On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent), ruling that the method of treatment patent is valid. The Janssen Patent relates to the use of ustekinumab in the treatment of ulcerative colitis (UC).
Samsung Bioepis had challenged the validity of the Janssen Patent on the grounds of lack of novelty and lack of inventive step. However, the challenge failed on both grounds, with the Dutch court upholding the validity of the Janssen Patent and ordering Samsung Bioepis to pay Janssen’s costs of the proceeding, estimated to date to be €190,000. Samsung Bioepis has appealed the judgment.
Samsung Bioepis’ court action is the latest in a series of court actions in The Netherlands, including a case pending in the Dutch Supreme Court regarding an SPC waiver for producing a Stelara® biosimilar for export to third countries. The Supreme Court hearing date is yet to be published.
The Dutch actions are part of a global suite of actions between Samsung Bioepis and Janssen, with Samsung Bioepis having recently claimed victory in other key jurisdictions including:
- 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 UC, 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 invalidate Janssen’s CA Patent 3,113,837 for 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.
- Australia: On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016). The Court’s revocation orders, made before the scheduled end of the trial, bring to a conclusion the patent infringement proceedings commenced by Janssen Biotech (and Janssen-Cilag Pty Ltd) against Samsung Bioepis in August 2024. The Janssen innovation patents all related to a method of treating UC with ustekinumab.
- 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 for treating UC.