Judgment of the Court of Justice of 19 December 2024, Teva Finland (C-119/22 and C-149/22)
1. Facts
The matter stems from applications for supplementary protection certificates (“SPCs”) filed by Merck Sharp & Dohme LLC based on a European patent (“basic patent”) covering a DPP-4 inhibitor active ingredient (sitagliptin) and its potential combination with other active ingredients. An initial SPC was granted in Finland for sitagliptin alone. Subsequently, Merck applied for a second SPC for a medicinal product combining sitagliptin with another active ingredient (metformin), based on the same basic patent.
The plaintiff companies, Teva BV (and subsidiaries) (in case C-119/22) and Clonmel Healthcare Limited (in case C-149/22), challenged the validity of that second SCP before national courts, alleging that the sitagliptin + metformin combination did not meet the conditions of Article 3 of the Regulation (EC) No. 469 / 2009 (“SPC Regulation”), since metformin was in the public domain and the combined product would already have been the subject of another SPC. The national courts referred preliminary questions to the CJEU on the interpretation of the notion of “product” protected by the patent and on whether a combined product can be the subject of an SPC when one of its components has already been the subject of an SPC.
2. Pronouncements
The CJ declares that Article 3(c) of the CCP Regulation does not preclude the granting of a CCP for a product consisting of two active ingredients, even if one of those active ingredients has already been the subject of a previous CCP on its own.
Regarding the condition of Article 3(a) - which requires that the product be protected by a basic patent in force - the Court reiterates its jurisprudence (as in the judgment Teva UK C-121 / 17) and clarifies that it is not enough for the combination to be mentioned in the claims: it is necessary that, from the point of view of a person skilled in the art and in light of the description and drawings of the patent, the combination constitutes part of the protected invention.
Consequently, the fact that the second substance is in the public domain on the priority date does not exclude per se the granting of the CCP, provided that the combination is necessarily included in the invention of the basic patent.
3. Comment
This ruling provides clarity on the possibility of obtaining CCP for therapeutic combinations, even if one of the components has already been subject to complementary protection.
At the same time, the ruling emphasizes that the therapeutic combination must be included in the invention protected by the base patent, and not merely mentioned. This ensures that the patentable combination covers the specific advances that justify the patent.
For patent holders, the lesson is twofold: first, the route of combined SCPs remains open; second, they must ensure that the base patent clearly discloses the combination, otherwise the protection may be challenged.
Maria CadarsoSenior Associate of the Area Legal by ELZABURU.
