Whooping for joy! Medeva's SPC applications book a trip to Luxembourg

Supplementary protection certificates (SPCs) for pharmaceutical patents don't get much column space on this weblog, mainly because it is a reputedly nerdish subject that only SPC addicts are interested in and, more importantly, because there is already a perfectly good weblog -- The SPC Blog -- to carry the latest developments in this undeniably recondite corner of IP. However, Medeva BV v Comptroller General of Patents [2010] EWCA Civ 700, an order of the Court of Appeal for England and Wales earlier this week, has had so many of the IPKat's readers jumping up and down with excitement that he really felt he should give it a mention.

In short, on 20 April 1990 [yes, it was a World Cup year -- and Germany beat England on penalties ...] Medeva applied for a patent for a method of making acellular vaccine compositions against whooping cough by combining two antigens, pertactin (69kDa protein) and filamentous haemagglutinin (FHA). This happy combination produced so synergistic an effect such that a third antigen, pertussis toxin (LPF) was not required. This patent expired in April 2010. One year ahead of expiry, Medeva filed five applications for SPCs. Three of these related to vaccines against whooping cough, diphtheria, tetanus, meningitis and polio; the other two covered just four, leaving out the vaccine against meningitis.

The hearing officer rejected all five applications. In the case of four, he concluded that the active ingredients included vaccines against diseases other than whooping cough, which were not protected by the original patent. In the case of the fifth, though the active ingredients were limited to those protected by Medeva's patent, the market authorisation covered a combination vaccine which included vaccines against the other four diseases. To put it another way, in the case of all five there was a mismatch between the active ingredients protected by the patent and the active ingredients in the vaccine or medicinal product for which the relevant market authorisations had been given.

Medeva appealed, arguing that the hearing officer had misconstrued the meaning of the words "product protected by a basic patent" in Article 3(a) of Regulation 469/2009 on SPCs for medicinal products. That term, said Medeva, covered any product which could be subject to successful proceedings for infringement of the patent ("the infringement test"). The appeal was dismissed by the Patents Court (see The SPC Blog here) and Medeva appealed further to the Court of Appeal.

The Court of Appeal, rightly sizing up the Regulation and identifying it as a can of worms, has now prudently referred a number of questions to the Court of Justice of the European Union, Luxembourg, for a preliminary ruling

On Article 3(a)

1. Regulation 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 absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation 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 the Regulation 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 the Regulation and, if so, what are those further or different criteria?

4. For the purposes of Article 3(a), 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), 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”?

On Article 3(b)

6. Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate 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 2001/82/EC which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market?

The sealed order of the Court of Appeal, kindly furnished to this Kat by Tom Mitcheson (3 New Square) and the effervescent Hayley Hill (Rouse), can be read here.

Whooping cough here

Whooping cough for cats here