Pharma

A quarter-century after supplementary protection certificates (SPCs) were introduced in the European Union, there are still a number of unresolved questions as to which types of products are, in…

Why would anyone want to have their own supplementary protection certificate (SPC) revoked? – The answer is, quite simply, Article 3(c). Under Article 3(c) of Regulation (EC) 469/2009 on SPCs for…

(Corrected) The American Food Drug Administration (FDA) will follow the European Medicines Agency from London to Amsterdam because of the Brexit.  That is clear from a report on the website of the…

The District Court of the Hague granted a provisional injunction against Sandoz' generic darunavir product. As it was already offered in the G-standard, price erosion was an imminent danger for which…

A consolidation and modernization of Europe’s intellectual property framework, featuring a “recalibration” of patent and SPC protection and possibly the creation of a unitary SPC title – those were…

In its judgment of 25 July 2018 (Case C-121/17 Teva v. Gilead), the CJEU had its latest say on the interpretation of article 3 (a) of Regulation (EC) 469/2009 concerning the Supplemental Protection…

Over the past few years the pan-European and parallel national patent litigation based on Eli Lilly’s pemetrexed patent has attracted considerable attention, as it has resulted in a number of diverse…

In order to provide adequate incentives for the research and development of high-quality medicinal products adapted for paediatric needs, special rewards, such as a 6-month paediatric extension of…

The Ukrainian Supreme Court in Merck Sharp & Dohme Corp v Aurobindo Pharma Limited has recently introduce a bold approach to applying interim injunctions in disputes between originators and generics…