“Nivolumab and pembrolizumab cases”: the French Supreme Court clarifies the interpretation of Article 3 a) of the SPC Regulation

In two decisions rendered on February 1st, 2023, the French Supreme Court (“Cour de cassation”) overturned the decisions of the Paris Court of Appeal which had confirmed the rejections by the French PTO (“INPI”) of the supplementary protection certificate (“SPC”) applications for nivolumab and pembrolizumab.

On this occasion, the Supreme Court clarified the interpretation of Article 3 a) of Regulation (EC) No. 469/2009 (the “SPC Regulation”), i.e., when to consider whether a product is protected or not by a basic patent if it is only claimed in a functional manner in the said patent, that is without being expressly named or identified structurally. The adopted approach is in line with the one already used by the Paris Court of Appeal in the avelumab case.

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