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Author: Admin | 2025-04-28
The eagerly awaited CJEU decision on the two joined referrals Teva v. MSD (C-119/22) and MSD v. Clonmel (C-149/22) relating to SPCs for combination products was handed down today on December 19, 2024.The two referrals arose from national litigation involving SPCs for a combination of active ingredients, i.e., the combination of sitagliptin and metformin in C-119/22 and the combination of ezetimibe and simvastatin in C-149/22. In both cases, SPC holder Merck/MSD had previously obtained an SPC for one single component of the respective drug combination, i.e., sitagliptin alone or ezetimibe alone. The questions referred to the CJEU thus revolved around the interpretation of Article 3(c) of the SPC Regulation, requiring that no prior SPC must have been granted for the same product to the same patent holder, and the interpretation of Article 3(a), requiring that the product is protected by the basic patent.Falling back into old habits, the CJEU reformulated no less than six of the carefully phrased questions referred by the Market Court of Finland and the Supreme Court of Ireland into a single new question, namely whether Article 3(c) of the SPC Regulation precludes the grant of an SPC for a product consisting of two active ingredients where one of these active ingredients alone has already been the subject of an earlier SPC (and where the other active ingredient was already known in the art).According to the CJEU, it follows from the strict interpretation of the term “product” endorsed in its prior decisions Abraxis Bioscience (C-443/17) and Santen (C-673/18) that a product which is a combination of two active ingredients A+B must necessarily be regarded as different from a product which is a single active ingredient A or B. There is no basis for giving the term “product” a different meaning in the context of Article 3(c) than in connection with Article 3(a). Therefore, an SPC for the combination A+B generally cannot be refused under Article 3(c) merely because a prior SPC has already been granted for one of the respective single active ingredients A or B alone. In line with this, the disclosure-content of the basic patent is plainly irrelevant in the context of Article 3(c).While it may appear self-evident that A+B is a product different from A alone, this decision puts an end to the CJEU’s prior Actavis case law (Actavis v. Sanofi, C-443/12, and Actavis v. Boehringer Ingelheim, C-577/13), in which it had been held, simply put, that a combination product is different from a single active ingredient claimed in the same basic patent only if it concerns “a totally separate innovation” (using the Court’s words in Actavis v. Sanofi). Under the new approach established in the present decision C-119/22, no such assessment is required
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