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 ulcerative colitis with ustekinumab. The Court is yet to issue any reasons for judgment in these proceedings.
This is a second victory for Samsung Bioepis in Australia with the earlier January 2024 Federal Court of Australia patent proceeding concluding with Janssen surrendering the two innovation patents in suit. These innovation patents again related to a method of treating ulcerative colitis with ustekinumab.
Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was approved in Australia in October 2024. Other ustekinumab biosimilars approved in Australia are Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Ajemnye® (May 2024) and Wezlana® (January 2024).
Janssen’s Stelara® remains the only PBS-listed ustekinumab product at this stage. Amgen’s Wezlana® was recommended for listing at the March 2024 PBAC meeting, but the company has advised that it is not proceeding in the PBS listing process at this time. Celltrion’s SteQeyma® was recommended for PBS-listing at PBAC’s November 2024 meeting and Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting.