Two recent decisions in the UK and Australia in the long-running pregabalin litigations demonstrate the different approaches in these jurisdictions to determine if a patent specification has…
In the Netherlands, Minister for Health Care Bruno Bruins clashed with Novartis last month about lutetium-octreotaat, after the Swiss pharma company had fivefolded the price of this cancer drug, an …
The introduction of an SPC “manufacturing waiver” in the European Union, aimed at boosting the competitiveness of EU-based generics and biosimilar industry, gains momentum as the current EU…
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…
