Pharma, an abbreviation commonly used for the pharmaceutical industry, discovers, develops, produces and markets drugs or pharmaceutical drugs for use as medication. Pharma depends heavily on patents to protect its inventions worldwide, as well as on Supplementary Protection Certificates (SPCs). Pharmaceutical companies are subject to laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. Pharma includes production of generic medicines. Pharma may also refer to (patent) litigation related to pharmaceutical products.
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 run up to the Easter vacation is always a busy time in the English Patents Court as litigants seek have applications determined to set the direction of travel for the next period of the case and Judges, understandably, try and clear their desks before the break. 2019 was no exception to this rule and…
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…
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…
