Medeva ruling now out

The Court of Justice of the European Union gave its ruling this morning in Case C‑322/10, Medeva BV v Comptroller General of Patents, Designs and Trade Marks, a reference for a preliminary ruling from the Court of Appeal (England and Wales).

 Bordetella pertussis

In brief, in April 1990 Medeva applied for a European patent for a method for the preparation of an acellular vaccine against Bordetella pertussis (whooping cough agent), also known as ‘Pa’. This preparation consisted of a combination of two antigens as active ingredients -- pertactin and filamentous haemagglutinin (‘filamentous haemagglutinin antigen’). Their ratio was such as to provide a synergistic effect in vaccine potency. The patent was granted by the EPO on 18 February 2009, expiring on 25 April 2010.

Medeva filed five SPC applications with the UK's IPO, seeking supplementary protection for DTPa-IPV/HIB vaccines covering diphtheria (D), tetanus (T), whooping cough (Pa), poliomyelitis (IPV) and/or meningitis (Haemophilus influenzae, also known as ‘HIB’). In support of those applications, Medeva submitted marketing authorisations (MAs) granted by the French, German and UK authorities for a range of medicinal products each of which contained, in addition to the combination of pertactin and filamentous haemagglutinin, between eight and 11 other active ingredients.

In November 2009 the IPO refused to grant the SPCs applied for. In the case of four of the applications, more active components or ingredients were specified in the applications for SPCs covering those components than were identified in the wording of the claims of the basic patent, and they were not therefore protected by the basic patent under Article 3(a) of Regulation 469/2009. As for the fifth application, while the active components or ingredients identified in the patent were the same as those specified in the SPC application (ie combination of pertactin and filamentous haemagglutinin), the MAs submitted in support of that application did not fulfil the conditions laid down in Article 3(b) since they related to medicinal products containing nine active ingredients, that is to say vaccines which did not contain only the active components or ingredients specified in the SPC application and in the patent claims.

Medeva appealed unsuccessfully to the High Court and then again to the Court of Appeal, which stayed the proceedings and referred the following questions for a preliminary ruling:

‘1 Regulation No 469/2009 … recognises, amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8 [in the preamble to that regulation]. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of … Regulation [No 469/2009] by “the product is protected by a basic patent in force” and what are the criteria for deciding this? 

2 In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria? 

3 In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria? 

4 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if one antigen of the vaccine is “protected by the basic patent in force”? 

5 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if all antigens directed against one disease are “protected by the basic patent in force”?
…
6 Does … Regulation [No 469/2009] and, in particular, Article 3(b), permit the grant of a [SPC] for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and
(b) 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 authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’

The Court has just ruled as follows:

"1. Article 3(a) of Regulation ... 469/2009 ... 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 ... 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".

Comments to follow, as well as a post on this morning's other ruling in Georgetown.