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 legislative period draws to a close. Under the EU’s legislative procedure, the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal…

It is often said that ‘tomorrow never comes’.  Likewise, a recurring theme for some years has been that ‘the UPC will start next year’. As 2019 is now well under way, it is time to consider whether this year we can be more optimistic than this, and how the turmoil in the UK Parliament affects…

Gilead Sciences vs Sandoz – Round One The history of the case started in 2018, where Gilead Sciences Inc., brought preliminary injunctions before the court against several companies. On 7 March 2018, the High Court of Eastern Denmark delivered a preliminary injunction against Accord Healthcare Limited, thereby reversing an earlier decision from the Danish Maritime…

While the UK is holding its breath ahead of Parliament’s vote on the Brexit deal, many patent specialists think a ‘no deal’ will be a fatal blow for the UK’s ambition to stay in the Unitary Patent system. But according to Alfonso Sabán, attorney at law and political scientist in Madrid, it is obvious that,…

What were the most popular articles of the Kluwer Patent Blog in 2018? A look at the list shows that – even more strongly than in previous years – one topic drew more readers than anything else: the functioning of European Patent Office. Episodes of last year’s series on the EPO by Thorsten Bausch –…

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 of invalidity justify the revocation of an SPC may become highly relevant. This question is all the more intriguing in light of the CJEU’s corresponding case…

The preparations for the Unified Patent Court are going on so the court can start functioning as soon as possible if the German Constitutional Court rejects the challenges to the Unitary Patent project. The UPC Preparatory Committee has declared this in an update which was published on its website on 19 december 2018. It is…

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 principle, eligible for SPC protection. One further important piece in this puzzle will be provided by the CJEU’s forthcoming decision in the pending referral Abraxis Bioscience…

Early on Monday 10 December 2018, the Court of Justice of the European Union issued its judgment in Wightman et al v Secretary of State for Exiting the European Union (C-621/18), on whether the UK can unilaterally withdraw its Brexit notification. Although of course the judgment is strictly a legal reasoning, it also comes as…

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 medicinal products (and, likewise, under Article 3(1)(c) of Regulation (EC) 1610/96 on SPCs for plant protection products), an SPC shall be granted only if…