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…

In our last blog (Will the Spanish Patent Office accept the modification of an SPC’s term after the Incyte judgment?), published on 8 January 2018, we raised the question as to whether the Spanish Patent and Trademark Office (“SPTO”) would accept the modification of the term of a supplementary protection certificate (“SPC”) after the judgment…

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…

Readers will recall that, in its judgment of 6 October 2015 (Case C-471/14, Seattle Genetics), the CJEU concluded that the relevant date for calculating the term of a supplementary protection certificate (“SPC”) is not the date on which a marketing authorisation (“MA”) is granted, but the date when the addressee is notified of the decision…

When a company is not prepared to charge a socially acceptable price in the Netherlands for a medicine, the government should use other instruments such as compulsory licences, encouraging pharmacy preparation and allowing patients to order medicinal products abroad in order to ensure that the medicine is available for patients. The Dutch Council for Public…