Pharma

185 articles available

Regardless of whether someone intends to enforce their own supplementary protection certificate (SPC) or finds themself at the receiving end of an SPC infringement action, the question which grounds…

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…