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Samsung Bioepis files IPR against Janssen alleging invalidity of Stelara® (ustekinumab) patent

Jun 21, 2023

Samsung Bioepis has filed an IPR against Janssen’s US patent no. 10,961,307 (‘307 patent) relating to Stelara® (ustekinumab).  Samsung Bioepis argues that all claims of the ‘307 patent are invalid. Claims 1-4, 6-22, and 24-34 allegedly lack novelty and are anticipated by a Janssen clinical overview summary for a phase III clinical trial of ustekinumab (NCT-236).   All claims (1-34) are allegedly obvious in light of NCT-236 combined with a journal article and the Stelara® Prescribing Information.

On the same day, Samsung Bioepis filed an IPR against Alexion’s US patent no. 10,703,809 (’809 patent) relating to Soliris® (eculizumab).

On 12 June 2023 Alvotech and Teva announced they reached a settlement and licence agreement with J&J for AVT04 (Alvotech’s biosimilar to Stelara®) providing a licensed US launch date of no later than 21 February 2025, and on 22 May 2023 Amgen settled its Stelara® patent invalidity suit with Janssen in the US with a licensed US launch date of no later than 1 January 2025.