The legislative procedure introducing an SPC manufacturing waiver in the European Union has been completed today on 11 June 2019 with the publication of the corresponding new Regulation (EU) 2019/933 of 20 May 2019 (PDF) in the Official Journal of the EU. The manufacturing waiver provisions will enter into force on the 20th day after…

After the European Parliament adopted a controversial new regulation introducing an SPC manufacturing waiver for export and stockpiling in its last plenary session on 17 April 2019, as previously reported on this blog, the corresponding legislative act has now also been adopted by the Council of the European Union in its meeting today on 14…

The European Parliament has finally adopted the legislation introducing an SPC manufacturing waiver in its last plenary session before the upcoming European elections. The corresponding legislation was endorsed today on 17 April 2019, with 572 votes in favor, 36 votes against, and 22 abstentions. The vote was preceded by a discussion in plenum yesterday late…

In a post yesterday our colleagues at Vossius commented on the CJEU’s decision, which had just been handed down in Abraxis*. As Vossius have explained, although the decision appears to give clarity for new formulations of old products, it remains unclear as to how this can be reconciled with Neurim, which was not overturned. In…

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®)…

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,…

In nullity proceedings initiated by Accord Healthcare (“Accord”) the District Court of The Hague has held Shire-NPS Pharmaceuticals’ (“NPS”) patent EP 1 203 761, the basic patent for an SPC covering cinacalcet, invalid for lack of inventive step and declared the SPC null. In short, the court considered that the (selection of) cinacalcet provided no…