Bristol-Myers Squibb Company, E.R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd. filed Bristol-Myers Squibb Company et al. v. Amgen Inc., No. 1:26-cv-01134 (D. Del.), on September 8, 2026. The suit follows BPCIA patent exchange under 42 U.S.C. § 262(l). Amgen has appeared. A redacted complaint is on the docket.
Patents and accused products
The patents in the case are U.S. Patents 8,008,449; 9,856,320; 10,072,082; 12,590,154; 12,624,107; 12,590,153; and 12,479,917. The accused product is Amgen's proposed nivolumab biosimilar of Plaintiffs' Opdivo (the Proposed Amgen Nivolumab Biosimilar), tied to Amgen's aBLA. Plaintiffs seek to stop manufacture, use, sale, offer for sale, and importation before the patents expire, including composition-of-matter and method-of-treatment theories.
What the patents cover
U.S. Patent 8,008,449 covers human monoclonal antibodies that bind PD-1 with high affinity, including antibodies that cross-compete with reference anti-PD-1 antibodies defined by specified heavy- and light-chain variable sequences. That is the composition-of-matter patent Plaintiffs describe as covering nivolumab itself.
U.S. Patents 9,856,320; 10,072,082; 12,590,154; and 12,624,107 cover cancer immunotherapy methods that disrupt PD-1/PD-L1 signaling, including dosing regimens that combine nivolumab with ipilimumab for indications such as hepatocellular carcinoma and renal cell carcinoma, then continue nivolumab alone.
U.S. Patent 12,590,153 covers treating PD-L1-negative melanoma with a combination of an anti-PD-1 antibody and an anti-CTLA-4 antibody. U.S. Patent 12,479,917 covers treating NSCLC with platinum-doublet chemotherapy followed by anti-PD-1 / anti-CTLA-4 immunotherapy.
What the lawsuit is about
Plaintiffs allege Amgen seeks to commercialize a nivolumab Opdivo biosimilar under an aBLA and that the product and its proposed labeling will infringe the seven agreed patents from the BPCIA exchange. Counts pair infringement with declaratory-judgment theories for each patent. The complaint emphasizes Opdivo's role as a first-approved anti-PD-1 therapy and asks for injunctive relief timed to patent expiry.
What it means
This is a Delaware BPCIA biologics fight over a proposed Opdivo biosimilar. Early issues will include which patents remain in the dance, labeling-driven inducement theories for the method patents, and the timing of any preliminary injunction relative to the '449 composition patent.
What to watch next
Watch Amgen's answer and any early motions. Also watch whether the parties narrow the patent list further and how the court schedules the composition-of-matter versus method-of-treatment claims.