Case C-130/11: Judgment of the Court (Fourth Chamber) of 19 July 2012 (reference for a preliminary ruling from the Court of Appeal (England & Wales) (Civil Division) — United Kingdom) — Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining a supplementary protection certificate — Medicinal product having obtained a valid marketing authorisation — First authorisation — Product successively authorised as a veterinary medicinal product and a human medicinal product)
Date: 2012-07-19
Institutions: Court of Justice
Subjects: drug surveillance, market approval, medicinal product, patent








C_2012295EN.01000902.xml










29.9.2012   


EN


Official Journal of the European Union


C 295/9





Judgment of the Court (Fourth Chamber) of 19 July 2012 (reference for a preliminary ruling from the Court of Appeal (England & Wales) (Civil Division) — United Kingdom) — Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents
(Case C-130/11) (1)

(Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining a supplementary protection certificate - Medicinal product having obtained a valid marketing authorisation - First authorisation - Product successively authorised as a veterinary medicinal product and a human medicinal product)
2012/C 295/15
Language of the case: English

Referring court

Court of Appeal (England & Wales) (Civil Division)

Parties to the main proceedings


Applicant: Neurim Pharmaceuticals (1991) Ltd

Defendant: Comptroller-General of Patents

Re:

Reference for a preliminary ruling — Court of Appeal (England and Wales) (Civil Division) — Interpretation of Articles 3 and 13(1) 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 (codified version) (OJ 2009 L 152, p. 1) — Interpretation of Article 8(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67)) — Conditions for obtaining a supplementary protection certificate — Date of the first placement on the market to be taken into account for the grant of a certificate — Products comprising a common active ingredient having each received a marketing authorisation, the first for a veterinary medicinal product for a particular indication, the second for a medicinal product for human use for a different indication

Operative part of the judgment







1.


Articles 3 and 4 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 meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.










2.


Article 13(1) of Regulation (EC) No 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.










3.


The answers to the above questions would not be different if, in a situation such as that in the main proceedings where the same active ingredient is present in two medicinal products having obtained successive marketing authorisations, the second marketing authorisation required a full application in accordance with Article 8(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, or if the product covered by the first marketing authorisation of the corresponding medicinal product is within the scope of protection of a different patent which belongs to a different registered proprietor from the supplementary protection certificate applicant.






(1)  OJ C 179, 18.6.2011.