The eagerly-awaited judgment of the Court of Justice of the European Union (CJEU) in the SPC referral Abraxis Bioscience (C-443/17) has been handed down today. In the case underlying this referral, the UK IPO had refused an SPC application filed by Abraxis Bioscience for the product “paclitaxel formulated as albumin-bound nanoparticles” (nab-paclitaxel; marketed as Abraxane®)…

Claims for methods of administering beta-alanine to increase muscles’ working capacity were valid treatment claims, not merely directed to natural laws. Claims for the supplement products and means of making them were directed to specific formulations, not natural phenomena. Case date: 15 March 2019 Case number: No. 2018-129 Court: United States Court of Appeals, Federal Circuit…

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,…

The fundamental question which types of products are amenable to SPC protection and which types of marketing authorizations allow the filing of SPCs has aroused much controversy in Europe, and reached a climax when the CJEU in its judgment Boston Scientific (C-527/17) of 25 October 2018 denied the grant of SPCs on the basis of…

The introduction of an SPC manufacturing waiver in the European Union is now all but a done deal. Following the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal products (COM(2018) 317 final) issued on 28 May 2018, the European Parliament’s Committee on Legal Affairs (JURI) adopted its final…

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 sufficiently disclosed an invention.  Readers will recall that the judgments concerned Warner-Lambert’s Swiss-style claims for the use of the compound pregabalin (marketed as Lyrica) in the treatment of…

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 ‘orphan medicine’ for patients with neuroendocrine tumors. It is the latest of a series of controversies about medicine pricing. Kluwer IP Law discussed the case…

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…