Judgment of the Court of Justice of December 19, 2024, Teva Finland (C-119/22 and C-149/22)
1. Facts
The matter stems from applications for a supplemental protection certificate (“SPC”) 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. In Finland, an initial SPC was granted for sitagliptin alone. Subsequently, Merck applied for a second SPC for a medication 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 SPC before national courts, arguing that the sitagliptin + metformin combination did not meet the conditions of Article 3 of Regulation (EC) No. 469/2009 (“SPC Regulation”), since metformin was in the public domain and the combination product had already been the subject of another SPC. The national courts referred questions to the Court of Justice for a preliminary ruling regarding the interpretation of the concept of a “product” protected by the patent and whether a combination product can be the subject of a SPC when one of its components has already been the subject of an SPC.
2. Statements
The Court of Justice holds that Article 3(c) of the SPC Regulation does not preclude the grant of an SPC for a product consisting of two active ingredients, even if one of those active ingredients has already been the subject of a prior SPC on its own.
With regard to the condition set forth in Article 3(a)—which requires that the product be protected by a valid basic patent—the Court reiterates its case law (as in the Teva UK judgment, C-121/17) and clarifies that it is not sufficient for the combination to be mentioned in the claims: it is necessary that, from the perspective of a person skilled in the art and in light of the patent’s description and drawings, the combination constitute part of the protected invention.
Consequently, the fact that the second substance is in the public domain as of the priority date does not, in and of itself, preclude the grant of the CCP, provided that the combination is necessarily included in the invention of the basic patent.
3. Comment
This ruling clarifies whether it is possible to obtain a CCP for therapeutic combinations, even if one of the components has already been granted supplementary protection.
At the same time, the ruling emphasizes that the therapeutic combination must be included in the invention protected by the parent patent, and not merely mentioned. This ensures that the CCP covers the specific advances that justify the patent.
For patent holders, the lesson is twofold: first, the path to combined CCPs remains open; second, they must ensure that the underlying patent clearly discloses the combination, as otherwise the protection may be challenged.
María Cadarso, Senior Associate in theLegalDepartment at ELZABURU.