As previously reported, in 2017 the Danish Maritime and Commercial Court declined to grant an application filed by Gilead to grant an injunction against Accord offering the pharmaceutical a combination product consisting of Emtricitabine and Tenofovir Disoproxil (TD), holding that the granted SPC was invalid (Ground-breaking decision on Gilead’s Tenofovir SPC in Denmark). In a…

Practitioners dealing with supplementary protection certificates (SPCs) have been holding their breath at the unfolding of the “Truvada saga” around Gilead’s SPCs for the HIV medicament Truvada, which contains the active ingredients tenofovir disoproxil and emtricitabine. The lawsuits involving the Truvada SPCs in various European countries have already given rise to such noteworthy decisions as…

In a decision issued this summer, the Swiss Federal Patent Court had the opportunity to comment on the catalogue of grounds for invalidity which can be brought against a Swiss SPC. The Federal Patent Court issued a PI based on Genzyme Corporation’s Swiss SPC for sevelamer, although it was unclear whether the Swiss Institute of…

The SPC system was introduced in the European Union in 1992 to compensate for the heavy penalties imposed on pharmaceutical research due to the curtailment in effective patent term resulting from time-consuming and costly regulatory review. As expressly noted in the Explanatory Memorandum to the original SPC Regulation (COM(90) 101 final-SYN 255), the legislative intent…

Supplementary protection certificates (SPCs) used to be granted in the European Union only for novel active ingredients, but not for new therapeutic applications of previously authorized active ingredients. While this practice fundamentally changed as a result of the CJEU’s landmark decision Neurim (C-130/11) of 19 July 2012, the scope of this ruling has given rise…

Just a few months before the CJEU’s judgment in C-121/17 Teva UK Ltd and Others v Gilead Sciences Inc. came out a the Metropolitan Court of Budapest handed down a decision regarding Merck Sharp and Dohme Corp’s (MSD) application for an SPC re the combination of ezetimibe and rosuvastatin. The Hungarian court which regularly deals…

The Court of Justice of the European Union (CJEU) has clarified when a product is ‘protected by a basic patent’ within the meaning of article 3(a) of the SPC Regulation. In a long awaited preliminary ruling, the CJEU decided last week that: ‘Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May…

Historically, the Spanish Patents and Trademarks Office (“SPTO”) has rejected the correction of the registered term of supplementary protection certificates (“SPCs”), even in cases where such term has had to be recalculated due to the new case law emanating from the Court of Justice of the European Union (“CJEU”). As reported in our posts of…

The Swiss Federal Supreme Court issued a landmark decision concerning the requirements for Supplementary Protection Certificates (SPCs) for combination products. Until recently, Switzerland stood solid as a rock and defended the so-called infringement test for SPCs for combination products. The Federal Supreme Court has now ruled that while the infringement test shall still apply to…

Establishing a unitary SPC is one of the recommendations of the study carried out by the Max Planck Institute for Innovation and Competition for the European Commission. Either an (existing or a future) EU authority or the European Patent Office can be charged with granting these unitary SPCs. According to the study, the choice between…