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…

A recent study by two eminent scholars from the Max Planck Institute for Innovation and Competition (MPI) on „The Impact of Brexit on Unitary Patent Protection and its Court“, which is available here, casts significant doubts whether it will be possible for the United Kingdom to stay in the UPC Agreement after the UK has…

One of the points sometimes debated in patent cases is the date when a claim for patent infringement becomes “time-barred” (i.e. the date on which it “prescribes”). The traditional position adopted by the courts in countries like Germany and Spain is that in the case of continuing acts of infringement, the time-barred period (e.g. 5…

…great forces are up against each other and a dispute arises. Fortunately, it is not a war of biblical dimensions, but only a lawsuit, a significant and legally interesting one though, about an Supplementary Protection Certificate. The parties were Teva (Hebrew word for nature) and Gilead (aka Hill of Testimony, a mountainous region east of…

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 French National Institute of Industrial Property (INPI) has just dispelled doubts by means of an official statement( https://www.inpi.fr/fr/nationales/communique-relatif-au-calcul-de-la-date-d-expiration-des-certificats-complementaires-de-protection ) it is now possible for holders of a supplementary protection certificate (SPC), issued in France before October 6, 2015, to require extension of their protection duration. The conditions are simple: (1) the SPC shall still be in…

Adding to the long series of referrals concerning the interpretation of Art. 3(a) Reg. (EC) No. 469/2009 (“SPC Regulation”) (“the product is protected by a basic patent in force”) the UK Court of Appeal (Sandoz/Searle, Case No. A3 2017 1483) on 25 January 2018 referred further questions to the CJEU. This latest referral from the…

Co-author: Zsolt Lengyel, Danubia Patent and Law Office Just before Christmas, on 20 December 2017, the Court of Justice of the European Union (CJEU) announced its judgment in C-492/16, Incyte, in a preliminary ruling proceeding initiated by the Budapest High Court. The decision can be considered a sequel to the CJEU’s earlier judgment C-471/15, Seattle…