Language of document : ECLI:EU:C:2011:780

Case C-630/10

University of Queensland

and

CSL Ltd

v

Comptroller General of Patents, Designs and Trade Marks

(Reference for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court))

(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’))

Summary of the Order

1.        Approximation of laws – Uniform legislation – Industrial and commercial property – Patent law – Supplementary protection certificate for medicinal products – Conditions for granting – Product covered by a basic patent in force

(European Parliament and Council Regulation No 469/2009, Art. 3(a))

2.        Approximation of laws – Uniform legislation – Industrial and commercial property – Patent law – Supplementary protection certificate for medicinal products – Medicinal product protected by several basic patents – Right to only one certificate for each basic patent

(European Parliament and Council Regulation No 469/2009, Art. 3(c))

3.        Approximation of laws – Uniform legislation – Industrial and commercial property – Patent law – Supplementary protection certificate for medicinal products – Conditions for granting – Product covered by a basic patent in force

(European Parliament and Council Regulation No 469/2009, Arts 3(b), and 5)

4.        Approximation of laws – Uniform legislation – Industrial and commercial property – Patent law – Supplementary protection certificate for medicinal products – Conditions for granting – Product other than that identified in the wording of the claims of the basic patent – Not permissible

(European Parliament and Council Regulation No 469/2009, Art. 3(a))

1.        Article 3(a) of Regulation No 469/2009 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 that are not identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

(see para. 31, operative part 1)

2.        When a medicinal product is protected by a number of basic patents in force, each of those patents may be designated for the purpose of the procedure for the grant of a supplementary protection certificate for medicinal products but only one certificate may be granted for a basic patent.

(see para. 35)

3.        Article 3(b) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products 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.

(see para. 36, operative part 2)

4.        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 concerning the supplementary protection certificate for medicinal products precludes a supplementary protection certificate’s 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.

(see para. 41, operative part 3)