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 ...

Autho r Brenton Licence CC BY-SA 4.0 Source Wikimedia Commons Jane Lambert Patents Cour t (HH Judge Hacon) S andoz AG and others v Bayer Intellectual Property GmbH [2024] EWHC 796 (Pat) (12 April 2024 ) These were conjoined actions by several generic pharmaceutical manufacturers against Bayer Intellectual Property GmbH ("Bayer") for the revocation of European patent (UK) 1 845 961 ("the Patent") for the treatment of thromboembolic disorders with rivaroxaban . There were also counterclaims by Bayer for injunctions to restrain the threatened infringement of the Patent. Those threats were conceded for the purposes of the trial. Consequently, the validity of the Patent was the only issue to be tried. His Honour Judge Hacon tried those actions on 9, 12, 13,14, 15 and 16 Jan and 21 and 22 Feb 2024. By para [272] of his judgment in Sandoz AG and others v Bayer Intellectual Property GmbH [2024] EWHC 796 (Pat) handed down on 12 April 2024, the learned judge found t...

  Jane Lambert Patents Court (Mr Justice Mellor)  Astellas Pharma Industries Ltd v Teva Pharmaceutical Industries Ltd and other s [2023] EWHC 2571 (Pat) (17 Oct 2023) This was an action for patent infringement and a counterclaim for revocation. The patent in suit was European patent (UK) 2,345,410 entitled Pharmaceutical Composition for Modified Release  and concerned a modified release pharmaceutical composition containing mirabegron (or a salt thereof) as an active ingredient.   Astellas Pharma Industries Ltd, (Astellas) alleged that generic mirabegron tablets that Teva Pharmaceutical Industries Ltd. and Teva UK Ltd ("Teva") and Sandoz AG and Sandoz Ltd  (Sandoz) proposed to launch would infringe the patent.   Teva and Sandoz each counterclaimed for revocation of the patent on the grounds of obviousness, insufficiency and added matter.   Astellas responded to the counterclaim by applying for the amendment of the patent....

  Jane Lamber t Patents Court  (Mr Justice Meade) G ilead Sciences Inc and another NuCana PLC  [2023] EWHC 611 (Pat) (21 March 2023) This was an action by Gilead Sciences Inc. and its British subsidiary Gilead Sciences Ltd ("Gilead") for revocation of two European Patents (UK) that had been granted to NuCana Plc ("NoCana"), namely  EP 2 955 190 B1 (“EP190”)  and   EP 3 904 365 B1 (“EP365”) .  NuCana complained that Gilead's product  sofosbuvir  infringed its patents. Mr Justice Meade, who tried the action, could see no real defence to the counterclaim if the claims of the patents were valid. Grounds of Revocation Gilead sought revocation of the patents on the following grounds: Added matter in that the  Markush group definitions of the claims  of the patents are not clearly and unambiguously disclosed in the original application; Lack of plausibility in that the Patents do not plausibly disclose any technical contribu...