On October 1, 2025, the PTAB granted Amgen’s request for adverse judgment based on Bristol-Myers Squibb’s (“BMS”) statutory disclaimer of all challenged claims prior to institution of trial.

Amgen’s IPR2025-00603 challenged all the claims of BMS’s U.S. Patent No. 11,332,529 (“the ’529 patent”), related to BMS’s Opdivo^® (nivolumab) and Yervoy^® (ipilimumab).  Amgen is currently developing a biosimilar of Opdivo^®, referred to as ABP 206.

The Board noted that “entry of adverse judgment [prior to institution of trial] … is appropriate in situations where a patentee seeks to regain, through continued prosecution, subject matter that is patentably indistinct from previously surrendered subject matter,” which the Board determined was the situation here (citing Smith & Nephew, Inc. v Arthrex, Inc., IPR2016-00917, Paper 12 (PTAB Sept. 21, 2015), aff’d 880 F.3d 1345 (Fed. Cir. 2018)).

In July 2025, two Amgen IPRs challenging related BMS U.S. Patents, U.S. Patent No. 9,856,320 and U.S. Patent No. 10,174,113, were discretionarily denied (previously reported PTAB Director Discretionarily Denies Opdivo^® IPRs Based on Settled Expectations of Patent Owner).

BMS reported U.S. sales of $5.35B for Opdivo^® in 2024.

For more information about these and other biosimilars and biosimilar disputes, please visit BiologicsHQ.com.

 

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The authors would like to thank April Breyer Menon for her contributions to this article.