Article 3(c) of regulation (EG) 469/2009 excludes the issuance of a second supplementary protection certificate („SPC“), if a first SPC has already been issued for the product being protected by the base patent. This wording should not exclude the issuance of more than one SPC based on two different products of a base patent in general, for instance if an active ingredient „A“ and a combination of active ingredients „A+B“ is claimed in the base patent and if both the ingredient „A“ and the combination „A+B“ are approved as components of two products as two self-contained drugs. Confusion has therefore been created by the judgment of the European Court of Justice (ECJ) of November 24, 2011 in the matter C-322/10, from which it apparently could be inferred that only a single SPC per base patent is possible, irrespective of how many products are protected by the patent [see for instance C-322/10, recital 41: „On the other hand, according to Art. 3, letter c of Regulation No. 469/2009, if a product is protected by a patent, no more than one SPC can be issued for this base patent (cf. Judgement Biogen, recital 28)“].
The ECJ judgement of December 12, 2013 in the case C-484/12 now addressed this legal uncertainty. According to the judgement, multiple SPCs can be issued pertaining to single, different products based on a single base patent, provided that these different products are protected by the base patent and that the products are contained in a drug for which a marketing authorization exists. In simple terms: For the case mentioned above a first SPC on „A“ and a second SPC on „A+B“ can be obtained on the basis of one and the same base patent.