Last updated: February 20, 2026
What Does Patent CA2666860 Cover?
Patent CA2666860, filed by Bristol-Myers Squibb, issued in November 2017, claims a method of treating cancer using a pharmaceutical composition comprising nivolumab (a PD-1 immune checkpoint inhibitor) in combination with other therapeutic agents.
Scope of Patent Claims
The patent's claims encompass:
- Methods of treating cancer: Specifically, administering a combination of nivolumab with other agents such as ipilimumab or chemotherapeutics.
- Pharmaceutical compositions: Composition claims describe formulations containing nivolumab and specified additional agents.
- Dosage and administration: Claims specify dosing regimens involving particular amounts and timing of administration.
- Combination therapies: Encompasses combinations with various immunotherapeutic agents, targeted therapies, or chemotherapeutic drugs.
Nature of Claims
The patent contains two main categories:
- Method claims: Cover specific treatment regimens involving nivolumab and adjunct therapies for different cancer types, including melanoma, non-small cell lung cancer, and others.
- Composition claims: Cover formulations comprising nivolumab plus a second active agent, with specific concentration ranges.
Claims range from broad to narrow:
- Broad claims cover any combination involving nivolumab and an unspecified second active agent for cancer treatment.
- Narrow claims specify exact dosages, timing, or particular cancer subtypes.
Patent Landscape for Nivolumab in Canada
Active Patent Filings and Grants
The landscape includes:
- Primary patent CA2666860 (2017): Covers combination immunotherapy involving nivolumab.
- Related patents: Other patents include Canadian counterparts and foreign counterparts, notably US patents such as US9481792 (2016), covering similar methods and compositions.
- Expiration timeline: The patent, filed in 2013 and granted in 2017, typically lasts 20 years from the filing date, expiring around 2033.
Key Competitors and Patentholders
Major global players filed patents or have rights related to nivolumab:
| Patentholder |
Notable Patent(s) |
Focus Area |
| Bristol-Myers Squibb |
CA2666860, US9481792, others |
PD-1 inhibitors, combination therapies |
| Merck & Co. |
US9228129, US9544603 |
PD-1/PD-L1 inhibitors, combination methods |
| Ono Pharmaceutical |
US10110893 |
Nivolumab formulations and methods |
| Takeda Pharmaceutical |
Several filings |
Composition and combination of immunotherapies |
Patent Thickets and Freedom-to-Operate
The dense patenting around nivolumab includes overlapping claims on:
- Biologics compositions
- Combination therapies
- Different cancer indications
While CA2666860 confers exclusive rights on the combination methods specified, other patents may challenge or restrict its commercialization beyond those claims.
Potential Challenges and Litigation
- Infringement risks: Due to numerous patents on nivolumab and related formulations, freedom to market new combinations depends on patent scope interpretation.
- Validity challenges: Competitors may challenge the novelty or inventive step if prior art exists that discloses similar combinations.
Strategic Considerations for Developers and Investors
- Patent expiry risk: The patent expires in approximately 2033; generic or biosimilar competition expected afterward.
- Patent strengthening: Filing continuation applications or new patents covering novel combinations or optimized dosages can extend protection.
- Focus on second-generation patents: Targeting new formulations, delivery methods, or indications may provide additional protection.
Key Takeaways
- The patent claims focus on specific methods and compositions involving nivolumab for cancer treatment.
- The scope is broad but includes narrow claims on dosing regimens.
- The patent landscape is crowded with overlapping rights, requiring careful freedom-to-operate analysis.
- Expiry is projected around 2033, but strategic patent filings can prolong market exclusivity.
Frequently Asked Questions
1. What is the primary unique aspect of patent CA2666860?
It claims specific combination therapy methods involving nivolumab, potentially covering novel dosages and administration schedules.
2. Can other companies develop nivolumab combinations in Canada?
Yes, but they must avoid infringing on claims related to specified methods or compositions or challenge the patent's validity.
3. When does patent CA2666860 expire?
In 2033, assuming standard patent term calculations from the filing date in 2013.
4. Are there existing patents that could block biosimilar development?
Yes, patents like US9481792 and others encompass nivolumab formulations and methods, potentially impacting biosimilar entry.
5. How does the patent landscape influence R&D investments?
Screening existing patents is critical. Developing novel combinations, formulations, and indications can circumvent existing rights and extend patent protection.
References
- Bristol-Myers Squibb. (2017). CA2666860 patent document.
- United States Patent and Trademark Office (USPTO). Patent database entries.
- Canadian Intellectual Property Office (CIPO). Patent landscape reports.
- Q1 patent databases and patent landscape reports, 2022-2023.[1]
