Amgen has initiated a significant patent challenge against Bristol-Myers Squibb's blockbuster immunotherapy combination, filing three inter partes review (IPR) petitions targeting patents that protect methods of treating cancer with Opdivo (nivolumab) and Yervoy (ipilimumab). The February 28, 2025 filings represent the first patent challenges to Opdivo by a potential biosimilar competitor, as Amgen advances its own nivolumab biosimilar through Phase III development.
Patent Challenge Details
The three IPR petitions target distinct aspects of the combination therapy's patent protection. IPR2025-00601 challenges U.S. Patent No. 9,856,320, which covers methods for treating cancer by administering the two well-known checkpoint inhibitors anti-PD-1 and anti-CTLA-4. IPR2025-00602 targets U.S. Patent No. 10,174,113, focusing specifically on methods of treating melanoma using the same antibody combination.
The third petition, IPR2025-00603, challenges U.S. Patent No. 11,332,529, which covers use of the drug combination to treat colorectal cancer tumors exhibiting a high degree of microsatellite instability (MSI-H), where the body's DNA mismatch repair system malfunctions.
Regulatory Approvals and Market Position
Bristol-Myers Squibb's combination therapy has secured multiple FDA approvals across different cancer indications. The FDA first approved the YERVOY-OPDIVO combination in October 2015 for patients with BRAF V600 wild-type unresectable or metastatic melanoma. In July 2018, the agency expanded approval to include 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.
Bristol-Myers Squibb recently announced that the FDA has accepted for review a supplemental biologics license application for the combination as a potential first-line treatment for the same colorectal cancer indication, potentially expanding the therapy's market reach.
Commercial Stakes and Biosimilar Development
The patent challenge comes as Opdivo maintains substantial commercial success, with Bristol-Myers Squibb reporting $5.35 billion in U.S. sales for the anti-PD-1 antibody in 2024. Amgen's challenge is directly tied to its development of ABP 206, an investigational biosimilar of Opdivo currently undergoing Phase III trials.
The timing of the patent challenge coincides with recent regulatory developments for the Opdivo franchise. On December 27, 2024, the FDA approved a subcutaneous version of Opdivo called Opdivo Qvantig (nivolumab; hyaluronidase-nvhy), providing patients with an alternative administration route.
Implications for Cancer Treatment Access
The patent dispute highlights the complex intellectual property landscape surrounding combination immunotherapy treatments. The challenged patents protect methods of using two distinct checkpoint inhibitors - nivolumab targeting the PD-1 pathway and ipilimumab targeting CTLA-4 - which work through complementary mechanisms to enhance immune system recognition and destruction of cancer cells.
Success in these IPR proceedings could potentially clear patent obstacles for Amgen's biosimilar entry, potentially increasing treatment access and reducing costs for patients requiring these combination therapies across multiple cancer types.
