NIPC Law

  Jane Lambert Court of Appeal (Lords Justices Peter Jackson, Arnold and Stuart Smith) Generics (UK) Ltd and others v AstraZeneca AB    [2025] EWCA Civ 903 (16 July 2025) This was an appeal by AstraZeneca AB from the judgment of Dr Michael Tappin KC sitting as a deputy judge of the High Court in    Generics (UK) Ltd v AstraZeneca AB [2025] EWHC 1012 (Pat) (28 April 2025).  In that case, Generics (UK) Limited and several other generic pharmaceutical manufacturers had claimed a declaration that the following supplementary protection certificates were invalid and an order for their revocation: SPC/GB13/021  for dapagliflozin and pharmaceutically acceptable salts thereof;   and SPC/GB14/050  for a combination of dapagliflozin or a pharmaceutically acceptable salt thereof and metformin or a pharmaceutically acceptable salt thereof.  Those SPCs derived from  European patent (UK) 1 506 211 B1 .  The claimants contended that the ...

A utho r Fvasconcellos   Public Domain Source Wikimedia Commons     Jane Lambert Patents Court (Mr Justice Mead)  Halozyme, Inc v The Comptroller-General of Patents, Designs and Trade Mark s [2024] EWHC 3202 (Pat) (16 Dec 2024) This was an appeal against Dr Lawrence Cullen's decision in  Halozyme, Inc. v The Comptroller General of Patents, Designs and Trade Marks   BL O/0257/24 of 27 Mar 2024 in which he refused Halozyme Inc.'s applications for supplementary protection certificates for  Trastuzumab and recombinant human hyaluronidase and  Rituximab and recombinant human hyaluronidase. Supplementary Protection Certificate In my article Supplementary Protection Certificate s  I described a supplementary protection certificate ("SPC") as  "an intellectual property right ("IPR") that protects the active ingredients in pharmaceutical or plant protection products."   I explained that: "The right comes into force upon the expi...

  Jane Lambert Patents Court (Douglas Campbell KC) Newron Pharmaceuticals SpA v Comptroller-General of Patents, Trade Marks and Designs [2023] EWHC 1471 (Ch) (16 June 2023) This was an appeal by Newron Pharmaceutical SpA ("Newron") against the decision of Dr L Cullen in Re SPC/GB15/046, Newron Pharmaceuticals S.p.A v Comptroller  BLO/1053/22 1 Dec 2022.  Newron is the proprietor of European patent (UK) 1613296 B1 for Methods for treatment of Parkinson's disease ("the Patent") which will expire on 24 April 2024. The appellant sought a supplementary protection certificate ("SPC") for a combination product comprising safinamide and “levodopa/PDI”, that is to say, a levodopa and a peripheral decarboxylase inhibitor (PDI) such as carbidopa .  The hearing officer refused the application on the grounds that it did not meet the requirements of art 3 (b) of Regulation (EC) No. 469/2009 (“the SPC Regulation”). The appeal came on before Mr Dougla...

  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...

Jane Lambert On 1 July 2019  Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance.)  OJ L 153, 11.6.2019, p. 1–10 came into force.  It consists of 30 paragraphs of recitals but only 2 articles. Art 1 amends  Regulation (EC) No 469/2009 of the Europea Parliament and of the Council f 6 May 2009concerning the supplementary protection certificate for medicinal products OJ 16.6.2009 L 152 p1-9 so as to enable generic and biosimilar manufacturers to make products that are protected by supplementary protection certificates ("SPC") for export to third countries or to stockpile them for distribution from the moment the SPC expires.  Art 2 provided for Regulation 2019/933 to enter into force on the 20th day following its publication in the Official Journal. What is an SPC? An SPC...