On February 28, Amgen, Inc. (“Amgen”) filed three petitions for inter partes review, challenging the validity of all claims in three patents assigned to Bristol-Myers Squibb Co. (“BMS”). The claims of all three patents are directed to methods of treating cancer with the combination of two checkpoint inhibitor immunotherapeutic antibodies, anti-PD-1 and anti-CTLA-4.
IPR2025-00601 challenges the validity of claims 1–22 of U.S. Patent No. 9,856,320, which, according to Amgen, “recite[s] methods for treating cancer by administering two well-known checkpoint inhibitors (anti-PD01 and anti-CTLA-4).” IPR2025-00602 challenges the validity of claims 1–20 of U.S. Patent No. 10,174,113, which are directed to methods of treating melanoma using the same combination of antibodies. Lastly, IPR2025-00603 challenges the validity of claims 1–18 of U.S. Patent No. 11,332,529, directed to use of the same drug combination “to treat colorectal cancer tumors ‘exhibiting a high degree of microsatellite instability (MSI-H),’ in which the body’s DNA mismatch repair (MMR) system malfunctions.”
BMS currently markets an anti-CTLA-4 antibody, ipilimumab, under the brand name YERVOY®, and an anti-PD-1 antibody, nivolumab, under the brand name OPDIVO®. In October 2015, the FDA approved the combination of YERVOY® and OPDIVO® for patients with BRAF V600 wild-type unresectable or metastatic melanoma. In July 2018, the FDA approved the combination for the treatment of adults and children aged 12 years and over with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. And BMS recently announced that the FDA has accepted for review a supplemental BLA for the combination as a potential first-line treatment for the same colorectal cancer.
Amgen has a nivolumab biosimilar referencing OPDIVO®, ABP 206, in the pipeline undergoing Phase III trials.