The CJEU decisions in Medeva (C-322/10), Georgetown (C-422/10), Yeda (C-518/10), Queensland (C-630/10) and Daiichi (C-6/11)

The CJEU rendered in late November 2011 its decision in a number of cases referred by the English courts regarding the possibility of obtaining a Supplementary Protection Certificate for combination products. The CJEU stated that Supplementary Protection Certificates are only to be granted in accordance with the wording of the patent claim.

What is an SPC?

The purpose of obtaining a Supplementary Protection Certificate (SPC) for a medicinal product is to prolong the patent protection for a period of up to five years. The conditions for obtaining an SPC are laid down in Regulation no. 469/2009, article 3, which among other things requires that the product is protected by a basic patent in force, cf. article 3 (a), and that a marketing authorization (MA) has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate, cf. article 3 (b).

Background

All the referred cases relate to SPC applications where either the patent claims consisted of a combination of two or more active ingredients or the MA was granted for a product consisting of two or more active ingredients. The question before the CJEU was whether it is possible to obtain an SPC for a combination product, when the active ingredients according to the patent claims are not identical to the active ingredients in the product covered by the MA.

Wording of the patent claim

The Court stated in the Medeva case that article 3 (a) precludes the granting of an SPC for active ingredients which are not specified in the wording of the claims of the basic patent. This means that if the patent claims consist of A+B and the product covered by the MA consists of A+B+C there can be no SPC granted for A+B+C. This was confirmed in both the Queensland and Daiichi cases.

Similarly, the Court stated in the Medeva case that if a patent claims that a product is composed of two (or more) active ingredients, but makes no claim in relation to one of those active ingredients individually, there can be no SPC granted on the basis of such a patent for the one active ingredient considered in isolation. This means that if the patent claims consist of A+B and the product covered by the MA of only A, there can be no SPC granted for A in isolation according to article 3 (a). This was confirmed in the Yada case.

Marketing Authorization

Contrary, the Court stated that article 3 (b) does not preclude the granting of an SPC for a combination of two active ingredients, corresponding to that specified in the wording of the patent claims in cases where the medicinal product covered by the MA combines not only those two active ingredients but others as well. This means, where the patent consists of A+B and the medicinal product covered by the MA of A+B+C, an SPC can be granted for A+B.

Conclusion

On this basis we note:

  • The CJEU's judgement leaves open the question of what "specified in the wording of the claim" means. Is, for example, a Markush claim (i.e. a single patent claim defining alternatives) sufficient to obtain an SPC for a product?
  • On this basis we assess that it will only be a matter of time before we see a new referral regarding SPCs for combination products.

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