Teva and Others v Merck Sharp & Dohme and Merck Sharp & Dohme v Clonmel (CJEU, C-119/22 and C-149/22, 2024)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On references from the Finnish Market Court (Markkinaoikeus) and the Supreme Court of Ireland, the Court of Justice held that Article 3(c) of Regulation 469/2009 does not preclude the grant of an SPC for a combination of two active ingredients where one of them has already been the subject of an SPC and was the only one disclosed in the basic patent (operative part, point 1). Under Article 3(a), however, express mention of a product in the claims is not enough: it must also necessarily fall under the invention covered by the patent (operative part, points 2 and 3). The judgment separates the two conditions: the content of the patent is irrelevant under Article 3(c) (point 54) but decisive under Article 3(a), particularly where the combination includes an active ingredient already in the public domain.

Facts and procedure

In Case C-119/22, Merck Sharp & Dohme holds EP 1 412 357, covering DPP-IV inhibitors for treating diabetes, including sitagliptin; claim 30 covers sitagliptin combined with metformin, long known. It holds an SPC for sitagliptin alone (Januvia) and an SPC for sitagliptin with metformin (Janumet), which Teva challenged before the Markkinaoikeus under Article 3(a), (c) and (d) (points 15 to 24). In Case C-149/22, EP 0 720 599 covers ezetimibe, and its claim 17 expressly covers ezetimibe combined with simvastatin, which was in the public domain at the priority date. After a first SPC for ezetimibe alone (Ezetrol), Merck obtained an SPC for the combination (Inegy); the High Court annulled it under Article 3(a) and (c), and the Court of Appeal upheld that ruling applying Teva (points 25 to 36).

The applicable law

Article 3 of Regulation 469/2009 makes the grant of an SPC subject to four cumulative conditions, including protection of the product by a basic patent in force (point (a)) and the absence of an earlier certificate for that product (point (c)). A product means the active ingredient or combination of active ingredients (Article 1(b)). The extent of protection conferred by the patent is governed by Article 69 EPC and its Protocol on Interpretation.

Question

Does Article 3(c) preclude an SPC for a combination A and B where A has already been the subject of an SPC, and are the Teva and Royalty Pharma criteria, or the subject matter of the invention, relevant to it? Under Article 3(a), is express mention of a combination in the claims sufficient?

Decision

The concept of product is strict: the combination A and B is a product distinct from A or B taken alone (points 41 to 45, citing Santen and Abraxis). An application cannot therefore be refused under Article 3(c) merely because A has already been the subject of an SPC (point 47). The conditions in Article 3 are cumulative and autonomous: Article 3(a) defines the material scope by reference to the patent, while Article 3(c) sets a separate limit (points 49 to 51). The Royalty Pharma and Teva concepts are not relevant to Article 3(c) (point 52), and it is immaterial that only one of the two ingredients was disclosed in the patent (points 53 and 54), the legislature having intended a simple system with easily verifiable conditions (point 55). Under Article 3(a), the Court restated the two-step Teva test (points 59 to 61): express mention meets only the second step, and the product must also necessarily fall under the invention (points 61 to 64 and 68). A mere mention of a combination with a known ingredient is not enough; the patent must make clear why the combination is necessary to solve the technical problem (point 69), which a combined effect going beyond simple addition may establish (point 70). For Inegy, the Court noted that simvastatin was in the public domain and that no combined effect appears to be disclosed, the final assessment being left to the referring court (point 72).

Key points for practice

• An earlier SPC for a single active ingredient does not bar, under Article 3(c), an SPC for its combination with another ingredient (operative part, point 1).
• The content of the basic patent is irrelevant under Article 3(c) (point 54).
• Under Article 3(a), an express combination claim is not enough if the combination does not necessarily fall under the invention (operative part, points 2 and 3).
• Practical point: for a combination SPC including a known ingredient, the patent must explain how the combination contributes to solving the technical problem, for instance through a combined effect beyond simple addition (points 69 and 70).

Provisions applied

Regulation (EC) No 469/2009

Arts 1(b), 3(a) and 3(c)

European Patent Convention

Art. 69 and Protocol on Interpretation

National law

Finnish Patents Act (patenttilaki), section 39

Case law cited

Teva UK and Others (C-121/17); Royalty Pharma Collection Trust (C-650/17); Actavis Group PTC and Actavis UK (C-443/12); Actavis Group PTC and Actavis UK (C-577/13); Abraxis Bioscience (C-443/17); Santen (C-673/18); Forsgren (C-631/13)

Related decisions

• Teva UK and Others v Gilead Sciences, CJEU, 25 July 2018, two-step test under Article 3(a) restated by the Court (points 59 to 61).
• Royalty Pharma Collection Trust, CJEU, 30 April 2020, whose concepts the Court held irrelevant to Article 3(c) (point 52).
• Santen, CJEU, 9 July 2020, cited on the strict concept of product (points 41 to 44).
• Abraxis Bioscience, CJEU, 21 March 2019, cited on the same concept (points 41 to 44).

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, French version), consulted on 11 October 2026. Only the official text is authoritative.