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Samsung Bioepis Successfully Opposes Grant of Janssen’s AU Ustekinumab Patent Application

Oct 3, 2025

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: