Pharmaceutical Regulation, Patents and Supplementary Protection Certificates

• Validity and infringement of product, process, second medical use and formulation patents.
• Supplementary protection certificates: grant, duration, challenges, paediatric extension.
• Generic and biosimilar entry disputes, for claimants and defendants.
• Bolar exemption and acts preparatory to marketing authorisation.
• Interaction with trade secrets over dossier data and manufacturing processes.
• Actions before the Paris Judicial Court and before the Unified Patent Court.

For an active ingredient protected by a basic patent and authorised as a medicinal product, the SPC extends protection beyond the expiry of the patent. Its duration equals the period between the filing of the patent application and the date of the first marketing authorisation in the Union, reduced by five years, up to a maximum of five years (Regulation (EC) No 469/2009). A six-month extension may be added under a paediatric investigation plan (Regulation (EC) No 1901/2006).

Litigation rarely concerns the principle and almost always the conditions: is the product protected by the basic patent within the meaning of the regulation, is the authorisation relied upon really the first for that product, does a combination give rise to a separate certificate. Since 2019, a waiver has also allowed manufacture within the Union during the term of the certificate, for export to third countries and for stockpiling with a view to day-one entry (Regulation (EU) 2019/933).

Article L. 613-5 (d) of the Intellectual Property Code excludes from infringement the studies and trials necessary to obtain a marketing authorisation for a medicinal product, together with the acts necessary to carry them out and to obtain that authorisation. The exact scope of the exemption, in particular for suppliers of active ingredients and for acts performed with a view to authorisations outside the Union, remains a field of litigation in its own right. The line runs between preparing market entry, which is lawful, and acts of early marketing, which are not.

A generics company that enters the market before the title expires takes a calculated risk. A proprietor that obtains a preliminary injunction against a product ultimately held not to infringe takes another: that of compensating the loss caused by an unjustified prohibition. The provisional measures are therefore prepared on both sides well before the expiry date: technical file, quantified guarantees, mapping of stocks and markets and, for the entrant, early preparation of the grounds of revocation arguments that will serve in defence.