Supplementary protection certificate (SPC)

The supplementary protection certificate, or SPC (certificat complémentaire de protection, CCP, in French), is a title that extends the protection conferred by a basic patent for a medicinal product or a plant protection product, in order to compensate for the length of themarketing authorisationprocedure. For medicinal products, it is governed by Regulation (EC) No 469/2009, as amended by Regulation (EU) 2019/933, which introduced the manufacturing waiver; for plant protection products, by Regulation (EC) No 1610/96. In France, it is granted by theINPI. The supplementary protection certificate takes effect on expiry of the basic patent and confers the same rights, within the limits of the product covered by the authorisation.

The conditions of the supplementary protection certificate

First, the product must be protected by a basic patent in force on the date of the application. Second, the product must have obtained, as a medicinal product or a plant protection product, a valid marketing authorisation, and that authorisation must be the first for the product. Third, the product must not already have been the subject of a certificate. The application is filed within six months of the first authorisation or of the grant of the patent. The Court of Justice of the European Union has clarified these conditions in abundant case law, notably on the notion of a product protected by the basic patent and on combinations of active ingredients. The regulations are available on EUR-Lex.

Duration and effects

The duration of the certificate is equal to the period elapsed between the filing of the basic patent and the first marketing authorisation in the Union, reduced by five years, and may not exceed five years. Total protection, patent and certificate combined, therefore cannot exceed fifteen years from the first authorisation. A six-month paediatric extension rewards the completion of paediatric studies. A waiver allows manufacturing during the term of the certificate for export outside the Union or for stockpiling with a view to launch on expiry.

Litigation over the supplementary protection certificate

The certificate is a major issue in pharmaceutical litigation, as it covers the last years of exclusivity, often the most profitable. Its validity is challenged by manufacturers of generics and biosimilars, and its infringement gives rise to applications for provisional measures. Certificates based on European patents fall within the jurisdiction of the Unified Patent Court, unless opted out. In practice, the firm handles such disputes, as presented on the page pharmaceutical patents and regulation.

On the interpretation of Article 3(a) of Regulation (EC) No 469/2009, the Paris Court of Appeal set aside on 25 May 2022 the INPI's refusal to grant an SPC for avelumab, departing from the nivolumab case law: see our commentary on the Avelumab case.