March 2011

The referral to the European Court of Justice in the case of Medeva BV vs Comptroller General of Patents will provide clarity on two important issues regarding Supplementary Protection Certificates (SPC) – firstly what is meant by "the product is protected by a basic patent in force"; and secondly, how is that phrase to be interpreted in considering a SPC for a product with multiple active ingredients and multiple approved uses.

An SPC may only be granted in respect of a product that is protected by a basic patent and for which a marketing authorisation has been granted. If an SPC is granted the protection conferred by that SPC will only extend to the product as covered by the marketing authorisation and any use of the product as a medicinal product that has been authorised prior to the grant of the certificate.

In 1990 Medeva applied for a patent for a method of making vaccine compositions against whooping cough through the combination of two antigens: pertactin and FHA. The application was successful and the patent granted. The patent expired in April 2010.  Medeva filed five applications for SPCs covering different combinations of active ingredients. Marketing Authorisations for 4 different products were submitted in support of the SPC applications: Pediacel (which has a combination of 11 active ingredients); Infanrix – IPV Hib (9 active ingredients); Infanrix – IPV (8 active ingredients); and Repevax (9 active ingredients).

The Controller General of Patents rejected all five applications. With respect to 4 of the 5 combinations for which the SPCs were sought, he held that they were not covered by the basic patent. In respect of the fifth combination (which was for pertactin and FHA, the combination claimed in the original patent), the Comptroller rejected the case for the SPC on the basis that the Marketing Authorisation for the product submitted in support claimed 11 active ingredients and not just pertactin and FHA.

Medeva's appeal to the Patents Court was dismissed. Mr Justice Kitchin held that (1) only those combinations of ingredients which fell within the scope of a claim of the basic patent could be protected under a SPC and (2) the meaning of product was the same under article 1(b) and 3(a) and thus Medeva could not argue that the product meant both the combination of just pertactin and FHA and the 9 active ingredient combination in Infanrix (Medeva having decided that was the relevant product).

Medeva appealed further to the Court of Appeal. The Court of Appeal, recognising the complexity of the area of law in question, referred questions on Articles 3(a) and 3(b) of the Regulation to the Court of Justice of the European Union.

The questions on Article 3(a) relate to:

1. what is meant by "the product is protected by a basic patent in force" and the criteria for deciding this, in general and in the specific circumstances of cases such as the present one. In relation to the specific circumstances, the questions cover whether there are further or different criteria (and if so what these are) where the case concerns a medicinal product comprising more than one active ingredient or a multi-disease vaccine; and
2. whether a multi-disease vaccine comprising multiple antigens is "protected by a basic patent" if:

(i) one antigen of the vaccine is "protected by the basic patent in force"; and/or

(ii) all antigens directed against one disease are "protected by the basic patent in force".

The question on Article 3(b) is whether the Regulation and in particular Article 3(b) permit the grant of an SPC for a single active ingredient or combination of active ingredients where:

(i) a basic patent in force protects the single active ingredient or combination of active ingredients; and

(ii) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid marketing authorisation, which is the first marketing authorisation that places the single active ingredient or combination of active ingredients on the market?

The decision of the European Court of Justice is expected later this year.