INDUSTRIES, LIFE SCIENCES | The ECJ weighs in on supplementary protection certificates in Merck v Teva/Clonmel decision

On 19 December 2024, the European Court of Justice (ECJ) issued its judgment in joined Cases C-119/22 and C-149/22 (Teva BV and Teva Finland Oy v Merck Sharp & Dohme Corp. and Merck Sharp & Dohme Corp. v Clonmel Healthcare Limited, respectively) concerning the interpretation of the requirements necessary to obtain a supplementary protection certificate (the “SPC”) for a medicinal product, which, as is well known, is governed by Article 3 of Regulation (CE) No. 469 of 6 May 2009 (the “Regulation”). The two cases brought up to the European Court address the issue of the requirement of patent coverage of the medicinal product, and the presence of a pre-existing SPC on a pharmaceutical product whose composition partially overlaps with that of another medicinal product. The Court recalls that the identity or difference of two products depends on a comparison of the active ingredient(s) contained in them, irrespective of their therapeutic application: thus, where a product consists of a combination of two different active ingredients, the final product is to be considered different from the medicinal product consisting of only one of the two active ingredients. Therefore, an SPC application for a product consisting of active ingredient A and active ingredient B cannot be rejected on the basis of a pre-existing SPC for a product that has only active ingredient A or B.  In the further question noted, the Court held that the requirement under Article 3(a) of the Regulation, concerning the mentioning of active ingredients in the basic patent, must be interpreted to mean that it is not sufficient to mention them in the basic patent claim, but that such a product must fall (to an expert in the field), in the light of the description and drawings of the patent itself, within the invention covered by the patent on the filing date.

Newsletter n. 105 – March 2025