Supplementary Protection Certificates (pharmaceutical products)

Working of pharmaceutical inventions (human and animal drugs, phytopharmaceutical products, methods for obtaining said drugs/products) requires an Official Marketing Authorization (“Autorisation de mise sur le marché”), usually delivered several years after the filing of the basic patent. SPCs provide supplementary protection for medicines subject to an Official Marketing Authorization.

Legal basis: since July 2, 1992, SPC applications are governed by European Regulations No. 1768/92, No. 1610/96, No. 1901/2006 and No. 469/2009, modified by Regulation 2019/933 of May 20, 2019. The French Intellectual Property Law (CPI) transposes the Regulation in Articles L.611-2-3°, L611-3, R.617-1 to R.617-2-2 CPI.

Application: SPCs can be requested no later than six months after the Official Marketing Authorization or no later than six months after the grant of the basic patent. The SPC will only be granted to the holder of the basic patent or his successor in title. An application for a SPC must be filed with INPI. The basic patent must be in force at the date of application for the SPC.

Duration and maintenance: SPCs provide a protection up to five years from either the date when the basic patent is granted or fifteen years after the Marketing Authorization (the shortest term applies). An additional six-month term may be obtained for Marketing Authorizations in the pediatric field. SCPs are subject to the payment of annual fees. SPCs remain in force only if the fees are paid and if the Marketing Authorization remains valid.

Case Law: both the French Patent Office (INPI) and the Court of Appeal of Paris have currently a rather strict approach of the meanings of Article 3a of Regulation No. 469/2009. It is noticeable that the Court of Appeal has a very strong tendency to confirm SPC refusals decided from INPI, which are mainly based on the strict interpretation of Article 3a.