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.
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…
In preliminary injunction proceedings, the Barcelona Court of Appeal (Section 15) ruled on the interpretation of the wording “protected by a basic patent” in Article 3.a) of the SPC Regulation, on the same facts decided by the High Court of Justice of England and Wales in the 2018 judgment in Teva v Gilead and, following…
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…
