CJEU’s Ruling on the SPC Regulation and Combination SPCs

Authors: Vilhelm Schröder and Hilma Mäkitalo-Saarinen

On 19 December 2024, the Third Chamber of the Court of Justice of the European Union (the “Court”) issued a judgment in joined cases Teva v. MSD (C‑119/22) and MSD v. Clonmel (C‑149/22). These cases, referred by the Market Court of Finland and the Supreme Court of Ireland, challenged the validity of supplementary protection certificates (SPCs) granted for pharmaceutical combinations. In both cases, Merck/MSD had already secured SPCs for the individual active ingredients before seeking SPC protection for the combination product.

The questions referred to the Court primarily concerned the interpretation of Articles 3(a) and 3(c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products (the “SPC Regulation”). Article 3(a) requires that a product be protected by a basic patent in force to qualify for an SPC, while Article 3(c) prevents the issuance of an SPC if the same product has already been the subject of a previous SPC in the Member State where the application is made. The judgment addressed key questions regarding the eligibility of SPCs for combination products and the scope of protection granted by a basic patent.

Eligibility of SPCs for Combination Products (Article 3(c))

The first to fourth questions in Case C‑119/22 and the third and fourth questions in Case C‑149/22 concerned the interpretation of Article 3(c) of the SPC Regulation. The referring courts sought clarification on whether Article 3(c) prevents the granting of an SPC for a combination product consisting of two active ingredients, where one ingredient has already been subject to an earlier SPC and disclosed by the basic patent and the other was known at the time of the patent's filing or priority date.

The Court clarified that under the SPC Regulation, the concept of a “product” is based on the active ingredients or combination of active ingredients, not their therapeutic application. The Court reaffirmed that a combination of active ingredients (A+B) is considered a different product from a single active ingredient (A or B). The content of the basic patent is not relevant for the analysis under Article 3(c), as this provision addresses whether the same product has already been granted an SPC in the Member State at the time of the application.

In short, the Court concluded that Article 3(c) does not prevent granting an SPC for a combination product, even if one of the ingredients has already been subject to an earlier SPC, provided that the combination itself has not been previously granted an SPC. This ruling clarifies that combination products can receive SPC protection even when one of their active ingredients has already been granted an SPC.

Scope of the Basic Patent for SPCs (Article 3(a))

The first question in Case C-149/22 concerned the interpretation of Article 3(a) of the SPC Regulation, specifically whether a product must be expressly mentioned in the claims of a basic patent to be considered “protected by the basic patent” under this provision. The Court affirmed that the two-stage test established in the Teva v. Gilead (C-121/17) judgment applies to this scenario as well.

In Teva v. Gilead, the Court ruled that to determine whether a product is protected by a basic patent under Article 3(a) of the SPC Regulation, it must first be shown that the product, from the perspective of a person skilled in the art, necessarily falls under the invention covered by the patent. This evaluation is made in light of the patent’s description and drawings. In the second stage, the product must either be explicitly mentioned in the claims of the patent or be specifically identifiable based on the patent’s disclosure and prior art at the time of filing or priority.

The Court clarified that the mere mention of a product in the claims is not enough for the product to be considered “protected by the basic patent”. To meet the requirements of Article 3(a), the product must also fall within the invention protected by the patent. In other words, it must be identifiable as part of the invention described in the patent from the perspective of a person skilled in the art, considering the patent’s description and drawings.

The Court emphasised that granting an SPC for a product not covered by the invention claimed in the basic patent would undermine the purpose of SPCs, which is to extend protection to products that result from research directly related to the basic patent. Therefore, an SPC should only be granted for a product that is both mentioned in the claims and part of the protected invention.

Combination of Active Ingredients and SPC Protection

In Case C-149/22, the second question addressed whether a combination product consisting of two active ingredients (A+B) is “protected by the basic patent” under Article 3(a) when both A and B are expressly mentioned in the patent’s claims and the patent’s specification teaches that A can be used alone or in combination with B, with B already being in the public domain at the patent’s filing date.

The Court confirmed that the two-stage test from the Teva v. Gilead judgment applies universally, whether or not the product is expressly mentioned in the claims of the basic patent. For a product consisting of two active ingredients, the first stage requires that the combination of A and B, from the perspective of a person skilled in the art, necessarily falls under the invention covered by the patent. The second stage ensures that the active ingredients can be identified in light of the patent's description.

Furthermore, the Court clarified that the fact that one of the active ingredients was known at the time of filing and is in the public domain does not automatically disqualify the product. If the patent discloses that the combination of the two active ingredients has a combined effect going beyond the sum of the individual effects of each active ingredient and which contributes to the solution of the technical problem, this may fulfil the first stage of the test, and the product could be deemed protected by the basic patent.

Conclusion

The CJEU's rulings in Teva v. MSD (C-119/22) and MSD v. Clonmel (C-149/22) provide important insights into the interpretation of the SPC Regulation, particularly concerning combination products. The Court ruled that:

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.