BMS and Ono File BPCIA Suit Against Amgen for Nivolumab Biosimilar

On September 8, 2026, Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., (collectively, “BMS”) and Ono Pharmaceutical Co., Ltd. (“Ono”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Amgen Inc. (“Amgen”), alleging that Amgen’s proposed nivolumab biosimilar, ABP 206, will infringe seven patents related to BMS’s OPDIVO® (nivolumab).

BMS/Ono allege infringement of U.S. Patent Nos. 8,008,449 (“the ’449 Patent”); 9,856,320 (“the ’320 Patent”); 10,072,082 (“the ’082 Patent”); 12,590,154 (“the ’154 Patent”); 12,624,107 (“the ’107 Patent”); 12,590,153 (“the ’153 Patent”); and 12,479,917 (“the ’917 Patent”).  According to BMS/Ono, the ’449 patent includes claims directed to the amino-acid sequence of nivolumab. The remaining six patents generally concern methods of treating cancer with anti-PD-1 antibodies, including dosing regimens and combination treatments involving ipilimumab, or patient selection based on PD-L1 expression.

BMS/Ono allege that the parties engaged in the “patent dance,” during which “BMS provided Amgen with a list of twenty-four patents for which BMS believed an infringement claim might reasonably be asserted against Amgen.”  After exchange of contentions, the parties negotiated down to the list of the seven asserted patents for first-wave litigation.

This litigation follows Amgen’s earlier inter partes review challenges to three BMS patents concerning anti-PD-1 and anti-CTLA-4 combination treatments. As previously reported, the USPTO’s Acting Director denied institution of two of those petitions in July 2025, including Amgen’s challenge to the asserted ’320 patent.  In response to the third petition, relating to U.S. Patent No. 11,332,529, BMS filed a statutory disclaimer and the PTAB granted an adverse judgment prior to institution.

BMS/Ono seek a declaratory judgment that Amgen has infringed or will infringed the asserted patents, a preliminary and/or permanent injunction to prevent Amgen from manufacturing, using, offering to sell, selling, distributing, and importing any current or future version of ABP 206, damages, attorneys’ fees, and costs.

Stay tuned to Big Molecule Watch for further updates on this new BPCIA litigation.

The post BMS and Ono File BPCIA Suit Against Amgen for Nivolumab Biosimilar appeared first on Big Molecule Watch.