Industrial Property Law

The supplementary protection certificate, created by the Law of 25 June 1990 , is an industrial property right that allows the prolongation of the protection initially granted by a patent to the active ingredient or to the composition of active ingredients of a medicine or a plant protection product that has been authorized for placing on the market . It is intended to compensate for the delay in the commercial exploitation of the invention due to the gap in time between the date of filing of the patent application and the date of obtaining the first marketing authorization, corresponding to the clinical trial phase .

Regulation No 1768/92 of 18 June 1992  established a harmonized system for supplementary protection certificates relating to medicinal products, which has gradually replaced the national system provided for in particular in Articles L. 611-2, 3° and L. 611-3 of the Intellectual Property Code, so that there is no longer any supplementary protection certificate governed by this code. The regulation was replaced by Regulation No 469/2009 of 6 May 2009 , itself amended by Regulation No 2019/933 of 20 May 2019 . The conditions for the issue and validity of certificates for plant protection products are based on Regulation No 1610/96 of 23 July 1996 , which came into force on 8 February 1997.

Law No 90-510 of 25 June 1990 to make the effective duration of patent protection identical for medicines and other products, OJ No 147 of 27 June 1990.

Regulation No 469/2009 Judgment of 6 May 2009, concerning the supplementary protection certificate for medicinal products, OJ L 152 of 16 June 2009, recitals 2-8; Case C-210/12 Sumitomo Chemical Co. Ltd, Judgment of 17 October 2013,.

CJEU Case C-443/12 Sanofi, Judgment of 12 December 2013, LawLex202300006976JBJ; CA Paris, 12 April 2016, LawLex202200009205JBJ.

Regulation No 1768/92 of 18 June 1992, concerning the creation of a supplementary protection certificate for medicinal products, OJ L 182 of 2 June 1992. 

Regulation No 469/2009 of 6 May 2009, recitals 2-8, cited above.

Regulation No 2019/933 of 20 May 2019 amending Reg.No 469/2009 concerning the supplementary protection certificate for medicinal products, OJ L 153 of 11 June 2019, which provides, inter alia, for a derogation from the protection conferred by the certificate for generic or biosimilar products manufactured for export to third countries where protection does not exist or has expired (Art. 5(2).

Regulation No 1610/96 of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, OJ L198/31 of 8 August 1996.

230. Supplementary protection certificate