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…

Just as the case has been in other European jurisdictions, Gilead is currently attempting to enforce its (Danish) SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine in Denmark. In the first decision regarding Gilead’s enforcement of this SPC in Denmark, the Danish specialty patents court, the Maritime and Commercial High Court, turned…

A positive view is spreading on post-filing experimental data in China since the recent official post of the proposed revisions to the Guidelines for Patent Examination (the “Guidelines”) by the State IP Office (the “SIPO”) of China.  People tend to think that the window is about to open to post-filing experimental data, just like it…

by Steven Willis In a judgment handed down at the end of last week, Arnold J has indicated his intention to make a reference to the CJEU concerning the interpretation of Article 3(d) of the SPC Regulation i.e. the requirement for the marketing authorisation (“MA”) on which an SPC application is based to be the…