The question whether SPCs should be available for new therapeutic applications of previously approved active ingredients has been a matter of debate ever since the SPC Regulation for Medicinal Products came into force in the European Union more than a quarter-century ago. While a literal reading of the SPC Regulation would clearly seem to exclude…

The English Patents Court has often been regarded as a relatively favourable jurisdiction for patentees seeking interim relief in the life sciences arena. This is for various reasons, including the fact that the English Court follows the approach adopted by the House of Lords in the American Cyanamid case, in which an assessment of the…

Today, Advocate General (AG) Mr. Giovanni Pitruzzella handed down his opinion in the referral C-673/18 (Santen). The case concerns an SPC based on a second medical use/formulation patent and stems from a referral to the CJEU made by the Paris Court of Appeal with decision of 9 October 2018 in Santen v. INPI (see here…

The Higher Regional Court of Vienna confirmed that the “second medical use” of an already known substance, as required for patent protection, can be that the substance is used for a specific group of patients with specific effects. Case date: 11 May 2017 Case number: 34R113/16m Court: Higher Regional Court of Vienna A full summary of…

On 4 March 2019, we uploaded a post noting that the English Patents Court had decided to refer a question to the CJEU on whether it was permissible for a patentee to rely on a third party’s MA to obtain an SPC in the absence of consent from that third party. We briefly summarised the…

On Friday 1 March 2019, Arnold J handed down his judgment in the patent dispute between Eli Lilly and Genentech regarding IL-17A/F antibodies*1. This lengthy judgment, which as the Judge observed: “was one of most complex patent cases I have ever tried”, is littered with interesting legal points. However, to many life sciences patent lawyers,…

AstraZeneca tried to enjoin Hexal from marketing its Fulvestrant-medicament in main proceedings (after already having failed in PI-proceedings) due to alleged patent infringement of AstraZeneca’s Swiss-type claim patent. The Dusseldorf Court of Appeal, however, dismissed the appeal (docket-no I-2 U 29/18). To understand the implications of this case, one has to first step back and…

Patent lawyers in the UK have spent the last three months pondering, debating and at times indulging in an element of despair (to put it mildly) about what might be the impact of the judgment of the Supreme Court in Actavis v Eli Lilly [2017] UKSC 48 on issues of validity (see here). Today they…

Second medical use cases have been making their way through patent courts around the world. In the Novartis / Sun litigation the Hague Court of Appeal (PI decision) and District Court (interlocutory merits decision) already provided their thoughts on indirect infringement in 2015. The Court of Appeal concluded that Sun did indirectly infringe Novartis’ patent,…