Industrial Property Law

Advances in science have led to the rapid development of biotechnologies. But to what extent can living organisms be patented? This question raises ethical questions, as industrial logic clashes with moral concerns. 
1) Treatment and diagnostic methods
For ethical and public health reasons, Article L. 611-16 of the Intellectual Property Code excludes from the scope of patents methods of surgical o …

Patentability of life forms

Advances in science have led to the rapid development of biotechnologies. But to what extent can living organisms be patented? This question raises ethical questions, as industrial logic clashes with moral concerns. 

For ethical and public health reasons, Article L. 611-16 of the Intellectual Property Code excludes from the scope of patents methods of surgical or therapeutic treatment  of human or animal bodies, and diagnostic methods applied to human or animal bodies. Nevertheless, substances or compositions included in the state of the art that allow the implementation of these methods are patentable if their use in these circumstances is innovative (Art. L. 611-11, paragraph 4, IP Code). In addition, they can be patented for any new therapeutic application within the framework of such methods, as long as the new application is not included in the state of the art (Art. L. 611-11, para. 5, IP Code).

2) Human dignity/Public order/Moral standards

In order to protect the human genome from any commercial appropriation, the French legislator has specified that the human body, at the various stages of its constitution and development, as well as the simple discovery of one of its elements, including the total or partial sequence of a gene, cannot constitute a patentable invention (Art. L. 611-18 IP Code). In addition, any invention whose exploitation would be contrary to human dignity, public order or morality cannot be patented (Art. L. 611-17 IP Code).

On 6 July 1998, the EU adopted Directive No 98/44 on the legal protection of biotechnological inventions . The directive aims to guarantee “high-risk” investments in research and development, particularly in the field of genetic engineering (recital 2). Member States are required to protect biotechnological inventions under their national patent laws by transposing the text by 31 July 2000 at the latest (Art. 1 Directive No 98/44). The directive proclaims the non-patentability of the human body and its genes (Art. 5(1)), but recognizes the patentability of an element isolated from the human body or otherwise produced by a technical process, including the total or partial sequence of a gene (Art. 5(2)). The criterion of industrial application must, however, be respected. An element of the human body may form part of a product eligible for patent protection, but it may not, in its natural environment, be the subject of any appropriation . The aim of these provisions is to provide a sufficiently rigorous framework for patent law to ensure that living matter of human origin remains effectively available and inalienable so that human dignity is safeguarded .

In France, the transposition of Directive No 98/44 raised a number of difficulties. The Council of State (Conseil d'État) was not in favor of transposing the directive as it stood. In effect, the text overturned the principles of French law on living matter (blood, organs or genes), and its transposition, according to the Council, established choices contrary to those made by the legislator in 1994 . The National Consultative Ethics Committee (Comité consultatif national d’éthique) also considered that it would be inappropriate to amend French law to comply with the European text . The government agreed. As a result, the bill transposing the directive, adopted by the Council of Ministers on 31 October 2001, set aside the controversial provisions of Article 5 of the directive. In the end, Articles 5 and 6 of the directive were transposed by Law No 2004-800 of 6 August 2004 on bioethics  while the rest of the European text was incorporated into national law by Law No. 2004-1338 of 8 December 2004 on the protection of biotechnological inventions. In the meantime, France was censured by the Court of Justice for failing to meet its transposition obligation .

While Article L. 611-18, paragraph 1, of the Intellectual Property Code reproduces the wording of Article 5(1) of Directive No 98/44, the provisions of paragraph 2 are more restrictive than those of Article 5(2) of the directive, as the French text limits patent protection to the technical application of an element of the human body. This protection covers the element of the human body only to the extent necessary to implement and exploit this particular application. This restrictive position is reinforced by the wording of Article L. 613-2-1 of the Intellectual Property Code, which limits the scope of a claim covering a gene sequence to that part of the sequence directly linked to the specific function set out in the description. The scope of patent protection for biotechnological inventions, on the other hand, is more in line with Directive No 98/44. According to Article L. 613-2-2 of the Intellectual Property Code, the protection conferred by a patent on a product containing or consisting of genetic information extends to any material in which the product is incorporated and in which the genetic information is contained and performs the function indicated.

Paragraph 3 of Article L. 611-18 of the Intellectual Property Code explicitly excludes from patentability certain processes relating to the human body, the commercial exploitation of which would be contrary to public policy and standards of morality. Thus, processes for cloning human beings, processes for modifying the genetic identity of human beings, the use of human embryos for industrial or commercial purposes, or total or partial gene sequences taken as such, cannot be patented. The Court of Justice has clarified the scope of the exclusion relating to the use of human embryos. A “human embryo” is any human ovum from the stage of fertilization, or any unfertilized human ovum into which the nucleus of a mature human cell has been implanted, or which, by means of parthenogenesis, has been induced to divide and develop , provided in the latter case that, in the light of current scientific knowledge, it has the intrinsic capacity to develop into a human being . The exclusion from patentability applies to the use of embryos for industrial or commercial purposes, as well as for scientific research. Only therapeutic or diagnostic uses applicable to and useful for the human embryo can be patented . The Court of Justice has thus ruled that an invention whose technical instruction requires the prior destruction of human embryos or their use as starting material is excluded from patentability, whatever the stage at which this occurs and even if the description of the technical instruction claimed does not include the use of human embryos .

Patents may not be granted for animal breeds or essentially biological processes for obtaining animals, products obtained exclusively by such processes or processes for modifying the genetic identity of animals in such a way as to cause them suffering without any significant medical benefit for man or animal, nor for animals resulting from such processes (Art. L. 611-19 IP Code). These provisions are strictly interpreted to facilitate the granting of patents for transgenic animals. In the field of genetic engineering, the European Patent Office has ruled that the impossibility of cloning does not preclude any inventive step characteristic of a patent .

However, subject to Articles L. 611-16 to L. 611-19 of the Intellectual Property Code, inventions relating to a product consisting wholly or partly of biological material, or to a process for producing, treating or using biological material, are patentable. Biological material is considered to be material that contains genetic information and can reproduce itself or be reproduced in a biological system (Art. L. 611-10, para. 4, IP Code).

As plant varieties are not industrial inventions, patent law would appear to be an inappropriate means of protection. A more appropriate system has therefore been put in place by the UPOV Convention (Union for the Protection of New Varieties of Plants) of 2 December 1961 (Art. L. 623-1 et seq. IP Code). The Intellectual Property Code expressly excludes plant varieties from patent protection, as well as essentially biological processes for obtaining plants and products obtained exclusively by such processes. On the other hand, microbiological processes , products obtained by such processes or inventions whose technical feasibility is not limited to a plant variety are patentable (Art. L. 611-19 IP Code) . An invention that incorporates a gene and concerns a genetic modification of a plant species is a patentable invention .

Cass. com. 17 June 2003, LawLex202200000632JB, a treatment method is not patentable when it inevitably has a therapeutic effect.

Directive No 98/44 of 6 July 1998 OJEC, L 213 of 30 July 1998. See ECJ Case C-377/98 Netherlands, Judgment of 9 October 2001, , dismissing the action for annulment of Directive No 98/44 brought by the Netherlands. In June 1999, the Administrative Council of the European Patent Office incorporated the provisions of the into the Implementing Regulations of the European Patent Convention: OJ EPO, 1999, 425. See EPO, 8 December 1994, OJ EPO, 1995, 388.

Case C-34/10 Brûstle v Greenpeace eV, Judgment of 18 October 2011, LawLex202300007307JBJ, on the unpatentable nature of the use of human embryos for scientific research.

Case C-34/10 Brûstle v Greenpeace eV, Judgment of 18 October 2011, LawLex202300007307JBJ.

A microbiological process is any process using or producing biological material or involving an intervention on such material.

EPO, 25 March 2015, No G 2/12 and G 2/13, for plants obtained by an essentially biological process of crossing or selection (Tomato II and Broccoli II). 

Case C-377/98 Netherlands, Judgment of 9 October 2001, .

Directive No 98/44, recital 20; CJEU, Case C-456/03 Commission v Italy, Judgment of 16 June 2005, LawLex202300007309JBJ.

Report submitted to the Prime Minister in November 1999 “Les lois de bioéthique. Cinq ans après” (Bioethics laws. Five years on) 

See the opinion of the Comité consultatif national d'éthique, No 64 of 8 June 2000, on the draft transposition law; see Decree No 2001, 1354. 

OJ of 7 August 2004. See Constitutional Council decision No 2004-498 DC of 29 July 2004.

ECJ Case C-448/03 Commission v France, Judgment of 1 July 2004, OJEU, C 217 of 28 August 2004, not available in English.

Case C-364/13 International Stem Cell Corporation, Judgment of 18 December 2014, LawLex202300007314JBJ, on the distinction between unfertilized human ovum and human embryo.

Industrial Property Law

243. Patentability of life forms

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Les décisions de justice citées dans ce paragraphe :

Les notions juridiques connexes

243. Patentability of life forms

Demandez un accès gratuit au contenu exclusif Livv – juristes d’entreprise

Les décisions de justice citées dans ce paragraphe :

Les notions juridiques connexes

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au contenu exclusif Livv – juristes d’entreprise