delivered to it. Teva therefore entered the market in the United Kingdom, with several other generic companies, on 12 July 2007.

G. The Sector Inquiry

29 On 15 January 2008, the Commission of the European Communities decided to open an inquiry into the pharmaceutical sector pursuant to Article 17 of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101] and [102 TFEU] (OJ 2003 L 1, p. 1) in order to identify the factors contributing to the decline in innovation in that sector, measured by the number of new medicines reaching the market, and the reasons for the delayed entry into the market of certain generic medicines.

30 The Commission published a preliminary report on the results of its inquiry on 28 November 2008 as a basis for a public consultation. On 8 July 2009, it adopted a communication giving a summary of its pharmaceutical sector inquiry report. The Commission stated, inter alia, in that communication, that the monitoring of patent settlements concluded between originator companies and generic companies should continue in order better to understand the use of that type of agreement and to identify those agreements that delay generic market entry to the detriment of EU consumers and may constitute an infringement of competition rules. The Commission subsequently published six annual reports on the monitoring of patent settlement agreements.

H. The administrative procedure and the contested decision

31 On 24 November 2008, the Commission made unannounced inspections, inter alia, of Teva's premises. The Commission sent requests for information to several companies, including Teva, in January 2009.

32 On 2 July 2009 the Commission decided to open proceedings against Servier and certain generic companies involved. It formally opened proceedings against Teva on 27 July 2009.

33 In August 2009 and then between December 2009 and May 2012, the Commission sent new requests for information to Teva. Between 2009 and 2012, Teva was invited to attend a number of state of play meetings.

34 On 27 July 2012, the Commission issued a Statement of Objections to several companies including Teva, which submitted its reply on 16 November 2012.

35 Following the hearing held on 15 to 18 April 2013 and attended by the companies concerned, further state of play meetings were arranged and additional requests for information sent.

36 On 18 December 2013, the Commission granted access to evidence gathered or more widely disclosed after the Statement of Objections and sent a Letter of Facts to which Teva replied on 17 January 2014.

37 The Hearing Officer issued his final report on 7 July 2014.

38 On 9 July 2014, the Commission adopted Decision C(2014) 4955 final relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 - Perindopril (Servier)] ('the contested decision').

39 Under Article 3 of the contested decision, the applicants infringed Article 101 TFEU by participating, from 13 June 2006 to 6 July 2007, in a reverse payment and exclusive purchasing patent dispute settlement agreement covering the United Kingdom.

40 The Commission imposed on the applicants, jointly and severally, a fine in the amount of EUR 15 569 395 (Article 7(3)(a) of the contested decision).

II. Procedure and forms of order sought

41 By application lodged at the Registry of the General Court on 19 September 2014, the applicants brought the present action.

42 By document lodged at the Registry of the General Court on 7 January 2015, the European Generic medicines Association AISBL ('the EGA') applied for leave to intervene in support of the form of order sought by the applicants in the present case.

43 The Commission requested confidential treatment, vis-à-vis the EGA, of certain elements of the application, the defence and the rejoinder.

44 By order of the President of the Second Chamber of the General Court of 17 June 2015, the EGA was granted leave to intervene in support of the form of order sought by the applicants. Since the EGA did not challenge the requests for confidential treatment, the Court did not rule on whether they were well founded.

45 In the context of the measures of organisation of procedure provided for in Article 89(3)(a) and (d) of the Rules of Procedure of the General Court, the Commission was invited to respond to a question and to produce documents relating to the consultation of the Advisory Committee on Restrictive Practices and Dominant Positions and to produce the amendment to the Agreement. It responded to that question and sent the documents required within the prescribed period, requesting confidential treatment of a statement in the amendment to the Agreement.

46 Acting on a proposal from the Judge-Rapporteur, the Court decided to open the oral part of the procedure and, by way of measures of organisation of procedure pursuant to Article 89(3)(a) of the Rules of Procedure, put written questions to the parties, requesting them to answer those questions at the hearing.

47 At the hearing on 22 June 2017, the parties presented oral argument and their answers to the written and oral questions put by the Court.

48 At the hearing, in response to a question put by the Court, the Commission waived its right to request confidential treatment in respect of all the information disclosed in the public version of the contested decision, which was noted in the minutes of the hearing.

49 The applicants claim that the Court should:

- annul Articles 3 and 7 of the contested decision in so far as they concern them;

- in the alternative, reduce the amount of the fine imposed on them;

- order the Commission to pay the costs.

50 The Commission contends that the Court should:

- dismiss the action;

- order the applicants and the intervener to pay the costs.

51 The intervener contends that the Court should:

- annul Article 3 of the contested decision in so far as it concerns the applicants;

- order the Commission to pay the costs.

III. Law

A. The plea alleging procedural errors

1. Infringement of the principle of sound administration and the presumption of innocence

(a) Arguments of the parties

52 The applicants accuse the Commission of having displayed a lack of care and impartiality in the conduct of the inquiry and in the selection and evaluation of the evidence contained in the file, as shown by their arguments put forward in support of their pleas challenging the Commission's analysis of the potential competition and the restriction of competition and by numerous statements made by the responsible Commissioner when finalising the inquiry into the pharmaceutical sector. The Commission has, therefore, also disregarded their right to the presumption of innocence.

53 The Commission considers that that complaint by the applicants is not sufficiently substantiated. It points out that the statements referred to did not take a position on the outcome of the inquiry concerning the applicants and that the Commissioner in question was no longer a member of the Commission when the contested decision was adopted.

(b) Findings of the Court

54 It should be borne in mind that the guarantees afforded by the EU legal order in administrative proceedings include, in particular, the principle of sound administration, affirmed in Article 41 of the Charter of Fundamental Rights of the European Union, which entails the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case (judgments of 30 September 2003, Atlantic Container Line and Others v Commission, T 191/98 and T 212/98 to T 214/98, EU:T:2003:245, paragraph 404, and of 27 September 2012, Shell Petroleum and Others v Commission, T 343/06, EU:T:2012:478, paragraph 170). That requirement of impartiality encompasses, on the one hand, subjective impartiality, in so far as no member of the institution concerned who is responsible for the matter may show bias or personal prejudice, and, on the other hand, objective impartiality, in so far as there must be sufficient guarantees to exclude any legitimate doubt as to bias on the part of the institution concerned (see judgment of 11 July 2013, Ziegler v Commission, C 439/11 P, EU:C:2013:513, paragraph 155 and the case-law cited).

55 The principle of the presumption of innocence - now laid down in Article 48 of the Charter of Fundamental Rights and which applies inter alia to the procedures relating to infringements of the competition rules applicable to undertakings that may result in the imposition of fines or periodic penalty payments (judgments of 8 July 1999, Hüls v Commission, C 199/92 P, EU:C:1999:358, paragraphs 149 and 150; of 8 July 1999, Montecatini v Commission, C 235/92 P, EU:C:1999:362, paragraphs 175 and 176; and of 25 October 2005, Groupe Danone v Commission, T 38/02, EU:T:2005:367, paragraph 216) - implies that every person accused is presumed to be innocent until his guilt has been established according to law. That presumption thus precludes any formal finding and even any allusion to the liability of an accused person for a particular infringement in a final decision unless that person has enjoyed all the usual guarantees accorded for the exercise of the rights of the defence in the normal course of proceedings resulting in a decision on the merits of the case (judgments of 6 October 2005, Sumitomo Chemical and Sumika Fine Chemicals v Commission, T 22/02 and T 23/02, EU:T:2005:349, paragraph 106, and of 27 March 2014, Saint-Gobain Glass France and Others v Commission, T 56/09 and T 73/09, EU:T:2014:160, paragraph 99). That presumption also implies that the Commission must produce precise and consistent evidence to support the firm conviction that the alleged infringement took place (see judgment of 5 October 2011, Romana Tabacchi v Commission, T 11/06, EU:T:2011:560, paragraph 129 and the case-law cited).

56 In the present case, the applicants put forward, in essence, two arguments in support of their allegation of breach of the principle of sound administration and of the presumption of innocence.

57 In the first place, the applicants refer to their arguments set out in the context of the pleas challenging the Commission's analysis of potential competition and of the restriction by object, which, according to the applicants, demonstrates an obvious lack of care and impartiality in the conduct of the investigation and in the selection and appraisal of evidence of the infringement.

58 In making that reference, the applicants rely on mere assertions, which are not such as to show that the Commission did in fact pre-judge the outcome of the administrative procedure or lacked objectivity in its investigation (see, to that effect, judgment of 6 July 2000, Volkswagen v Commission, T 62/98, EU:T:2000:180, paragraph 272). Moreover, and in any event, the applicants' line of argument is indissociable from the alleged errors of law and of assessment made by the Commission in analysing Teva's classification as a potential competitor and the competition-restricting nature of the Agreement (see, to that effect, judgment of 24 October 1991, Atochem v Commission, T 3/89, EU:T:1991:58, paragraph 39), examined below in the context of the corresponding pleas.

59 In the second place, while the applicants invoke the 'numerous declarations' made by the Commission, they cite only a single 'declaration' of a Commissioner and refer to a press article reporting certain statements made by that Commissioner at a press conference on the presentation of the pharmaceutical sector inquiry report (see paragraph 30 above).

60 It can indeed be seen from the press article mentioned in paragraph 59 above - and this is not disputed by the Commission - that the Commissioner responsible for competition, Ms Kroes, stated that 'overall it [was] indeed a conclusion that there [was] something rotten in the state'. However, given the wording of that statement and the context in which it was made, namely the presentation of the abovementioned pharmaceutical sector inquiry report, the expression in question referred to the practices of anticompetitive collusion and abuses of dominant position in the pharmaceutical sector and not to the Agreement as such. Likewise, while the article also refers to the opening of proceedings against Servier and several generic companies and to Ms Kroes' response to a question put to her by a journalist concerning the reasons for opening those proceedings, according to which the Commission 'hoped to get out a case that [was] really damaging', it must be observed that that statement simply shows that the Commission believed it had sufficient evidence to open proceedings and cannot, by itself, suggest that the Commissioner considered that there was an infringement of the competition rules, especially since, according to the same press article, the Commission had noted, through that Commissioner, that the imposition of fines was subject to the collection of sufficient evidence of the infringement.

61 It must therefore be held that, at that press conference, the Commissioner in question merely informed the public about an ongoing investigation, without, moreover, mentioning the applicants' names, with all the discretion and circumspection necessary in order to respect the presumption of innocence and the duty of impartiality.

62 It follows that the first part of the present plea, alleging that the Commission breached the principle of sound administration and the presumption of innocence, must be rejected.

2. The lack of effective consultation of the Advisory Committee on Restrictive Practices and Dominant Positions

(a) Arguments of the parties

63 The applicants submit that the Commission infringed the essential procedural requirement of consulting the Advisory Committee on Restrictive Practices and Dominant Positions ('the Advisory Committee'), set out in Article 14 of Regulation No 1/2003. Indeed, probably on account of the excessively short period between the notice convening the meeting of the Advisory Committee and that meeting being held, only representatives from the competition authorities of three Member States which were not primarily concerned by the investigation took part in that meeting, which, in addition, gave rise to only a brief opinion by the Advisory Committee.

64 The Commission states that the Advisory Committee met on two occasions, on 30 June and on 7 July 2014, and that the notices convening those meetings were sent on 12 and 30 June 2014, the relevant parts of the draft decision having been sent to the Member States on 12 and 20 June 2014. It submits that, since the Member States did not object to the dates set for those meetings, it complied with Article 14(3) of Regulation No 1/2003. It notes, moreover, that that provision allows the Advisory Committee to issue an opinion even if some members are absent. The Commission considers, finally, that there was no reason to suppose that the members of the Advisory Committee were unable to express an opinion, noting that it had informed the Member States, given the low turnout at the first meeting, that the second meeting would also concern the substantive issues addressed in the draft decision.

(b) Findings of the Court

65 Article 14(1) of Regulation No 1/2003, which is contained in Chapter IV on cooperation between the Commission and the competition authorities and courts of the Member States, provides that '[t]he Commission shall consult an Advisory Committee on Restrictive Practices and Dominant Positions prior to the taking of any decision under Articles 7, 8, 9, 10, 23, Article 24(2) and Article 29(1)' of that regulation. Article 14(2) of Regulation No 1/2003 provides that '[f]or the discussion of individual cases, the Advisory Committee shall be composed of representatives of the competition authorities of the Member States'. Article 14(3) of Regulation No 1/2003 stipulates that the Advisory Committee is to deliver a written opinion on the Commission's preliminary draft decision and Article 14(5) of that regulation provides that '[t]he Commission shall take the utmost account of the opinion delivered by the Advisory Committee' and 'shall inform the Committee of the manner in which its opinion has been taken into account'. Furthermore, 'at the request of one or several members, the positions stated in the opinion shall be reasoned' (Article 14(3) of Regulation No 1/2003). Paragraph 58 of the Commission Notice on cooperation within the Network of Competition Authorities (OJ 2004 C 101, p. 43, 'the Notice on cooperation within the network of competition authorities') provides that 'the Advisory Committee is the forum where experts from the various competition authorities discuss individual cases and general issues of [EU] competition law'.

66 As regards procedure, Article 14(3) of Regulation No 1/2003 provides that the consultation of the Advisory Committee 'may take place at a meeting convened and chaired by the Commission, held not earlier than 14 days after dispatch of the notice convening it, together with a summary of the case, an indication of the most important documents and a preliminary draft decision'. Nevertheless, 'where the Commission dispatches a notice convening the meeting which gives a shorter period of notice than those specified above, the meeting may take place on the proposed date in the absence of an objection by any Member State'. Paragraph 66 of the Notice on cooperation within the Network of Competition Authorities states that 'the Council Regulation allows for the possibility of the Member States agreeing upon a shorter period of time between the sending of the invitation and the meeting'. Article 14(3) of Regulation No 1/2003 provides, moreover, that the Advisory Committee 'may deliver an opinion even if some members are absent and are not represented'. Article 14(4) of Regulation No 1/2003 provides, lastly, that 'consultation may also take place by written procedure', but that 'if any Member State so requests, the Commission shall convene a meeting'. According to that provision, 'in case of written procedure, the Commission shall determine a time-limit of not less than 14 days within which the Member States are to put forward their observations for circulation to all other Member States'.

67 The document entitled 'Working Arrangements for the Antitrust Advisory Committee' of 19 December 2008 ('the Working Arrangements for the Antitrust Advisory Committee'), adduced by the Commission on 6 November 2015 in response to a measure of organisation of procedure (see paragraph 45 above), sets out the various steps leading up to the consultation of the Advisory Committee and, in particular, those allowing the national competition authorities to assess the case as the investigation progresses.

68 It should be noted, in that respect, that, under Article 11(2) of Regulation No 1/2003, 'the Commission shall transmit to the competition authorities of the Member States copies of the most important documents it has collected with a view to applying Articles 7, 8, 9, 10 and Article 29(1)' of that regulation and, 'at the request of the competition authority of a Member State, the Commission shall provide it with a copy of other existing documents necessary for the assessment of the case'. Article 11(6) of Regulation No 1/2003 provides, in addition, that 'the initiation by the Commission of proceedings for the adoption of a decision under Chapter III shall relieve the competition authorities of the Member States of their competence to apply Articles [101 and 102 TFEU]' and that, 'if a competition authority of a Member State is already acting on a case, the Commission shall only initiate proceedings after consulting with that national competition authority'. Under those provisions, the Commission is to immediately deliver to the national competition authorities, after their notification to the undertaking concerned or their reception, the initial decision initiating the proceedings, the statement of objections addressed to that undertaking, the latter's response to that statement of objections and the other most important documents relating to the case (see paragraphs 6 and 7 of the provisions on the working methods of the Advisory Committee).

69 According to the case-law on the corresponding provisions of Regulation No 17 of the Council of 6 February 1962, First Regulation implementing Articles [101 and 102 TFEU] (OJ, English Special Edition 1959-1962, p. 87), which was succeeded by Regulation No 1/2003, consultation of the Advisory Committee is an essential procedural requirement, breach of which affects the legality of the Commission's final decision if it is proved that the failure to comply with the rules on consultation prevented the Advisory Committee from delivering its Opinion in full knowledge of the facts.The substance of the obligations under the provisions governing the consultation of the Advisory Committee, and the question whether or not they constitute essential requirements, must therefore be determined in each case in the light of that purpose of enabling the committee to carry out its advisory task in full knowledge of the facts (see, to that effect, judgments of 10 July 1991, RTE v Commission, T 69/89, EU:T:1991:39, paragraphs 21 and 23, and of 15 March 2000, Cimenteries CBR and Others v Commission, T 25/95, T 26/95, T 30/95 to T 32/95, T 34/95 to T 39/95, T 42/95 to T 46/95, T 48/95, T 50/95 to T 65/95, T 68/95 to T 71/95, T 87/95, T 88/95, T 103/95 and T 104/95, EU:T:2000:77, paragraph 742).

70 In the present case, the applicants submit that the Commission did not effectively consult the Advisory Committee because of the short notice period for the meetings and the transmission of the draft decision to its members, the excessively brief nature of the reasoning for the Advisory Committee's opinion and the low number of members present at its meetings. Those arguments must be examined in the light of the documents in the file and, in particular, the factual details provided by the Commission on 6 November 2015 in response to the abovementioned measure of organisation of procedure.

71 As regards the notice period for the meetings and the transmission of the draft decision, it is apparent from the file that the Commission sent that draft decision to the national competition authorities of the Member States in three steps: chapters 1 to 4 were sent on 12 June 2014 with the invitation to the first meeting of the Advisory Committee on 30 June 2014, chapters 5 to 9 were sent on 20 June 2014 with a summary of the draft decision and chapter 10, concerning the fines (excluding the exact amount of those fines), was sent on 3 July 2014, with a reminder of the invitation sent on 30 June 2014 to the second meeting of the Advisory Committee of 7 July 2004, which was to cover the entirety of the draft decision. It is clear from the file that, in the present case, the Commission expressly indicated, in the invitation to the second meeting, sent on 30 June 2014, and in the email of 3 July 2014, that the agenda for the meeting of 7 July 2014 concerned the discussion of the case in its entirety.

72 It is true that that staggered transmission of the documents, which in some cases did not comply with the prescribed period of 14 days, showed some haste on the Commission's part - probably linked to the fact that it had, as from its transmission of the invitation to the meeting of 30 June 2014, announced to the national competition authorities that it intended to adopt its decision on 9 July 2014 - and that it did not place the members of the Advisory Committee in the best conditions to express their views. However, it must be noted that no national competition authority raised any objection to the dates of these meetings, even though, under Article 14(3) of Regulation No 1/2003, such objections would have prevented the meetings in question from being held. In addition, it is clear from the file that the Commission sent the national competition authorities, on 6 July 2009, the initial decision opening the proceedings, on 31 July 2012, the statement of objections addressed to the undertakings concerned, on 23 July 2013, the responses of the undertakings to the statement of objections, on 19 December 2013, a letter of facts, on 13 February 2014, the replies of the undertakings to that letter and, on 20 May 2015, a letter of facts concerning the imputation of the liability for the infringements and the replies of some of the undertakings concerned to that letter. In addition, on 25 June 2014, the Commission sent the national competition authorities the draft final report drawn up by the Hearing Officer.

73 Consequently, although it may be regrettable, in particular, that Chapters 5 to 9 of the draft decision, given their length (approximately 600 pages) and complexity, were sent by the Commission to the national competition authorities of the Member States only 10 days before the first meeting of the Advisory Committee, it must be considered, in the light of all the considerations set out in paragraphs 71 and 72 above, that the members of the Advisory Committee were sufficiently informed of the substance of the case and of the content of the draft decision and that, consequently, the Advisory Committee was able to give its opinion in full knowledge of the facts.

74 It must also be noted that neither Article 14(3) of Regulation No 1/2003 nor paragraph 66 of the Commission Notice on cooperation within the Network of Competition Authorities provide that the Commission must obtain the express prior agreement of the competition authorities of the Member States in order to derogate from the prescribed period of 14 days between the transmission of the invitation to the members of the Advisory Committee and the meeting of that committee. Indeed, it follows from the very wording of Article 14(3) of Regulation No 1/2003 that, where the Commission dispatches a notice convening a meeting which gives a period of notice shorter than 14 days, it is for Member States to raise any objection in that respect, failing which the meeting is to take place on the date set by the Commission.

75 As regards the opinion delivered by the Advisory Committee, it must be borne in mind that, under Article 14(3) of Regulation No 1/2003, it is only at the request of one or several members of that committee that the positions stated in that opinion are to be reasoned (see paragraph 65 above). No such request was made in this case.

76 It follows that the provisions governing the content of the opinions of the Advisory Committee were not infringed. It also follows that the fact that the opinion was brief and lacking in detail does not mean that the Advisory Committee did not have at its disposal all the elements necessary to reach a decision in full knowledge of the facts, nor that that committee did not deliver its opinion in full knowledge of the facts, even if its opinion was brief.

77 As regards the fact that only a small number of representatives of the Member States attended the meetings of the Advisory Committee, it can be seen from the file that, at the meeting of 30 June 2014, only five national competition authorities were represented (Spain, Italy, Austria, Finland and Sweden) and that, at the meeting of 7 July 2014, only two national competition authorities were represented (Germany and Finland). It is therefore clear that only a small number of representatives of Member States took part in the opinion delivered by the Advisory Committee in the present case, since, according to points 20 and 21 of the Working Arrangements for the Antitrust Advisory Committee, only the observations and comments made by the members present at the meeting are to be taken into account in the opinion delivered by the Advisory Committee.

78 It cannot, however, be inferred from the low number of representatives of Member States at the meetings that the Commission disregarded the procedural requirement to consult the Advisory Committee in the present case.

79 It should be noted, first of all, that, although it may seem unusual and scarcely compatible with a certain conception of sound administration, no provision is made for any quorum rule for the adoption of opinions of the Advisory Committee. Moreover, Article 14(3) of Regulation No 1/2003 expressly provides that the Advisory Committee may deliver an opinion 'even if some members are absent and are not represented'. Next, it must be borne in mind that the Commission is required to enable the competition authorities of the Member States to participate in the Advisory Committee and that, in the present case, it took all the necessary steps to that end, since it sent them the invitations to the meetings of the Advisory Committee of 30 June and 7 July 2014 as well as all the necessary documents since the opening of the proceedings (see paragraphs 71 and 72 above) and that no objection was raised as regards the date of those meetings (see paragraph 72 above). Lastly, it should be noted that the Advisory Committee can act as a forum helping to safeguard the consistent application of the EU competition rules, as stated in recital 19 of Regulation No 1/2003, only if the competition authorities of the Member States are willing to cooperate effectively, since the Commission has no enforcement powers in that respect.

80 Lastly, as regards the reference made by the applicants at the hearing to the arguments put forward in Case T 691/14, Servier v Commission, by other applicants in support of their plea alleging infringement of the obligation to consult the Advisory Committee, the arguments in question must be rejected as inadmissible. To accept the admissibility of pleas in law not set out expressly in the application on the ground that they were raised by a third party in another case, to which reference is made in that application, would be to allow the mandatory requirements in the Rules of Procedure concerning the presentation of applicants' pleas and arguments to be circumvented (see, to that effect, judgments of 14 December 2005, Honeywell v Commission, T 209/01, EU:T:2005:455, paragraphs 63 and 64, and of 27 September 2012, Dura Vermeer Infra v Commission, T 352/06, not published, EU:T:2012:483, paragraphs 25 and 26).

81 The second part of the present plea must therefore be rejected, as must, accordingly, that plea in its entirety.

B. The plea alleging errors of law and of assessment in the analysis of potential competition on the market

1. The misinterpretation of the concept of 'potential competition' and its role in the assessment of a restriction of competition by object

(a) Arguments of the parties

82 The applicants submit that the Commission has tried to avoid its obligation to examine the legal and economic context of the Agreement, by classifying the applicants as potential competitors to Servier in order to infer automatically that the Agreement constituted a restriction by object. According to the applicants, supported by the intervener, the Commission adopts an excessively broad approach in order to classify agreements as restrictions by object and uses criteria which have generally been disregarded by the case-law on 'potential competition', namely the mere fact that generic companies engage in the development of commercially viable technologies and the perception of a market incumbent. The intervener adds that the existence of competitive pressure requires evidence of an effect on price prior to the launch of the product at issue.

83 The Commission contends that, in the contested decision, it demonstrated that the applicants had a real and concrete possibility of entering the market within a sufficiently short period. It notes, in that regard, that it relied on the fact that the applicants form one of the largest companies in the world in the generics sector; the two opportunities they had to enter the market, independently of Servier; the expertise guaranteeing that there was no infringement on their part; and certain undertakings by Servier. The Commission adds, on the basis of the case-law, that the perception of the incumbent plays a role in the assessment of potential competition and that the intervener's claim regarding price effects creates confusion between actual competition and potential competition.

(b) Findings of the Court

84 The applicants dispute, first, the automatic nature, allegedly established by the contested decision, of a finding of a restriction by object on the basis of a finding of potential competition and, secondly, the criteria used to classify them as potential competitors.

85 As regards, in the first place, links between potential competition and restriction by object, it should be noted that it in no way follows from the contested decision that the Commission inferred that the Agreement was restrictive of competition by object on the sole basis of the classification of the applicants as potential competitors. On the contrary, after having examined whether the applicants were potential competitors of Servier (recitals 1527 to 1540 of the contested decision), it examined the content of the Agreement's clauses and the objectives that it pursued (recitals 1541 to 1608 of the contested decision). The Commission found a restriction by object only after carrying out that analysis (recitals 1622 to 1627 to the contested decision). Thus, in the present case, the Commission did not circumvent its obligation to examine inter alia the content of an agreement's provisions and its objectives in order to assess whether that agreement can be regarded as a restriction of competition by object (see paragraph 182 below).

86 Nor did the Commission circumvent its obligation to examine the economic and legal context of the agreement at issue, which is also necessary in order to determine whether the agreement constitutes a restriction by object (see also paragraph 182 below). It should be borne in mind that, according to the case-law, that context must be taken into account in examining the conditions of competition on a given market, and inter alia potential competition, since, in order to determine whether there is potential competition on a market, it is necessary to ascertain whether, in the light of the structure of the market and the economic and legal context within which it functions, there are real concrete possibilities for a new competitor to enter the relevant market and compete with established undertakings (judgment of 14 April 2011, Visa Europe and Visa International Service v Commission, T 461/07, EU:T:2011:181, paragraph 68; see also paragraph 87 above). Thus, contrary to the applicants' assertions, the Commission took into account, in its analysis of the generic companies in question as potential competitors, the consequences of both Servier's patents and the fact that the applicants had not obtained a marketing authorisation (see paragraphs 109, 111 and 114 below).

87 As regards, in the second place, the criteria for assessing potential competition, it should be noted that, according to settled case-law, also cited by the applicants, an undertaking is a potential competitor if there are real concrete possibilities for it to enter the market in question and compete with established undertakings. Such a demonstration must not be based on a mere hypothesis, but must be supported by evidence or an analysis of the structures of the relevant market. Accordingly, an undertaking cannot be described as a potential competitor if its entry into a market is not an economically viable strategy (judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T 360/09, EU:T:2012:332, paragraph 86; see also, to that effect, judgment of 14 April 2011, Visa Europe and Visa International Service v Commission, T461/07, EU:T:2011:181, paragraphs 166 and 167 and the case-law cited). It necessarily follows that, while the intention of an undertaking to enter a market may be of relevance in order to determine whether it can be considered to be a potential competitor in that market, nonetheless the essential factor on which such a description must be based is whether it has the ability to enter that market (judgments of 14 April 2011, Visa Europe and Visa International Service v Commission, T461/07, EU:T:2011:181, paragraph 168; of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T 360/09, EU:T:2012:332, paragraph 87; and judgment delivered today, Servier and Others v Commission, T691/14, paragraph 318 to 321).

88 Contrary to the applicants' assertions, in the present case the Commission did not apply any criteria for assessing potential competition which were not consistent with the criterion of real concrete possibilities for market entry, as established in the case-law cited in paragraph 87 above.

89 It is true that the Commission stated, in recital 1125 of the contested decision, that potential competition from generic companies starts when the companies that want to launch a generic medicine upon expiry of the exclusivity on the compound patent begin developing commercially viable technologies for production of the API and the finished product.

90 However, by that statement, the Commission, first, in accordance with the criteria for assessing the real concrete possibilities of entry, took into account the willingness or the intention to enter the market in question. Secondly, and also in accordance with those assessment criteria, it relied in particular on the generic companies' ability to enter the market. The statement, in recital 1125 of the contested decision, taking into account the launch of the development of commercially viable technologies is followed, first of all, in the same recital, by an explanation of that launch in which the Commission listed the factors (putting in place 'strategies to enter the market', investment of 'extensive resources' in 'product development' and in 'resolving regulatory and patent barriers') used to assess the ability to enter and, subsequently, in the parts of the contested decision devoted to determining whether each of the generic companies at issue could be classified as a potential competitor, by an analysis of those factors indicating the ability to enter in the present case.

91 Contrary to the intervener's submission, it is irrelevant that the launch of development of commercially viable technologies is ultimately unsuccessful. To take into account only a launch which was successful, and thus enabled market entry, at the time of assessing potential competition would amount to denying the distinction between potential competition, which implies an absence of market entry, and actual competition, which implies that that entry has taken place (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 159). It is therefore also irrelevant that that launch does not by itself lead to a fall in prices, since such a fall in prices is not inherent in potential competition, but rather occurs as a result of a competitor entering the market and thus as a result of actual competition.

92 In addition, the criticism that the Commission took into account Servier's subjective perception of the applicants as a potential competitor and disregarded the objective test of potential competition, namely whether there are real concrete possibilities of entering the market in question, cannot be accepted.

93 It is apparent from the contested decision that the Commission used the criterion of the incumbent's perception as one of a number of criteria to determine whether the generic companies were potential competitors. In particular, it considered, in its presentation of the criteria for assessing potential competition, that, in order to ascertain whether the generic companies exerted competitive pressure on Servier, the perception of the incumbent, Servier, and that of other generic competitors would 'also' be taken into account (recital 1163 of the contested decision). Subsequently, in its assessment of the generic companies, including the applicants, as potential competitors, the Commission took account of Servier's perception together with other elements showing their ability and intention to enter the market and, moreover, that perception played only a very marginal role in comparison with the other elements (see paragraphs 109 to 114 below).

94 It should be added that the use of the criterion of the incumbent's perception as one of a number of criteria for assessing potential competition is consistent with the case-law applicable in the present case, according to which that criterion is relevant, but not sufficient, for assessing the existence of potential competition. As the applicants rightly submit, given its subjective, and thus variable nature - which depends on the operators in question, their knowledge of the market and their contacts with their possible competitors - the perception of these operators, even experienced ones, cannot by itself lead to the conclusion that another operator is one of their potential competitors. However, that perception may support the conclusion that an operator has the ability to enter a market and, accordingly, may contribute to its classification as a potential competitor (see, to that effect, judgments of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraphs 103 and 104, and of 8 September 2016, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission, T 460/13, not published, under appeal, EU:T:2016:453, paragraph 88).

95 Thus, contrary to the applicants' assertions, the General Court clearly took account of the criterion of the incumbent's perception in the judgment of 12 July 2011, Hitachi and Others v Commission (T 112/07, EU:T:2011:342) in order to establish the existence of potential competition. It follows in particular from paragraphs 90, 226 and 319 of that judgment, referred to in recital 1160 of the contested decision, that not only did the agreements at issue in that case between the European and Japanese producers constitute serious indicators that the Japanese producers were perceived by the European producers as potential credible competitors, they also showed that there were possibilities for the Japanese producers to penetrate the European market (see also, to that effect, judgment of 21 May 2014, Toshiba v Commission, T 519/09, not published, EU:T:2014:263, paragraph 231). It is true that the General Court also carried out an objective analysis of potential competition, by examining inter alia the ability of the Japanese producers to enter the European market (judgment of 12 July 2011, Hitachi and Others v Commission, T 112/07, EU:T:2011:342, paragraphs 157, 160 and 319 to 332), as, moreover, the Commission pointed out in recital 1160 of the contested decision. However, that objective analysis only serves to demonstrate that the subjective criterion of the incumbent's perception is only one criterion among others for assessing the existence of potential competition.

96 It follows from all the foregoing that the Commission did not disregard the relationships between restriction by object and potential competition and did not use incorrect criteria in order to assess that potential competition.

2. The incorrect assessment of Teva as a potential competitor

(a) Arguments of the parties

(1) The failure to take account of the risk of market exclusion caused by Servier's patents

97 According to the applicants, the failure to take account of their market exclusion, first, contradicts a previous decision by the Commission and a number of other findings in the contested decision. In the decision of 13 October 2011 (Case COMP/M.6258 - Teva/Cephalon) ('the Teva/Cephalon decision'), the Commission concluded from the existence of patent disputes that there was no significant competitive pressure from other generic companies, whereas in the contested decision it considered that, despite the existence of those same disputes that could lead to the applicants' market exclusion, the applicants were potential competitors to Servier capable of exerting a significant competitive pressure on Servier's perindopril. Moreover, the Commission, in a contradictory manner, recognised the exclusionary power of Servier's patents in the part of the contested decision dedicated to the abuse of Servier's dominant position and ruled out the risk of the applicants being excluded from the market as a result of those patents when examining whether they were a potential competitor. The intervener adds, on the basis of the case-law, that patents form legal barriers to entry so it cannot be concluded, without disregarding the presumption of patent validity, that the mere possibility that those patents can be challenged attests to the existence of potential competition. Finally, the applicants note the entirely 'exogenous' nature of the risks associated with patent litigation, which means that those risks cannot be treated as barriers that have been regarded as insurmountable in the case-law.

98 According to the applicants, the Commission's analysis of their risk of market exclusion is, secondly, incomplete and incorrect and, consequently, infringes the principle of sound administration.

99 The applicants submit, in particular, that the Commission wrongly inferred from a number of documents (internal presentation by the applicants in May 2006, expert opinions received by the applicants in November 2005 and February 2006) that they could have launched their own product (see paragraph 12 above) on the market, despite the major risk of an interim injunction and the actual liability for infringing the UK 339 patent, which they were facing and which were attested by numerous documents in the file (correspondence between the applicants and Servier, statement by the applicants' IP counsel, internal email exchanges between the applicants), but which were not taken into account. They add that the case-law regarding interim injunctions cited by the Commission both postdates the facts in the present case and remains an isolated instance.

100 The applicants consider that the same applies with regard to their market entry with Krka's product (see paragraph 13 above). They note, in that regard, that the Commission failed to take into account that a final arrangement was not concluded between Krka and the applicants and that, in other passages of the contested decision, it noted the alleged risks of an injunction against Krka's product under the UK 340 patent, without calling them into question. In addition, the applicants consider that the Commission's claim that the applicants' withdrawal from their discussions with Krka is explained by the large sum of money promised by Servier is contradicted by a number of documents in the file, including two documents cited by the Commission itself.

101 Finally, the applicants state that the Commission overlooked the fact that Servier's undertakings with regard to the UK 947 patent (see paragraph 18 above) expressly excluded process patents (the UK 339 and UK 340 patents) from their scope and therefore increased the probability of the UK courts issuing an injunction against the applicants on the basis of those patents.

102 The Commission submits, first, that the comparison of the present case with the case giving rise to the Teva/Cephalon decision is flawed, in so far as, in that decision, the Commission did not take a view on the real and concrete possibility of entering the market in question. It adds that, even if it were considered that it had taken a view on that possibility, the Teva/Cephalon decision is consistent with the contested decision, in that the existence of barriers to entry, on account of the possibility of patent litigation, does not mean that no undertaking has a realistic chance of overcoming those barriers to enter the market in question. The Commission considers that the same applies with regard to the barrier created by Servier's dominant position and infers from this that there is no contradiction in the contested decision. It adds that the intervener's claims infringe the rules of EU pharmaceutical law in accordance with which marketing is not subject to demonstrating that there is no patent infringement, the contested actions against such a patent, moreover, being for the most part won by the generic companies. Finally, the Commission contends that the issue whether or not the barrier to be overcome is exogenous is not relevant for the purposes of assessing potential competition and, in addition, submits that the barriers at issue in the case-law cited by the applicants were also exogenous in part.

103 Secondly, the Commission denies any error or inadequacy in the analysis of the applicants' risk of exclusion. It states that it does not dispute the existence of a risk of Servier relying on its process patents to prevent the applicants' market entry. It argues, however, that that risk has been greatly overstated by the applicants.

104 The Commission gives a detailed analysis of each of the documents relied on by the applicants to rule out the existence of a risk, which they stated was almost certain, of an interim injunction against their product. It notes that it took account of all of those documents, and others, in the contested decision. It also rules out the risk of an interim injunction in the present case, relying on the conditions laid down in case-law for granting that type of injunction in the United Kingdom. The Commission adds that a mere likelihood of an interim injunction cannot rule out the real and concrete possibility of Teva entering the market and that, even if an interim injunction had been issued, there was still the prospect of a full litigation procedure being completed in a sufficiently short period for Teva to exert competitive pressure. Finally, it states that if the injunction procedure were clearly in Servier's favour, Servier would have brought such proceedings rather than entering into an agreement with Teva.

105 As regards Krka's product, the Commission notes that an interim injunction based on the UK 340 patent is not incompatible with the existence of a real and concrete possibility of market entry. Moreover, it relies on a number of documents from the applicants themselves to minimise the alleged risk of an interim injunction. Furthermore, it notes that the applicants' withdrawal from their discussions with Krka is explained by the large sum of money promised by Servier rather than by the abovementioned risk of an injunction.

106 With regard to Servier's undertakings, the Commission states that it clearly set out in the contested decision that, although the applicants were the only ones to benefit from those undertakings, they still faced a possible threat in relation to Servier's process patents. It adds that the applicants have not explained how Servier's undertakings increased the likelihood of the UK courts ruling in Servier's favour if it sought an interim injunction on the basis of its process patents.

(2) The failure to take account of the delay incurred in the authorisation procedure and the stability and packaging issues faced by Teva's generic product

107 The applicants submit that the Commission did not take due account of the fact that they were unable to enter the market when the Agreement was signed because they did not have a marketing authorisation issued by the UK authorities. The regulatory approval was postponed on a number of occasions and those delays, and the uncertainty surrounding them, were a major problem for the applicants, since they were prevented from becoming the first generic company to enter the market following the probable invalidation of the 947 patent by the EPO. The applicants also state, relying on a number of documents, that those regulatory delays were a key factor in their decision to enter into the Agreement, since they anticipated that their own product would be competitively less attractive on account of the stability and packaging issues. Moreover, they accuse the Commission of not taking any account of the commercial disadvantages of their product.

108 The Commission acknowledges, as it stated in the contested decision, that the applicants encountered unexpected difficulties in obtaining approval for their medicine from the UK authorities. Nevertheless, it considers that the gravity of those difficulties was not such that the applicants had no real and concrete possibilities of entering the market and, in that regard, states that the documents invoked by the applicants are irrelevant. The Commission notes in particular that, even if Teva had not succeeded in being the first generic company on the market on account of the delays in granting the marketing authorisation, entry with its own product was still viable and profitable. It adds, moreover, that the applicants' argument concerning the impact on their market entry of their medicinal product's stability and packaging issues is unsubstantiated.

(b) Findings of the Court

109 It should be borne in mind that, in the contested decision, the Commission considered that Teva was a prominent potential competitor of Servier that had the intention and the ability to enter the market within a short period of time (recitals 1528 and 1540) - even if it had not yet received a marketing authorisation and had not launched a generic version of perindopril on the United Kingdom market - on the basis of the following five considerations.

110 First, the Commission noted that, at the time of signing the Agreement, Teva had a stock of generic perindopril manufactured and supplied by Alembic Pharmaceuticals on the basis of Hetero Drugs' API. It considered that that product was viable, despite its shelf life - which was allegedly shorter than that of other versions of perindopril, but which corresponded to that of Servier's perindopril erbumine - and despite the size of its packaging and its stability problems, and it was not established that those problems affected the viability of Teva's perindopril (recitals 1529 and 1530 of the contested decision).

111 Secondly, the Commission stated that it acknowledged the regulatory difficulties that Teva was facing at the time. It nevertheless considered, relying on the judgment of 3 April 2003, BaByliss v Commission, T 114/02, EU:T:2003:100, paragraph 102), that delays in obtaining the marketing authorisation did not mean that market entry would not occur, especially since the envisaged delays were not longer than a 'short period of time', as set out in the case-law and the Guidelines on the applicability of Article 101 TFEU to horizontal co-operation agreements (OJ 2011 C 11, p. 1). The Commission added that Teva had taken into account the possibility of not being the first generic company to enter the market and had not abandoned its marketing project for that reason. It noted, in that respect, that there was no certainty that Teva would not have been the first to enter the market and that, even if it had not been the first, it could have been part of the first wave of entrants, given its significant resources and experience in the United Kingdom (recital 1531, referring to recitals 674 and 675, and recital 1538 of the contested decision).

112 Thirdly, the Commission found that Teva was in advanced negotiations with Krka as a potential supplier of the final product for distribution in the United Kingdom. It highlighted that there was a possibility - not a certainty - that Krka's product infringed the UK 340 patent (recital 1532 of the contested decision).

113 Fourthly, the Commission considered that, in view of the contemporaneous documents, Teva's market entry with its own product would have been 'quite profitable' and thus economically viable (recital 1533 of the contested decision).

114 Fifthly, according to the Commission, Teva appeared confident that, on the one hand, its product did not infringe the process patents, despite Servier's threats to sue it for infringement of the UK 339 patent, and, on the other hand, that the 947 patent was invalid, since Ivax had been the first to challenge that patent in the United Kingdom and Teva had brought opposition proceedings against that patent before the EPO. The Commission also noted that Teva was the only generic company out of the addressees of the contested decision to which Servier had given an undertaking that it would not sue for infringement. Lastly, it pointed out that Teva could have obtained a marketing authorisation and thus entered the market before the annulment of the 947 patent (recitals 1534 to 1539, referring to recitals 677 to 681 of the contested decision).

115 It should be noted, as a preliminary point, that the applicants do not dispute that they had a stock of viable perindopril (see paragraph 110 above) as well as significant resources and experience in the United Kingdom (see paragraph 111 above), and that their own documents demonstrated that their market entry with their own product would have been 'quite profitable' (see paragraph 113 above).

116 Those elements, since they show steps to produce perindopril, a significant local position and prospects of profitability from the marketing of Teva's perindopril, demonstrate that Teva had not only the intention to take the risk of entering the United Kingdom market, but also the ability to enter it.

117 It must therefore be determined whether the applicants' arguments concerning the barriers linked to Servier's patents, the infringement and interim injunction risks that they faced, their difficulties in obtaining a marketing authorisation and their product's defects are capable of calling into question their ability and their intention to enter the market, as inferred from the abovementioned elements, and thus their real concrete possibilities of competing with Servier (see, to that effect, judgment delivered today, Servier and Others v Commission, T 691/14, paragraphs 386 and 588).

(1) The barriers linked to Servier's patents and the infringement and interim injunction risks

118 The applicants, supported by the intervener, argue, in essence, first, that Servier's patents constitute - having regard to the presumption of validity which they enjoy, to an earlier decision of the Commission, to the considerations in the contested decision relating to the abuse of Servier's dominant position and to their 'exogenous' nature - insurmountable barriers to market entry and, secondly, that the Commission in the present case analysed incorrectly and incompletely their risk of market foreclosure because of those patents.

(i) The nature of insurmountable patent-related barriers

119 In the contested decision, the Commission considered that the parties were wrong to contend, relying in particular on the judgment of 1 July 2010, AstraZeneca v Commission (T 321/05, EU:T:2010:266, paragraph 362), that market entry was impossible because the existence of a patent excluded any possibility of competition, and to draw the conclusion that Servier's patents created a 'one-way blocking position' within the meaning of the Guidelines on the application of Article [101 TFEU] to technology transfer agreements (OJ 2004 C 101, p. 2; 'the 2004 Guidelines on technology transfer agreements'), which, moreover, were not applicable in the present case (recitals 1167 and 1168 and footnote 1638).

120 The Commission added that, in any event, first, the generic companies could challenge the validity of Servier's patents. It referred, in that respect, to the judgment of 25 February 1986, Windsurfing International v Commission (193/83, EU:C:1986:75, paragraph 92), according to which it is in the public interest to eliminate, inter alia by contesting the validity of the patents, any obstacle to economic activity which may arise where a patent was granted in error, and to the judgment of 6 December 2012, AstraZeneca v Commission (C 457/10 P, EU:C:2012:770, paragraph 108), which stated that potential competition may exist even before the expiry of the compound patent (recitals 1132, 1165 and 1169 and footnote 1640 of the contested decision). The Commission added that the fact that Servier had alleged or was expected to allege infringements of its patents was inconclusive for the determination whether those patents were able to block the entry of generic medicinal products, emphasising that there was no presumption of infringement and that, throughout the relevant period, no court decision had established such an infringement (recitals 1169 to 1171 of the contested decision). It stated that, with respect to the perceived possibility of invalidity or of infringement of Servier's patents, it would rely on the assessments of the parties themselves, as well as third parties, as indicated in documents predating or contemporaneous with the conclusion of the agreements at issue (recital 1172 of the decision).

121 The Commission took the view that, secondly, the generic companies could also use alternative routes to access the markets where litigation was taking place (recital 1175 of the contested decision). The generic companies remained free to launch perindopril at risk, that is to say with the risk that the originator undertaking might bring an infringement action. The Commission noted, in that respect, that, given the practice of filing process patents following the expiry of the compound patent, virtually all sales after that expiry are at risk and that Apotex's market entry at risk in 2006 resulted in a judgment invalidating the UK 947 patent and the award of damages against Servier (recitals 1176 and 1177 of the contested decision). Furthermore, the generic companies could have changed their processes, either directly or by switching to another API supplier, in order to avoid infringement claims. According to the Commission, while those changes in the manufacturing process might have engendered some regulatory delays, they represented a viable alternative route to the market (recital 1178 of the contested decision).

122 The Commission concluded, in recital 1179 of the contested decision, as follows:

'... the settlements were concluded in a situation where the perindopril compound patent had expired, and all of the generic parties were involved, directly or indirectly, in legal actions or disputes concerning one or more of Servier's remaining patents, whether in the form of a defence against claims of infringement or actions or counterclaims to invalidate such patents. Generics could also elect other patent related measures as potential avenues to the market. The Commission will examine in detail if generic undertakings seeking to overcome patent barriers and launch generic perindopril were a source of competitive pressure on Servier in spite of its patents. It may be recalled, in this respect, that all of the agreements covered by this Decision were concluded at a point in time where there was uncertainty whether any patent had been infringed and whether in particular the '947 patent could be invalidated. The mere existence, and enforcement, of Servier's patents thus did not bar all scope for potential or actual competition.'

123 Contrary to the applicants' assertions, those findings of the Commission are not vitiated by any errors.

124 Although the exclusive right conferred by a patent normally has the effect of keeping competitors away, since public regulations require them to respect that exclusive right (judgment of 1 July 2010, AstraZeneca v Commission, T 321/05, EU:T:2010:266, paragraph 362), that competition-excluding effect concerns the actual competitors selling infringing products. A patent confers on its holder the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, as well as the right to oppose infringements (judgments of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraph 9; of 14 July 1981, Merck, 187/80, EU:C:1981:180, paragraph 9; and of 16 July 2015, Huawei Technologies, C 170/13, EU:C:2015:477, paragraph 46), but does not, by itself, preclude operators from taking the necessary steps to be in a position to enter the relevant market following the expiry of the patent and, thus, exerting competitive pressure on the patent holder characteristic of the existence of potential competition before that expiry. Nor does it preclude operators from carrying out the actions necessary for the manufacture and marketing of a non-infringing product, as a result of which they may be regarded as actual competitors of the patent holder upon their market entry and, as the case may be, as potential competitors until that market entry (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 164).

125 Ruling on the appeal brought against the judgment of 1 July 2010, AstraZeneca v Commission (T 321/05, EU:T:2010:266), the Court of Justice itself acknowledged, in its judgment of 6 December 2012, AstraZeneca v Commission (C 457/10 P, EU:C:2012:770, paragraph 108), that potential competition could exist in a market even before the expiry of a patent. More specifically, the Court of Justice held, in paragraph 108 of that judgment - which, contrary to the intervener's submissions at the hearing, is not merely obiter dictum, and to which the Commission referred in recitals 1165 and 1169 of the contested decision - that supplementary protection certificates which are intended to extend the protection conferred by a patent lead to significant exclusionary effects after the expiry of the patents, but that they were 'also liable to alter the structure of the market by adversely affecting potential competition even before that expiry', and that finding concerning the exertion of potential competition before the expiry of the patents was independent of the fact that the supplementary protection certificates at issue in that judgment had been obtained fraudulently or irregularly.

126 That is particularly the case in the pharmaceutical sector, in which, under the legislation governing the grant of the marketing authorisations required in order to market a medicinal product, the competent authorities may grant a marketing authorisation for a generic product even if the reference product is protected by a patent. It follows from Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended, that marketing authorisation applications for generic products may be dealt with in a shortened procedure based on the results of tests and trials submitted in the marketing authorisation application for the originator product and that the data relating to these results may be used and allow, consequently, the grant of a marketing authorisation before the expiry of the patent on the originator product (Article 10 of Directive 2001/83; see also recitals 74 and 75 of the contested decision). Thus, the legislation on the marketing of pharmaceutical products itself states that a generic company can enter the market with a lawfully granted marketing authorisation or, at the very least, begin the procedure for obtaining the marketing authorisation, during the protection period of the originator undertaking's patent.

127 Furthermore, the system of protection of patents is designed in such a way that, although patents are presumed to be valid from the date of their registration (judgment of 1 July 2010, AstraZeneca v Commission, T 321/05, EU:T:2010:266, paragraph 362), that presumption of validity does not automatically imply that all products placed on the market are infringing (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraphs 121 and 122). As the Commission rightly points out in the contested decision (recitals 1169 to 1171 of that decision), there is no presumption of infringement, since infringement must be established by a court. As can be seen from the judgment of 25 February 1986, Windsurfing International v Commission (193/83, EU:C:1986:75, paragraph 52), if a private operator which holds a patent could substitute its own discretion for that of the competent authority as regards the existence of an infringement of its patent, it could use that discretion in order to extend the protection of its patent (see also recital 1171 and footnote 1642 of the contested decision).

128 Contrary to the intervener's assertions, the Commission's approach in that respect does not overturn the presumption of validity enjoyed by patents. The intervener relies on an erroneous reading of the contested decision, since the Commission indicated in that decision, in essence and correctly (see paragraphs 124 to 127 above), not that the patent was presumed invalid until the adoption of a court decision relating to its validity and to the existence of an infringement, but that, until the adoption of such a decision, the presumption of validity of the patent did not prevent an at risk market entry (see recitals 1171 and 1176 of the contested decision).

129 It should be noted that the same lack of a presumption of infringement applies where the patent in question has been declared valid by a competent authority. Since a patent does not, as such, prevent the market entry of actual or potential competitors, the declaration of validity of that patent, if it is not accompanied by a declaration of infringement, does not preclude such competition.

130 It is therefore possible for an operator to take the risk of entering the market with a product, including a product that potentially infringes the patent in force, and that at risk entry or launch (see inter alia recitals 75 and 1176 of the contested decision) could be successful, if the patent holder decides not to bring an infringement action or, in the event that such an action is brought, if that infringement action is dismissed (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraphs 128 and 165).

131 It may also be noted in that regard that, contrary to the intervener's assertions, the Commission was entitled to take the view, in recitals 1132 and 1169 of the contested decision, that patent challenges and decisions in relation to these patents constituted an 'expression of competition' as regards patents. In view of the risk of infringement to which all generic companies are exposed and the fact that private operators are not competent to determine whether infringement has occurred (see paragraph 127 above), litigation is one of the means by which generic companies can reduce that risk and enter the market, either by obtaining a declaration of non-infringement or by having the potentially infringed patent declared invalid (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 122). It also follows that, as long as the generic company has the possibility to bring litigation to challenge the patents concerned and thus clear a path to the market, it may be considered that those patents do not constitute insurmountable barriers to access and, accordingly, do not prevent potential competition from taking place.

132 It follows that the Commission did not err in finding that, in the present case, Servier's patents were not insurmountable barriers to the market entry of the generic companies. At the time the agreements at issue were concluded, no final decision on the merits of an infringement action had found that the products of those companies were infringing.

133 Those considerations are not called into question by the case-law cited by the intervener, by the 2004 Guidelines on technology transfer agreements (see paragraph 119 above), by an earlier Commission decision mentioned by the applicants, by the considerations in the contested decision relating to Servier's abuse of a dominant position, or, lastly, by the alleged exogenous nature of the patent-related barriers.

134 As regards the judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission (T 360/09, EU:T:2012:332), cited by the intervener, it must be noted first of all that that judgment does not concern patents, but rather exclusive rights precluding, de jure or de facto, the provision of the services at issue. Next, even though the 'de facto territorial monopolies' mentioned in the judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission (T 360/09, EU:T:2012:332, paragraph 102) are not unlike the exclusive rights which patents constitute (see paragraph 124 above), it is clear from that judgment that the Court found that there was no potential competition, not because of the mere existence of those monopolies, but because the Commission had not demonstrated to the requisite legal standard that there were real concrete possibilities for another gas supplier to enter the German gas market despite those monopolies, thereby acknowledging that such monopolies did not suffice by themselves to preclude the existence of potential competition (see, to that effect, judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T 360/09, EU:T:2012:332, paragraphs 103 to 107).

135 It is true that the 2004 Guidelines on technology transfer agreements state that the parties to an agreement are not potential competitors where there is a 'blocking position', defined as a situation in which one party infringes the intellectual property rights of the other (paragraphs 28, 29 and 32 of those guidelines). However, even if those guidelines were directly applicable in the present case, they concern a situation in which there is an infringement of intellectual property rights and thus of patents, and such an infringement may only be found by a court (see paragraph 127 above). It is also noteworthy that, in paragraph 32 of those guidelines, 'court decisions' are mentioned as 'relevant evidence' of the existence of a blocking position. Thus, in the absence of a final court decision finding that the applicants infringed Servier's patents, it cannot be considered that, in the present case, they were in a blocking position within the meaning of those guidelines, preventing them from being regarded as potential competitors to Servier.

136 The Teva/Cephalon decision does not contradict the contested decision. It must first of all be borne in mind that since patents do not, in principle, constitute insurmountable barriers to the market entry of a competitor, but may give rise to such barriers depending on the outcome of litigation and have an impact on the real concrete possibilities of entering that market (see paragraph 132 above and paragraphs 140 to 147 below), it cannot be ruled out that the Commission could, in some of its decisions, including inter alia the abovementioned Teva/Cephalon decision, have relied on the existence of patents in order to find a lack of potential competition. It must next be observed that, in that decision, the Commission considered that the generic companies would not be able to exert 'significant competitive pressure' - as opposed to mere competitive pressure, which is sufficient to establish the existence of potential competition - on the parties to the merger during a certain period, relying on the fact that several ongoing proceedings had provisionally been resolved in favour of the originator undertaking and could not be called into question during the period concerned, with the result that the competitive pressure exerted, while real, could not be regarded as significant during that period (paragraphs 93 to 98 of the Teva/Cephalon decision).

137 As regards the assessments in the contested decision relating to Servier's abuse of a dominant position, it suffices to note that, in the passages of the contested decision mentioned by the applicants, devoted to defining the finished product market and determining whether Servier held a dominant position on that market, the Commission considered in essence that Servier's patents were not absolute barriers to market entry, in accordance with its assessment of the potential competition on that market.

138 As regards the allegedly entirely exogenous risks associated with patent litigation, in that those risks are beyond the control of the litigants, it must be considered that while that lack of control over patent-related barriers may have an influence on the means used to overcome those barriers, it does not, by itself, justify the conclusion that there are no possibilities of overcoming them.

139 It follows from all of the foregoing that, since, at the time the Agreement was concluded, no interim injunction, nor a fortiori any final decision on an action concerning the infringement of Servier's patents had been delivered in relation to the applicants' products or those of Krka, Servier's patents could not be regarded as insurmountable barriers to the applicants' market entry.

(ii) The infringement and interim injunction risks

140 It should be noted, as a preliminary point, that the applicants challenge the inaccurate and incomplete assessment of the infringement and interim injunction risks in relation to Servier's patents. The applicants acknowledge however that there was no injunction risk concerning the UK 947 patent, at the very least, at the time the Agreement was concluded (see paragraph 101 above), since Servier had undertaken not to seek an injunction against the applicants on that basis until a final decision was delivered in the opposition proceedings before the EPO (see paragraph 18 above). Thus, there remained only potential interim injunction risks as regards the applicants' products for infringement of the UK 339 patent and, as regards Krka's product, for infringement of the UK 340 patent, which the applicants allege were not given sufficient consideration in the present case.

141 It should be noted in that respect that, contrary to the applicants' submissions, even if those infringement and interim injunction risks were established - although no such action had been brought at the time the Agreement was concluded - and there was a significant probability that those risks would materialise, that could not rule out in the present case the existence of real concrete possibilities for the applicants to overcome the barriers linked to the patents at issue.

142 First, besides the fact that an interim injunction is not an insurmountable barrier to market entry (judgment delivered today in Servier and Others v Commission, T 691/14, paragraphs 366 and 367), it entails, by its very nature, the continuation of the litigation, since it is merely an intermediary procedural step affording protection to the interests of the patent holder provisionally until a decision on the merits of the infringement action has been adopted and, as the case may be, that action has been dismissed. In addition, such a decision dismissing the infringement action and finding in favour of the alleged infringer may, in principle, be delivered soon after the injunction is issued, as shown in particular by the period of less than a year that elapsed between the interim injunction issued against Apotex and the judgment of the High Court of Justice (England & Wales), Chancery Division (Patents Court) ruling on the counterclaim for annulment of the UK 947 patent brought following Servier's action for infringement. That finding is also supported by the statistics on the average duration of interim injunction measures and the average duration of proceedings concerning the infringement or the validity of patents in the United Kingdom, set out in the Commission's Pharmaceutical Sector Inquiry of 8 July 2009 (Figures 82 and 86). Thus, either the applicants would rapidly obtain a declaration of non-infringement and the injunction would be lifted, allowing them to enter the market, with the result that an interim injunction could be regarded as preserving the real concrete possibilities of entering the market, or the court would deliver a decision finding infringement, a decision which, while not an insurmountable barrier to market entry (judgment delivered today in Servier and Others v Commission, T 691/14, paragraph 368), could undermine their real concrete possibilities of entering the market, but only as from the delivery of that decision.

143 Secondly, it should be noted that litigation, including the defence in the context of an action for infringement brought by the originator undertaking which gave rise to an interim injunction, is an expression of competition in relation to patents, since it enables the generic company to limit the potential risks of market entry (see paragraph 131 above). It may also be emphasised, in that respect, that the strategy of 'clearing the way' - whereby the generic company takes measures to initiate proceedings, either by bringing an action for a declaration of non-infringement or by informing the originator company that it intends to launch a medicinal product and asking the originator company to bring infringement proceedings soon, if it intends to do so - is considered to be a litigation strategy for launching at risk, mentioned by the parties themselves.

144 In the present case, all of the documents which the applicants argue were incorrectly interpreted or were not taken into account show - as, moreover, they submit - that the applicants were aware of the infringement and injunction risks and that they took those risks into account. It is thus evident from those documents produced by the applicants themselves, by their intellectual property advisers, by their representatives and by Servier that the applicants were informed as from November 2005 of the risks of infringement, of the risks of interim injunction applications made by Servier, of the potential results of those injunction proceedings and of ways of dealing with them. Thus, inter alia, according to an internal email of the applicants' of 30 March 2006, produced in annex to the application, it was indicated that they 'expect[ed] that Servier [would] attempt to injunct [them] sometime soon stating that [they] infringe[d] at least one of [its] patents (most probably the '339 patent)', that they 'ha[d] taken several external opinions on infringement and in each case the opinion [was] that [their] process [did] not infringe the ... patents', that 'a list of perindopril prior art' had been given to their representative and that 'she [was] currently considering possible attacks on the validity of the '339 patent'. Thus, it can also be seen from those documents that the applicants had inquired into the possible consequences of litigation and the means of ensuring their defence. It therefore follows that the applicants' comment during the negotiations of the Agreement that they 'clearly believe[d] that the patents [were] not infringed and [were] invalid' (quoted in recital 1536 of the contested decision) reflected their defence strategy and not a posture adopted in the context of those negotiations. It should be noted, moreover, that the documents which the Commission allegedly failed to take into account were all cited in the contested decision, with the result that it cannot be accused of having infringed the principle of sound administration by not taking into account certain relevant documents.

145 It follows, as the Commission essentially and correctly considered in the contested decision, that, in the present case, given their resources and experience (see paragraph 115 above), the applicants had real and concrete possibilities of defending themselves in an infringement action, especially since none of the documents in question establishes that they did not intend to defend themselves.

146 It follows that, in any event, infringement and interim injunction risks do not, by themselves, preclude the classification of the applicants as potential competitors, in view of the continuation and swift resolution of the litigation that they imply, and the real concrete possibilities they offer the applicants of defending themselves.

147 It cannot therefore be inferred from the applicants' arguments relating to the infringement and interim injunction risks that they did not have real and concrete possibilities of competing with Servier, and it is not necessary to rule on their allegations concerning the practice of granting interim injunctions in the United Kingdom and the effects of Servier's undertakings concerning the UK 947 patent, nor on their allegations concerning their negotiations with Krka.

(2) The difficulties in obtaining the marketing authorisation

148 It should be noted that the Commission, in the contested decision, relying on documents or submissions from the applicants, found that the United Kingdom regulatory authority had requested bioequivalence data from them in March 2006, that the grant of a marketing authorisation in the United Kingdom had therefore been delayed by several months, that the applicants considered in May 2006 that the glucuronide issue was the only remaining obstacle to the grant of the marketing authorisation and that they expected that it would be granted by September 2006 (recitals 674 to 676 of the contested decision). The Commission also emphasised that it acknowledged the regulatory difficulties faced by the applicants at that time. It nevertheless took the view, relying on the judgment of 3 April 2003, BaByliss v Commission, T 114/02, EU:T:2003:100, paragraph 102), that delays in obtaining the marketing authorisation did not mean that market entry would not occur, especially since the envisaged delays were not longer than a 'short period of time', as set out in the case-law and the Guidelines on the applicability of Article 101 TFEU to horizontal co-operation agreements (recitals 1531 and 1538 to the contested decision; see also paragraph 111 above).

149 It follows that the Commission acknowledged that the applicants had encountered difficulties in the marketing authorisation procedure in the United Kingdom and that those difficulties would cause delays in the grant of a marketing authorisation. Thus, contrary to the applicants' submissions, it took account of the fact that the applicants did not have a marketing authorisation at the time the Agreement was concluded. The Commission nevertheless considered that those delays did not support the conclusion that it no longer had real concrete possibilities of entering the United Kingdom market when the Agreement was concluded. The delays suffered in the marketing authorisation procedure are not enough, by themselves, to preclude the classification of the marketing authorisation applicants concerned by those delays as potential competitors, since potential competition is likely to be exerted as from the filing of a marketing authorisation application and for as long as efforts are made to obtain the marketing authorisation and those efforts do not encounter objectively insurmountable difficulties (see judgment delivered today in Servier and Others v Commission, T 691/14, paragraph 478 and the case-law cited).

150 None of the applicants' arguments, or the documents presented in support of those arguments, can call into question the efforts that they made, or demonstrate the objective and insurmountable nature of the difficulties encountered.

151 As regards the documents produced by the applicants to establish the seriousness of the impact of the regulatory delays, it must be noted that those email exchanges between employees of the applicants dated April and May 2006 show, at most, that they expected to suffer delays, which, it should also be underlined, amounted to no more than a few months. However, these exchanges do not demonstrate that the applicants encountered any objectively insurmountable difficulty in the marketing authorisation procedure. In particular, the reference, in one of the emails, to the concern that the United Kingdom regulatory authority was 'dancing to Servier's tune' - even if it were to be interpreted as expressing the fear that a marketing authorisation would be refused - merely reflects the applicants' subjective perception which cannot by itself show the existence of objectively insurmountable problems. It may also be noted that some of the emails in question highlight the efforts made to resolve the problem identified by the United Kingdom regulatory authority.

152 As regards the document adduced by the applicants to establish that the regulatory delays were a key factor in their decision to conclude the Agreement, it follows from the application that the applicants seek, by that document and the related line of argument, to argue that those delays limited their commercial interest in entering the market, given that numerous generic companies would probably be present on the market at a later date and the price of perindopril would fall accordingly. Such an interest on the part of generic companies to be the first to enter the market may, at the most, have an impact on their intention to enter that market, but not, as such, on their ability to enter it, which must be examined in the light of the economically viable strategy criterion (see paragraph 87 above), that is to say it corresponds to a merely profitable entry, and not to the most profitable of possible market entries, in which the generic company in question would be the first to enter the market and thus the only company to compete with the originator company during a certain period (judgment delivered today, Servier and Others v Commission, T 691/14, paragraph 340). Since it does not call into question the efforts made to obtain the marketing authorisation, the interest invoked in essence by the applicants in being the first to enter the market is therefore irrelevant for assessing the alleged delays and, a fortiori, inferring from those delays that the grant of a marketing authorisation faced objectively insurmountable problems.

153 The applicants arguments relating to the regulatory difficulties encountered cannot, therefore, call into question their real concrete possibilities of competing with Servier.

(3) The defects in Teva's product

154 According to the applicants, their perindopril would have been commercially less attractive than that of their competitors, because they were required to use larger packaging on account of the instability of their perindopril.

155 It should be noted, as a preliminary point, that the Commission rightly considered, in the contested decision (recitals 1529 and 1530), that the fact that an undertaking has a 'viable' or 'profitable' product is enough to classify that undertaking as a potential competitor with real concrete possibilities of entering the market at issue. Those possibilities must be examined in the light of the economically viable strategy criterion, which refers to a merely profitable entry, and not to the most profitable of possible market entries (see paragraph 152 above).

156 It follows that, contrary to the applicants' argument, even if it were established that their product was less commercially attractive than those of other generic companies, already present on the market as the case may be, and thus less profitable than those other products, that could not by itself call into question their real concrete possibilities of entering the market.

157 It also follows that the Commission did not have to take into account the evidence adduced by the applicants in order to establish the less commercially attractive nature of their product, unless that evidence demonstrated that the applicants had decided not to enter the market on that ground and had terminated their perindopril-related activities at the time the Agreement was concluded.

158 In the present case, no such decision appears from any of the evidence adduced by the applicants. Most of that evidence merely highlights the problem of Teva's product packaging, or the less commercially attractive nature of that product for that reason. In particular, the minutes of an internal meeting of the applicants of 19 May 2005 indeed mentions the need to use packaging adapted to the product's stability problems, but does not mention any concerns in that respect, nor a fortiori any measures to be taken as a consequence.

159 As regards the only document from which it could be inferred that the applicants gave up, at least temporarily, marketing their product, it must be noted that that email sent by the applicants to their supplier on 15 October 2007, that is to say after the conclusion of the Agreement, is clearly intended to implement that agreement, stating that the applicants would not enter the market with their own product and would purchase their perindopril from Servier, without revealing to their supplier that the measures taken were the result of the Agreement. The applicants indicate in that email that they had not launched their product in the United Kingdom and that they had destroyed their stock due to the risk of patent litigation and that, although the UK 947 patent had been revoked, they were not planning any launch until stability work on alternative packaging formats had been carried out. Accordingly, the Commission rightly considered that, contrary to the applicants' submissions, that email had to be read with caution (recital 1530 of the contested decision).

160 It follows that the alleged defects in the applicants' product - and the applicants do not dispute that they had manufactured a stock of that product and that it would have been profitable (see recital 1533 of the contested decision) - cannot call into question their real concrete possibilities of entering the United Kingdom market.

161 Accordingly, none of the applicants' arguments concerning the barriers linked to Servier's patents and to their technical and regulatory difficulties are capable of calling into question their ability and their intention to enter the market, as established by the Commission in the contested decision (see paragraph 116 above).

162 Consequently, the complaint alleging that they were incorrectly classified as a potential competitor must be rejected.

C. The plea alleging errors of law and of assessment in the classification of the Agreement as a restriction by object

163 The applicants submit, in essence, that the Commission wrongly considered that the Agreement restricted competition in exchange for an inducement from Servier and that, even if the Agreement could be interpreted in that way, it cannot be classified as a restriction of competition by object, in view of both the case-law relating to the concept of restriction of competition by object and the fact that it relates to a patent dispute settlement agreement.

164 It is appropriate, before examining whether the Commission rightly found that the patent dispute settlement at issue restricted competition in exchange for an inducement from Servier, to verify whether such settlements may be classified as a restriction of competition by object.

1. The error of law in defining the concept of a restriction of competition by object

(a) Arguments of the parties

(1) The concept of a restriction of competition by object

165 The applicants, supported by the intervener, consider that the contested decision is vitiated by the same errors as those for which the General Court was criticised in the judgment of 11 September 2014, CB v Commission (C 67/13 P, EU:C:2014:2204), according to which the concept of the restriction of competition by object must be interpreted restrictively. Relying on an incorrect interpretation of the judgment of 4 June 2009, T-Mobile Netherlands and Others (C 8/08, EU:C:2009:343), the Commission wrongly classified the Agreement as restrictive by object for the purposes of Article 101 TFEU, on the sole ground that it was capable of restricting competition by removing the possibility for Teva to enter the market, without examining whether that agreement could reveal, by its very nature, a sufficient degree of harm to competition, in particular having regard to its legal and economic context. However, it is clear from both the context, which is complex in the present case, and the terms and object of the Agreement that Teva concluded that agreement in order to enter the market as lawfully and as quickly as possible with the result that it may have ambivalent effects and could not be compared to an agreement that, as shown by extensive experience, typically contains flagrant or obvious restrictions of competition, such as a market-sharing agreement.

166 The applicants add that an agreement such as that in the present case, which, when it was fully implemented, did not produce any anticompetitive effect and even proved to be pro-competitive, cannot be regarded as restrictive by object.

167 The Commission submits that it gave a sufficient explanation in the contested decision as to why the Agreement, by its very nature, revealed a sufficient degree of harm to competition. It states, in that regard, that the conditions of the Agreement were those of a market-sharing agreement and disputes that the case-law precluded categorising agreements with ambivalent effects as a restriction by object.

168 With regard to the claim that an agreement which produces no anticompetitive effects when implemented does not have an anticompetitive object, the Commission relies on the case-law to submit that the absence of anticompetitive effects is irrelevant where a restriction by object is established.

(2) The application of the concept of a restriction of competition by object to patent dispute settlement agreements

169 The applicants, supported by the intervener, consider that, even if the Agreement were considered to be an agreement by which they agreed to delay their market entry in exchange for a value transfer, it could not be classified as a restriction of competition by object. Since the Agreement relates to the area of intellectual property, which is governed by the fundamental principles upheld by the EU Courts (judgments of 1 July 2010, AstraZeneca v Commission, T 321/05, EU:T:2010:266, paragraph 362, and of 17 July 1998, ITT Promedia v Commission, T 111/96, EU:T:1998:183, paragraph 60), such as the presumption of validity of patents and the fundamental freedom of undertakings to assert or waive their rights, competition law intervention in the resolution of bona fide intellectual property disputes should be precluded in principle or should at least respect those principles, as, moreover, the courts of the United States of America have recognised, in particular in the judgment of the Supreme Court of the United States of 17 June 2013, Federal Trade Commission v Actavis and Others [570 U.S. 756 (2013)] (the judgment in 'Actavis'). The applicants and the intervener note, in that regard, that the Commission's analysis that the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C 209/07, EU:C:2008:643) is of particular interest to the facts of the present case overlooks an essential element, namely the existence of the bona fide intellectual property rights owned by the originator company.

170 The applicants, supported by the intervener, also relying on the Guidelines on the application of Article 101 [TFEU] to technology transfer agreements (OJ 2014 C 89, p. 3, 'the 2014 Guidelines on technology transfer agreements'), state that the Commission's classification, moreover without any real explanation, of all of the patent dispute settlement agreements containing restrictions on generic entry and involving a value transfer as restrictions by object is contrary to the case-law of the Court, in accordance with which only those agreements that are highly likely to restrict competition may be categorised as a restriction by object, and does not take account of the specific circumstances of each case which may lead to certain agreements producing pro-competitive effects. Furthermore, according to the applicants and the intervener, that classification as a restriction by object may lead to generic companies no longer entering into legitimate and pro-competitive patent settlement agreements and, in the long term, discourage investment in generic medicinal products.

171 The intervener adds that, even though the Commission has sought to moderate the unreasonableness of its position by categorising as restrictive only those settlement agreements containing a 'significant' value transfer, that significance has not been clearly defined and, moreover, is irrelevant, given the asymmetry of the risks between originator companies and generic companies, which prevents a value transfer of a comparable magnitude to the profits from the generic companies' market entry from being considered as entailing a restriction of competition.

172 The Commission disputes having considered that all patent settlement agreements between competitors infringed competition law and states that it limited the classification as a restriction by object to agreements containing an incentive not to enter the market. It explains, moreover, that the applicants are misinterpreting the case-law of the EU Courts, which have never held that the existence of patent protection overrides the usual application of the competition rules, but which, on the contrary, have affirmed that the freedom of contract to conclude settlement agreements in particular does not mean that parties have the right to agree on terms that infringe the competition rules. Furthermore, the judgment in Actavis found that patent settlement agreements can sometimes infringe antitrust laws, which is precisely the case with regard to the agreement, the obligations of which go beyond the scope of Servier's patents. Finally, the Commission notes that, contrary to the applicants' unsubstantiated assumption, the number of patent settlement agreements entered into has increased since 2009.

(b) Findings of the Court

173 By the first part of that plea, the applicants submit, in essence, that the Commission erred in law by classifying a patent dispute settlement agreement as a restriction of competition by object and that it disregarded the scope of the intellectual property rights represented by the patents. Consequently, it is for the Court to determine whether such settlement agreements may constitute a restriction of competition by object and, if so, under what conditions, and also to examine whether, in its analysis, the Commission disregarded the scope of the patents.

174 It should be borne in mind, in that regard, that, in the contested decision, the Commission analysed how, in its view, patent dispute settlement agreements should be assessed in the light of the provisions of Article 101(1) TFEU and, in particular, the possibility of classifying such agreements as restrictions by object (recitals 1102 to 1155 of the contested decision).

175 In essence, while acknowledging that companies are generally entitled to settle litigation, including patent litigation (recital 1118 of the contested decision), the Commission considered that patent dispute settlement agreements must comply with EU competition law and, more specifically, with the provisions of Article 101(1) TFEU (see inter alia recitals 1119, 1122 and 1123 of the contested decision).

176 The Commission also took into account the specific context in which competition operates between originator undertakings and generic companies in the pharmaceutical sector. In particular, it referred to the importance of patent challenges in that sector (recitals 1125 to 1132 to the contested decision).

177 In the light of those factors, the Commission considered that, in principle, it might be reasonable for parties to conclude a settlement agreement to resolve a dispute and even to include non-marketing and non-challenge clauses (recitals 1133 and 1136 of the contested decision).

178 However, the Commission took the view that, depending on the specific circumstances of the case, a patent dispute settlement agreement by which a generic company accepts restrictions on its ability and incentives to compete in return for a value transfer, either in the form of significant sums of money or another significant inducement, could be a restriction of competition by object contrary to Article 101 TFEU (recital 1134 of the contested decision). In such a situation, the generic company's decision not to pursue its independent efforts to enter the market results, not from the parties' assessment of the merits of the patent, but from a transfer of value from the originator company to the generic company (recital 1137 of the contested decision) and, accordingly, from an exclusionary payment which amounts to the 'buying off' of competition (recital 1140 of the contested decision).

179 Consequently, the Commission stated that, in order to determine whether or not the settlement agreements at issue constituted restrictions of competition by object, it would carry out a case-by-case analysis of the facts relating to each of those agreements. To that end, it stated that it would seek in particular to determine, (i) whether 'the generic undertaking and the originator undertaking were at least potential competitors', (ii) whether 'the generic undertaking committed itself in the agreement [at issue] to limit, for the duration of [that] agreement, its independent efforts to enter one or more EU markets with a generic product' and (iii) whether 'the agreement [at issue] was related to a transfer of value from the originator undertaking as a significant inducement which substantially reduced the incentives of the generic undertaking to independently pursue its efforts to enter one or more EU markets with the generic product' (recital 1154 of the contested decision).

180 The Commission then applied the three criteria referred to in the above paragraph to each of the patent dispute settlement agreements at issue and concluded, in respect of each of those agreements, that those three criteria were met and that, consequently, those agreements should be classified, inter alia, as restrictions of competition by object.

(1) Restrictions of competition by object

181 The concept of restriction of competition by object can be applied only to certain types of coordination between undertakings that reveal, by their very nature, a sufficient degree of harm to the proper functioning of normal competition that it may be found that there is no need to examine their effects (see, to that effect, judgments of 30 June 1966, LTM, 56/65, EU:C:1966:38, p. 249; of 11 September 2014, CB v Commission, C 67/13 P, EU:C:2014:2204, paragraphs 49, 50 and 58 and the case-law cited; of 16 July 2015, ING Pensii, C 172/14, EU:C:2015:484, paragraph 31; and of 26 November 2015, Maxima Latvija, C 345/14, EU:C:2015:784, paragraph 20).

182 According to the case-law of the Court of Justice, in order to determine whether an agreement between undertakings reveals a sufficient degree of harm that it may be considered a 'restriction of competition by object' within the meaning of Article 101(1) TFEU, regard must be had to the content of its provisions, its objectives and the economic and legal context of which it forms part (see judgment of 16 July 2015, ING Pensii, C 172/14, EU:C:2015:484, paragraph 33 and the case-law cited). When determining the economic and legal context, it is also necessary to take into consideration the nature of the goods or services affected, as well as the real conditions of the functioning and structure of the market or markets in question (see judgment of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C 286/13 P, EU:C:2015:184, paragraph 117 and the case-law cited). Nevertheless, it must be borne in mind that, contrary to what the applicants suggest (see paragraph 165 above), the examination of the real conditions of the functioning and structure of the market in question - as complex as the context in question may be - cannot lead the General Court to assess the effects of the coordination concerned (see, to that effect, judgment of 11 September 2014, CB v Commission, C 67/13 P, EU:C:2014:2204, paragraphs 72 to 82), since otherwise the distinction established in Article 101(1) TFEU would lose its effectiveness.

183 In addition, although the parties' intention is not a necessary factor in determining whether a type of coordination between undertakings is restrictive, there is nothing prohibiting the competition authorities, the national courts or the Courts of the European Union from taking that factor into account (see judgment of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C 286/13 P, EU:C:2015:184, paragraph 118 and the case-law cited). However, the mere fact that an agreement also pursues legitimate objectives is not sufficient to preclude a finding of restriction of competition by object (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C 209/07, EU:C:2008:643, paragraph 21; see also, to that effect, judgments of 8 November 1983, IAZ International Belgium and Others v Commission, 96/82 to 102/82, 104/82, 105/82, 108/82 and 110/82, EU:C:1983:310, paragraph 25, and of 6 April 2006, General Motors v Commission, C 551/03 P, EU:C:2006:229, paragraph 64).

184 Article 101(1) TFEU provides that all agreements between undertakings, decisions by associations of undertakings and concerted practices which have 'as their object or effect' the prevention, restriction or distortion of competition within the internal market are to be prohibited as incompatible with the internal market. According to settled case-law established by the judgment of 30 June 1966, LTM (56/65, EU:C:1966:38, p. 249), the alternative nature of those requirements, indicated by the use of the conjunction 'or', leads to the need to consider, in the first place, the precise purpose of the agreement at issue, in the economic context in which it is to be applied. Where, however, an analysis of the terms of the agreement at issue does not reveal a sufficient degree of harm to competition, the effects of the agreement should then be considered and, for it to be caught by the prohibition, it is necessary to find that factors are present which show that competition has in fact been prevented, restricted or distorted to an appreciable extent (see judgments of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C 286/13 P, EU:C:2015:184, paragraph 116 and the case-law cited, and of 16 July 2015, ING Pensii, C 172/14, EU:C:2015:484, paragraph 30 and the case-law cited). However, where the anticompetitive object of an agreement is established, it is not necessary to examine its effects on competition (see judgment of 20 January 2016, Toshiba Corporation v Commission, C 373/14 P, EU:C:2016:26, paragraph 25 and the case-law cited).

185 Furthermore, the presence of an anticompetitive object cannot be rebutted by the absence, in a specific case, of negative effects on the operation of the market, since doing so would confuse the prohibition on collusions with an anticompetitive object with the prohibition on collusive practices with an anticompetitive effect. The specific capability of an agreement to produce competition-restricting effects characteristic of agreements with an anticompetitive object does not depend on the real and specific effects of that agreement (see, to that effect, judgments of 13 December 2012, Expedia, C 226/11, EU:C:2012:795, paragraph 37; of 14 March 2013, Allianz Hungária Biztosító and Others, C 32/11, EU:C:2013:160, paragraph 38; of 16 July 2015, ING Pensii, C 172/14, EU:C:2015:484, paragraph 55; of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T 360/09, EU:T:2012:332, paragraph 252 and the case-law cited; and the Opinion of Advocate General Kokott in T-Mobile Netherlands and Others, C 8/08, EU:C:2009:110, paragraph 45). Thus, contrary to the applicants' submissions (see paragraph 166 above), the fact that the Agreement does not generate anticompetitive effects, or even that it generates pro-competitive effects, if such effects were established, could not call into question the finding that the Agreement has an anticompetitive object. It may be added that, in any event, contrary to the applicants' submissions, Teva's market entry in July 2007 after the invalidation of the UK 947 patent by the High Court of Justice (England & Wales), Chancery Division (Patents Court) cannot be regarded as an early entry or entry at the earliest date on which Teva's entry was lawful in the light of Servier's patents (see paragraph 272 below).

186 However, the Commission and the Courts of the European Union cannot, when examining whether an agreement restricts competition by object and, in particular, in assessing the economic and legal context of that agreement, completely ignore its potential effects (Opinion of Advocate General Wahl in ING Pensii, C 172/14, EU:C:2015:272, paragraph 84). It should be borne in mind that agreements which are restrictive of competition by object are those which reveal a sufficient degree of harm to the proper functioning of normal competition that it may be found that there is no need to examine their specific effects on the market (see judgment of 11 September 2014, CB v Commission, C 67/13 P, EU:C:2014:2204, paragraphs 49 and 51 and the case-law cited; see, also, paragraph 185 above). However, it is apparent from the case-law that establishing the existence of a restriction of competition by object cannot, under the guise, inter alia, of the examination of the economic and legal context of the agreement at issue, lead to the assessment of the effects of that agreement, since otherwise the distinction between a restriction of competition by object and by effect laid down in Article 101(1) TFEU would lose its effectiveness (see paragraph 182 above). For the purposes of verifying the specific capability of an agreement to produce competition-restricting effects characteristic of agreements with an anticompetitive object, the analysis of the potential effects of an agreement must therefore be limited to those resulting from information objectively foreseeable at the time of the conclusion of that agreement (see, to that effect, judgment of 11 September 2014, CB v Commission, C 67/13 P, EU:C:2014:2204, paragraphs 80 to 82, and the Opinion of Advocate General Wahl in ING Pensii, C 172/14, EU:C:2015:272, paragraph 84).

187 In the present case, it must be held that, contrary to the applicants' assertions (see paragraph 165 above), the Commission, in the contested decision, correctly applied the concept of restriction of competition by object and the criteria for assessing that concept, as explained in paragraphs 181 to 183 above, and it is therefore irrelevant that it did not use the terms 'sufficient degree of harm' in that decision. It indicated in recitals 1110 and 1113 of the contested decision that those restrictions were those which, '"by their very nature", can be regarded as being injurious to the proper functioning of normal competition', that, 'in order to assess if an agreement involves a restriction by object, regard must be had inter alia to the content of its provisions, the objectives it seeks to attain and the economic and legal context of which it forms a part', and that 'when determining that context, it is also appropriate to take into consideration the nature of the goods or services affected, as well as the real conditions of the functioning and structure of the market or markets in question'. It also correctly noted that, 'although the parties' intention is not a necessary factor in determining whether an agreement involves a restriction of competition by object, there is nothing prohibiting the Commission or the Courts of the Union from taking that aspect into account' (recital 1113 of the contested decision).

188 In particular, it cannot be maintained that the Commission erred in law by considering that a mere possibility that an agreement would harm competition was sufficient in order to classify it as a restriction of competition by object. It is true that, in recital 1111 of the contested decision, the Commission stated, citing the case-law of the Court of Justice (judgments of 4 June 2009, T-Mobile Netherlands and Others, C 8/08, EU:C:2009:343, paragraph 31, and of 14 March 2013, Allianz Hungária Biztosító and Others, C 32/11, EU:C:2013:160, paragraphs 35 to 38) that, '[i]n order for an agreement to be regarded as having an anticompetitive object, it is sufficient that it has the potential to have a negative impact on competition' and that '[i]n other words, the agreement [in question] must simply be capable in an individual case, having regard to the specific legal and economic context, of resulting in the prevention, restriction or distortion of competition within the internal market'.

189 In that respect, it is necessary, first of all, to bear in mind that the Commission correctly set out the case-law on the definition and assessment of restrictions of competition by object in the contested decision, in particular in recitals 1109 and 1110, 1112 to 1117 and 1211 (see also paragraph 187 above), and to note that it applied that case-law in the analysis of the Agreement (see, inter alia, recitals 1622 to 1628 of the contested decision).

190 Next, it must be pointed out that, in paragraph 31 of the judgment of 4 June 2009, T-Mobile Netherlands and Others (C8/08, EU:C:2009:343), repeated in paragraph 38 of the judgment of 14 March 2013, Allianz Hungária Biztosító and Others (C 32/11, EU:C:2013:160), the Court of Justice did not intend to assert that an agreement with a low degree of harm which, as a consequence, only might have a negative effect on competition could constitute a restriction of competition by object, but only, first, that the identification of the actual effects of an agreement on competition was not relevant in the analysis of a restriction of competition by object and, secondly, that the mere fact that an agreement was not implemented cannot preclude a finding that it constitutes a restriction of competition by object. A reading of paragraph 31 of the judgment of 4 June 2009, T-Mobile Netherlands and Others (C 8/08, EU:C:2009:343), in particular in the light of paragraphs 29 and 30 thereof and of point 46 of the Opinion of Advocate General Kokott in that case, to which the judgment refers expressly, and point 47 of that Opinion, allows that paragraph to be placed in the context of the distinction between restrictions of competition by effect and by object.

191 In addition, as regards the applicants' argument based on the judgment of 1 September 2014, CB v Commission (C 67/13 P, EU:C:2014:2204, paragraph 58), according to which the concept of infringement by object should be interpreted restrictively, contrary to the approach taken by the Commission in the contested decision (see paragraph 165 above), it must be noted that, in that judgment, the Court of Justice stated that the concept of restriction of competition by object could be applied only to certain types of coordination between undertakings which reveal a sufficient degree of harm to competition that it may be found that there is no need to examine their effects and not to agreements which are in no way established to be, by their very nature, harmful to the proper functioning of normal competition. It therefore held that the General Court had erred in law in finding that the concept of restriction of competition by object must not be interpreted restrictively. The Court of Justice did not, however, call into question the case-law according to which the types of agreement referred to in Article 101(1)(a) to (e) TFEU do not constitute an exhaustive list of prohibited collusion (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C 209/07, EU:C:2008:643, paragraph 23; see also, to that effect, judgment of 11 September 2014, CB v Commission, C 67/13 P, EU:C:2014:2204, paragraph 58), which is clear from the use of the term 'in particular' in Article 101(1) TFEU (Opinion of Advocate General Trstenjak in Beef Industry Development Society and Barry Brothers, C 209/07, EU:C:2008:467, point 46).

192 It must next be pointed out that, in the present case, the Commission took an approach consistent with the judgment of 11 September 2014, CB v Commission (C 67/13 P, EU:C:2014:2204), by assessing the agreements at issue in the light of the criteria set out in paragraphs 181 to 183 above (see paragraph 189 above), criteria which are in themselves restrictive, since they require the identification of a sufficient degree of harm. Contrary to the applicants' assertions, the Commission's analysis did not, a priori, have to apply a more restrictive approach than that entailed by the criteria for assessing the concept of restriction of competition by object, but it required the identification of a restriction of competition revealing a sufficient degree of harm or, failing that, an analysis of the actual anticompetitive effects of the agreements at issue.

193 Likewise, contrary to the applicants' submissions, restrictions by object are not limited to restrictions which experience has shown to be flagrant or obvious (see paragraph 165 above). It follows from the case-law that, even though experience may undoubtedly show that certain types of cooperation are inherently harmful to competition (judgment of 11 September 2014, CB v Commission, C 67/13 P, EU:C:2014:2204, paragraph 51), the fact that the Commission has not, in the past, considered that a certain type of agreement was, by its very object, restrictive of competition is not, in itself, such as to prevent it from doing so in the future following an individual and detailed examination of the measures in question (see judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 438 and the case-law cited).

194 Nor does the case-law require that an agreement be considered to be prima facie or undoubtedly sufficiently harmful to competition, without an individual and concrete examination of its content, its purpose and its legal and economic context being carried out by the Commission or the Courts of the European Union, in order to be regarded as a restriction of competition by object within the meaning of Article 101(1) TFEU (see, to that effect, judgments of 14 March 2013, Allianz Hungária Biztosító and Others, C 32/11, EU:C:2013:160, paragraph 51, and of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 775).

195 Having set out the conditions for applying the concept of restriction of competition by object and having examined the applicants' complaints criticising the interpretation of that concept, the Court notes that, in the present case, the Agreement was intended, according to the applicants, to settle disputes between the contracting parties and was concluded in the specific context of patent law, since the disputes in question concerned Servier's patents. Since determining whether there is a restriction by object entails an examination of the content of the terms of the agreement in question, its objectives, and its economic and legal context (see paragraph 182 above), it is necessary in the present case to analyse the clauses prohibiting patent challenges and the clauses prohibiting the marketing of products which infringe those patents, contained in settlement agreements in general and in the Agreement in particular, in the light of their objective of settling patent disputes and their specific context, namely that of patents, in order to verify whether the Commission classified the Agreement as restrictive of competition by object correctly and in accordance with legally appropriate criteria.

(2) Intellectual property rights and, in particular, patents

196 The Court notes that the specific purpose of industrial property is, inter alia, to ensure that the patentee, in order to reward the creative effort of the inventor, has the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, either directly or by the grant of licences to third parties, as well as the right to oppose infringements (judgment of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraph 9). When granted by a public authority, a patent is normally assumed to be valid and an undertaking's ownership of that right is assumed to be lawful. As the applicants emphasise, the mere possession by an undertaking of an exclusive right normally results in keeping competitors away, since public regulations require them to respect that exclusive right (see, to that effect, judgment of 1 July 2010, AstraZeneca v Commission, T 321/05, EU:T:2010:266, paragraph 362).

197 The exercise of the rights arising under a patent granted in accordance with the legislation of a Member State does not, of itself, constitute an infringement of the rules on competition laid down by the Treaty (judgment of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, p. 71). Intellectual property rules are even essential in order to maintain competition undistorted on the internal market (judgment of 16 April 2013, Spain and Italy v Council, C 274/11 and C 295/11, EU:C:2013:240, paragraph 22). First, by rewarding the creative effort of the inventor, patent law contributes to promoting an environment conducive to innovation and investment and, secondly, it is intended to make public the modes of operation of inventions and thus allow further breakthroughs to emerge. Paragraph 7 of the 2004 Guidelines on technology transfer agreements, the provisions of which were included in their entirety in point 7 of the 2014 Guidelines on technology transfer agreements, thus acknowledges that:

'[There is no] inherent conflict between intellectual property rights and the [EU] competition rules. Indeed, both bodies of law share the same basic objective of promoting consumer welfare and an efficient allocation of resources. Innovation constitutes an essential and dynamic component of an open and competitive market economy. Intellectual property rights promote dynamic competition by encouraging undertakings to invest in developing new or improved products and processes. So does competition by putting pressure on undertakings to innovate. Therefore, both intellectual property rights and competition are necessary to promote innovation and ensure a competitive exploitation thereof.'

198 According to settled case-law, the fundamental right to property, which includes intellectual property rights such as copyright, constitutes a general principle of EU law (judgment of 29 January 2008, Promusicae, C 275/06, EU:C:2008:54, paragraph 62; see also, to that effect, judgment of 12 July 2005, Alliance for Natural Health and Others, C 154/04 and C 155/04, EU:C:2005:449, paragraph 126 and the case-law cited).

199 However, the right to intellectual property, and inter alia the right to patents, are not absolute; rather they must be viewed in relation to their social function and must be reconciled with other fundamental rights, and they may be restricted in order to meet the objectives of general interest pursued by the European Union, provided that those restrictions do not constitute, in relation to the aim pursued, a disproportionate and intolerable interference, impairing the very substance of the right guaranteed (see judgment of 12 July 2005, Alliance for Natural Health and Others, C 154/04 and C 155/04, EU:C:2005:449, paragraph 126 and the case-law cited). For example, the Court of Justice has held, in disputes relating to the interpretation of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ 2009, L 152, p. 1), that it is necessary to balance the interests of the patent-holding pharmaceutical industry and those of public health (see, to that effect, judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C 577/13, EU:C:2015:165, paragraph 36 and the case-law cited).

200 It should also be borne in mind that Article 3(3) TEU states that the European Union is to establish an internal market, which - in accordance with Protocol (No 27) on the internal market and competition (OJ 2010 C 83, p. 309), which, under Article 51 TEU, has the same legal value as the Treaties - includes a system ensuring that competition is not distorted. Articles 101 and 102 TFEU are among the competition rules referred to in Article 3(1)(b) TFEU which are necessary for the functioning of that internal market. The function of those rules is precisely to prevent competition from being distorted to the detriment of the public interest, individual undertakings and consumers, thereby ensuring the well-being of the European Union (judgment of 17 February 2011, TeliaSonera Sverige, C 52/09, EU:C:2011:83, paragraphs 20 to 22).

201 Although the Treaties never expressly provided for reconciliation between intellectual property rights and competition law, Article 36 EC (which became Article 30 EC), the provisions of which were reproduced in Article 36 TFEU, nevertheless provided for a reconciliation of intellectual property rights with the principle of free movement of goods, by indicating that the provisions of the Treaty relating to the prohibition of quantitative restrictions between Member States were not to preclude restrictions on imports, exports or goods in transit justified, inter alia, on grounds of the protection of industrial and commercial property, while specifying that those restrictions should not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. The Court of Justice considers that Article 36 EC was thus intended to draw a distinction between the existence of a right conferred by the legislation of a Member State in regard to the protection of artistic and intellectual property, which cannot be affected by the provisions of the Treaty, and the exercise of such right, which might constitute a disguised restriction on trade between Member States (see, to that effect, judgment of 6 October 1982, Coditel and Others, 262/81, EU:C:1982:334, paragraph 13).

202 The EU legislature has moreover had occasion to point out the need for such reconciliation. Thus, Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ 2004 L 157, p. 45), the objective of which is to approximate national laws so as to ensure a high, equivalent and homogeneous level of protection of intellectual property in the Internal Market (recital 10 of that directive) and 'to ensure full respect for intellectual property, in accordance with Article 17(2) of [the Charter of Fundamental Rights]' (recital 32 of that directive), states that it 'should not affect the application of the rules of competition, and in particular Articles [101] and [102 TFEU]' and that '[t]he measures provided for in this Directive should not be used to restrict unduly competition in a manner contrary to the Treaty' (recital 12 of that directive).

203 The Court of Justice has developed case-law in relation to various types of intellectual property rights intended to reconcile the competition rules with the exercise of these rights, without affecting their substance, by using the same reasoning as that which allows it to reconcile those rights and the free movement of goods. Thus, for the Court of Justice, the misuse of intellectual property rights must be penalised, but not the lawful exercise of those rights, which it defines on the basis of their specific subject matter, a concept which is used synonymously in the Court's case-law with the concepts of the actual substance of those rights and the essential prerogatives of their proprietor. According to the Court of Justice, the exercise of the rights which form part of the specific subject matter of an intellectual property right thus concerns the existence of that right (see, to that effect, the Opinion of Advocate General Gulmann in RTE and ITP v Commission, C 241/91 P, EU:C:1994:210, points 31 and 32 and the case-law cited). Nevertheless, the Court considers that the exercise of the exclusive right by the proprietor may, in exceptional circumstances, also give rise to conduct contrary to the competition rules (judgment of 6 April 1995, RTE and ITP v Commission, C 241/91 P and C 242/91 P, EU:C:1995:98, paragraph 50; see also, to that effect, judgment of 17 September 2007, Microsoft v Commission, T 201/04, EU:T:2007:289, paragraph 691).

204 As regards patents, the Court of Justice has ruled that it is possible that the provisions of Article 101 TFEU may apply if the use of one or more patents, in concert between undertakings, should lead to the creation of a situation which may come within the concepts of agreements between undertakings, decisions of associations of undertakings or concerted practices within the meaning of Article 101(1) TFEU (judgment of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, p.110). It further considered, in 1974, that although the existence of rights recognised under the industrial property legislation of a Member State is not affected by Article 101 TFEU, the conditions under which those rights may be exercised may nevertheless fall within the prohibitions contained in that article and that this may be the case whenever the exercise of such a right appears to be the object, the means or the consequences of a restrictive agreement (judgment of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraphs 39 and 40).

205 It must borne in mind that, in the absence of harmonisation at the European Union level of the patent law applicable in the present case, the extent of the patent protection conferred by a patent granted by a national patent office or by the EPO can only be determined in the light of non-European Union rules, that is to say, national law or the European Patent Convention (see, to that effect, judgments of 16 September 1999, Farmitalia, C 392/97, EU:C:1999:416, paragraph 26, and of 24 November 2011, Medeva, C 322/10, EU:C:2011:773, paragraphs 22 and 23). Consequently, where, in the context of an action for annulment brought against a Commission decision, the EU judicature is called upon to examine a settlement agreement in relation to a patent governed by rules other than those of EU law, it is not for it to define the scope of that patent or to rule on its validity. It should also be noted that, in the present case, in the contested decision, although the Commission referred, in recitals 113 to 123, to Servier's strategy of creating a 'patent cluster' and 'paper patents', it did not, however, rule on the validity of the disputed patents at the time the agreements were concluded.

206 While it is not for the Commission or the General Court to rule on the validity of a patent, the existence of the patent must nevertheless be taken into account in the analysis carried out in the framework of the EU competition rules. The Court of Justice has already stated that although the Commission is not competent to determine the scope of a patent, it is still the case that it may not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Article 101 or 102 TFEU, since even in cases where the protection afforded by a patent is the subject of proceedings before the national courts, the Commission must be able to exercise its powers in accordance with the provisions of Regulation No 1/2003, the Commission's findings do not in any way pre-empt the determinations made later by national courts in disputes brought before them on the subject of patent rights and the Commission's decision is subject to review by the EU judicature (judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraphs 26 and 27).

207 Lastly, it must be noted that intellectual property rights are protected by the Charter of Fundamental Rights. Under Article 17(1) of the Charter of Fundamental Rights, to which the Treaty of Lisbon has conferred the same legal value as the Treaties (Article 6(1) TEU), '[e]veryone has the right to own, use, dispose of and bequeath his or her lawfully acquired possessions', '[n]o one may be deprived of his or her possessions, except in the public interest and in the cases and under the conditions provided for by law, subject to fair compensation being paid in good time for their loss' and '[t]he use of property may be regulated by law in so far as is necessary for the general interest'. Article 17(2) of the Charter of Fundamental Rights states, moreover, that '[i]ntellectual property shall be protected'. Consequently, the guarantees provided for in Article 17(1) of the Charter of Fundamental Rights, apply also to intellectual property. The Court of Justice has held that the recognition of intellectual property rights in the Charter of Fundamental Rights entails a need for a high level of protection of those rights and that it is necessary to strike a balance between maintaining free competition - in respect of which primary law and, in particular, Articles 101 and 102 TFEU prohibit abuses of a dominant position - and the requirement to safeguard intellectual-property rights, guaranteed by Article 17(2) the Charter of Fundamental Rights (see, to that effect, judgment of 16 July 2015, Huawei Technologies, C 170/13, EU:C:2015:477, paragraphs 42 and 58).

(3) Patent dispute settlements

208 As a preliminary point, it must be noted that the discussion below does not concern patents obtained fraudulently, 'fictitious' disputes or disagreements which have not reached the judicial stage. The Commission acknowledged in recital 1170 of the contested decision that, at the time the settlement agreements were concluded, Servier and the generic companies were all parties to, or associated with a dispute before a national court or the EPO concerning the validity of some of Servier's patents or the infringing nature of the product developed by the generic company.

209 First of all, it should be noted that, as the applicants and the intervener submit, it is a priori legitimate for the parties to a dispute relating to a patent to conclude a settlement agreement rather than pursuing litigation before a court. As the Commission rightly stated in recital 1102 of the contested decision, companies are generally entitled to settle litigation, including patent litigation, and those settlements often benefit the parties to the dispute and allow for a more efficient allocation of resources than if litigation were to be pursued to judgment. An applicant is not required to pursue litigation which it voluntarily initiated. It should be added that the judicial settlement of disputes, in addition to the fact that it generates a cost to society, cannot be regarded as the preferred and ideal route for conflict resolution. An increase in litigation before the courts may reflect failures or shortcomings which could be remedied in other ways or be dealt with by appropriate prevention actions. If the national systems for granting patents or that of the EPO were experiencing such difficulties, for example by being too liberal in granting protection to processes which are devoid of inventive character, those problems could not justify an obligation or even an incentive for undertakings to pursue patent disputes until a judicial outcome is reached.

210 Likewise, paragraphs 204 and 209 of the 2004 Guidelines on technology transfer agreements, which are applicable at the very least to agreements concerning the licensing of technology, acknowledge the possibility of concluding settlement agreements and non-assertion agreements which include the granting of licences and indicate that, in the context of such a settlement and non-assertion agreement, non-challenge clauses are generally considered to fall outside Articles 101(1) TFEU. As the intervener submits (see paragraph 170 above), paragraph 235 of the 2014 Guidelines on technology transfer agreements, which replaced the 2004 Guidelines, also states that 'settlement agreements in the context of technology disputes are, as in many other areas of commercial disputes, in principle a legitimate way to find a mutually acceptable compromise to a bona fide legal disagreement'. That paragraph also states that '[t]he parties may prefer to discontinue the dispute or litigation because it proves to be too costly, time-consuming and/or uncertain as regards its outcome', and that '[s]ettlements can also save courts and/or competent administrative bodies effort in deciding on the matter and can therefore give rise to welfare enhancing benefits'.

211 Moreover, the Commission itself uses an administrative procedure in relation to agreements and concerted practices which is similar in some respects to a settlement agreement. The settlement procedure, which was established by Commission Regulation (EC) No 622/2008 of 30 June 2008 amending Regulation No 773/2004, as regards the conduct of settlement procedures in cartel cases (OJ 2008 L 171, p. 3), is intended to simplify and speed up administrative procedures and to reduce the number of cases brought before the EU judicature, and thus to enable the Commission to handle more cases with the same resources (judgment of 20 May 2015, Timab Industries and CFPR v Commission, T 456/10, EU:T:2015:296, paragraphs 59 and 60).

212 In addition, according to the case-law, the ability to assert one's rights through the courts and the judicial control which that entails constitute the expression of a general principle of law which underlies the constitutional traditions common to the Member States and which is laid down in Articles 6 and 13 of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950. As access to the courts is a fundamental right and a general principle ensuring the rule of law, it is only in wholly exceptional circumstances that the fact that legal proceedings are brought is capable of constituting an infringement of competition law (judgment of 17 July 1998, ITT Promedia v Commission, T 111/96, EU:T:1998:183, paragraph 60). As the Court of Justice noted, the need for a high level of protection for intellectual-property rights means that, in principle, the proprietor may not be deprived of the right to have recourse to legal proceedings to ensure effective enforcement of his exclusive rights (judgment of 16 July 2015, Huawei Technologies, C 170/13, EU:C:2015:477, paragraph 58). Symmetrically, and as the applicants argue, the fact that a company decides to use extrajudicial means of resolving a dispute rather than pursuing the litigation route is merely an expression of the same freedom to choose the means of defending its rights and cannot, in principle, constitute an infringement of competition law.

213 Although access to the courts is a fundamental right, it cannot however be considered that it is an obligation, even if it would help to increase competition between economic operators. First, it should be noted that, despite the wide range of procedures and systems for the grant of patents in the various EU Member States and before the EPO at the time of the facts of the present case, an intellectual property right granted by a public authority is normally assumed to be valid and an undertaking's ownership of that right is assumed to be lawful (judgment of 1 July 2010, AstraZeneca v Commission, T 321/05, EU:T:2010:266, paragraph 362). Secondly, while it is indeed in the public interest to eliminate any obstacle to economic activity which might arise where a patent was granted in error (see, to that effect, judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraphs 92 and 93) and while it is generally acknowledged that public budgets, including those dedicated to covering health expenditure, are under significant constraints and that competition, in particular competition provided by generic medicinal products developed by generic companies, can effectively contribute to keeping those budgets under control, it should also be borne in mind, as the Commission rightly stated in recital 1201 of the contested decision, that any undertaking remains free to decide whether or not to bring an action against the patents covering the originator medicinal products held by the originator companies. In addition, such a decision to bring or not to bring an action or to settle a dispute does not, in principle, prevent other undertakings from challenging those patents.

214 It follows from all of the foregoing that, for the purposes of reconciling patent law and competition law in the particular context of settlements between parties to a patent dispute, a balance must be struck between, on the one hand, the need to allow undertakings to make settlements, the growth of which is favourable to society and, on the other hand, the need to prevent the risk of misuse of settlement agreements, contrary to competition law, leading to entirely invalid patents being maintained and, especially in the medicinal products sector, an unjustified financial burden for public budgets.

(4) The reconciliation of patent settlement agreements and competition law

215 It should be noted that the use of a settlement to resolve a patent dispute does not exempt the parties from the application of competition law (see, to that effect, judgments of 27 September 1988, Bayer and Maschinenfabrik Hennecke, 65/86, EU:C:1988:448, paragraph 15, and of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 118; see, by analogy, judgment of 30 January 1985, BATCigaretten-Fabriken v Commission, 35/83, EU:C:1985:32, paragraph 33; see, also, paragraph 204 of the 2004 Guidelines on technology transfer agreements and point 237 of the 2014 Guidelines on technology transfer agreements).

216 The Court has thus held, in particular, that a no-challenge clause in respect of a patent, including when it was inserted into an agreement in order to settle a dispute pending before a court, might, in the light of the legal and economic context, restrict competition within the meaning of Article 101(1) TFEU (judgment of 27 September 1988, Bayer and Maschinenfabrik Hennecke, 65/86, EU:C:1988:448, paragraphs 14 to 16).

217 It is therefore necessary to identify the relevant factors which justify a conclusion that a non-challenge clause in respect of a patent and, more broadly, a patent settlement agreement restricts competition by object, bearing in mind that determining whether there is a restriction by object entails an examination of the content of the terms of the agreement in question, its objectives, and its economic and legal context (see paragraph 182 above).

218 As a preliminary point, it should be noted that a patent dispute settlement agreement may have no negative impact on competition. That is the case, for example, if the parties agree that the patent at issue is not valid and therefore provide for the immediate market entry of the generic company.

219 The agreements at issue in the present case, and in particular the Agreement, do not fall into that category because they contain non-challenge clauses in respect of patents and non-marketing clauses in respect of products, which are, by themselves, restrictive of competition. The non-challenge clause undermines the public interest in eliminating any obstacle to economic activity which may arise where a patent was granted in error (see, to that effect, judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraph 92) and the non-marketing clause entails the exclusion from the market of one of the competitors of the proprietor of the patent.

220 Nevertheless, the insertion of such clauses may be legitimate, but only in so far as it is based on the parties' recognition of the validity of the patent in question and, consequently, of the infringing nature of the generic products concerned.

221 First, non-marketing and non-challenge clauses are necessary for the settlement of certain disputes related to patents. If the parties to a dispute were unable to make use of such clauses, the settlement of the dispute would be of no interest in cases in which both parties agree on the validity of the patent. It must, moreover, be noted in this connection that the Commission stated, in point 209 of the 2004 Guidelines on technology transfer agreements that '[i]t is inherent in [settlement agreements] that the parties agree not to challenge ex post the intellectual property rights covered by the agreement [since] the very purpose of the agreement is to settle existing disputes and/or to avoid future disputes'. However, it is also necessary, in order to achieve that purpose, that the parties agree that no counterfeit product may be marketed.

222 Secondly, the insertion of non-marketing clauses merely, in part, reinforces the pre-existing legal effects of a patent which the parties explicitly or implicitly recognise as valid. A patent normally enables its holder to prevent its competitors from marketing the product covered by the patent or a product obtained through the process covered by the patent (see paragraph 196 above). However, by agreeing to a non-marketing clause, the generic company undertakes not to sell products likely to infringe the patent in question. If that clause is limited to the scope of the patent at issue, it may be regarded as essentially duplicating the effects of that patent, in so far as it is based on the recognition of the validity of that patent. As regards non-challenge clauses, the patent cannot be interpreted as affording protection against actions brought in order to challenge the validity of a patent (judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraph 92). The effects of those clauses therefore do not overlap with the effects of the patent. However, when a non-challenge clause is adopted as part of the settlement of a genuine dispute in which the competitor has already had the opportunity to challenge the validity of the patent concerned and ultimately acknowledges that validity, such a clause cannot be regarded, in that context, as undermining the public interest in eliminating any obstacle to economic activity which may arise where a patent was granted in error (see paragraph 219 above).

223 The Commission itself stated, in the contested decision, that non-marketing clauses and non-challenge clauses were generally inherent in any settlement. It thus considered that 'when in a patent dispute or patent litigation, a settlement is reached on the basis of each party's assessment of the patent case before them, such a patent settlement is unlikely to infringe competition law even though it may contain an obligation on the generic undertaking not to use the invention covered by the patent during the period of patent protection (e.g. a non-compete clause) and/or an obligation not to challenge the patent concerned in court (e.g. a non-challenge clause)' (recital 1136 of the contested decision).

224 Thus, the mere presence, in settlement agreements, of non-marketing clauses and non-challenge clauses the scope of which is limited to that of the patent in question, does not - despite the fact that those clauses are, by themselves, restrictive (see paragraph 219 above) - support a finding of a restriction of competition sufficiently harmful to be described as a restriction by object, where those agreements are based on the recognition, by the parties, of the validity of the patent and, consequently, the infringing nature of the generic products concerned.

225 The presence of non-marketing and non-challenge clauses whose scope is limited to that of the patent in question is, however, problematic when it becomes apparent that the generic company's agreement to those clauses is not based on its recognition of the validity of the patent. As the Commission rightly points out, 'even if the limitations in the agreement [at issue] on the generic undertaking's commercial autonomy do not go beyond the material scope of the patent, they constitute a breach of Article 101 [TFEU] when those limitations cannot be justified and do not result from the parties' assessment of the merits of the exclusive right itself' (recital 1137 of the contested decision).

226 In this respect, it should be noted that the existence of a 'reverse payment', that is to say a payment from the originator undertaking to the generic undertaking, is doubly suspect in the context of a settlement agreement. In the first place, it must be borne in mind that a patent is intended to reward the creative effort of the inventor by allowing him to make a fair profit from his investment (see paragraph 196 above) and that a valid patent must, in principle, allow a transfer of value to its holder, and not vice versa. In the second place, the existence of a reverse payment gives rises to doubts as to whether the settlement is actually based on the recognition, by the parties to the agreement at issue, of the validity of the patent in question.

227 However, the mere existence of a reverse payment does not mean that there is a restriction by object. It is possible that some reverse payments, where they are inherent in the settlement of the dispute in question, may be justified (see paragraphs 286 to 289 below). However, where an unjustified reverse payment occurs in the conclusion of the settlement, the generic company must then be regarded as having been induced by that payment to agree to the non-marketing and non-challenge clauses and it must be concluded that there is a restriction by object. In that case, the restrictions of competition introduced by the non-marketing and non-challenge clauses no longer relate to the patent and to the settlement, but rather can be explained by the conferral of a benefit inducing the generic company to abandon its competitive efforts.

228 It must be pointed out that, although neither the Commission nor the Courts of the European Union (see paragraphs 205 and 206 above) are competent to rule on the validity of the patent, it is nevertheless the case that those institutions may, in the context of their respective powers and without ruling on the intrinsic validity of the patent, find that it has been misused, in a manner which has no relation to its specific subject matter (see, to that effect, judgments of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, pp. 71 and 72, and of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraphs 7 and 8; see also, by analogy, judgments of 6 April 1995, RTE and ITP v Commission, C 241/91 P and C 242/91 P, EU:C:1995:98, paragraph 50, and of 4 October 2011, Football Association Premier League and Others, C 403/08 and C 429/08, EU:C:2011:631, paragraphs 104 to 106).

229 Inducing a competitor to accept non-marketing and non-challenge clauses, in the sense described at paragraph 227 above, or its corollary, accepting such clauses because of an inducement, constitutes an abnormal use of the patent.

230 As the Commission rightly stated in recital 1137 of the contested decision, 'patent law does not provide for a right to pay actual or potential competitors to stay out of the market or to refrain from challenging a patent prior to entering the market'. Likewise, according to the Commission, 'patent holders are not entitled to pay generic companies to keep them off the market and reduce the risks of competition, whether in the context of a patent settlement agreement or otherwise' (recital 1141 of the contested decision). Lastly, the Commission correctly added that 'paying or otherwise inducing potential competitors to stay out of the market [was] not part of any patent right, nor [was] it one of the means provided for under patent law to enforce the patent' (recital 1194 of the contested decision).

231 Where it found that there has been an inducement, the parties may no longer rely on their recognition, in the context of the settlement, of the validity of the patent. The fact that the validity of the patent is confirmed by a judicial or administrative body is, in that regard, irrelevant.

232 It is therefore the inducement, and not the recognition of the validity of the patent by the parties to the settlement, which must be regarded as the real cause of the restrictions on competition introduced by the non-marketing and non-challenge clauses (see paragraph 219 above), which - since they are entirely illegitimate - therefore reveal a sufficient degree of harm to the proper functioning of normal competition that a restriction by object may be found.

233 Where there is an inducement, the agreements in question must be regarded as being market exclusion agreements, in which the stayers are to compensate the goers. Such agreements actually constitute a buying-off of competition and must therefore be classified as restrictions of competition by object (Opinion of Advocate General Trstenjak in Beef Industry Development Society and Barry Brothers, C 209/07, EU:C:2008:467, point 75). Moreover, the exclusion of competitors from the market constitutes an extreme form of market sharing and of limitation of production (judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 435), which, in a context such as that of the agreements in question, reveals a degree of harm which is all the greater since the companies excluded are generic companies, the market entry of which is, in principle, favourable to competition and which also contributes to the public interest in lowering the cost of healthcare. In addition, that market exclusion is augmented, in the agreements at issue, by the fact that it is not possible for the generic undertaking to challenge the patent at issue.

234 It follows from all the foregoing that, in the context of patent dispute settlement agreements, a finding of a restriction of competition by object presupposes that the settlement agreement contains both an inducement to the generic company and a corresponding limitation of the generic company's efforts to compete with the originator company. Where those two conditions are fulfilled, a finding of restriction of competition by object must be made in view of the degree of harm to the proper functioning of normal competition of that agreement.

235 Thus, where a patent settlement agreement contains non-marketing and non-challenge clauses, the inherently restrictive nature of which (see paragraph 219 above) has not been validly called into question, the existence of an inducement for the generic company to agree to those clauses supports the conclusion that there is a restriction by object, even if there is a genuine dispute, the settlement agreement includes non-marketing and non-challenge clauses the scope of which does not exceed that of the patent at issue and that patent could - having regard, in particular, to the decisions adopted by the competent administrative authorities or courts - legitimately be regarded as valid by the parties to the agreement at issue at the time it was adopted.

236 In the contested decision (see inter alia recitals 1154 and 1188 to 1191 and, as regards the Agreement, recitals 1575 to 1608 of that decision), the Commission rightly examined whether each settlement agreement involved a value transfer from the originator company to the generic company representing a 'significant' inducement, that is to say liable to lead the latter to accept non-marketing and non-challenge clauses, and concluded, having found such an inducement, that there was a restriction of competition by object. The Commission explained, in the contested decision, that in order to do so it would assess the precise purpose of the net value transfer, whether that transfer was justifiable as remuneration for the costs incurred by the generic company and the significance of the amount transferred in view of the profits expected by the generic company if it had entered the market (see inter alia recitals 1575 and 1576), before carrying out an overall assessment of whether there was a significant inducement. Accordingly, the intervener cannot succeed in its argument that the Commission (see paragraph 171 above) either failed to define the significant inducement criterion clearly or based its assessment on the expected profits of the generic company - which were taken into account only as one piece of evidence amongst others in the assessment of that criterion - particularly since the Commission itself put those profits into perspective by stating that a value transfer inferior to the expected profits could not be considered an inducive value transfer (recital 1191 of the contested decision).

237 The Commission therefore rightly applied the inducement criterion for the purpose of distinguishing settlement agreements which constitute restrictions by object from those which do not constitute such restrictions (the 'inducement' criterion), and, contrary to the intervener's submission (see paragraph 170 above), sufficiently explained its assessment in that respect.

238 It follows that, contrary to the submissions of the applicants and the intervener (see paragraph 170 above), the Commission did not consider that any patent dispute settlement containing restrictions on the market entry of generics and a value transfer should be regarded as a restriction by object. It also expressly indicated, in recitals 1195 and 1200 of the contested decision, that the mere presence of a transfer of value from the originator company to the generic company cannot support a finding of a restriction by object (see also recitals 1154 and 1211 of the contested decision). It cannot therefore be alleged that the Commission discouraged, by imposing a broad prohibition on settlements, both the conclusion of such settlements and investments in generic medicinal products.

239 It also follows that, in the light of the foregoing (see, in particular, paragraphs 227 to 235 above) the Commission rightly inferred from the finding of an inducement to accept the non-marketing clauses and non-challenge clauses in the settlement agreements in question that those agreements were restrictive of competition by object. In doing so the Commission did not, contrary to the applicants' submissions (see paragraph 165 above), rely on the mere fact that such agreements were capable of restricting competition (see also paragraphs 188 to 190 above). On the contrary, it relied on a criterion - that of the inducement to accept non-marketing and non-challenge clauses - that allowed it to infer, rightly, that those agreement revealed, by their very nature, a sufficient degree of harm to the proper functioning of normal competition (see paragraphs 232, 236 and 237 above).

240 Moreover, recital 1144 of the contested decision does not support the applicants' argument. By stating in that recital, as highlighted by the applicants, that the removal of a possibility of entering the market constituted a restriction by object, the Commission precisely treated the agreements in question as agreements to exclude a potential competitor from the market, which are regarded as a restriction by object in the case-law (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C 209/07, EU:C:2008:643, paragraphs 9, 32 to 34 and 38). It may be noted that that assimilation is also indicated in other recitals of the contested decision (recitals 1139, 1140 and 3106).

241 It must also be considered in addition that, contrary to the submissions of the applicants and the intervener (see paragraph 169 above), the Commission rightly classified the settlement agreements concerned as market exclusion agreements, like the agreements examined in the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C 209/07, EU:C:2008:643) (see also paragraph 233 above), and did not, in doing so, disregard the fact that those agreements concerned intellectual property rights. The finding of an inducement in those agreements implies that the market exclusion of generic companies which they entail results, not from the effects of the patents at issue, but rather from a payment or another commercial benefit, representing the consideration for that exclusion, like the financial consideration paid to the undertakings which agreed to leave the Irish beef market at issue in the case that gave rise to that judgment. It should also be underlined that, contrary to the submissions of the applicants and the intervener (see paragraph 169 above), the Commission fully respected the conditions for the application of competition law to intellectual property rights (see paragraphs 203 and 204 above) and the presumption of validity enjoyed by those rights (see paragraph 213 above), since it classified as restrictions by object only those agreements which constituted a misuse of the patent in that they were based on a financial inducement and not on the recognition of the validity of the patent (see paragraphs 229 and 232 above).

242 Lastly, it is necessary to reject the argument put forward by the applicants and the intervener (see paragraph 169 above) based on the approach adopted by the courts of the United States of America, in particular in the Actavis judgment to which they refer and which is also cited by the Commission in the contested decision (recital 1199 of that decision).

243 It should be noted, in that respect, that, according to settled case-law, national practices, even on the supposition that they are common to all the Member States, cannot prevail in the application of the competition rules set out in the Treaty (see, to that effect, judgment of 17 January 1984, VBVB and VBBB v Commission, 43/82 and 63/82, EU:C:1984:9, paragraph 40) and that is the case, a fortiori, as regards the national practices of third countries (see, to that effect, judgment of 28 February 2002, Compagnie générale maritime and Others v Commission, T 86/95, EU:T:2002:50, paragraph 341 and the case-law cited). The approach adopted by EU competition law as regards the distinction between restrictions on competition by object and by effect differs from United States antitrust law, which draws a distinction between restrictions of competition 'per se', namely cases in which the anticompetitive effects are so obvious that they require only a 'quick look' approach, without taking the context into account, and which are necessarily and irremediably prohibited, and infringements which must be proved according to the rule of reason, that is to say following an examination balancing the pro- and anticompetitive effects of the agreement at issue. First, EU law does not regard any restriction of competition as necessarily and irremediably unlawful, since a restriction of competition by object may, in principle, fall within the exceptions laid down in Article 101(3) TFEU. Secondly, as noted in the case-law, the existence of a rule of reason in EU competition law cannot be upheld (judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T 360/09, EU:T:2012:332, paragraph 65; see also, to that effect, judgment of 23 October 2003, Van den Bergh Foods v Commission, T 65/98, EU:T:2003:281, paragraph 106). Moreover, the differences between the prevailing regulatory context in the United States and in the European Union, as regards pharmaceutical patents in particular, make it even more difficult to apply the approach adopted in the Actavis judgment, by analogy, to the present case (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 513).

244 It follows from all the foregoing that the first part of the present plea in law must be rejected.

2. Errors of assessment in classifying the Agreement as a restriction of competition by object

245 The applicants submit that the Commission erroneously considered that the Agreement restricted competition in exchange for a significant inducement from Servier. They submit, in that respect, that none of the provisions of the Agreement restricted competition and that the inducement found by the Commission was consideration exchanged in the context of a genuine supply agreement.

246 That line of argument therefore criticises the Commission's assessment of the two conditions required for a patent settlement agreement to be classified as a restriction by object, namely the existence of an inducement to the generic company and a corresponding limitation of its efforts to compete with the originator company (see paragraph 234 above). In the present case, since the finding of an inducement depends in part on the restrictive nature of certain clauses in the agreement at issue, the complaints directed against the assessment of the clauses of the Agreement will be examined in the first place, before those criticising the assessment of the value transfer provided for in that agreement.

(a) The incorrect assessment of the non-challenge clause

(1) Arguments of the parties

247 The applicants submit that the Commission was wrong to consider that the non-challenge clause restricted competition by excluding the competitive threat of a challenge to Servier's patents, whereas they did not undertake to withdraw their opposition before the EPO and, after all, did bring those opposition proceedings.

248 The Commission notes that the non-challenge clause cannot be examined in isolation from the other clauses of the Agreement. It adds that, in any case, litigation before the national court may be the most effective and quickest way of determining that a patent is invalid, as illustrated by the national dispute between Servier and Apotex.

(2) Findings of the Court

249 Under the non-challenge clause, Teva undertook not to challenge the UK 947, UK 339, UK 340 and UK 341 patents in the United Kingdom for the duration of the Agreement, it being stipulated that it was not prevented from continuing opposition proceedings against the equivalent European patents before the EPO (Clause 2.4 of the Agreement).

250 The Commission considered, in the contested decision, that the non-challenge clause had two main consequences: first, it prevented Teva from establishing that the product it intended to market was non-infringing and, secondly, it prevented the possibility of an objective legal review of the validity of Servier's patents in the United Kingdom (recital 1546 of the contested decision). It concluded that that clause had granted Servier complete certainty that Teva would not represent a competitive threat through a challenge to Servier's patents for the duration of the Agreement (recital 1548 of the contested decision).

251 As the Commission rightly pointed out in its pleadings, the applicants merely assert that the non-challenge clause did not cover the challenges to the 947 patent before the EPO, but do not contest that it covered challenges to the UK 947 patent and especially the UK 339, UK 340 and UK 341 patents before the United Kingdom courts.

252 In those circumstances, it is irrelevant that the non-challenge clause covers only litigation in the United Kingdom and does not include proceedings before the EPO, since the territorial scope of the Agreement is limited to the United Kingdom, within which any challenge to the validity of the UK 947 patent in prohibited. It should be borne in mind, in that respect, that an agreement may be classified as a restriction by object, even if its territorial scope is limited to one Member State (see judgment of 24 September 2009, Erste Group Bank and Others v Commission, C 125/07 P, C 133/07 P and C 137/07 P, EU:C:2009:576, paragraph 38 and the case-law cited).

253 Moreover, even if the non-challenge clause were not capable of affecting the proceedings for the revocation of the UK 947 patent initiated in the United Kingdom by a subsidiary of Teva that were suspended pending a final decision in the opposition proceedings before the EPO not covered by the Agreement, which could, according to the applicants, lead to the revocation of the UK 947 patent, that clause nevertheless prevents the introduction of other invalidity actions against that patent for the term of the Agreement and, under Clause 2.4 of the Agreement, that prohibition applies to both Teva UK and its subsidiaries and both to direct actions and to any assistance to a third party with a view to invalidating Servier's patents. Teva's active participation in the opposition proceedings before the EPO - inter alia by bringing an action against the decision of the opposition division of the EPO that confirmed the validity of the 947 patent (see paragraph 15 above) - as alleged by the applicants (see paragraph 247 above), is therefore irrelevant.

254 It follows that the arguments put forward by the applicants do not call into question the restrictive nature of the non-challenge clause in the Agreement.

(b) The incorrect assessment of the exclusive purchasing clause, combined with the non-termination clause and the amendment to the Agreement

(1) Arguments of the parties

255 The applicants accuse the Commission of having considered that the Agreement was restrictive by object on account of the exclusive purchasing clause combined with the non-termination clause, whereas those clauses had no anticompetitive effect in view of the context of the Agreement. Even though the combination of those two clauses amounted to giving Servier a non-supply option and that option was confirmed by the amendment to the Agreement, that option is not anticompetitive since the two clauses combined only delay the supply to Teva until the first date on which their market entry was lawful in the light of Servier's patents and the EPO decisions concerning them. The applicants also put forward a plausible pro-competitive explanation for the conclusion of the Agreement, which is irrespective of the EPO's decision concerning the validity of the 947 patent. If the EPO had revoked the 947 patent, the Agreement would have expedited - as the Commission also acknowledged in the defence - and improved Teva's market entry, since it would have entered with Servier's product which did not raise any issues in terms of either patent enforcement or obtaining marketing authorisations. If, on the contrary, that patent had been upheld, the Agreement would have been competitively neutral since the date of market entry provided for in the Agreement was the expiry date of the 947 patent.

256 The applicants add that exclusive purchasing obligations are standard in supply agreements concluded in the pharmaceutical sector and that the non-termination clause is inherent to the settlement agreement. Moreover, those clauses were imposed by Servier on account of the serious nature of its actions for infringement brought against Teva. In that regard, in the reply, the applicants dispute the Commission's claim that the Agreement goes beyond the scope of the patent litigation between themselves and Servier, submitting, in particular, that Clause 3.1 of the Agreement is a standard clause in any exclusive purchasing agreement. Furthermore, the contested clauses of the Agreement are identical to those in an agreement concluded between Servier and Generics UK ('the Servier/Generics agreement') which was considered not to raise competitive concerns.

257 The Commission argues, relying on the decision of the High Court of Justice (England & Wales), Chancery Division (Patents Court) of 9 October 2008 in the dispute between Servier and Apotex (see paragraph 19 above), that the overall legal effect of the exclusive purchasing clauses and non-termination clauses is to allow Servier to exclude Teva from the market, by precluding it from purchasing or selling perindopril other than that produced by Servier without, however, obliging Servier to supply that perindopril to Teva. The Commission submits, whilst criticising the distortion of its written pleadings by the applicants, that, if the EPO had revoked the 947 patent, the Agreement would have enabled Servier to prevent Teva from entering the market with its own or Krka's medicinal product and, if that patent had not been revoked, the Commission maintains that Teva had real and concrete possibilities of entering the market with its own or Krka's medicinal product before the expiry of the 947 patent.

258 The Commission adds that the applicants' arguments disregard the fact that they are Servier's competitors and that the combination of the two clauses is not common and forms an essential feature of the Agreement. Moreover, the prohibition imposed on Teva is not dependent on the actions for infringement brought by Servier and, in addition, goes beyond the scope of any patent litigation limited to the 947 patent. Finally, the Commission notes the clear and marked differences between the Agreement and the Servier/Generics agreement, the latter agreement having been concluded between two companies that were not competitors and not containing any equivalent clause to those at issue in the present case.

(2) Findings of the Court

259 Article 3 of the Agreement stipulates as follows:

'3. Exclusive purchasing obligation

3.1. For the duration of this Agreement, Teva shall purchase all Teva and its Affiliates' requirements for Perindopril for supply or disposal in the United Kingdom exclusively from Servier or Servier's Affiliates.

...

3.3. Teva shall not, and shall procure that its Affiliates shall not, actively sell or promote Product to consumers outside the United Kingdom.

3.4. Subject to receipt by Servier or its Affiliates of confirmed orders from Teva for the quantities of Product set out below, submitted on or before the Order Dates, Servier or its Affiliates shall supply Teva with the following quantities of Product by the following dates:

3.4.1. 150,000 (one hundred and fifty thousand) packs of 30, 2 mg tablets by 1 August 2006 and in subsequent months 75,000 (seventy five thousand) such packs per month;

3.4.2. 240,000 (two hundred and forty thousand) packs of 30, 4 mg tablets by 1 August 2006 and in subsequent months 120,000 (one hundred and twenty thousand) such packs per month; and

3.4.3. 80,000 (eighty thousand) packs of 30, 8 mg tablets by 1 January 2007 (or such date as the parties may agree) and in subsequent months 40,000 (forty thousand) such packs per month.

...

3.8. If, in respect of any month during the term of this Agreement:

3.8.1. Servier has received from Teva confirmed orders for Product, for delivery for the United Kingdom during such month, such confirmed orders having been submitted on or before the relevant Order Dates; and

3.8.2. Servier and its Affiliates have, within ten Working Days of the delivery date thereof, failed to deliver to Teva the total Product ordered by Teva in accordance with the provisions of Clause 3.4 and 3.8.1 for delivery during such month,

3.8.3. Servier shall, subject to Clause 3.9 pay Teva the Liquidated Damages in respect of that month and Teva and its Affiliates shall have no other right or remedy (including any right of termination) in respect of any failure by Servier to supply Product to Teva.

...'

260 It must also be borne in mind that, under the non-marketing clause laid down in Clause 2.3 of the Agreement, Teva was to refrain, in the United Kingdom, from making, having made, keeping, importing, supplying, offering to supply or disposing of generic perindopril either manufactured in accordance with the process it had developed, and which Servier regarded as infringing the UK 947, UK 339, UK 340 and UK 341 patents, or infringing those patents until the termination or expiration of the Agreement or the expiration of those patents.

261 The Commission considered, in recitals 1552 to 1555 of the contested decision, that, since the non-marketing clause (Article 2.3) and the exclusive purchasing clause (Article 3.1) of the Agreement affected Teva's ability to compete or to choose independently its source of perindopril for supply on the United Kingdom market, they should be analysed together as a single non-compete obligation. It stated that, whatever the patent situation of the possible alternative sources of perindopril (infringing or non-infringing), the only options left open to Teva by the exclusive purchasing clause were either to sell Servier's product exclusively, or to receive compensation for failure to supply (liquidated damages of GBP 500 000 per month of default).

262 It must be pointed out that the applicants' arguments challenging the Commission's assessment in that respect are based on an erroneous interpretation of the exclusive purchasing clause and the non-termination clause of the Agreement.

263 It is apparent from the Agreement that there was an alternative between supply and the payment of damages in the event of a failure to supply, since, alongside the obligation to supply, which is indeed mentioned as such in Article 3.4 of the Agreement, that agreement envisaged the possibility of non-supply, which could not be challenged before a court, would not enable Teva to terminate the agreement, and was not even subject to any conditions, such as a temporal limitation, other than the payment of damages (Clauses 3.8.2, 3.8.3 and 8.3 of the Agreement). It should be noted that the prohibition of challenges and of termination in the event of failure to supply played a decisive role in that interpretation of the exclusive purchase clause, since it replaced the penalisation of a breach of a contractual obligation by a court or by the termination of the contractual relationship with pre-established pecuniary compensation and thus created an alternative between supply and damages. In that regard, it is irrelevant whether those damages result from a breach of the supply obligation or from a possibility for Servier not to supply Teva.

264 The result is, in any event, as the Commission rightly considered in the contested decision (recital 1559 of that decision), a non-supply option, left entirely to Servier's discretion, which prevented Teva from entering the market and which also distinguishes the clauses concerned from the clauses typically contained in a supply agreement. The applicants' assertion (see paragraph 255 above) that Servier's refusal to supply would occur in the event of an EPO decision confirming the validity of the 947 patent and, thus, could be explained by compliance with the decisions of the EPO is, in that respect, irrelevant.

265 By contrast, Teva was subject to an exclusive purchasing obligation, rightly described as an 'absolute' obligation by the Commission (recital 1588 of the contested decision), since Teva could not withdraw from it in order to source perindopril from other perindopril suppliers - whether that perindopril was infringing or not - and enter the market with that perindopril, even if Servier failed to supply, since, under the non-termination clause, the Agreement could not be terminated on that basis. As the Commission rightly stated in recital 1557 of the contested decision, the non-termination clause, combined with the exclusive purchasing clause, obliged Teva to source generic perindopril exclusively from Servier, and thus prevented it from sourcing from other suppliers, including those that did not infringe any of Servier's patents. Accordingly, contrary to the applicants' submissions (see paragraph 256 above), the non-termination clause cannot be regarded as inherent in the settlement provided for in the Agreement since, in order to be inherent in the settlement, the clauses at issue would have to, at the very least, have a link with the Servier patents that gave rise to the dispute between Servier and Teva and, thus, with the settlement intended to resolve that dispute.

266 It follows that the exclusive purchasing and non-termination clauses not only overlap with the non-marketing obligation laid down in Clause 2.3 of the Agreement, since they prohibit the acquisition and, accordingly, the sale of perindopril produced by third parties that infringes the patents at issue, but also extend that obligation beyond the patents at issue, since they prohibit the acquisition and the sale of perindopril produced by third parties that does not infringe the patents at issue; moreover, according to the Commission, some of those third parties had reached an advanced stage of product development when the Agreement was concluded (recitals 1648 and 1651 of the contested decision).

267 It follows that the Agreement's exclusive purchasing and non-termination clauses are, by themselves, particularly capable of preventing Teva from procuring and thus entering the market with a third party's product, just as that entry is moreover already prevented both as regards the applicants' products and those of third parties by the non-marketing clause set out in Article 2.3 of the Agreement, the competition-restricting nature of which is not disputed by the applicants.

268 That interpretation of the exclusive purchasing clause and the non-termination clause is, moreover, not called into question by the amendment to the Agreement. In addition to the fact that that amendment was signed on the day of the first delivery of the product from Servier to Teva on a consignment basis, namely 23 February 2007, in order to stipulate the date on which Teva could enter the market with that product, and therefore relates to the implementation of the Agreement and the analysis of its specific restrictive effects, as the applicants essentially acknowledged at the hearing, it must be noted - as the Commission found (recital 1568 of the contested decision) - that that amendment merely confirmed that Servier would not supply Teva on the delivery dates stipulated in the Agreement, namely 1 August 2006 and 1 January 2007. Furthermore, it should be noted that the three dates set out in Clause II of the amendment to the Agreement, in particular the date on which the 947 patent would cease to be in force, following its revocation or its expiry, and the date on which Apotex would begin distributing generic perindopril, following a judgment invalidating the UK 947 patent, correspond solely to dates on which Teva could potentially enter the market with Servier's product and do not, by themselves, entail any obligation for Servier to supply Teva so that it could enter the market on one of those dates.

269 Nor can it be inferred from the amendment to the Agreement and from the exclusive purchasing clause that the Agreement was not likely to produce anticompetitive effects, or indeed that it was likely to produce pro-competitive effects and is therefore an agreement with ambivalent potential effects which is not sufficiently harmful to be classified as a restriction of competition by object.

270 It must be borne in mind that the potential effects of an agreement, based on circumstances which were hypothetical and thus not foreseeable when the agreement in question was concluded, such as, in the present case, the EPO's decision relating to the validity of the 947 patent (see paragraph 255 above), cannot be taken into account in assessing whether that agreement is restrictive of competition by object (see paragraph 186 above). It may be added that, in any event, contrary to the applicants' submissions, it cannot be considered that the alleged potential effects of the Agreement were not restrictive of competition, or indeed pro-competitive, even if the supplying of Teva by Servier had to be taken into account (see paragraph 268 above).

271 If the 947 patent had been invalidated by the EPO, the Agreement would have prevented Teva from entering the market with its product or that of Krka by virtue of the non-marketing clause, which would have remained in force - as shown by the reference to the 'expiration' of the patents in Clause 2.3 of the Teva Agreement, as opposed to the term 'revocation' used in Clause II of the amendment to the Agreement - even though that invalidation would have removed the obstacle to the market entry of generic products that potentially infringed that patent. In addition, the market entry of Teva with Servier's generic product as permitted under the Agreement would not have created a situation of competition as regards Servier and Teva would not, moreover, have been the sole, and thus the first, market entrant given the abovementioned entry of other generic companies. Likewise, in the event that the validity of the 947 patent had been confirmed by the EPO, Teva would still have been prevented from obtaining generic perindopril, including generic perindopril which did not infringe that patent, from any undertakings other than Servier, and its supply by Servier would also not have allowed it to enter into competition with Servier. Contrary to the applicants' submissions at the hearing, the fact that the Commission set the end of the infringement on the date that Teva had entered the United Kingdom market with Servier's product cannot be interpreted as acknowledgement, by the Commission, that Teva had entered the market in July 2007 in competition with Servier. The Commission itself indicated in the contested decision (recitals 2125 and 3133 of that decision) and affirmed, in essence, at the hearing that the end date of the infringement was set at 6 July 2007 in order to adopt a conservative approach and to use a date which would be favourable to the parties to the Agreement.

272 It may be added that, even if entering the United Kingdom market with Servier's product could be regarded as entering into competition with Servier, that entry, which would have to occur, according to the terms of the amendment to the Agreement, when the 947 patent and the UK 947 patent expired (see paragraph 268 above), was neither an early entry, nor even an entry corresponding to the first date on which lawful market entry could take place in the absence of an agreement. In view of Servier's undertakings given to Teva in October 2005, whereby Servier undertook not to bring proceedings for infringement of the UK 947 patent against the company that became a subsidiary of Teva (see paragraph 18 above), that patent was not a barrier, nor a fortiori an insurmountable barrier to Teva's entry (see paragraph 139 above), and the latter had real concrete possibilities of entering the United Kingdom market without having to wait for the revocation or the expiry of the 947 and UK 947 patents (see paragraphs 141 to 147 above).

273 For the same reasons, the applicants' allegations concerning Teva's objective of early entry to the United Kingdom market are also irrelevant in the present case.

274 It follows from all the foregoing that the Commission did not erroneously assess the exclusive purchasing and non-termination clauses in the Agreement in considering that those two clauses, as combined in the non-marketing clause set out in Article 2.3 of the Agreement, had to be analysed together as a 'non-compete obligation' (recital 1552 of the contested decision) and, thus, as an overall non-marketing obligation imposed on Teva (together 'the non-marketing clauses').

275 It follows that, contrary to what the applicants essentially submit, those clauses do not correspond to those typically set out in a supply agreement, nor to those in a typical exclusive purchasing agreement (see also paragraphs 264 and 265 above), and cannot therefore be analysed in the same way as clauses contained in a side deal to a settlement, since such side deals correspond to typical commercial agreements (see judgment delivered today, Servier and Others v Commission, T 691/14, paragraph 672).

276 It also follows that the applicants' arguments based on typical supply agreements or exclusive purchasing agreements must be rejected.

277 In particular, the applicants' allegation that such agreements are a common practice in the pharmaceutical sector is irrelevant in the present case, since the exclusive purchasing clause of the Agreement does not correspond to the typical clauses mentioned by the applicants. It should be added that, in any event, practices of private undertakings cannot prevail in the application of the competition rules set out in the Treaty, even where they are tolerated or approved by the authorities of a Member State (see, to that effect, judgment of 17 January 1984, VBVB and VBBB v Commission, 43/82 and 63/82, EU:C:1984:9, paragraph 40).

278 In addition, it should be noted that, as the Commission submits, the Agreement is also different from supply agreements which are generally regarded as fulfilling the conditions for exemption under Article 101(3) TFEU pursuant to the block exemption regulations, in particular Commission Regulation (EC) No 2790/99 of 22 December 1999 on the application of Article [101(3) TFEU] to categories of vertical agreements and concerted practices (OJ 1999 L 336, p. 21), which does not apply to exclusivity agreements concluded by competing undertakings, under Article 2(4) thereof.

279 As regards the Commission's assessment of the Servier/Generics agreement concluded less than a year after the Agreement, it should be noted that the Commission found, in recital 745 of the contested decision, without being contradicted by the applicants, that the exclusive purchasing clause contained in the Servier/Generics agreement did not provide for any payment or damages in the event of failure to supply by Servier. In addition, the Commission stated, also without being contradicted, that that clause also was not combined with a non-termination clause and a non-marketing clause, since Generics had not developed any competing perindopril, with the result that the assessments relating to that agreement could not be transposed to the Agreement.

280 Lastly, the applicants' argument that the exclusive purchasing clause and the non-termination clause were imposed by Servier is irrelevant in the present case, since that circumstance, even if it were established, could be taken into account only in the context of an analysis of the Agreement in the light of Article 102 TFEU and has no effect on its analysis in the light of Article 101 TFEU, where, as in the present case, the conclusion and the existence of an agreement are not disputed (see, to that effect, judgments of 28 June 2005, Dansk Rørindustri and Others v Commission, C 189/02 P, C 202/02 P, C 205/02 P to C 208/02 P and C 213/02 P, EU:C:2005:408, paragraph 370, and of 29 November 2005, Union Pigments v Commission, T 62/02, EU:T:2005:430, paragraph 63).

281 It follows from all of the foregoing that the Commission rightly considered that the Agreement restricted Teva's efforts to compete with Servier.

(c) The manifest error of assessment of the clauses providing for the payment of an initial lump sum and monthly compensation

(1) Arguments of the parties

282 The applicants submit that the Commission wrongly considered that the payments they received constituted a 'net value transfer' or a 'reverse payment' from the patent holder to a generic competitor which, by nature, was restrictive of competition. The payments were made in consideration of easily identifiable commercial benefits and were unrelated to Teva's allegedly delayed market entry, as can be seen by the amount of those payments, which is clearly less than the cost of the litigation that was avoided and the damages that Servier may have been required to pay for unlawfully prohibiting market entry. The applicants refer in that regard to the amount of compensation that Servier was ordered to pay to Apotex following a similar prohibition (see paragraph 19 above).

283 The applicants add that each of the payments was reasonable and justified. The initial lump sum could not offset their delayed market entry since a delayed entry of that kind was not provided for in the initial agreement and the monthly liquidated damages reflect what could have been granted by a court for failure to comply with a supply obligation.

284 The Commission contends that it is clear from the evidence in the file that the payments at issue and Teva's delayed market entry were in fact closely linked. As regards the payment amounts, it states that account had to be taken of the total sum of the initial lump sum and the monthly liquidated damages, that the amount of the monthly liquidated damages was the same as, or even greater than, the applicants' forecasted profits as a result of their market entry and that, in concluding the Agreement, the applicants had avoided the costs of market entry, unlike Apotex.

(2) Findings of the Court

285 The Commission considered, in the contested decision, that the lump sum of GBP 5 million ('the lump sum') and the liquidated damages of GBP 500 000 per month totalling GBP 5.5 million for the 11 months of non-supply by Servier ('the final liquidated damages'), represented a substantial sum of money - GBP 10.5 million - which had served as a significant inducement for Teva to refrain from competing (recital 1622 of the contested decision).

286 In order to establish whether or not a reverse payment, that is to say a transfer of value from the originator company to the generic company, constitutes an inducement to accept non-marketing and non-challenge clauses, it is necessary to examine, taking into account its nature and its justification, whether the transfer of value covers only costs inherent in the settlement of the dispute. In the contested decision, the Commission therefore rightly examined whether the value transfer corresponded to the specific costs of the settlement for the generic company (see recitals 1592 to 1599 of the contested decision).

287 If a reverse payment provided for in a settlement agreement containing clauses restrictive of competition is aimed at compensating costs borne by the generic company that are inherent in that settlement, that payment cannot in principle be regarded as an inducement. Because they are inherent in the settlement agreement, there is an implication that those costs are, as such, based on the recognition of the validity of the disputed patents which that settlement is intended to affirm by bringing to an end the challenges to that validity and the potential infringement of those patents. It therefore cannot be considered that such a reverse payment creates doubts as to whether that settlement is based on the parties' recognition of the validity of the patent in question (see paragraphs 226 and 227 above). Nevertheless, a finding of an inducement and of a restriction of competition by object is not ruled out in such a case. It means however that the Commission must prove that the amounts corresponding to those costs inherent in the settlement, even if they are established and precisely quantified by the parties to that settlement, are excessive (see, to that effect, recitals 1338, 1465, 1600 and 1973 of the contested decision). Such a disproportion would demonstrate that the costs concerned are not inherently linked with the settlement and, accordingly, it could not be inferred from the reimbursement of those costs that the settlement agreement is based on the recognition of the validity of the patents at issue.

288 It may be considered that the costs inherent in the settlement of the dispute include, in particular, litigation expenses incurred by the generic undertaking in the context of the dispute between it and the originator company. These expenses were incurred solely for the purposes of the litigation concerning the validity or the infringement of the patents in question, which the settlement is intended to bring to an end on the basis of an agreement acknowledging the validity of the patents. The compensation of those costs is therefore directly linked to that settlement. Consequently, where the litigation expenses of the generic company are established by the parties to the settlement, the Commission can find them to be inducive only by showing that they are disproportionate. In that respect, amounts corresponding to litigation expenses which have not been proved, on the basis of specific and detailed documents, to be objectively indispensable for the conduct of the litigation - having regard inter alia to the legal and factual complexity of the issues dealt with and the generic company's financial interest in the dispute - must be regarded as disproportionate.

289 By contrast, some costs incumbent upon the generic company are, a priori, too extraneous to the dispute and to its settlement to be regarded as inherent in the settlement of a patent dispute. Those include, for example, the costs of manufacturing the infringing products, corresponding to the value of the stock of those products, and research and development expenses incurred in developing those products. Such costs and expenses are a priori incurred independently of the occurrence of litigation and its settlement and do not represent losses because of that settlement, as is clear from, in particular, the fact that, despite the marketing of the products in question being prohibited under the settlement agreement in question, they are often sold on markets not covered by that agreement and the fact that the research in question may be used to develop other products. The same is true of sums which must be paid by the generic undertaking to third parties as a result of contractual commitments which were not undertaken in the context of the dispute (for example supply contracts). Such costs incurred in terminating contracts concluded with third parties or in compensating third parties are usually imposed by the contracts in question or are directly connected with those contracts, which, moreover, were concluded by the generic company concerned independently of any dispute with the originator company or its settlement. It is therefore for the parties to the agreement in question, if they do not wish the payment of those costs to be regarded as an inducement, and indicative of a restriction of competition by object, to demonstrate that those costs are inherent in the dispute or in its settlement, and then to justify the amount. They could also, to the same end, invoke the insignificant amount of the repayment of those costs which are a priori not inherent in the settlement of the dispute, showing that that amount is insufficient to constitute a significant inducement to accept the clauses restricting competition stipulated in the settlement agreement in question (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 360).

(i) The final liquidated damages

290 Contrary to the applicants' submissions, the Commission rightly considered that the final liquidated damages represented a payment made to Teva in exchange for its commitment not to compete with Servier (recital 1588 of the contested decision) and, accordingly, an inducement to accept a non-marketing obligation. The Commission rightly considered that the exclusive purchasing and non-termination clauses amounted to the imposition of a non-marketing obligation excluding Teva from the market (see paragraph 274 above) and, since Clauses 1.8 and 3.8.3 of the Agreement provided for the payment of liquidated damages of GBP 500 000 per month in the event that Servier failed to supply the product and that market exclusion thus materialised, the liquidated damages clearly constituted the quid pro quo for Teva's not entering the market.

291 In that respect, the applicants' argument that the liquidated damages reflects what could have been granted by a court for non-compliance with a supply obligation must be rejected as irrelevant. The existence of an inducement may be inferred in the present case from the fact that the payment was made, not in order to compensate for costs inherent in the settlement agreement or in the performance of a normal supply agreement, but as a quid pro quo for Teva's not entering the market as provided for in the abovementioned clauses, irrespective of whether that quid pro quo corresponds to the damages that a court would have granted (see paragraphs 286 and 287 above).

(ii) The lump sum

292 The arguments put forward by the applicants as regards the lump sum, provided for in Clause 10.1 of the Agreement, do not call into question the Commission's finding of an inducement.

293 It should be noted, in that respect, that Clause 10.1 of the Agreement stipulates as follows:

'Servier shall, subject to receipt of an appropriate invoice from Teva, pay or procure that one of its Affiliates shall pay, Teva [GBP] 5 000 000 ... within 10 Working Days of receipt of Teva's invoice. Such invoice may be raised on signature of this Agreement and will be due immediately, always provided that Servier shall have 10 Working Days to make payment. Such payment shall be a contribution towards the costs incurred by Teva in preparing to enter into this Agreement, including without limitation the costs of terminating its supply arrangements for the United Kingdom.'

294 In the contested decision, the Commission found, as a preliminary point, that no specific amount had been reported by Teva ex post for the various costs alleged to have been compensated by the lump sum, with the exception of legal costs of less than EUR 100 000 for the litigation brought by Ivax against Servier in the United Kingdom (recitals 1594 and 1597 of the contested decision). It nevertheless evaluated the other costs liable, in its view, to fall within the scope of Clause 10.1 of the Agreement, including those corresponding to the value of Teva's perindopril stock that had to be destroyed and to Teva's perindopril development costs, and found that they represented in total less than 40% of the lump sum (recitals 1596 to 1599 of the contested decision).

295 It follows that the Commission considered that, even though some of the costs covered by Clause 10.1 of the Agreement could be regarded as inherent in the settlement of the dispute between Servier and Teva, the latter had not quantified the costs in question, nor a fortiori established the amount of those costs, with the exception of legal costs that had been quantified, but in an approximate way and without establishing the amount of those costs. In the contested decision, the Commission referred to the fact that Teva only 'reported' (recital 797 of the contested decision) or 'submitted' (recital 1597 of the contested decision) legal costs of 'less than EUR 100 000'.

296 The applicants do not put forward any argument, nor a fortiori adduce any evidence, such as the 'appropriate invoice' mentioned in Clause 10.1 of the Agreement, capable of calling into question the Commission's analysis in that respect.

297 The applicants merely submit, first, that the total amount of GBP 10.5 million, and thus a fortiori the lump sum, which forms part of that amount, is clearly less than the amount that Servier would have had to pay as costs in the litigation that was avoided and as damages for unlawfully prohibiting market entry. The applicants refer in that regard to the amount of compensation that Servier was ordered to pay to Apotex following a similar prohibition, namely GBP 17.5 million (see paragraph 19 above).

298 It must first of all be noted that, by that allegation, the applicants seek, in essence, to prove that the lump sum was justified by comparing that sum to the amount of costs of a different nature which are not covered by Article 10.1 of the Agreement, since that provision - although drafted in a non-restrictive manner - is limited to the 'costs incurred by Teva' and does not include costs incurred or avoided by Servier. By their allegation, the applicants also confuse the issue whether the lump sum is justified in the light of the settlement, which is the only settlement at issue in the present case, and the issue of the proportionality of that amount; the proposed comparison might in certain circumstances be relevant for assessing the latter. However, it should be noted that they are two separate assessments that the Commission must carry out in turn. Thus, it is for the Commission, when assessing the restrictive nature of a patent dispute settlement involving a value transfer, to examine, in the first place, whether the costs covered by the value transfer are justified in the light of the settlement and, in particular, whether the value transfer corresponds to the established amount of costs which may by their very nature be regarded as inherent in the settlement, then, in the second place, if it considers those costs are justified, to verify that the amount of those costs is not disproportionate in view of, inter alia, the type of costs concerned (see paragraphs 286 and 287 above).

299 It should also be noted that, even if the proposed comparison were relevant for the purpose of ascertaining whether the lump sum was justified in the light of the settlement, the applicants have not established that their situation is comparable to that of Apotex. As the Commission rightly observes, Apotex, unlike Teva, entered the market before the interim injunction prohibited it from marketing its perindopril and was therefore reimbursed for the costs incurred in entering the market, costs which Teva incurred only in part and for which it could not therefore have been reimbursed. It may also be added that, as the Commission submits, the decision awarding damages to Apotex was made after the conclusion of the Agreement.

300 The applicants submit, secondly, that the lump sum could not have compensated for their delayed market entry, since that delayed entry was not initially provided for in the Agreement. When the lump sum was agreed, the contractual documents exchanged between Teva and Servier did not contemplate any restriction of Teva's ability to enter the market, since the 'non-compete provision' and the non-termination clause became part of the negotiations only at a later stage, and, moreover, Teva sought to enter the market as from 15 June 2006.

301 It must be observed, first of all, that those allegations relating to the conduct of the negotiations of the Agreement and, in particular, to the parties' intentions during those negotiations cannot prevail over the analysis of the clauses of the Agreement, which imposes at the very least, in Clause 2.3 thereof, a non-marketing obligation on Teva and, in Clause 2.2 thereof, an obligation to destroy its perindopril, thus preventing it from entering the market with its product. While it is settled case-law that the intention of the parties may be taken into account in order to find a restriction by object where that intention reveals a blatant attempt to restrict competition, proof of the intention to restrict competition is not a necessary factor in determining whether an infringement has such a restriction as its object (judgment of 4 June 2009, T-Mobile Netherlands and Others, C 8/08, EU:C:2009:343, paragraph 27; see also, to that effect, judgment of 9 July 2009, Peugeot and Peugeot Nederland v Commission, T 450/05, EU:T:2009:262, paragraph 55; see, also, paragraph 183 above). Accordingly, the parties' intentions alone are not enough to exclude the existence of a restriction by object or, as in the present case, an inducement to accept clauses that restrict competition.

302 It must be noted, next and in any event, that the Commission referred, in the contested decision (recitals 788 and 1585 of that decision) and in its written pleadings, to several documents from the parties - which the applicants do not dispute - according to which the lump sum was paid in return for Teva's not entering the market.

303 It follows that the Commission validly found that the Agreement contained an inducement for the applicants to accept the non-marketing and non-challenge clauses set out in the Agreement.

304 It also follows that, in view of the foregoing (see, in particular, paragraphs 227 to 232 above), the Commission rightly inferred from the finding of that inducement, the two parts of which were provided for in the Agreement, that the latter restricted competition by object.

305 That conclusion is not called into question by the objective allegedly pursued by the Agreement.

306 The applicants' allegation that the Agreement pursues legitimate objectives, including inter alia Teva's early entry to the United Kingdom market, is not capable of calling into question either the existence of an inducive benefit or the competition-restricting nature of the non-marketing and non-challenge clauses in the Agreement (see also paragraphs 183 and 273 above). Consequently, even if the arguments in question had an established factual basis, they would not be capable, in any event, of invalidating the Commission's finding that the Agreement constituted a restriction by object.

307 It should also be noted that the parties' intention is not a necessary factor in determining whether a type of coordination between undertakings is restrictive (see paragraphs 183 and 301 above).

308 In addition, since the Agreement contained non-marketing and non-challenge clauses, the inherently restrictive nature of which has not been validly called into question, and since the Commission found that there was an inducement, it could correctly regard that agreement as a market exclusion agreement, which thus pursued an anticompetitive objective. According to settled case-law, the mere fact that an agreement also pursues legitimate objectives is not enough to preclude the classification of that agreement as a restriction of competition by object (see paragraph 183 above).

309 It follows that the plea alleging errors of law and of assessment in relation to the classification of the Agreement as a restriction of competition by object must be rejected in its entirety.

D. The plea alleging errors of law and of assessment in the classification of the Agreement as a restriction by effect

1. Arguments of the parties

310 The applicants submit that the Commission erred in law in taking the view that, to establish the existence of a restriction of competition by effect, it should examine a priori the likely effects of an agreement (ex ante analysis), at the time it is concluded, and should not assess a posteriori whether the implementation of the agreement at issue entailed any anticompetitive effects (ex post analysis).

311 The applicants also argue that the assessment of whether there was a restriction by effect in the present case is vitiated by errors of assessment. In particular, the applicants accuse the Commission of having presented only a series of unsubstantiated possibilities of what might have happened, and not a likely counterfactual scenario. As regards the assessment of the effects of the Agreement, they submit that, as a result of the Agreement, they entered the United Kingdom market in July 2007, following the invalidation of the UK 947 patent in the United Kingdom, and that they could not have entered that market sooner in the absence of an agreement. The applicants add that, even if the Commission had correctly examined the likely consequences of the Agreement at the time it was entered into, those consequences are not adverse compared to the likely counterfactual scenario.

312 The Commission contends that the applicants are relying on a distorted reading of the contested decision and states that it rightly considered in the contested decision that, under the principle of legal certainty, the developments after the conclusion of the Agreement cannot influence the analysis of the anticompetitive effect of the Agreement at the time it was entered into.

313 As regards the alleged errors of assessment, the Commission submits that it carried out a detailed counterfactual analysis which demonstrates that, without the Agreement, the applicants would probably have decided to launch at risk. It also disputes both the ex post analysis and the ex ante analysis of the effects of the Agreement by the applicants.

2. Findings of the Court

314 It should be borne in mind that where some of the grounds in a decision on their own provide a sufficient legal basis for the decision, any errors in the other grounds of the decision have no effect on its operative part. Moreover, where the operative part of a Commission decision is based on several pillars of reasoning, each of which would in itself be sufficient to justify that operative part, that decision should, in principle, be annulled by the Court only if each of those pillars is vitiated by an illegality. In such a case, an error or other illegality which affects only one of the pillars of reasoning cannot be sufficient to justify annulment of the decision at issue because that error could not have had a decisive effect on the operative part adopted by the Commission (see judgment of 14 December 2005, General Electric v Commission, T 210/01, EU:T:2005:456, paragraphs 42 and 43 and the case-law cited).

315 As noted in paragraph 184 above, in deciding whether an agreement is prohibited by Article 101(1) TFEU, there is no need to take account of its actual effects once it is apparent that its object is to prevent, restrict or distort competition within the internal market.

316 Consequently, where the Commission bases a finding of infringement both on the existence of a restriction by object and on the existence of a restriction by effect, an error rendering unlawful the ground based on the existence of a restriction by effect does not, in any event, have a decisive effect on the operative part adopted by the Commission in that decision, since the ground based on the existence of a restriction by object, which can by itself justify the finding of an infringement, is not vitiated by an illegality.

317 In the present case, it is clear from the examination of the plea alleging errors of assessment and of law in relation to the classification of the Agreement as a restriction of competition by object that the applicants have not shown that the Commission erred in concluding, in the contested decision, that the agreements in question had as their object the prevention, restriction or distortion of competition within the internal market, within the meaning of Article 101(1) TFEU.

318 The present plea in law must therefore be rejected as ineffective.

E. The plea, raised in the alternative, alleging infringement of Article 101(3) TFEU and inadequate reasoning

1. Arguments of the parties

(a) The incorrect assessment of the condition relating to the efficiencies provided for in Article 101(3) TFEU and the insufficient reasoning for that assessment

319 The applicants dispute the Commission's requirement that they explain the 'qualitative efficiencies' of the Agreement other than their entry to the market, even though they had identified the difficulties they were facing in entering the market by their own means, without the Agreement, at that time. Moreover, since the Commission itself had recognised that removing a competitor would have had an impact on the structure of the market in question, it should have acknowledged that the entry of a single undertaking such as Teva would improve that structure.

320 Furthermore, the applicants accuse the Commission of having, in fact, refused to examine their arguments and their evidence demonstrating that, in general, reverse payment settlements enable the early market entry of generics.

321 The Commission refers to its previous arguments disputing that the Agreement represented for the applicants the fastest route to enter the market. It adds that, even if the Agreement facilitated the applicants' entry, they were able to enter the market only with Servier's generic medicine and therefore the only efficiencies, which, moreover, have not been established, concern the distribution of Servier's perindopril.

322 The Commission considers that the applicants' criticism of an alleged general prohibition of reverse payment settlement agreements is irrelevant since the contested decision concerns the Agreement with its particular characteristics.

(b) The incorrect assessment of the other conditions provided for in Article 101(3) TFEU and the insufficient reasoning for that assessment

323 The applicants, first, criticise the Commission for not having examined their argument that the Agreement benefited consumers by increasing competition from perindopril generics and for having wrongly rejected as irrelevant their line of argument concerning the beneficial effects of reverse payment settlement agreements for consumers and society.

324 Secondly, the applicants argue that the Commission does not justify its peremptory assertion that the value transfer provided by the Agreement was not indispensable to achieve the alleged efficiency gains. Moreover, the Commission disregarded the Guidelines on the application of Article [101](3) [TFEU] (OJ 2004 C 101, p. 97; 'the Guidelines on Article 101(3) TFEU'), and in particular paragraph 75 of those guidelines, by second guessing the business judgment of the applicants and wrongly rejected their arguments concerning reverse payment settlement agreements as being too general.

325 Thirdly, the applicants criticise the Commission for not having examined the condition concerning the non-elimination of competition and for not having responded to the arguments they put forward in that regard.

326 The Commission refers to its previous arguments to dismiss the claim that the Agreement accelerated the competition from perindopril generics. Moreover, it considers that the general statements which are unrelated to the present case concerning the beneficial effects of settlement agreements and the need to make reverse payments in the context of those agreements are irrelevant. Finally, the Commission considers that it rightly held that it was unnecessary to examine the condition in Article 101(3) TFEU concerning the elimination of competition, in the light of the cumulative nature of the conditions provided for in that provision.

2. Findings of the Court

327 Article 101(3) TFEU provides for a derogation from the provisions of Article 101(1) TFEU by virtue of which agreements covered by paragraph 1 which satisfy the requirements of paragraph 3 are not prohibited.

328 The requirements laid down in Article 101(3) TFEU are as follows: first, the agreement concerned must contribute to improving the production or distribution of the goods in question, or to promoting technical or economic progress; secondly, consumers must be allowed a fair share of the resulting benefit; thirdly, it must not impose on the participating undertakings any restrictions which are not indispensable; and, fourthly, it must not afford them the possibility of eliminating competition in respect of a substantial part of the products in question.

329 Those conditions were reproduced in paragraph 34 of the Guidelines on Article 101(3) TFEU. They are cumulative (judgments of 13 July 1966, Consten and Grundig v Commission, 56/64 and 58/64, EU:C:1966:41, p. 505; of 17 January 1984, VBVB and VBBB v Commission, 43/82 and 63/82, EU:C:1984:9, paragraph 61; and of 15 July 1994, Matra Hachette v Commission, T 17/93, EU:T:1994:89, paragraph 104).

330 Pursuant to Article 2 of Regulation 1/2003 '[t]he undertaking or association of undertakings claiming the benefit of Article [101(3) TFEU] shall bear the burden of proving that the conditions of that paragraph are fulfilled'.

331 The Court of Justice - relying on Regulation No 1/2003 and, in particular, on recital 5 thereof, according to which, first, it is for the party or the authority alleging an infringement of the competition rules to prove the existence thereof and, secondly, it is for the undertaking or association of undertakings invoking the benefit of a defence against a finding of an infringement to demonstrate to the required legal standard that the conditions for applying that defence are satisfied - has held that, although according to those principles the legal burden of proof is borne either by the Commission or by the undertaking or association concerned, the factual evidence on which a party relies may be of such a kind as to require the other party to provide an explanation or justification, failing which it is permissible to conclude that the burden of proof has been discharged (judgment of 7 January 2004, Aalborg Portland and Others v Commission, C 204/00 P, C 205/00 P, C 211/00 P, C 213/00 P, C 217/00 P and C 219/00 P, EU:C:2004:6, paragraphs 78 and 79).

332 Thus, in some cases, the facts relied on by the undertaking invoking the benefit of the exemption under Article 101(3) TFEU may be such as to oblige the Commission to provide an explanation or justification, failing which it is permissible to conclude that the burden of proof has been discharged (judgments of 6 October 2009, GlaxoSmithKline Services and Others v Commission and Others, C 501/06 P, C 513/06 P, C 515/06 P and C 519/06 P, EU:C:2009:610, paragraph 83, and of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 711).

333 Lastly, it must also be noted that any agreement which restricts competition, whether by its effects or by its object, may in principle benefit from an exemption under Article 101(3) TFEU (judgments of 13 July 1966, Consten and Grundig v Commission, 56/64 and 58/64, EU:C:1966:41, pp. 342 and 343 and 347 to 350; of 13 October 2011, Pierre Fabre Dermo-Cosmétique, C 439/09, EU:C:2011:649, paragraphs 49 and 57; and of 15 July 1994, Matra Hachette v Commission, T 17/93, EU:T:1994:89, paragraph 85).

334 In the present case, the Commission focused its examination on the first requirement for the application of Article 101(3) TFEU. It examined, inter alia, two types of efficiency gains alleged by the applicants. As regards, first, the claim that the Agreement facilitated and expedited Teva's early market entry, the Commission considered that, even if the Agreement allowed Teva to procure perindopril, that market entry would occur at the same time as that of the other generic companies, with the result that the applicants would have needed to explain which objective qualitative efficiencies would flow from it distributing Servier's perindopril, and no such explanation was provided. It added that the restrictions involved in the exclusive purchasing clause were not indispensable for a distribution agreement (recitals 2091 to 2095 of the contested decision). As regards, secondly, the argument that reverse payment patent settlement agreements facilitate early entry, the Commission emphasised that the Agreement did not provide for Teva's early entry. It added that, in order to establish that reverse payment patent settlement agreements are indispensable and benefit consumers, the applicants merely relied on general statements and concepts. It therefore concluded that it was not necessary to examine the fourth requirement laid down by Article 101(3) TFEU, namely whether the Agreement eliminated all competition (recitals 2112 to 2122 of the contested decision).

335 The applicants primarily dispute the Commission's analysis of the first requirement for the application of Article 101(3) TFEU (see paragraphs 319 and 320 above).

336 It should be borne in mind, in that respect, that, in order to meet that first requirement, an agreement must contribute to improving the production or distribution of goods or to promoting technical or economic progress. That contribution is not identified with all the advantages which the undertakings participating in the agreement derive from it as regards their activities, but with appreciable objective advantages, of such a kind as to offset the resulting disadvantages for competition (judgment of 13 July 1966, Consten and Grundig v Commission, 56/64 and 58/64, EU:C:1966:41, p. 348; see, also, judgment of 27 September 2006, GlaxoSmithKline Services v Commission, T 168/01, EU:T:2006:265, paragraph 247 and the case-law cited; see, lastly, paragraph 50 of the Guidelines on Article 101(3) TFEU).

337 It is therefore for the Commission to examine whether the factual arguments and the evidence submitted to it show, in a convincing manner, that the agreement in question must enable appreciable objective advantages to be obtained (see judgment of 27 September 2006, GlaxoSmithKline Services v Commission, T 168/01, EU:T:2006:265, paragraph 248 and the case-law cited).

338 That approach may entail a prospective analysis, in which case it is appropriate to ascertain whether, in the light of the factual arguments and the evidence provided, it seems more likely either that the agreement in question must enable appreciable objective advantages to be obtained or that it will not (see judgment of 27 September 2006, GlaxoSmithKline Services v Commission, T 168/01, EU:T:2006:265, paragraph 249 and the case-law cited).

339 In the present case, the applicants first allege an efficiency gain linked to Teva's early market entry.

340 However, it is clear from the plea relating to the restriction by object that the Agreement prevented Teva from entering the market (see paragraph 274 above). It is also clear that, even if the Agreement could be interpreted, in the context of a prospective analysis (see paragraph 338 above), as allowing Teva to enter the United Kingdom market, that entry would not correspond to the entry of a new competitor or early entry.

341 First, the generic perindopril distributed by Teva under the Agreement was that of Servier (see also paragraph 271 above), which, moreover, the latter could have sold in competition with the other generic companies irrespective of Teva. It can be seen from the contested decision (recital 2085 of that decision), that the applicants do not dispute that Servier had entered into an agreement for the distribution of its generic perindopril in the United Kingdom with another generic company. The Commission thus rightly considered that only qualitative efficiency gains linked to the broader or more efficient distribution of perindopril by Teva could have allowed an exemption (recital 2094 of the contested decision), and the applicants do not dispute that they did not establish such qualitative gains (recitals 2085 and 2094 of the contested decision). Secondly, Servier would not have supplied and indeed did not supply its perindopril to Teva before the validity of its patents came to an end, with the result that it cannot be considered that the Agreement would have allowed Teva to enter the market early during the period of validity of the patents (see also paragraph 272 above). In that respect, it is irrelevant that, as the applicants submit, the Agreement would have allowed them to enter the market with Servier's perindopril before they could have entered it with their own product. It must be borne in mind that only objective benefits may be taken into account, since the efficiency gains are not assessed from the subjective perception of the parties (see judgment of 8 September 2016, Generics (UK) v Commission, T 469/13, not published, under appeal, EU:T:2016:454, paragraph 354 and the case-law cited; see, also, paragraph 49 of the Guidelines on Article 101(3) TFEU and paragraph 337 above).

342 As regards the second alleged efficiency gain, concerning general benefits in relation to patent challenges and the early entry of generic companies as a result of reverse payment patent dispute settlement agreements, it must be noted that, contrary to the applicants' submission (see paragraph 320 above), the Commission examined the applicants' arguments in support of their allegation, although it rightly confined itself to brief and general considerations (recital 2119 of the contested decision). In order to assess whether the Agreement should, if necessary be exempted, the Commission had to examine the specific clauses of the Agreement and not the clauses generally included in reverse payment patent dispute settlements.

343 It follows that the Commission rightly held that the first requirement laid down in Article 101(3) TFEU was not met by the Agreement.

344 It also follows that, given the cumulative nature of the four exemption requirements (see paragraph 329 above), the Commission was entitled to decide that the Agreement could not enjoy an exemption under Article 101(3) TFEU. Accordingly, contrary to the applicants' submission (see paragraphs 323 and 325 above), the Commission cannot be criticised for not examining whether the Agreement fulfilled the second or the fourth condition laid down by Article 101(3) TFEU (see, to that effect, judgment of 13 July 1966, Consten and Grundig v Commission, 56/64 and 58/64, EU:C:1966:41, p. 505, and the order of 25 March 1996, SPO and Others v Commission, C 137/95 P, EU:C:1996:130, paragraph 34), particularly since it had considered, for the sake of completeness, that the third exemption requirement was not satisfied (recitals 2095 and 2121 of the contested decision).

345 It should be noted, in that respect and also for the sake of completeness, that the Commission did not disregard the Guidelines on Article 101(3) TFEU (paragraph 75 of those guidelines) when it examined the third exemption requirement relating to the indispensable nature of the restriction. As regards the first alleged efficiency gain, the Commission inferred that some of the conditions in the Agreement were not indispensable solely from the wording of the clauses concerned, without prejudice to Teva's commercial assessment of those clauses. Moreover, as regards the second alleged efficiency gain, the Commission rightly rejected as irrelevant the applicants' arguments intended to establish that reverse payment patent dispute settlement agreements are generally indispensable (see paragraph 342 above), since those arguments did not concern the Agreement specifically.

346 It follows from all the foregoing considerations that the plea alleging infringement of Article 101(3) TFEU and a failure to state sufficient reasons for the examination of the requirements for exemption from that provision must be rejected.

F. The pleas relating to the fine

1. Pleas in support of the application for annulment of Article 7 of the contested decision imposing a fine on the applicants

(a) Arguments of the parties

347 The applicants submit that the Commission has infringed the principles of legal certainty, non-retroactivity, the protection of legitimate expectations and nullem crimen, nulla poena sine lege by imposing a fine on them, although they could not reasonably have foreseen, at the time when the alleged offence was committed, that their conduct infringed competition rules. According to the applicants, in its decision-making practice, the Commission generally abstains from imposing fines, or imposes symbolic fines, when it examines new issues. Moreover, when the Agreement was concluded, no precedent existed in the European Union, with the exception of the guidance in favour of agreements, such as the one at issue, in the 2004 Guidelines on technology transfer agreements (paragraphs 29 and 209 of those guidelines), and the large majority of the courts in the United States considered that patent settlement agreements containing restrictions which fell within the scope of the patent did not infringe the competition rules. Furthermore, several years after the Agreement and following the drafting of several reports evaluating the competitive situation in the pharmaceutical sector, the Commission demonstrated extreme caution on several occasions with regard to the possible competitive issues raised by reverse payment settlements.

348 The Commission contends that the application of Article 101 TFEU to the Agreement was certainly foreseeable. Agreements between competitors, such as the Agreement in the present case, are not exempt from the application of competition law because they concern intellectual property rights, particularly since the restrictions provided for in the Agreement did not fall within the scope of the patents at issue. The Commission adds that the 2004 Guidelines on technology transfer agreements are irrelevant since the Agreement does not contain any transfer of technology and the decisions of the lower courts of the United States of America applied different competition rules from those applied by the Commission. Finally, the applicants, like the Commission in its reports on the pharmaceutical sector, should be cautious and nuanced in their claims regarding patent settlement agreements, in particular by not assuming that all such agreements are identical.

(b) Findings of the Court

349 As a preliminary point, it should be observed that the effective penalisation of infringements of competition law cannot go so far as to disregard the principle that offences and penalties must have a proper legal basis as enshrined in Article 49 of the Charter of Fundamental Rights (see, by analogy, as regards criminal penalties and the Member States' obligation to counter illegal activities affecting the financial interests of the Union, judgment of 5 December 2017, M.A.S. and M.B., C 42/17, EU:C:2017:936, paragraph 61).

350 It must next be observed that, according to the case-law of the Court of Justice, the principle that offences and penalties must have a proper legal basis implies that legislation must define clearly offences and the penalties which they attract. That requirement is satisfied where the individual concerned is in a position to ascertain from the wording of the relevant provision and, if need be, with the assistance of the courts' interpretation of it, what acts and omissions will make him criminally liable (see judgment of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 40 and the case-law cited).

351 The principle that offences and penalties must have a proper legal basis cannot be interpreted as precluding the gradual, case-by-case clarification of the rules on criminal liability by judicial interpretation, provided that the result was reasonably foreseeable at the time the offence was committed, especially in the light of the interpretation put on the provision in the case-law at the material time (see judgment of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 41 and the case-law cited).

352 The scope of the notion of foreseeability depends to a considerable degree on the content of the text in issue, the field it covers and the number and status of those to whom it is addressed. A law may still satisfy the requirement of foreseeability even if the person concerned has to take appropriate legal advice to assess, to a degree that is reasonable in the circumstances, the consequences which a given action may entail. This is particularly true in relation to persons carrying on a professional activity, who are used to having to proceed with a high degree of caution when pursuing their occupation. Such persons can therefore be expected to take special care in evaluating the risk that such an activity entails (see judgment of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 42 and the case-law cited).

353 It should be added that the need for professional advice appears all the more evident where, as was the case here, it is necessary to prepare and draft an agreement intended to prevent or to settle a dispute.

354 In that context, even though, at the time of the infringements found in the contested decision, the Courts of the European Union had not yet had the opportunity to rule specifically on a settlement agreement of the type concluded between Servier and Teva, the latter should have expected, if necessary after taking appropriate legal advice, its conduct to be declared incompatible with the EU competition rules, especially in the light of the broad scope of the terms 'agreement' and 'concerted practice' established by the case-law of the Court of Justice (see, to that effect, judgment of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 43).

355 In particular, Teva could assume that accepting non-marketing and non-challenge clauses, by themselves restrictive of competition, on the basis of an inducement and not its recognition of the validity of the patents in question, rendered the inclusion of such clauses in a patent settlement agreement entirely illegitimate and constituted a misuse of the patent, unrelated to its specific purpose (see paragraph 228 above). Teva could therefore reasonably have foreseen that its conduct was caught by the prohibition laid down in Article 101(1) TFEU (see, to that effect, judgments of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 46, and of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 764).

356 In addition, it must be noted, that, well before the date of conclusion of the Agreement, there was case-law on the application of competition law in fields characterised by the presence of intellectual property rights (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T 471/13, not published, under appeal, EU:T:2016:460, paragraphs 314 and 315).

357 In that regard, it should be noted, first of all, that the Court of Justice held, as early as 1974, that although the existence of rights recognised under the industrial property legislation of a Member State is not affected by Article 101 TFEU, the conditions under which those rights may be exercised may nevertheless fall within the prohibitions contained in that article and that this may be the case whenever the exercise of such a right appears to be the object, the means or the consequence of an agreement (judgment of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraphs 39 and 40).

358 Next, since the judgment of 27 September 1988, Bayer and Maschinenfabrik Hennecke (65/86, EU:C:1988:448), it is clear that patent dispute settlements may be categorised as agreements within the meaning of Article 101 TFEU.

359 Moreover, it must be pointed out that, by the Agreement, Teva and Servier actually decided to conclude a market exclusion agreement (see paragraph 241 above). Although it was only in a judgment delivered after the conclusion of the Agreement that the Court of Justice held that market exclusion agreements, in which the stayers are to compensate the goers, constitute a restriction on competition by object, it nonetheless made clear that that type of agreement conflicts patently with the concept inherent in the provisions of the Treaty relating to competition, according to which each economic operator must determine independently the policy which it intends to adopt on the market (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C 209/07, EU:C:2008:643, paragraphs 8 and 32 to 34). In concluding such an agreement, Teva could not, therefore, have been unaware of the anticompetitive nature of its conduct.

360 Indeed, although, because the Agreement was concluded in the form of a patent settlement, its unlawful nature might not have been evident to an outside observer such as the Commission, the same could not be said for the parties to the Agreement.

361 The conclusion in paragraph 355 above is not called in question by the other arguments submitted by the applicants.

362 In the first place, the argument alleging that the Commission has a practice of not imposing fines or imposing merely symbolic fines when it examines new legal issues cannot be accepted, since, in the present case, Teva could reasonably have foreseen that, in acting as it did, that is to say by agreeing to be paid to stay out of the market, its conduct was caught by the prohibition laid down in Article 101(1) TFEU (see paragraph 355 above). As noted in paragraph 359 above, it could not have been unaware of the anticompetitive nature of its conduct in the present case.

363 In addition, it should be noted that, in one of the Commission decisions cited by the applicants, it is apparent that, unlike in the present case, 'it was not sufficiently clear to [the party concerned] that its behaviour would constitute an infringement'.

364 In any event, according to the case-law, the Commission has a margin of discretion when setting the amount of fines, in order that it may channel the conduct of undertakings towards compliance with the competition rules. The fact that in the past the Commission has applied fines of a particular level for certain types of infringements, such as symbolic fines for infringements of an unprecedented nature, does not mean that it is precluded from increasing that level within the limits indicated in Regulation No 1/2003, if that is necessary to ensure the implementation of EU competition policy. The proper application of the European Union competition rules in fact requires that the Commission may at any time adjust the level of fines to the needs of that policy (judgment of 8 September 2016, Lundbeck v Commission, T 472/13, under appeal, EU:T:2016:449, paragraph 773).

365 In the second place, as regards, first, the applicants' reliance on paragraph 29 of the 2004 Guidelines on technology transfer agreements, under which the classification of a party to an agreement as a potential competitor seems to be linked to the absence of infringement of the other party's intellectual property rights, it suffices to note that, even if the guidelines were applicable to the Agreement, that line of argument has already been rejected in the context of the examination of the plea concerning potential competition, for the reasons set out in paragraph 135 above.

366 In any event, in view of the entire analysis of the plea relating to the finding of potential competition between Servier and Niche (see paragraphs 84 to 96 and 109 to 162 above) and taking into account the case-law of the Court of Justice, which allows for the gradual, case-by-case clarification of the rules on criminal liability by judicial interpretation (see paragraph 351 above), Teva could reasonably foresee that it would be regarded by the Commission as a potential competitor of Servier. It should be added that the very presence in the Agreement of a non-marketing clause is a factor which also justifies the conclusion that Teva saw itself as at least a potential competitor of Servier.

367 As regards, secondly, the applicants' reliance on paragraph 209 of the 2004 Guidelines on technology transfer agreements, still on the assumption that those guidelines were applicable to the Agreement, it is clear from that paragraph that non-challenge clauses are 'generally' considered to fall outside Article 101(1) TFEU. In view of the use of that word, that provision does not preclude that non challenge clauses may, in certain circumstances, constitute an infringement of the competition rules.

368 In addition, paragraph 209 of the 2004 Guidelines on technology transfer agreements provides that non-challenge clauses may fall outside Article 101(1) TFEU in so far as the 'very purpose' of those clauses, by preventing future challenges to the intellectual property rights covered by the agreements, is to settle an existing dispute or to avoid a future dispute.

369 Where, as in the present case, it is a reverse payment, and not the recognition by each of the parties of the validity of the patent, which led to the adoption of the Agreement, it cannot be considered that the 'very purpose' of that agreement - which is actually a market exclusion agreement with anticompetitive objectives - is 'to settle existing disputes and/or to avoid future disputes'.

370 The applicants cannot therefore rely on paragraph 209 of the 2004 Guidelines on technology transfer agreements in order to argue that the Agreement falls outside the scope of Article 101(1) TFEU.

371 Moreover, it is expressly provided, in point 243 of the 2014 Guidelines on technology transfer agreements, that a non-challenge clause may infringe Article 101(1) if the licensor, besides licensing the technology rights, induces, financially or otherwise, the licensee to agree not to challenge the validity of the technology rights.

372 The existence of that new provision, which was admittedly adopted after the events that constituted the infringement, but which was intended merely to clarify the provisions contained in the 2004 Guidelines on technology transfer agreements, confirms the conclusion set out in paragraph 370 above.

373 In the third place, the applicants cannot rely on the case-law of the courts of the United States of America.

374 Even if it were established that agreements of the type at issue in the present case are not contrary to the competition law applicable in the United States, that would not justify the conclusion that such agreements comply with EU law.

375 In that respect, it should be noted that an infringement of the competition law of the United States of America cannot constitute, by itself, a defect capable of rendering a decision adopted under EU law unlawful (see paragraph 243 above).

376 Given that autonomy of the respective laws, which does not preclude the potential convergence of certain aspects, the applicants could not infer from the fact that the Agreement corresponded, according to them, to the position adopted by the vast majority of the courts of the United States of America at the time that agreement was concluded that that agreement complied with EU law, especially since Teva could reasonably have foreseen that its conduct was caught by the prohibition laid down in Article 101(1) TFEU (see, inter alia, paragraphs 354 and 355 above).

377 In the fourth place, the applicants cannot rely on the Commission's reports issued following the pharmaceutical sector inquiry (see paragraph 30 above) in order to establish legitimate expectations.

378 It must first be borne in mind, in that respect, that the principle of the protection of legitimate expectations is the corollary of the principle of legal certainty, which requires that legal rules be clear and precise, and aims to ensure that situations and legal relationships governed by EU law remain foreseeable (see judgments of 15 February 1996, Duff and Others, C 63/93, EU:C:1996:51, paragraph 20, and of 5 September 2014, Éditions Odile Jacob v Commission, T 471/11, EU:T:2014:739, paragraph 90).

379 Next, in accordance with settled case-law, the right to rely on the principle of the protection of legitimate expectations extends to any person in a situation where an EU institution has caused him or her to have justified expectations. Three conditions must be satisfied in order for a claim to entitlement to the protection of legitimate expectations to be well founded. First, precise, unconditional and consistent assurances originating from authorised and reliable sources must have been given to the person concerned by the EU administration. Secondly, those assurances must be such as to give rise to a legitimate expectation on the part of the person to whom they are addressed. Thirdly, the assurances given must comply with the applicable rules (see judgment of 5 September 2014, Éditions Odile Jacob v Commission, T 471/11, EU:T:2014:739, paragraph 91 and the case law cited).

380 The evidence relied on by the applicants suggests, at most, that there were doubts concerning the validity of agreements such as the Agreement in the present case, but certainly not that precise, unconditional and consistent assurances were given that the Commission would consider such an agreement to be valid. In addition, even if such assurances had been given, they would in any event not comply with the applicable rules since, as noted in paragraph 304 above, the Commission was right to conclude that the Agreement constituted a restriction of competition by object.

381 Even if the applicants are relying on the Commission's reports issued following the pharmaceutical sector inquiry or comments made by the Commission in that respect, without, however, invoking the principle of the protection of legitimate expectations, but in support of their more general line of argument that Teva could not reasonably foresee that its conduct would infringe the competition rules, it would be sufficient, in order to reject that argument, to refer, inter alia, to paragraphs 354, 355 and 359 above.

382 It follows from all of the foregoing that the present pleas in law must be rejected.

2. Pleas in support of the application in the alternative for a reduction in the amount of the fine

(a) The failure to state reasons and infringement of the principles of legal certainty and the protection of legitimate expectations

(1) Arguments of the parties

383 The applicants submit that the Commission did not fulfil its obligation to state reasons and breached the principles of legal certainty and the protection of legitimate expectations by departing from the rules laid down in the Guidelines on the method of setting fines imposed pursuant to Article 23(2)(a) of Regulation No 1/2003 (OJ 2006 C 210, p. 2; 'the Guidelines on the method of setting fines') in order to set the basic amount of the fine, without giving appropriate reasons to justify that departure. The Commission simply observes, to rule out determining the basic amount by reference to the proportion of sales concerned by the infringement, that the parties did not have any sales in the geographic areas concerned and that the sales figures provided by the applicants do not relate to the relevant period of the infringement and to the market that existed at that time. Moreover, the Commission justified its decision to use the value allegedly transferred under the Agreement to calculate the basic amount of the fine on the ground that that value provided important indications as to the factors taken into account when setting the fine, such as the gravity of the infringement. However, as is clear from their arguments put forward in support of the plea relating to the restriction of competition by object, the applicants claim that the amount of the value transferred gives no indication as to, inter alia, the circumstances, purposes or results of the Agreement and, therefore, is unrelated to the gravity of the infringement.

384 Furthermore, the Commission disregarded the Guidelines on the method of setting fines, in particular paragraph 19 thereof, which provides that the basic amount of the fine must be related to a proportion of the value of sales, depending on the gravity of the infringement.

385 In addition, the applicants dispute having made 'improper gains' through the Agreement. They state, in any event, that the amount of such gains would have been far less than the Commission claimed, on account of the deductions that would have to be made.

386 The Commission explains that it departed from the general methodology for the setting of fines in applying paragraph 37 of the Guidelines on the method of setting fines. It states that it used the value transfer as a basis for setting the amount of the fine, relying on paragraph 31 of the Guidelines on the method of setting fines, which provides for the need to increase the fine in order to exceed the amount of gains improperly made as a result of the infringement where it is possible to estimate that amount. However, in the present case, in the Commission's view, using the value transferred not only ensured that the applicants would be deprived of the expected gains improperly made by entering into the Agreement but also took account of the sales the applicants would have achieved if they had entered the market, thus reflecting the 'loss of competition' resulting from the Agreement.

(2) Findings of the Court

387 It should be noted first of all that the plea raised by the applicants is somewhat ambiguous, since it refers to both a formal challenge to the contested decision - which, according to the applicants, is not supported by a sufficient statement of reasons - and a challenge to the substance of that decision. Those two challenges must be taken into account and examined in turn.

(i) The formal challenge to the contested decision

388 The applicants argue that the Commission failed to explain sufficiently, first, why it used a method of calculating the basic amount of the fine different from that set out in the Guidelines on the method of setting fines and, secondly, how the chosen method was adapted to the context in which the Agreement was concluded.

389 It should be noted that, according to settled case-law, the statement of reasons required by the second paragraph of Article 296 TFEU must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in question in such a way as to enable the persons concerned to ascertain the reasons for the measure in order to defend their rights and to enable the EU judicature to exercise its power of review (see judgment of 14 February 1990, Delacre and Others v Commission, C 350/88, EU:C:1990:71, paragraph 15 and the case-law cited).

390 In that regard, it must be borne in mind that the statement of reasons required by Article 296 TFEU must be appropriate to the nature of the measure in question. Thus, the requirements to be satisfied by the statement of reasons depend on the circumstances of each case, in particular the content of the measure and the nature of the reasons given. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons meets the requirements of Article 296 TFEU must be assessed with regard not only to its wording but also to its context (see, to that effect, order of 14 November 2013, J v Parliament, C 550/12 P, not published, EU:C:2013:760, paragraph 19 and the case-law cited).

391 In particular, it should be observed that, in the determination of the amount of the fine in a case of infringement of the competition rules, the Commission fulfils its obligation to state reasons when it indicates in its decision the factors which enabled it to determine the gravity of the infringement and its duration, and it is not required to indicate all the figures relating to the method of calculating the fine (see, to that effect, judgment of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 68 and the case-law cited).

392 Moreover, the Commission is not obliged, in stating the reasons for its decisions, to adopt a position on all the arguments relied on by the parties concerned during the administrative procedure. It is sufficient if the Commission sets out the facts and the legal considerations having decisive importance in the context of the decision (see, to that effect, judgment of 11 January 2007, Technische Glaswerke Ilmenau v Commission, C 404/04 P, not published, EU:C:2007:6, paragraph 30).

393 However, when the Commission decides to depart from the general methodology set out in the Guidelines on the method of setting fines, by which it limited the discretion it may itself exercise in setting the amount of fines, and relies, as in the present case, on point 37 of those guidelines, the requirements relating to the duty to state reasons incumbent upon it must be complied with all the more rigorously (see, to that effect, judgment of 13 December 2016, Printeos and Others v Commission, T 95/15, EU:T:2016:722, paragraph 48).

394 In the present case, the statement of reasons for the contested decision is set out, inter alia, in recital 3146 of the contested decision, in which the Commission stated the following:

'The generic undertakings agreed not to sell generic perindopril in the geographic area concerned by each agreement and therefore did not have any sales in the geographic areas concerned. Point 37 of the Guidelines on [the method of setting] fines should therefore be applied to the generic undertakings in this case. Point 37 of the Guidelines on [the method of setting] fines allows the Commission to depart from the normal methodology of the Guidelines on [the calculation of] fines because of the particularities of a given case or the need to achieve deterrence in a particular case.'

395 In recital 3152 of the contested decision, the Commission observed as follows:

'According to Regulation No 1/2003 and the Guidelines on [the method of setting] fines, the fine should relate to the following factors: (i) the gravity of the infringement, (ii) its duration, (iii) any aggravating or attenuating circumstances and (iv) the need to achieve deterrence. The Commission, in exercising its margin of discretion, considers that in the present case, given its particularities, the amount of the value transfer received by the generic companies provides important indications as to these factors. The sales figures for the period after the infringement proposed by Teva do not relate to the relevant period of the infringement and the market that existed at that time and therefore cannot be considered as the closest proxy.'

396 Lastly, the Commission concluded its analysis, in recital 3162 of the contested decision, as follows:

'In applying point 37 of the Guidelines on [the method of setting] fines, for the purpose of the calculation of the fine, the following amounts of value transferred to the generic undertaking in each infringement are taken into account and correspond to each generic company's basic amount:

...

- for Teva: EUR 15 569 395;

- ...'

397 Footnote 4111 to the contested decision states that the amount of the value transfer of GBP 10.5 million received by Teva was converted into euro at the exchange rate of 0.67440.

398 It is clear from the abovementioned extracts from the contested decision that (i) the Commission did not apply the method laid down in the Guidelines on the method of setting fines, which is based on the value of sales during the last full business year of the undertaking's participation in the infringement, but rather a method which used the amount of the value transfer received by Teva as the basic amount for the calculation of the fine, (ii) it did so because of the very purpose of the agreements, which were market exclusion agreements as a result of which the generic companies were not present on that market at the time of the infringement, (iii) it took the view that the method chosen enabled it to take into account, inter alia, the gravity and the duration of the infringement and (iv) that method was, in its view, more appropriate than the method proposed by Teva, since the latter was based on a value of sales after the infringement.

399 Consequently, the Commission provided a sufficient statement of reasons in the contested decision to enable the applicants to understand the reasons why it had applied a method of calculating the basic amount of the fine that differed from the general methodology set out in the Guidelines on the method of setting fines and, moreover, why that method, which was intended to allow it to take the gravity and duration of the infringement into account, was adapted to the specific circumstances of the case.

400 It follows from the foregoing that the present plea must be rejected in so far as it seeks to challenge the formal legality of the contested decision.

(ii) The challenge to the substance of the contested decision

401 In the first place, as regards the allegedly unjustified application of point 37 of the Guidelines on the method of setting fines, it should be noted that the Commission may, for the purpose of setting the fine, have regard both to the total turnover of the undertaking, which gives an indication, albeit approximate and imperfect, of the size of the undertaking and of its economic power, and to the proportion of that turnover accounted for by the goods in respect of which the infringement was committed, which gives an indication of the scale of the infringement (see, to that effect, judgment of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 62).

402 Thus, point 13 of the Guidelines on the method of setting fines states that '[i]n determining the basic amount of the fine to be imposed, the Commission will take the value of the undertaking's sales of goods or services to which the infringement directly or indirectly ... relates in the relevant geographic area within the EEA'. Point 6 of those Guidelines states that '[t]he combination of the value of sales to which the infringement relates and of the duration of the infringement is regarded as providing an appropriate proxy to reflect the economic importance of the infringement as well as the relative weight of each undertaking in the infringement' (see, to that effect, judgment of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 63).

403 It follows that point 13 of those Guidelines pursues the objective of adopting, in principle, as the starting point for the setting of the fine imposed on an undertaking, an amount which reflects the economic significance of the infringement and the relative size of the undertaking's contribution to it (see, to that effect, judgment of 22 October 2015, AC-Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 64).

404 As can be seen from the judgment of 22 October 2015, AC-Treuhand v Commission (C 194/14 P, EU:C:2015:717, paragraph 65), point 37 of the Guidelines on the method of setting fines states however that 'although these Guidelines present the general methodology for the setting of fines, the particularities of a given case or the need to achieve deterrence in a particular case may justify departing from such methodology.'

405 In the present case, it is common ground that, by reason of the very purpose of the Agreement, which is a market exclusion agreement, Teva was not present on that market at the time of the infringement.

406 Accordingly, the Commission was not able to use the value of sales made by Teva on the relevant market during the infringement and, in particular, during the last full business year of its participation in the infringement, that is to say the period to which reference is made in point 13 of the Guidelines on the method of setting fines.

407 Those particular circumstances entitled the Commission, on the basis of point 37 of the Guidelines on the method of setting fines, to depart from the methodology set out in those Guidelines (see, to that effect, judgments of 22 October 2015, AC Treuhand v Commission, C 194/14 P, EU:C:2015:717, paragraph 67, and of 6 February 2014, AC-Treuhand v Commission, T 27/10, EU:T:2014:59, paragraphs 301 to 305).

408 The Court has, moreover, already held, in similar circumstances, that it could not seriously be disputed that, in view of the lack of sales on the market by the generic undertaking, the Commission was obliged to depart from that methodology (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T 471/13, not published, under appeal, EU:T:2016:460, paragraph 421).

409 In the second place, as regards the Commission's alleged failure to take into account the gravity of the infringement, it is clear from the Court's case-law that the gravity of infringements must be determined by reference to numerous factors such as, in particular, the particular circumstances of the case, its context and the dissuasive element of fines, although no binding or exhaustive list of the criteria to be applied has been drawn up (order of 25 March 1996, SPO and Others v Commission, C 137/95 P, EU:C:1996:130, paragraph 54; judgments of 17 July 1997, Ferriere Nord v Commission, C 219/95 P, EU:C:1997:375, paragraph 33, and of 28 June 2005, Dansk Rørindustri and Others v Commission, C 189/02 P, C 202/02 P, C 205/02 P to C 208/02 P and C 213/02 P, EU:C:2005:408, paragraph 241).

410 The factors capable of affecting the assessment of the gravity of infringements include the conduct of each of the undertakings, the role played by each of them in the establishment of the agreement, decision or concerted practice, the profit which they were able to derive from it, their size, the value of the goods concerned and the threat that infringements of that type pose to the objectives of the European Union (judgments of 7 June 1983, Musique Diffusion française and Others v Commission, 100/80 to 103/80, EU:C:1983:158, paragraph 129, and of 28 June 2005, Dansk Rørindustri and Others v Commission, C 189/02 P, C 202/02 P, C 205/02 P to C 208/02 P and C 213/02 P, EU:C:2005:408, paragraph 242).

411 It should be noted that the value chosen by the Commission in the present case for the purpose of determining the amount of the fine, namely the amount of the value transfer received by the generic undertaking, is equivalent to the cost that Servier agreed to pay to exclude a competitor from the market and the price that the generic company agreed to receive to stay out of the market, which, in the light of the case-law cited in the above paragraph, gives a reliable indication of the gravity of the infringement and the particular circumstances of the case. That value is the result of negotiations in which the generic company participated and reflects the conduct of the generic company, the role that it played in the infringement and the benefit that it gained from it, as well as the value of the goods concerned, as estimated by the parties to the Agreement.

412 The value chosen by the Commission for the purpose of setting a fine that would reflect the gravity of the infringement is, in any event, more appropriate than the value proposed by the applicants, namely the value of Teva's sales during the period immediately following that of the infringement.

413 The Commission used the amount of the value transfers - which were considered to be inducive - that Teva received under the agreement. That amount gives a better estimation of the profits that Teva derived from its participation in the infringement than the value of Teva's sales during a period other than that of the infringement.

414 In addition, even though the amount of the value transfers - considered to be inducive - that Teva would receive under the agreement was not entirely determined at the time the Agreement was signed (see paragraph 498 below), the method of calculating those amounts, at least, was already set out in the Agreement. That amount, including the part which was not yet determined at the time the Agreement was signed, was therefore the result of the negotiation in which Teva had participated in order to reach that agreement. Accordingly, it is a better reflection of Teva's conduct and the role that it played in the infringement than the method proposed by the applicants, which is based on the value of Teva's sales during a period other than that of the infringement.

415 Lastly, the method proposed by the applicants does not reflect the economic significance of the infringement as adequately as the Commission's method. The applicants' method is based on the price of perindopril sold by the generic company after the infringement whereas the economic significance of the infringement depends, to a great extent, on the higher price of perindopril sold by the originator undertaking during the infringement. The economic significance of the infringement is therefore reflected more adequately in the amount of the fine through the method used by the Commission, since the parties necessarily took into account the maintenance of the price of perindopril in order to evaluate the amount of the value transfer to be granted to Teva.

416 In that respect, it must be noted that the economic significance of the infringement is one of the elements referred to in point 6 of the Guidelines on the method of setting fines, which may usefully be taken into account in the present case, even though the Commission did not apply the method laid down in those guidelines, since that element is not indicated in the part of those guidelines dedicated to the description of that method, but rather in the introduction.

417 In third place, although the applicants dispute that Teva obtained 'improper gains' from the infringement, it should be borne in mind that the Commission was entitled to find that Teva had received, as a result of the Agreement, value transfers which had induced it to accept the non-marketing and non-challenge clauses and that, accordingly, the Commission was also entitled to classify the Agreement as an infringement of the competition rules (see paragraphs 303 and 304 above). Consequently, the value transfers at issue constituted profits for Teva that it obtained from the infringement. The applicants are therefore not justified in claiming that Teva did not obtain 'improper gains'.

418 Furthermore, the applicants cannot validly argue that the amount of the fine should have been substantially lower than that set by the Commission, as a result of deductions that should have been applied to the value transfers that they received.

419 As regards the costs corresponding to the value of Teva's perindopril stock that had to be destroyed, since the amount of those costs has not been established by the applicants, inter alia by the production of the 'appropriate invoice' mentioned in Clause 10.1 of the Agreement (see paragraph 296 above), those costs cannot give rise to any reduction in the amount of the fine calculated, inter alia, on the basis of the lump sum provided for in that clause. Moreover, the applicants have not established that those costs were inherent in the settlement of the dispute in question (see paragraph 289 above).

420 As regards the expected annual operating profit if Teva had entered the market, it is necessary to reject the applicants' argument that the loss corresponding to the lack of operating profit due to its market exclusion must be regarded as falling within the category of costs presumed to be legitimate, because they are directly linked to the settlement of the dispute (see paragraph 288 and 289 above).

421 To regard a value transfer intended to compensate the generic undertaking for not entering the market as legitimate would amount, in essence, to accepting that the originator undertaking may pay a generic competitor to stay out of the market. That is the very definition of an inducement (see paragraph 230 above), which leads to the finding of a restriction of competition by object. Such a transfer cannot therefore be regarded as legitimate.

422 Furthermore, the loss of profit for the generic company corresponding to the profits they could have obtained had they entered the market cannot in any event be deducted from the amount of the value transfer in order to obtain a 'net' value transfer, which, according to the applicants, is the only amount capable of reflecting the scope of the 'improper gains' obtained by Teva and thus being taken into account for the purpose of determining the amount of the fine.

423 The purpose of a fine is not simply to remove the benefits that an undertaking has obtained through its anticompetitive conduct, but also, as is apparent from point 4 of the Guidelines on the method of setting fines, to deter that undertaking and other undertakings from engaging in such conduct (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T 471/13, not published, under appeal, EU:T:2016:460, paragraph 429). If the purpose of the fine were to be confined merely to negating the expected profit or advantage, insufficient account would be taken of the fact that the conduct in question constitutes an infringement of Article 101(1) TFEU and of the punitive nature of the fine in relation to the actual infringement committed (see, to that effect, judgment of 27 September 2006, Archer Daniels Midland v Commission, T 329/01, EU:T:2006:268, paragraph 141).

424 In the present case, if the fine imposed on Teva were set at a level below that of the inducive benefit which it enjoyed because of the infringement, the fine would not have a deterrent effect.

425 Admittedly, since the settlement agreement at issue is an exclusion agreement, it entails, for the excluded generic company, a loss as regards the profits it could have made by entering the market.

426 However, that loss, which is the direct result of the unlawful conduct of the generic company, cannot be taken into account for the purposes of reducing the amount of the fine designed to penalise that infringement.

427 Moreover, at the time a generic company is in a position to enter the market or, on the contrary, receive a value transfer not to do so, the payments arising under an agreement entered into with an originator company are certain, whilst the profits that might result from market entry are subject to the vagaries of a commercial operation of that kind (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T 471/13, not published, under appeal, EU:T:2016:460, paragraph 432), vagaries which are all the greater in the case of an at risk entry.

428 Thus, if the amount of the fine imposed on a generic company were set at a lower level than that of the inducive benefit which it enjoyed as a result of an infringement, that company might find it preferable to conclude an agreement with an originator undertaking allowing it, even if that agreement gave rise to a penalty, to retain a part of the inducive benefit obtained from the infringement, rather than to enter the market at risk.

429 In the light of the foregoing considerations, the deterrent effect of the fine justifies the fact that its amount is not less than the amount of the inducive value transfer provided for in the Agreement.

430 Consequently, the amount corresponding to Teva's expected annual operating profit if it had entered the market (see paragraph 420 above) must not be deducted, for the purpose of calculating the amount of the fine, from the amount of the value transfer received by Teva.

431 Having regard to the finding set out in paragraph 428 above, it must be concluded that, even if the applicants could be regarded as invoking, in the context of the present plea, the disproportionate nature of the fine imposed on Teva, that argument would have to be rejected.

432 In the fourth place, although the applicants argue that the amount of the fine imposed on Teva runs counter to paragraph 19 of the Guidelines on the method of setting fines, in that it is not proportionate to the value of sales, it must be pointed out that that provision is applicable only where the general methodology laid down by those guidelines is used.

433 Similarly, although the applicants submit that the Commission disregarded paragraph 31 of the Guidelines on the method of setting fines by taking the 'improper gains' made by Teva as a result of the infringement into account as the basic amount, and not as an increase intended to ensure the dissuasiveness of the fine, it should be noted that paragraph 31 of the Guidelines on the method of setting fines, according to which 'the Commission will also take into account the need to increase the fine in order to exceed the amount of gains improperly made as a result of the infringement', applies only where the general methodology laid down in those guidelines is used.

434 As noted in paragraph 407 above, the Commission was entitled, on the basis of paragraph 37 of the Guidelines on the method of setting fines, to depart from the general methodology set out in those Guidelines. Thus, it could not have breached the provisions of paragraphs 19 and 31 of those Guidelines, which were not applicable in the present case.

435 It follows from the foregoing that the present plea must also be rejected in so far as it is intended to challenge the substance of the contested decision.

436 It follows from all of the foregoing that the 10th plea must be rejected.

(b) Breach of the principles of equal treatment and proportionality

(1) Arguments of the parties

437 The applicants submit that the Commission infringed the principles of equal treatment and proportionality, first, by applying to them a different method of calculation from that applied to Servier resulting in the fine imposed on them being 3.6 times higher than that imposed, for the same infringement, on the originator company, which, moreover, imposed on them the contested provisions of the Agreement and which took the unilateral decision not to supply Teva in August 2006; secondly, by imposing on them a fine that significantly exceeds the fine they would have received if they had participated in a hardcore price-fixing cartel on the same market and for the same period of time and thirdly, by not imposing on them a more moderate fine than that imposed on other generic companies, even though the infringement in which they participated was less serious, of a shorter duration and had a more limited geographic scope.

438 The Commission maintains that there was no infringement of the principles of equal treatment and proportionality in relation to Servier, in so far as the applicants, under the principle of legality, cannot rely on an unlawful act - in this case the unlawful application of a correction factor to Servier - committed in relation to a third party and they have not established that Servier required them to enter into the Agreement. As regards the claim that it infringed the abovementioned principles on account of the comparison of the fine imposed with the fine that had been imposed on the participants of a hardcore price-fixing cartel, the Commission invokes the need for a deterrent effect and rejects as irrelevant the applicants' 2007 perindopril sales. The Commission also maintains that there was no infringement of the principles of equal treatment and proportionality in relation to other generic companies by noting that the value transfer amounts provided for in each of the settlement agreements at issue differed to reflect the gravity, duration and geographic scope of the various agreements.

(2) Findings of the Court

439 As a preliminary point, it should be noted that, according to the settled case-law of the Court of Justice, when the amount of the fine is determined, there cannot, by the application of different methods of calculation, be any discrimination between the undertakings which have participated in the same infringement of Article 101 TFEU (see judgment of 12 November 2014, Guardian Industries and Guardian Europe v Commission, C 580/12 P, EU:C:2014:2363, paragraph 62 and the case-law cited).

440 Moreover, it should be noted that, according to settled case-law, the principle of non-discrimination or equal treatment, which is a fundamental principle of law, prohibits comparable situations from being treated differently or different situations from being treated in the same way, unless such difference in treatment is objectively justified (see, to that effect, judgments of 8 October 1986, Christ-Clemen and Others v Commission, 91/85, EU:C:1986:373, paragraph 19, and of 8 January 2003, Hirsch and Others v ECB, T 94/01, T 152/01 and T 286/01, not published, EU:T:2003:3, paragraph 51 and the case-law cited).

441 The applicants submit, in the first place, that Servier received more favourable treatment than Teva, in the second place, that Teva received unfavourable treatment compared to the treatment that it would have received if it had participated in a price-fixing agreement on the same market and for the same duration and, in the third place, that other generic companies which concluded settlement agreements with Servier received more favourable treatment than Teva.

442 Each of those complaints must be examined in turn.

(i) The comparison with the treatment given to Servier

443 It should be pointed out, first of all, that there are fundamental differences between the method set out in the Guidelines on the method of setting fines which the Commission applied to Servier and the method which the Commission applied to the generic undertakings (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T 471/13, not published, under appeal, EU:T:2016:460, paragraph 423).

444 In the method set out in the Guidelines on the method of setting fines, the objective of taking into account the value of sales as provided for in point 13 of those guidelines is to adopt as the starting point for the setting of the fine to be imposed on an undertaking an amount which reflects the economic significance of the infringement and the relative size of the undertaking's contribution to it. Thereafter, pursuant to points 19 and 21 of the Guidelines on the method of setting fines, the Commission, according to the gravity of the infringement, will set the proportion of that value of sales to be used for determining the basic amount. That proportion may, as a rule, be set at up to 30% and must be multiplied by a coefficient based on the duration of the infringement, in accordance with point 24 of those guidelines. Next, pursuant to point 25 of the Guidelines on the method of setting fines, irrespective of the duration of the undertaking's participation in the infringement, the Commission will include in the basic amount a sum of between 15 and 25% of the value of sales in order to deter undertakings from entering into horizontal price-fixing, market-sharing and output-limitation agreements, or even other infringements (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T 471/13, not published, under appeal, EU:T:2016:460, paragraph 424).

445 However, the method adopted with regard inter alia to the generic companies does not provide for all those stages, given that the Commission directly used the value transfers made by Servier as the basic amount, but also as the final amount of the fine (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T 471/13, not published, under appeal, EU:T:2016:460, paragraph 425).

446 It must be emphasised that, given the very purpose of the Agreement, which is a market exclusion agreement concluded between an originator company and a generic company, the infringing conduct imputed to each of the parties to the Agreement is fundamentally different, unlike the situation, for example, in a market-sharing or price-fixing agreement. The originator company which has succeeded in preventing the market entry of the generic company sells its products at a price which is, as a rule, higher than that which it could have applied in the absence of an agreement, whereas the generic company does not enter the market but enjoys compensation in exchange for its agreement not to enter that market.

447 In view of the foregoing, it would be paradoxical to establish the amount of the fine to be imposed on the generic company excluded from the market on the basis of the value, even estimated, of its sales, since the infringement consists precisely, for that company, in not selling its products. The use of a method of calculating the fine based on that value therefore would not adequately take into account the nature of the infringement in question.

448 In addition, given the lack of sales made by the generic company during the infringement period, any method of calculating the fine based on the value of those sales would necessarily be artificial and hypothetical and would not take into account the gravity of the infringement adequately and precisely.

449 The only objective and certain element available to the Commission, and subsequently the EU judicature, is the amount of the value transfer which, as can be seen from paragraph 411 above, adequately reflects the gravity of the infringement and the particular circumstances of the case.

450 Therefore, in principle, the fine to be imposed on the generic company may most appropriately be calculated on the basis of that amount.

451 As regards the originator company, however, taking into account the value of its sales, in view of the very nature of its infringing conduct, appropriately reflects the gravity of the infringement and is an adequate method of calculating the fine.

452 The above reasoning is supported by the fact that, because of the differences in the infringing conduct of the originator company and the generic company, the profits that they obtain from the infringement are different in nature. Thus, the profit for the originator company depends on the earnings linked to the sales of its product during the course of the infringement period, whereas the profit for the generic company is disconnected from any sale.

453 In view of the considerations set out in paragraphs 446 to 452 above, it must be pointed out that Teva and Servier were not in a comparable situation, which justified the decision to apply different methods of calculating the fine to them.

454 That difference in method could lead the Commission, without infringing the principle of equal treatment, to impose a larger fine on Teva than that which it imposed on Servier for its participation in the same infringement.

455 In that respect, account must be taken of the size of the value transfer received by Teva relative to the limited temporal and geographic scope of the infringement concerned, namely an infringement of one year covering only the United Kingdom (recitals 2125 and 3134 of the contested decision). The size of the value transfer led the Commission, in a justified manner (see paragraph 411 above), to impose a fine on Teva which was itself sizeable. In contrast, the limited geographic and temporal scope of the infringement led it to impose a more limited fine on Servier, in accordance with the method laid down in the Guidelines on the method of setting fines (see paragraph 444 above).

456 Moreover, it should be noted that Servier had concluded several agreements relating to perindopril with different generic companies and that those agreements applied, to a large extent, to the same geographic areas and periods.

457 In that context, it was justifiable, in order to avoid a potentially disproportionate outcome, to limit the amount of the fine imposed on Servier for each infringement, as the Commission did in the contested decision (recital 3128 of that decision).

458 In view of the foregoing considerations, it must be concluded that the fact that the fine imposed on Teva was considerably larger than the fine imposed on Servier in respect of the Agreement does not permit the conclusion that the principle of equal treatment was breached.

459 The conclusion in paragraph 458 above is not called in question by the other arguments put forward by the applicants.

460 In the first place, the applicants submit that Teva was forced to sign the Agreement by Servier, without any possibility of resisting, and should therefore have received a lighter penalty.

461 However, it has not been established that Teva was forced in that way. Indeed, the very existence of an inducive benefit, which was found in paragraph 303 above, shows that Teva benefited from the Agreement, which contradicts the argument that Servier forced it to enter that agreement. That argument is even less credible given that the amount of the value transfer ultimately received by Teva, GBP 10.5 million, is sizeable, which is an indicator of the influence that it had in the negotiation.

462 In any event, even if Servier exerted irresistible pressure on Teva to the extent that it was forced to sign the Agreement, the latter could have reported the pressure to the competent authorities and lodged a complaint with the Commission under Article 7(2) of Regulation No 1/2003 (see, to that effect, judgments of 28 June 2005, Dansk Rørindustri and Others v Commission, C 189/02 P, C 202/02 P, C 205/02 P to C 208/02 P and C 213/02 P, EU:C:2005:408, paragraphs 369 and 370; of 8 December 2011, Chalkor v Commission, C 386/10 P, EU:C:2011:815, paragraph 79; and of 6 April 1995, Sotralentz v Commission, T 149/89, EU:T:1995:69, paragraph 53). Teva was therefore still able to prevent the implementation of the infringement in question.

463 In the second place, the applicants submit that Servier took the unilateral decision not to supply Teva, and that Teva should therefore have received a smaller fine than Servier.

464 In that respect, it should be noted that, under the exclusive purchasing clause and the non-termination clause, Servier could choose not to supply Teva and to pay liquidated damages instead, and Teva would not be able to terminate the agreement, oblige Servier to supply it or source supplies from third party suppliers.

465 Thus, it follows from the Agreement itself, as concluded by Teva, that Servier was free to make a decision not to supply Teva (see paragraph 264 above).

466 Since Teva concluded an agreement giving Servier the possibility to make such a decision, the fact that Servier made such a decision is the shared responsibility of both Teva and Servier and does not show that the latter played a dominant role in the infringement and that it should therefore have received a more severe punishment than Teva.

467 It follows from the forgoing that the present plea must be rejected.

(ii) The comparison with the treatment that Teva would have received if it had participated in an agreement on prices

468 By their line of argument, the applicants request the Court, first, to determine the amount of the fine that would have been imposed on Teva had it entered the market and participated in a price-fixing agreement on the same market as that on which the infringement was found and over the same period and, secondly, to find, on the basis of the difference between the amount thus obtained and the amount of the fine imposed on it, that Teva received unjustified unfavourable treatment.

469 It should be noted, first of all, that the market entry described in paragraph 468 above did not occur, with the result that the reference to a price-fixing agreement is irrelevant.

470 Assuming that it were, nevertheless, necessary to continue the analysis, it should first be determined whether the situations relating to the price-fixing agreement described in paragraph 468 above and those relating to the exclusion agreement concluded in the present case between Teva and Servier are comparable.

471 In that respect, it should be noted that the comparison between the two fines mentioned in paragraph 468 above is not, a priori, entirely unfounded with regard to the principle of equal treatment, since, even though one of the infringements in question is hypothetical, the two agreements on which those infringements are based would arise in similar contexts, relate to identical products and be concluded between the same parties (see, to that effect, judgment of 27 September 2006, Archer Daniels Midland v Commission, T 59/02, EU:T:2006:272, paragraph 316).

472 Next, it is necessary to refer to the considerations set out in paragraphs 443 to 445 above, which also apply to this complaint, since it is also based on the comparison between the amount of a fine calculated on the basis of the general method set out in the Guidelines on the method of setting fines and the amount of a fine calculated on the basis of the method that the Commission applied to the generic companies in the present case.

473 Lastly, it must be emphasised that, given the very purpose of the Agreement, which is a market exclusion agreement concluded between an originator company and a generic company, the infringing conduct imputed to the generic company is fundamentally different from that imputed to the parties to a price-fixing agreement. Thus, the parties to a price-fixing agreement are present on the market and sell their products at a price which is in principle higher than the prices that would have prevailed in the absence of an agreement whereas, in the context of an exclusion agreement, the generic company does not enter the market, but receives compensation in return for not entering that market.

474 It is therefore appropriate to refer to the considerations set out in paragraphs 447 to 450 above, and to note that, in principle, the fine to be imposed on the generic company excluded from the market may most adequately be calculated on the basis of the amount of the value transfer.

475 By contrast, as regards the parties to a price-fixing agreement, taking into account the value of sales of one of the undertakings participating in that agreement, having regard to the very nature of the infringing conduct in question, adequately reflects the gravity of the infringement committed by it.

476 The above reasoning is supported by the fact that the differences between the infringing behaviour of companies participating in a price-fixing agreement and that of a generic company excluded from the market are such that the profits that they derive from the infringement are of a different nature. Thus, the profits of the participants in a price-fixing agreement depend on income from the sales of their products during the infringement, whereas the profit of the generic undertaking is disconnected from any sale and depends on the value transfer.

477 In view of the considerations set out in paragraphs 472 to 476 above, it may be concluded that the Commission was entitled to apply a different method of calculating the fine to the generic companies that participated in the agreements at issue than it otherwise applies to undertakings that participate in price-fixing agreements.

478 The application of different methodologies leads to the imposition of fines of different amounts.

479 Consequently, the difference in amounts referred to by the applicants do not allow the conclusion that the Commission breached the principle of equal treatment.

480 In addition, the comparison between the amount of the fine imposed on Teva and that which would have been imposed on it if it had participated in a price-fixing agreement is all the more irrelevant since the applicants, in order to demonstrate the disproportionate nature of the fine, submit that it should be compared with the amount that would be obtained if it were calculated on the basis of the value of perindopril sales made by Teva in 2007 'upon generic entry' to the market.

481 A price-fixing agreement that led the participants in it to apply the price of perindopril that prevailed when the generic companies entered the market would have only a limited, or even non-existent, effect on competition and its economic significance would not be comparable to the Agreement, which specifically enabled the price of perindopril to be maintained at the level set by the originator company before the market entry of the generic companies.

482 Thus, the difference between the economic significance of the infringement in question and that of a price-fixing agreement leading to the application of the price of perindopril in force when the generic products entered the market justifies the difference in the amount of the fines referred to by the applicants.

483 It follows from all the foregoing that the fact that the amount of the fine imposed on Teva is, according to the applicants' calculations, three times higher than that which would have been imposed in the event of a price-fixing agreement does not permit the conclusion that the principle of equal treatment was breached or that the fine is disproportionate.

484 In the light of the foregoing, the present complaint must be rejected.

(iii) The comparison with the treatment given to other generic companies that concluded settlement agreements with Servier

485 As a preliminary point, it should be noted that the Courts of the European Union have held that the Commission's practice in previous decisions does not itself serve as a legal framework for the fines imposed in competition matters and that decisions in other cases can give only an indication for the purpose of determining whether there is discrimination (judgment of 19 April 2012, Tomra Systems and Others v Commission, C 549/10 P, EU:C:2012:221, paragraph 104), since the facts of those cases, such as the markets, the products, the undertakings and the periods concerned, are not likely to be the same (see, to that effect, judgment of 16 June 2011, Bavaria v Commission, T 235/07, EU:T:2011:283, paragraph 290).

486 However, although it is common ground that the agreements between Servier and each of the generic companies constituted separate infringements and that, consequently, the case-law cited in paragraph 439 above does not apply, those infringements were formally found and penalised in the same Commission decision and they concern contracts with certain similarities in terms of their object and the context in which they were adopted, having been, inter alia, concluded with the same originator company. Consequently, a comparison of the fines imposed on those different generic companies is not irrelevant from the point of view of observance of the principle of equal treatment (see, to that effect, judgment of 27 September 2006, Archer Daniels Midland v Commission, T 59/02, EU:T:2006:272, paragraph 316).

487 The applicants submit that the value chosen by the Commission to determine the amount of the fine did not allow it to take adequately into account the gravity, the geographic scope and the duration of each of the infringements found against the generic companies, which led it to breach the principle of equal treatment.

488 In that regard, it must be noted that even though the amount of the value transfers - considered to be inducive - that Teva would receive under the Agreement was not entirely determined at the time the Agreement was signed (see paragraph 498 below), the method of calculating those amounts, at least, was already set out in the Agreement. That amount, including the part which was not yet determined at the time the Agreement was signed, was therefore the result of the negotiation in which Teva participated in order to reach the Agreement.

489 It must be noted, first, that the value used by the Commission for the purpose of determining the amount of the fine gives a reliable indication of the gravity of the infringement and the particular circumstances of the case (see paragraphs 409 to 411 above).

490 As regards, secondly, the Commission's alleged failure to take into account the geographic scope of the Agreement, it should be noted that Regulation No 1/2003 and, in particular, Article 23(3) of that regulation, do not require the Commission to take into account the geographic scope of the infringement, as such, but rather its gravity.

491 As noted above, the value used by the Commission for the purpose of determining the amount of the fine imposed on the generic company concerned gives a reliable indication of the gravity of the infringement committed by that company and the particular circumstances of the case, and the Commission does not need to take into account, specifically, the geographic scope of the infringement.

492 In any event, during the negotiations which resulted in the amount of the value transfer ultimately used, the circumstances which the parties to the Agreement considered to be relevant for the purpose of determining that amount - including, as the case may be, the geographic scope of the Agreement (or the fact that the non-challenge clause did not apply to the proceedings before the EPO) - were necessarily taken into account by those parties. Those circumstances were therefore also taken into consideration, albeit indirectly, by the Commission, when it determined the amount of the fine on the basis of that value transfer.

493 As regards, thirdly, the Commission's alleged failure to take into account the duration of the infringement for the purpose of determining the amount of the fine, it should be noted that the fact that the Commission has not adjusted the amount of the value transfer to take account of the duration of the infringement does not justify the conclusion that it did not take that duration into account.

494 In the negotiations in which the amount of the value transfer to the generic company was determined, the parties necessarily took into consideration the profits that that generic company could have made, during the duration of the agreement at issue, if it had entered the market (recital 1196 of the contested decision), and the profits that the originator company would be able to make, during the duration of the agreement at issue, from the exclusion of the generic company from the market.

495 In setting the amount of the value transfer, the parties to the agreement in question therefore take into account the period during which the generic company agrees not to compete with the originator company, that is to say the foreseeable duration of the agreement at issue.

496 Thus, by using the amount of the value transfer received by the generic company as the amount of the fine, the Commission takes into account the foreseeable duration, as estimated by the parties, of the generic company's participation in the infringement.

497 It can therefore be concluded that the Commission took the duration of the infringement into consideration indirectly, but sufficiently, on the basis of the amount of the value transfer received by the generic company.

498 It should be added that certain clauses, such as the clause providing that Servier could choose not to supply Teva and instead pay it monthly liquidated damages, even allow the parties to adjust the overall amount of the value transfer to the actual - and not merely estimated - duration of some of the restrictions provided for in the agreement at issue.

499 By using the amount of the value transfer received by the generic company as the amount of the fine, the Commission therefore also took into account the actual duration of the generic company's participation in the infringement.

500 In addition, it should be noted that the generic company concerned was not present on the market at issue at the time of the infringement, because of the very purpose of the Agreement, which is a market exclusion agreement.

501 It was therefore impossible for the Commission to determine the amount of the fine on the basis of the value of sales made by the generic company on the market in question in one of the years during which the infringement took place.

502 It is the use of a method based on the annual value of the sales made by the undertaking concerned, as set out in the Guidelines on the method of setting fines, which then entails that, in order for the duration of the infringement to be duly taken into account, that annual value must be multiplied by the number of years that undertaking participated in the infringement.

503 That calculation, or an equivalent calculation applying a coefficient proportional to the actual duration of the infringement, is irrelevant in the context of a method based on the value transfer received by the generic company, since the amount of that transfer, unlike the annual value of the sales of the undertaking concerned, already takes account of the - actual or foreseeable - duration of the agreement at issue and therefore of the infringement.

504 Thus, the Commission was entitled to use, as the amount of the fine, the amount of the value transfer received by the generic company without it being necessary, or even appropriate, to take account of the duration of the infringement in some other way.

505 It follows from the foregoing that the value used by the Commission to establish the amount of the fines allowed it to take adequate account of the relevant circumstances specific to the context of each of the agreements in question, in particular the gravity and the duration of each of the infringements in which the generic companies were found to have participated.

506 The differences in the amounts of the value transfers received by the generic companies under the agreements in question therefore justify the equivalent differences in the amounts of the fines imposed on them.

507 Consequently, the applicants' argument that Teva was penalised more severely than the other generic companies - even though the contested decision did not find that the infringement it had committed was more serious, inter alia because of its geographic scope, or that it had lasted longer than that of the other generic companies - and that there was therefore a breach of the principle of equal treatment, is unfounded.

508 Furthermore, the fact that the fine imposed on Servier under the Agreement is less than that imposed on Teva, even though the fine imposed on Servier in respect of the agreements with the other generic companies is larger than the fines imposed on those companies, also does not justify the conclusion that those companies unduly received more favourable treatment than Teva. That difference is explained by the size of the value transfer received by Teva relative to the limited temporal and geographical scope of the infringement concerned. The size of the value transfer entails a justified increase of the amount of the fine imposed on the generic company, whereas the limited geographic and temporal scope of the infringement entails an equally justified limitation of the amount of the fine imposed on Servier (see paragraph 455 above).

509 Lastly, it is true, as the applicants submits, that the Commission indicated in recital 3151 of the contested decision that, in order to determine the amount of the fine imposed on each of the generic undertakings concerned, it had taken 'the value transferred to the generic undertaking in each infringement', 'without differentiating between the infringements on the basis of various factors of gravity such as nature, market share and geographical scope'.

510 However, as is apparent from recitals 3146 and 3152 of the contested decision (see paragraphs 394 and 395 above), the Commission considered that the method that it had adopted for calculating the amount of the fine imposed on the generic companies, which was based on the amount of the value transfer received by each of the generic companies in question, allowed it to take adequate account of the specific circumstances of each case and, in particular, the gravity and the duration of each infringement.

511 The present plea must therefore be rejected.

512 It should be added that, although the Commission appeared, in its pleadings, to ask the Court to increase the fine imposed on the applicants if it were 'to find a breach of the principles of equal treatment and proportionality by reason of a more favourable treatment of Teva', it clarified, at the hearing, as noted in the minutes thereof, that it did not intend thereby to introduce a counterclaim that the fine imposed on Teva should be increased, but simply to submit that there had not been any breach of the principle of equal treatment.

513 It follows from all the foregoing that the present complaint, and all the pleas in support of the application for a reduction of the fine, must be rejected. In addition, in view of all the considerations set out in the present judgment, it must be concluded that the amount of the fine is not disproportionate and that there is therefore no need to reduce it.

514 Since none of the pleas in law relied on by the applicants in support of their application for annulment of the contested decision is well founded or effective and since the examination of the arguments put forward in support of their application for reduction of the amount of the fine has not revealed inappropriate elements in the Commission's calculation of the amount of that fine, the action must be dismissed in its entirety.

IV. Costs

515 Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings. Since the applicants have been unsuccessful, they must be ordered to pay, in addition to their own costs, the costs incurred by the Commission, in accordance with the form of order sought by the Commission.

516 In accordance with Article 138(3) of the Rules of Procedure, the intervener must be ordered to bear its own costs.

On those grounds,

THE GENERAL COURT (Ninth Chamber)

hereby:

1. Dismisses the action;

2. Orders Teva UK Ltd, Teva Pharmaceuticals Europe BV and Teva Pharmaceutical Industries Ltd to pay, in addition to their own costs, the costs incurred by the Commission;

3. Orders the European Generic medicines Association AISBL (EGA) to bear its own costs.