On 16 August 2024, Janssen Biotech, Inc and Janssen-Cilag Pty Ltd commenced patent infringement proceedings against Samsung Bioepis AU Pty Ltd in the Federal Court of Australia. The proceeding is yet to be listed for a first case management hearing.
This is the second Federal Court of Australia patent proceeding this year between the parties. On 23 January 2024, Samsung Bioepis commenced proceedings for revocation of two Janssen patents regarding the use of Stelara® (ustekinumab) for the treatment of ulcerative colitis. This matter has been recently set down for a 5 day hearing starting 18 November 2024.
Samsung Bioepis UK Limited has already successfully revoked Janssen’s Stelara® (ustekinumab) UC Patent in the High Court of Justice of England and Wales. In that case, Mr Justice Meade held that European Patent No EP 3883606 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.