On 30 July 2024, Mr Justice Meade of the High Court of Justice of England and Wales delivered his decision in Samsung Bioepis UK Limited’s case against Janssen Biotech Inc seeking to invalidate the UK counterpart patent of European Patent No. EP 3883606 on the grounds of novelty and obviousness. Janssen’s patent relates to the use of ustekinumab for the treatment of ulcerative colitis and Janssen had counter-claimed against Samsung Bioepis for patent infringement.
The decision is a resounding success for Samsung Bioepis, with Justice Meade 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.
Samsung Bioepis is also currently challenging two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court, with a trial provisionally scheduled for November 2024.
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.
On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis. The FDA has provisionally determined Pyzchiva® as interchangeable with Stelara®. Samsung Bioepis is licensed to launch Pyzchiva® in the US in Q2 2025, under a settlement and licence agreement with J&J entered in November 2023 resolving US litigation between the companies.