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Showing posts with the label SPC

Interim Injunctions: AstraZeneca v Glenmark

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  Jane Lambert Court of Appea l (Lords Justices Coulson, Arnold and Warby) AstraZeneca AB and another v Glenmark Pharmaceuticals Europe Ltd [2025] EWCA Civ 480 (16 April 2025) This was an appeal against Michael Tappin KC's refusal in  AstraZeneca AB and another v Glenmark Pharmaceuticals Europe Ltd (Re Interim Injunction Application) [2025] EWHC 748 (Pat) (28 March 2025)   to grant AstraZeneca AB and AstraZeneca UK Ltd. an interim injunction to restrain Gelnmark Pharmaceuticals Europe Ltd. from selling a product containing dapagliflozin pending a hearing on the form of order following a trial to determine the validity of the first claimant's supplemental protection certificates  for dapagliflozin and a combination of dapagliflozin and metformin.  The appeal was heard by Lords Justices Coulson, Arnold and Warby on 9 April 2025.  At the end of the hearing, the Lords Justices announced that they would allow AstraZeneca's appeal.  Lord Justice Arno...

Supplementary Protection Certificates - The Appeal in Newron Pharmaceuticals SpA v Comptroller

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  Jane Lambert Court of Appeal (Lords Justices Lewison, Moylan and Birss)  Newron Pharmaceuticals SPA v The Comptroller General of Patents, Trade Marks and Designs [2024] EWCA Civ 128 (15 Feb 2024) This was an appeal against the decision of Mr Recorder Campbell KC to uphold  Dr L Cullen's refusal to grant a  supplementary protection certificate ("SPC")  to Newron Pharmaceuticals SpA ("Newron") for the reasons set out in his judgment in  Newron Pharmaceuticals SpA v Comptroller-General of Patents, Trade Marks and Designs  [2023] EWHC 1471 (Ch).  I discussed the proceedings before Dr Cullen and Mr Campbell in  Supplementary Protection Certificates - Newron Pharmaceuticals SpA v Comptroll e r  on 1 July 2023.    What is an SPC?  In that article, I quoted from my reference page on   Supplementary Protection Certificates  which I wrote on 31 Dec 2019 and updated on 11 Jan 2021 "A supplementary protection certifi...

Supplementary Protection Certificates - the Genentech Appeals

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Jane Lambert Court of Appeal (Lord Justices Floyd and Arnold and Lady Justice Nichola Davies) Genentech Inc v Comptroller and Master Data Center v Comptroller   [2020] EWCA Civ 475 (31 March 2020) These were appeals from the decision of Mr Recorder Campbell QC in Master Data Center, Inc v Comptrolle r [2020] EWHC 572 (Pat) (11 March 2020) which I blogged in Supplementary Protection Certificates - Master Data Center, Inc v The Comptroller   on   18 March 2020.  The cases are remarkable for the speed with which they progressed from the hearing officer to the Court of Appeal.  They were before Mr  Micklewright on 21 Feb 2020 (see  R e Genentech, Inc. and Master Data Center, Inc . BL O/111/20 21 Feb 2020), Mr Campbell on 4 March 2020 and the Court of Appeal on 26 of that month ( Genentech Inc v Comptroller and Master Data Center v Comptroller [2020] EWCA Civ 475 (31 March 2020).   The cases are also remarkable for being...

Supplementary Protection Certificates - Master Data Center, Inc v The Comptroller

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  Photo showing intermediate age-related macular degeneration Author US National Eye Institute Source Wikipedia Macular Degeneration   Jane Lambert Patents Court (Mr Recorder Campbell)  Master Data Center, Inc v Comptroller   [2020] EWHC 572 (Pat) (11 March 2020) A supplementary protection certificate ("SPC") is an intellectual property right ("IPR") that protects the active ingredients of a pharmaceutical or plant protection product. The IPR comes into being upon the expiry of a patent for the product. SPCs are granted because new pharmaceutical and plant protection products cannot be marketed unless and until they are found to be safe by the relevant national or European authorities. Evaluating the safety of a new drug or plant protection product can take time. As the maximum term of a patent is 20 years the time waiting for such evaluation reduces the effective term of the monopoly. The purpose of an SPC, as Lord Justice Floyd explained i...

Supplemental Protection Certificates - Eli Lilly and Co. v Genentch Inc

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Court of Justice of the European Union Autho r Cedric Puisney Licence CC NY 2.0   Wikipedia Jane Lambert Patents Court (Mr Justice Arnold)  Eli Lilly And Company v Genentech, Inc  No. 2 [2019] EWHC 388 (Pat) (1 March 2019)   One of the issues before Mr Justice Arnold when he tried Eli Lilly and Company and others v Genentech, Inc [2019] EWHC 387 (Pat) (1 March 2019) was whether Genentech was entitled to a supplemental protection certificate ("SPC"). A guidance note from the IPO published on 16 May 2014 and last updated on 27 June 2019 describes an SPC as a "form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products." The policy behind SPCs is as follows: "Pharmaceutical or plant protection products need regulatory approval to be sold in the UK and must obtain: a marketing authorisation or product licence If your patent protects the active ingredients used in t...