In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales has refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis, is invalid.
The matter involves litigation brought by Samsung Bioepis seeking to invalidate the Janssen patent on the grounds of novelty and obviousness. Janssen counter-claimed against Samsung Bioepis for patent infringement. On 30 July 2024, Justice Meade issued a decision in Samsung Bioepis’ favour, holding that the Janssen patent is invalid for obviousness in light of a slide presentation entitled “Safety and efficacy of Ustekinumab Induction Therapy in Patients with Moderate to Severe UC: Results from the Phase 3 UNIFI Study” delivered at the October 2018 American College of Gastroenterology conference.
Justice Meade’s ruling against Janssen’s application for leave to appeal his decision is another resounding success for Samsung Bioepis. Justice Meade stated that the key argument on which Janssen relied to seek leave to appeal had “no prospect of success” and it was “not legitimate to raise it at this stage. If it was to have been taken, it could and should have been taken at trial”.
The matter will now return to court for Justice Meade to deal with costs and other consequential matters.
Samsung Bioepis’ ustekinumab biosimilar (SB17) was approved in Europe in April 2024 as Pyzchiva®. Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.