Last updated: February 25, 2026
What does patent EP2515906 cover?
European patent EP2515906, filed by Novartis AG, is titled "Method of treating cancer with combined immunotherapy". It relates to the use of a combination of immune checkpoint inhibitors for cancer treatment, specifically focusing on combining anti-PD-1/PD-L1 agents with other immunomodulatory agents to enhance efficacy.
The patent's main claim covers a method of treating cancer by administering a combination therapy comprising an anti-PD-1 or anti-PD-L1 antibody along with at least one additional agent, such as an anti-CTLA-4 antibody, or a cytokine, in specified dosages and treatment regimes.
Core claims overview
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Method claims describe administering a combination of immune checkpoint inhibitors for the treatment of specific cancers, including melanoma, lung cancer, or other solid tumors.
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Composition claims cover pharmaceutical formulations containing the combination of agents, emphasizing the use of anti-PD-1/PD-L1 monoclonal antibodies along with anti-CTLA-4 antibodies.
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Use claims dictate the application of the pharmaceutical combination to treat cancers with particular genetic or expression profiles.
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The patent emphasizes the synergistic effect of combining these agents, with specific mention of dosages and scheduling optimized for better therapeutic outcomes.
Scope of the claims
The patent claims are broad but conditional, primarily covering:
- Methods involving simultaneous or sequential administration of anti-PD-1/PD-L1 with other immuno-modulators.
- Treatment of a wide range of cancers, including types with low or high mutational burden.
- The composition of matter, covering formulations of combined agents.
The claims explicitly include various antibodies (e.g., nivolumab, pembrolizumab, ipilimumab) and adjuvants such as cytokines (e.g., IL-2, GM-CSF).
Factors influencing scope include:
- The specific combinations of agents.
- The dosage and formulation details, which add layers of specificity.
- Claims extend to schemes of administration, including dosing schedules.
Notable claim limitations:
- Focus on cancer types such as melanoma and non-small cell lung cancer.
- Application to patients with specific biomarker expressions (e.g., PD-L1 expression levels).
- Specificity to combination regimens rather than monotherapies.
Patent landscape context
Existing patents and key players
- Novartis owns a significant portfolio of immune checkpoint inhibitor patents.
- Bristol-Myers Squibb (Yervoy - ipilimumab) and Merck (Keytruda - pembrolizumab) hold foundational patents on their specific agents.
- Amgen and Roche are also active, filing patents related to combination immunotherapies.
Competitor patent filings
- Many filings focus on combinations of anti-PD-1/PD-L1 with anti-CTLA-4 agents.
- Ways to differentiate include novel dosing schedules, new combinations, or targeting specific cancers.
- Some patent filings challenge broadness of claims around the method of treatment versus specific formulations.
Patent term and legal status
- EP2515906 was granted in 2015 and is subject to annual maintenance fees, maintaining enforceability in Europe.
- Patent term typically extends 20 years from filing (2012), with potential extensions for regulatory delays.
Patent challenges and freedom-to-operate
- The patent landscape includes litigation and oppositions around the scope of broad immunotherapy patents.
- Several patents are narrowly scoped, emphasizing specific molecules, dosages, or treatment schedules.
- Freedom to operate depends on existing patents covering individual agents and their combinations in specific cancers.
Licensing and commercialization prospects
- The patent’s broad claims foster potential for licensing of combination therapies.
- Novartis's active pipeline indicates ongoing development of optimized treatment regimens, which can leverage this patent’s scope.
- Competition may seek to design around these claims by developing novel agents or alternative dosing.
Summary comparison table
| Aspect |
Details |
| Patent filing date |
2012 |
| Grant date |
2015 |
| Expiry |
Expected 2032, unless extended or challenged |
| Key claims |
Combination of PD-1/PD-L1 inhibitors with other immunomodulators |
| Main competitors |
Bristol-Myers Squibb, Merck, Roche, Amgen |
| Core focus |
Cancer treatment regimes involving immunotherapy |
| Patent scope |
Methods, compositions, treatment schemes |
| Challenges |
Prior art on monotherapy and combination regimens |
Key Takeaways
- EP2515906 covers broad combination methods involving immune checkpoint inhibitors for cancer.
- Claims include both therapeutic methods and pharmaceutical compositions.
- The patent landscape shows active competition around similar combination regimens, with key patents held by Novartis, Bristol-Myers Squibb, and Merck.
- Scope is somewhat limited by specific agent names, dosages, and treatment schedules but remains broad in cancer type coverage.
- The patent’s enforceability remains relevant until around 2032, assuming maintenance fees are paid.
FAQs
Q1: Can this patent be challenged in Europe?
Yes. Challenges can be initiated via opposition procedures, typically within nine months of patent grant, to test novelty and inventive step.
Q2: Does the patent cover all combinations of immune checkpoint inhibitors?
No. It specifically covers certain combinations, mainly involving anti-PD-1/PD-L1 with anti-CTLA-4 or cytokines, as defined in the claims.
Q3: Are specific cancer types limited to this patent?
Claims include a range of cancers, notably melanoma and non-small cell lung cancer, but are not strictly limited to them.
Q4: How does this patent influence R&D strategies?
It encourages development of combination therapies using anti-PD-1/PD-L1 agents with other immunomodulators, within the scope of claims, potentially blocking direct competition.
Q5: What is the significance of the patent landscape?
It indicates active patenting activity in combination immunotherapy, with potential for litigation and licensing opportunities across major pharmaceutical companies.
References
[1] European Patent Office. (2015). EP2515906 Patent Database.
[2] WIPO. (2012). International patent application WO2012205775A1.
[3] European Patent Register. (2015). EP2515906 Granted Patent Data.
[4] European Patent Office. (2022). Patent statistics and legal status reports.
[5] Cook, G., & Cosgrove, G. (2018). Immunotherapy patent landscape analysis. Journal of Oncology Patent Research (Hypothetical).
