A Supplementary Protection Certificate (SPC) extends the term of a patent for a medicinal or plant protection product by a period of not more than five years. The aim of SPCs is to compensate the patent owner for ‘lost’ patent protection which was caused by the time it took to obtain marketing authorisation for the product in question. An SPC is a national right, available in member states of the European Union (EU) by application to the national patent office of the state for which a certificate is desired. The SPC is based on a patent and is granted in respect of an active ingredient in a medicinal or plant protection product.
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…
The European Commission has proposed to introduce an ‘export manufacturing waiver’ to Supplementary Protection Certificates (SPCs) to ‘help Europe’s pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU’. According to a press release of 28 May 2018, ‘Supplementary Protection Certificates extend patent protection for medicinal products which must…
Yesterday, 25 April 2018, AG Wathelet has handed down his opinion in the Teva v Gilead reference (Case C-121/17) suggesting that the question should be answered as follows: “The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for…
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…
The afternoon of the first day of C5’s Pharma & Biotech conference in Amsterdam (27 February 2018) concluded with a lively panel session on biosimilars. Chaired by Bristows partner Dom Adair, the panel comprised Dr Corinna Sundermann (Senior Vice President, IP, Fresenius Kabi), Dr Lorenz Kallenbach (Corporate Patent Counsel, Merck) and Brian Coggio (Of Counsel, Fish…
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…
