Case C-322/10: Judgment of the Court (Fourth Chamber) of 24 November 2011 (reference for a preliminary ruling from the Court of Appeal (England and Wales) (Civil Division) — United Kingdom) — Medeva BV v Comptroller General of Patents, Designs and Trade Marks (Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining a certificate — Concept of a ‘product protected by a basic patent in force’ — Criteria — Existence of further or different criteria for a medicinal product comprising more than one active ingredient or for a vaccine against multiple diseases ( ‘Multi-disease vaccine’ or ‘multivalent vaccine’ )
Date: 2011-11-24
Institutions: Court of Justice
Subjects: United Kingdom, labelling, market approval, medicinal product, patent








C_2012025EN.01001101.xml










28.1.2012   


EN


Official Journal of the European Union


C 25/11






Judgment of the Court (Fourth Chamber) of 24 November 2011 (reference for a preliminary ruling from the Court of Appeal (England and Wales) (Civil Division) — United Kingdom) — Medeva BV v Comptroller General of Patents, Designs and Trade Marks
(Case C-322/10) (1)

(Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Existence of further or different criteria for a medicinal product comprising more than one active ingredient or for a vaccine against multiple diseases (‘Multi-disease vaccine’ or ‘multivalent vaccine’)
(2012/C 25/17)
Language of the case: English

Referring court

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

Parties to the main proceedings


Applicant: Medeva BV

Defendant: Comptroller General of Patents, Designs and Trade Marks

Re:

Reference for a preliminary ruling — Court of Appeal (England and Wales) (Civil Division) — Interpretation of Article 3(a) and (b) 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 certificate — Concept of a ‘product protected by a basic patent in force’ — Criteria — Whether there exist further or different criteria for a medicinal product comprising more than one active ingredient or for a multi-disease vaccine

Operative part of the judgment







1.


Article 3(a) 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 the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.










2.


Article 3(b) of Regulation No 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients.






(1)  OJ C 246, 11.9.2010.