Joined Cases C-119/22 and C-149/22, Teva and Others: Judgment of the Court (Third Chamber) of 19 December 2024 (requests for a preliminary ruling from the Markkinaoikeus, Finland, and the Supreme Court, Ireland) – Teva BV, Teva Finland Oy (C-119/22), Merck Sharp & Dohme LLC, formerly Merck Sharp & Dohme Corp. (C-149/22) v Merck Sharp & Dohme LLC, formerly Merck Sharp & Dohme Corp. (C-119/22), Clonmel Healthcare Limited (C-149/22) (Reference for a preliminary ruling – Medicinal products for human use – Supplementary protection certificate (SPC) – Regulation (EC) No 469/2009 – Conditions for obtaining an SPC for medicinal products – Article 3(a) – Concept of product protected by a basic patent in force – Article 3(c) – Concept of product the subject of an SPC – Criteria for assessment)
Date: 2024-12-19
Institutions: Court of Justice
Subjects: drug surveillance, market approval, medicinal product, patent








C_202502040EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/2040


14.4.2025






Judgment of the Court (Third Chamber) of 19 December 2024 (requests for a preliminary ruling from the Markkinaoikeus, Finland, and the Supreme Court, Ireland) – Teva BV, Teva Finland Oy (C-119/22), Merck Sharp & Dohme LLC, formerly Merck Sharp & Dohme Corp. (C-149/22) v Merck Sharp & Dohme LLC, formerly Merck Sharp & Dohme Corp. (C-119/22), Clonmel Healthcare Limited (C-149/22)


(Joined Cases C-119/22
                (1)
and C-149/22,
                (2)
Teva and Others)

(Reference for a preliminary ruling - Medicinal products for human use - Supplementary protection certificate (SPC) - Regulation (EC) No 469/2009 - Conditions for obtaining an SPC for medicinal products - Article 3(a) - Concept of ‘product protected by a basic patent in force’ - Article 3(c) - Concept of ‘product the subject of an SPC’ - Criteria for assessment)
(C/2025/2040)
Language of the case: English and Finnish

Referring court

Markkinaoikeus and the Supreme Court

Parties to the main proceedings


Applicants: Teva BV, Teva Finland Oy (C-119/22), Merck Sharp & Dohme LLC, formerly Merck Sharp & Dohme Corp. (C-149/22)

Defendants: Merck Sharp & Dohme LLC, formerly Merck Sharp & Dohme Corp. (C-119/22), Clonmel Healthcare Limited (C-149/22)

Operative part of the judgment







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.






(1)  
            OJ C 171, 25.4.2022.

(2)  
            OJ C 191, 10.5.2022.


ELI: http://data.europa.eu/eli/C/2025/2040/oj
ISSN 1977-091X (electronic edition)