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…

Russian law provides that information on state registration of drugs shall be publicly available. For a long period, MoH used to turn a blind eye to this obligation, keeping information on all filed applications confidential. Absence of this information used to pose additional risks for patent holders lacking information on the upcoming launches of generic…

44 U.S. states filed a lawsuit last Friday accusing Teva Pharmaceuticals USA of conspiring illegally with 19 other drug companies to inflate drug prices – sometimes by more than 1,000 percent – and stifle competition for generic drugs. As is set out in the complaint, ‘the Plaintiff States allege that Defendant Teva consistently and systematically,…

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…

The UK Supreme Court today handed down its decision in Actavis v ICOS. The decision was unanimous, with Lord Hodge giving the only judgment. The case concerns two principal questions. First, how the test for obviousness applies to a dosage patent; and secondly, whether the Court of Appeal was entitled to reverse the judgment of…

The Supreme Court held that the mandatory arbitration court provided for litigation between patent holders and applicants for generic medicines does not have jurisdiction to decide, inter partes and incidenter tantum, the validity of a patent. The right of defence of the generic applicant is not disproportionally restricted because they can challenge the validity of…

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…