A key decision for the pharmaceutical sector: in a ruling dated 17 January 2025 (Paris Court of Appeal, Div. 5, Chamber 2, No. 23/13461), the Court upheld the refusal by the French National Institute of Industrial Property (INPI) to grant a Supplementary Protection Certificate (SPC).
INPI had concluded that the veterinary Marketing Authorisation (MA) submitted was not the first MA for the product concerned, within the meaning of Article 3(d) of Regulation (EC) No 469/2009. The reason: several earlier human MAs had already been issued for the same active ingredient.
The Court of Appeal recalled and confirmed several essential points:
- The concept of "product" in the Regulation is independent of the therapeutic indication or use (human or veterinary).
- The decisive MA is the very first one obtained for the active ingredient, regardless of the route of administration, formulation, or population (human or animal).
- The classification as a "new active substance" possibly attributed by the European Medicines Agency (EMA) to the veterinary MA does not bind INPI in its analysis.
This position is in line with the established case law of the Court of Justice of the European Union (CJEU) (Pharmacia Italia, Santen, Abraxis cases). It reaffirms a strict interpretation of the SPC eligibility criteria under Article 3(d). The Regulation's objective is indeed to reward the innovation linked to the first market placement of an active ingredient, not all subsequent pharmaceutical developments.
