Medeva v Comptroller General of Patents (CJEU, C-322/10, 2011)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Court of Appeal (England and Wales), the Court held that Article 3(a) of Regulation 469/2009 precludes the grant of a supplementary protection certificate (SPC) for active ingredients not specified in the wording of the claims of the basic patent. It accepted, however, under Article 3(b), an SPC for a combination of two active ingredients corresponding to that in the claims where the authorised medicinal product contains other active ingredients as well. The judgment makes the wording of the claims the reference point for Article 3(a) and allows an SPC to rest on the marketing authorisation (MA) of a multivalent product such as a combination vaccine.

Facts and procedure

Medeva held a European patent relating to an acellular whooping cough vaccine combining two antigens, pertactin and filamentous haemagglutinin, granted on 18 February 2009 and expired on 25 April 2010. It filed five SPC applications for DTPa-IPV/HIB vaccines, relying on French, German and UK MAs for six medicinal products each containing between eight and eleven active ingredients. On 16 November 2009 the UK Patent Office refused all five: for four, the active ingredients concerned were not all in the claims of the patent; for the fifth, the MAs covered products containing nine active ingredients. After the High Court dismissed the appeal on 27 January 2010, the Court of Appeal referred six questions by decision of 24 June 2010.

The applicable law

Regulation 469/2009, which codifies Regulation 1768/92, makes an SPC conditional, among other things, on the product being protected by a basic patent in force (Art. 3(a)) and on a valid MA (Art. 3(b)). Following Farmitalia, the Court recalled that patent law has not been harmonised in the Union (paras 21 to 23), whereas the Regulation seeks a uniform solution to prevent divergent developments between Member States (para 24). It relied on Article 5, under which the certificate confers the same rights as the patent (para 25), and on the 1990 explanatory memorandum and recital 14 of Regulation 1610/96 (para 27).

Question

Does Article 3(a) allow an SPC for active ingredients not specified in the claims of the basic patent, and does Article 3(b) preclude an SPC for the claimed combination where the authorised medicinal product contains other active ingredients?

Decision

The Court first held that Article 3(a) precludes the grant of an SPC relating to active ingredients not specified in the wording of the claims of the basic patent relied on (paras 25 and 28). Where a patent claims a product composed of two active ingredients without claiming each of them separately, no SPC may be granted for one of them alone (para 26). It then turned to the purpose of the certificate, which is to make up for the insufficient effective protection under the patent to recoup research investment (paras 30 to 32). Refusing an SPC for a combination merely because it forms part of a medicinal product containing other active ingredients would run counter to that purpose and might encourage the development of monovalent products, to the detriment of patients and public health (paras 33 to 36). The certificate protects the product covered by the MA, not the medicinal product as a whole (para 37), and covers all authorised uses of the product as a medicinal product (para 39). Article 3(b) therefore does not preclude, provided the other conditions of Article 3 are met, an SPC for a combination of two active ingredients corresponding to that specified in the claims where the authorised product also contains other active ingredients (para 42). Only the first MA of a medicinal product containing the combination counts for Article 3(d) (para 40), and only one certificate may be granted per basic patent protecting a product (para 41).

Key points for practice

• The wording of the claims of the basic patent is the reference point for Article 3(a): an active ingredient not specified there cannot be the subject of an SPC (paras 25 and 28).
• A patent claiming a combination does not support an SPC for one of its components on its own (para 26).
• The MA of a multivalent product may support an SPC for the claimed combination it contains, since the certificate concerns the product, not the medicinal product (paras 37 and 42).
• Practical point: eligibility for an SPC is shaped when the claims are drafted, since each active ingredient or combination that may later be the subject of a certificate must be specified there.

Provisions applied

Regulation (EC) No 469/2009

Arts 1, 3, 4 and 5

Regulation (EC) No 1610/96

recital 14

Regulation (EEC) No 1768/92

codified by Regulation 469/2009

Case law cited

Farmitalia (C-392/97); Spain v Council (C-350/92); Hässle (C-127/00); AHP Manufacturing (C-482/07); Biogen (C-181/95)

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.