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Samsung Bioepis IPR Terminated Following Agreement With Janssen For Stelara® (ustekinumab)

Aug 9, 2023

The USPTO Patent Trial and Appeal Board has terminated Samsung Bioepis’s Inter Partes Review (IPR) challenging Janssen’s US patent 10,961,307 relating to Stelara® (ustekinumab).  The Board’s decision follows Samsung and Janssen’s joint motion, dated 3 August 2023, stating that parties have resolved the dispute and request termination.  The motion states that the parties have entered into  a confidential settlement to resolve all present disputes and to avoid any additional disputes regarding the patent.

Samsung filed the IPR on 21 June 2023, arguing all claims of the patent are invalid, citing (amongst other things) a Janssen clinical overview summary for a phase III clinical trial of ustekinumab.

Samsung also filed a notice of opposition to the grant of an Australian counterpart, AU application no 2019346134, on 12 July 2023.  Law firm Reddie & Grose filed a post-grant notice of opposition (presumed to be on behalf of an unnamed client) to the European counterpart, EP patent no 3883606, on 27 July 2023.