Case C-443/12: Judgment of the Court (Third Chamber) of 12 December 2013 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Actavis Group PTC EHF, Actavis UK Ltd v Sanofi (Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining such a certificate — Successive marketing of two medicinal products containing, wholly or partially, the same active ingredient — Combination of active ingredients, one of which has already been marketed in the form of a medicinal product with a single active ingredient — Whether it is possible to obtain a number of certificates on the basis of the same patent and two marketing authorisations)
Date: 2013-12-12
Institutions: Court of Justice
Subjects: drug surveillance, health certificate, marketing standard, medicinal product, patent








C_2014052EN.01001802.xml










22.2.2014   


EN


Official Journal of the European Union


C 52/18





Judgment of the Court (Third Chamber) of 12 December 2013 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Actavis Group PTC EHF, Actavis UK Ltd v Sanofi
(Case C-443/12) (1)

(Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining such a certificate - Successive marketing of two medicinal products containing, wholly or partially, the same active ingredient - Combination of active ingredients, one of which has already been marketed in the form of a medicinal product with a single active ingredient - Whether it is possible to obtain a number of certificates on the basis of the same patent and two marketing authorisations)
2014/C 52/30
Language of the case: English

Referring court

High Court of Justice (Chancery Division)

Parties to the main proceedings


Applicants: Actavis Group PTC EHF, Actavis UK Ltd

Defendant: Sanofi

Intervening party: Sanofi Pharma Bristol-Myers Squibb SNC

Re:

Request for a preliminary ruling — High Court of Justice (Chancery Division) — Interpretation of Article 3(a) and (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 (OJ 2009 L 152, p. 1) — Conditions for obtaining a supplementary protection certificate — Concept of ‘product protected by a basic patent in force’ — Criteria — Possibility of granting the certificate for each medicinal product where there is a patent covering a number of medicinal products.

Operative part of the judgment

In circumstances such as those in the main proceedings, where, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, 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 precluding that patent holder from obtaining — on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent — a second supplementary protection certificate relating to that combination of active ingredients.


(1)  OJ C 389, 15.12.2012.