Yesterday the European Court of Justice (ECJ) has published three decisions concerning the question of how well defined the medicinal product has to be in the claims of the patent for which an SPC is sought. This question has been the key point of ongoing discussions that started with the “Medeva” decision of the ECJ, in which it was held that the active ingredient has to be “specified” in the claims. The three decisions of the ECJ issued yesterday give further explanations as to how the term “specified”, as used in the “Medeva” decision, should be interpreted.

In particular, in the decision “Eli Lilly” C-493/12, the Court stated that in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of SPC Regulation No 469/2009, it is not necessary for the active ingredient to be identified in the claims of the patent, but it is sufficient for the active ingredient to be covered by a functional formula in the claims of a patent. According to the Court the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, when interpreting the claims in the light of the description of the invention.

Further, in the decision “Actavis C 443/12, the Court ruled that a patent holder is precluded from obtaining, on the basis of the same patent but a subsequent MA for a different medicinal product containing an active ingredient in conjunction with another active ingredient which is not protected as such by the patent a second SPC relating to that combination of active ingredients, when the patent holder already obtained an SPC for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients. So, if the patent holder has a first SPC based on a product containing an active ingredient, he may not obtain a second SPC for the same patent for a combination product containing the active ingredient, when the combination product contains a second active ingredient that is not protected by the patent.

The situation above would be decided in a different manner, if the second ingredient is also protected by the claims. This has been made clear by the third decision of the EJC concerning SPCs which was published yesterday. In the decision “Georgetown” C-484/12, the Court decided that if a patent holder obtained a first SPC for a combination of several active ingredients based on a marketing authorization for a medicinal product consisting of the combination of several active ingredients, he may obtain a second SPC for one of those active ingredients provided that the single active ingredient is protected by the patent. Thus, a grant of multiple SPCs relating to different products on the basis of the same patent is possible.

Should you have any questions, please feel free to contact lenhard@mueller-bore.de