SPC for pharmaceuticals defined by a Markush formula
In a recent decision from the British High Court of Justice it was held that the supplementary protection certificate (SPC) for the HIV drug Darunavir, which is specified by means of a Markush formula in the claims of the basic patent, complied with the requirements of Article (3a) of the SPC Regulation.
Markush formula for Darunavir
In the basic patent Darunavir falls within the scope of several claims, and is not specified in individualized form. In fact, Darunavir is not mentioned in individualized form anywhere in the basic patent.
The decision was taken in the light of caselaw from the Court of Justice of the European Union (CJEU) interpreting Article 3(a) of the SPC Regulation not only to require that the product falls within the claims of the basic patent but also that it should be “specified” or “identified” in the claims (e.g. case C-322/10, Medeva). In a further ruling from the CJEU it was stated that it is not necessary for the active ingredient to be identified in the claims by means of a structural formula; it is sufficient for the active ingredient to be specified by a functional description (case C-493/12, Lilly).
In the present case, the British High Court of Justice interpreted the Lilly case in such a way that it is not necessary for the claim to individually name or depict the active ingredient, and that the claim may cover a number of other compounds in addition to the active ingredient. Accordingly, it was found that it is sufficient for the claim to specify the product by means of a Markush formula.