Lies don't travel far: Article 3(c) of the SPC Regulation from a German perspective

Abstract

Germany, Higher Regional Court of Düsseldorf, I-2 U 63/18, 15 March 2019 According to the Court of Justice of the European Union, Article 3(c) of the SPC Regulation precludes the holder of a patent on the basis of which a first SPC has been granted for an active ingredient thereby claimed from obtaining a second SPC for a combination if that active ingredient constitutes the sole ‘subject-matter of the invention’ (Case C-577/13) and the other active substance is not protected as such by the patent (Case C-443/12). However, this case law has raised questions that remain unanswered. In a recent decision, the Higher Regional Court of Düsseldorf sought to address the problem of how the ‘subject-matter of the invention’ is determined in case the patent is objectively incorrect. Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate (SPC) for medicinal products is a European piece of legislation in the larger context of patent term extensions. However, it is not a patent per se whose term is open for extension but rather a ‘part’ of it. This ‘part’ must be protected by the patent (Article 3(a) of Regulation No 469/2009) and relate to a ‘product’, which is defined in Article 1(b) of Regulation No 469/2009 as an active ingredient or combination of active ingredients of a medicinal product. However, the Court of Justice of the European Union (CJEU) does not seem to apply this definition in a strict or literal sense. Judge Meier-Beck of the German Federal Court of Justice (Bundesgerichtshof), writing extra-judicially (Meier-Beck, GRUR Int 2018, 657, 661), has suggested that the term ‘product’ is subject to a ‘valuation … under SPC law’. Therefore, if an active ingredient and a combination of that active ingredient and another substance have the same ‘value’ for the invention covered by the basic patent, Article 3(c) of Regulation No 469/2009 precludes the grant of a second SPC whenever one of them (either the active ingredient or the combination) has already been the subject of a first SPC. Now, the Higher Regional Court of Düsseldorf has put flesh on this suggestion to give a better understanding of how to tackle Article 3(c) of Regulation No 469/2009.