Order of the Court (Fourth Chamber) of 25 November 2011 (reference for a preliminary ruling from the High Court of Justice (Chancery Division) - United Kingdom) - University of Queensland, CSL Ltd v Comptroller-General of Patents, Designs and Trade Marks
(Article 104(3), first subparagraph, of the Rules of Procedure - 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'))
Language of the case: English
Referring court
High Court of Justice (Chancery Division)
Parties to the main proceedings
Applicants: University of Queensland, CSL Ltd
Defendant: Comptroller-General of Patents, Designs and Trade Marks
Re:
Reference for a preliminary ruling - High Court of Justice (Chancery 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 - 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')
Operative part of the order
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 identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.
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 an active ingredient 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 supplementary protection certificate application contains not only that active ingredient but also other active ingredients.
In the case of a basic patent relating to a process by which a product is obtained, Article 3(a) of Regulation No 469/2009 precludes a supplementary protection certificate being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it is possible to obtain the product directly as a result of that process is irrelevant in that regard.
____________1 - 2 - OJ C 89, 19.3.2011.