Pharmaceutical patents and medicines regulation

Medicines litigation is not argued like an ordinary patent dispute. It runs on three timetables that never coincide: that of the title, that of the marketing authorisation, and that of pricing and reimbursement. The firm works on:

• Validity and infringement of product, process, second medical use and formulation patents.
• Supplementary protection certificates: obtaining them, duration, challenges, paediatric extension.
• Generic and biosimilar entry disputes, in claim and in defence.
• The 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.

An SPC extends, for an active ingredient protected by a basic patent and authorised as a medicinal product, protection beyond expiry of the patent. Its term 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, capped at five years (Regulation (EC) No 469/2009). A six-month extension may be added on the basis of 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 on really the first for that product, does a combination give rise to a separate certificate. Since 2019 a waiver also permits 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 required to obtain a marketing authorisation for a medicinal product, together with the acts needed to carry them out and to obtain that authorisation. The precise 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 battleground of its own. The line runs between preparing market entry, which is lawful, and acts of early commercialisation, which are not.

Under Union law the existence of a patent is not a ground for refusing a marketing authorisation: the health authorities do not adjudicate on the patent position. The proprietor therefore cannot block the authorisation, it must go to court. Listing in the generic groups register, and then pricing and reimbursement decisions, follow their own logic and their own appeals before the administrative courts. Coordinating those three sequences, none of which waits for the others, is the essential part of the work.

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 injunction. provisional measures are therefore prepared on both sides well before the expiry date: technical file, quantified security, mapping of stocks and markets and, for the entrant, the advance assembly of the revocation arguments that will serve in defence.

A certificate expiry to prepare for, a generic entry announced, an injunction to obtain or to fend off: the useful window is counted in weeks, rarely in months. Tell us about your situation.

Le lexique du cabinet détaille les notions de la réglementation pharmaceutique liées aux brevets : AMM générique et hybride, data exclusivity, médicament orphelin, dérogation de fabrication au CCP, second medical use, Swiss-type claim, launch at risk and médicament générique.