On September 8, 2026, Bristol-Myer’s Squibb filed BPCIA Case No. 1:26-cv-01134 (D. Del.) against Amgen’s proposed Opdivo^® (nivolumab) biosimilar ABP 206.  This is the first BPCIA litigation to be filed against a proposed Opdivo^® biosimilar.  Amgen’s aBLA was accepted by the FDA on an undisclosed date prior to the filing of the lawsuit and is the first publicly disclosed aBLA for an Opdivo^® biosimilar.

According to the Complaint, the parties engaged in the BPCIA patent dance proceedings and agreed to litigate seven of 26 patents during this first phase of litigation.  The asserted patents include six with method of treatment claims and one with composition of matter and formulation claims.  The asserted composition of matter and formulation patent, U.S. Patent No. 8,008,449, was previously challenged by Dana Farber in IPR2023-00501, which resulted in a settlement prior to institution.

Prior to the litigation, Amgen filed three IPRs against Bristol-Myer’s Squibb’s patents, including IPR2025-00601 against U.S. Patent No. 9.856,320 that has been asserted in this litigation.  The IPR was discretionarily denied by the PTO Director based on settled expectations of the Patent Owner (previously reported PTAB Director Discretionarily Denies Opdivo^® IPRs Based on Settled Expectations of Patent Owner).  The remaining asserted patents have not previously been involved in patent disputes.

Bristol-Myer’s Squibb reported U.S. Opdivo^® sales of $5.9 billion in 2025.

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

 

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