On 3 October 2025, IP Australia delivered its decision in Samsung Bioepis’ opposition to the grant of Janssen’s AU2019346134 relating to a method of treating ulcerative colitis with Stelara® (ustekinumab). IP Australia ruled that the patent application was invalid for lack of novelty and inventive step in light of prior art, including a clinical trial record. Samsung Bioepis was unsuccessful on its third opposition ground, lack of support.
Janssen now has until 24 October 2025 by which to appeal the opposition decision to the Federal Court of Australia. IP Australia has also given Janssen until 3 December 2025 to propose amendments to seek to overcome the deficiencies in the claims.
The IP Australia decision marks yet another success for Samsung Bioepis in its Australian litigation against Janssen regarding Janssen’s Australian ustekinumab patent portfolio for the treatment of ulcerative colitis. On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016). In an earlier victory for Samsung Bioepis, Janssen surrendered two innovation patents (AU 2023100041 and 2023100042). The Janssen innovation patents all related to a method of treating ulcerative colitis with ustekinumab.
Samsung Bioepis’ Epyztek® (ustekinumab) was approved in Australia in October 2024 and was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.
The Australian ustekinumab legal actions are part of a global suite of actions between Samsung Bioepis and Janssen, with Samsung Bioepis having claimed victory in other key jurisdictions including:
- The Netherlands: the District Court of The Hague delivered its judgment in September 2025 in Samsung Bioepis’ revocation action against EP 3 883 606, with Samsung Bioepis invalidating the patent on the grounds of lack of novelty and lack of inventive step.
- UK: In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales 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, was invalid.
- Canada: On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings. Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.
- EU: In April 2025, Samsung Bioepis successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.
- US: On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar. J&J filed an appeal on 30 April 2025.
- Switzerland: The Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606. Janssen’s patent relates to the use of ustekinumab (the active ingredient in Stelara®) in the treatment of ulcerative colitis.