A Supplementary Protection Certificate (SPC) extends the term of a patent for a medicinal or plant protection product by a period of not more than five years. The aim of SPCs is to compensate the patent owner for ‘lost’ patent protection which was caused by the time it took to obtain marketing authorisation for the product in question. An SPC is a national right, available in member states of the European Union (EU) by application to the national patent office of the state for which a certificate is desired. The SPC is based on a patent and is granted in respect of an active ingredient in a medicinal or plant protection product.
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 Court concluded that the compound darunavir was not protected by a patent within the sense of Art. 3 of the SPC directive because, following the CJEU decision in Teva v Gilead, it is necessary that the compound for which the SPC is granted can be specifically identified in the patent. Case date: 08 January…
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…
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,…
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…
One has to have a lot of courage to accept the task of coordinating a book on Supplementary Protection Certificates (“SPCs”). The immense variety of the facts discussed in the numerous cases that have historically sparked the need for preliminary questions to the Court of Justice of the European Union (“CJEU”) on the interpretation of…
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…
