BIE juli/augustus 2014, p. 148-156, Tjibbe Douma and Margot Kokke: "Supplementary protection of medicine is essential for the pharmaceutical and agro industries. The rules governing supplementary protection certificates ('SPC's) for medicinal and plant protection products are harmonised in Europe by two regulations. However, some elements of these regulations are rather unclear and not applied uniformly by national granting authorities and national courts. Questions of interpretation are frequently referred to the Court of Justice of the European Union (the '-court') by national courts. In a series of rulings at the end of 2011 the Court attempted to clarify several issues regarding Regulation 469/2009 (the 'SPC Regulation') but created new uncertainties in the process. Recently the Court handed down some new decisions in an attempt to further clarify the interpretation of the SPC Regulation. In Eli Lilly v HGS , the Court sanctioned a broad interpretation of 'protected by a basic patent in force' by ruling that functional claims in patents that sufficiently specify a product in the wording of the claims can farm the basis for SPC protection. In Actavis v Sanofi and Georgetown II, the Court clarified the circumstances in which it is possible to grant more than one SPC per basic patent. In its reasoned order in GSK Biologics the Court ruled that an 'adjuvant' is not an active ingredient within the meaning of Article 1(b) SPC Regulation whereas in Bayer CropScience the Court ruled that a 'safener' can be the subject of an SPC if Regulation 1610/96 applies (the 'Plant SPC Regulation'1D).
In this article we first discuss the background of SPCs and of the regulations and, subsequently, the uncertainty that arose after the 2011 decisions which led to three of the recent decisions. We subsequently discuss the main teachings of the decisions and the implications they may have. In addition to the actual rulings, the Court's decisions contain some interesting considerations concerning, for example, the duration of SPCs. The Court also seems to introduce a new criterion for the granting of SPCs: if the granting of an SPC were to be contrary to the objective of the SPC Regulation, the SPC could be refused."
