Teva BV, Teva Finland Oy v. Merck Sharp & Dohme LLC, formerly Merck Sharp & Dohme Corp. and Merck Sharp & Dohme LLC, formerly Merck Sharp & Dohme Corp., v. Clonmel Healthcare Limited, CJEu, 19 December 2024, Joined cases Cases C‑119/22 and C‑149/22
1. Article 3(c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products
must be interpreted as not precluding the grant of a supplementary protection certificate (SPC) for a product consisting of two active ingredients even if one of those two active ingredients has already been, alone, the subject of an earlier SPC and it is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date or priority date of that patent.
2. Article 3(a) of Regulation No 469/2009
must be interpreted as meaning that it does not suffice that a product is expressly mentioned in the claims of the basic patent in order for that product to be regarded as being protected by that patent, within the meaning of that provision. It is also necessary, in order to satisfy the condition laid down in that provision, that that product necessarily fall, from the point of view of a person skilled in the art, and in the light of the description and drawings of that patent, under the invention covered by that patent at the filing date or priority date.
3. Article 3(a) of Regulation No 469/2009
must be interpreted as meaning that a product consisting of two active ingredients (A+B) is protected by a basic patent, within the meaning of that provision, where A and B are expressly mentioned in the claims of that patent and the specification of that patent teaches that A may be used as a medicinal product for human use alone or in combination with B, which is an active ingredient in the public domain at the filing date or priority date of that patent, provided that the combination of those two active ingredients necessarily falls under the invention covered by the same patent.
The judgment can be read here.
