Last updated: July 28, 2025
Introduction
European Patent EP2493466, titled "Methods of Treating Cancer and Other Diseases," pertains to pharmaceutical compositions and methods aimed at treating specific diseases, primarily cancer. Filed by OncoMed Pharmaceuticals, Inc., this patent exemplifies the strategic approach of biotech firms seeking broad therapeutic coverage through innovative claim structures. This analysis dissects the scope of EP2493466, evaluates its claims' breadth, and contextualizes its position within the current patent landscape pertaining to cancer therapies, particularly those targeting immune modulation and tumor microenvironment.
Patent Overview
Filing and Grant Status
EP2493466 was filed on December 6, 2010, and granted on September 24, 2014, granting exclusivity within Europe, with priority claimed from a U.S. application. The core technology encompasses novel methods of treating diseases, especially targeting tumor growth and metastasis mechanisms.
Abstract Summary
The patent claims centered on administering specific agents—such as anti-DLL4 antibodies or other modulators of Notch signaling pathways—to treat cancers and potentially other diseases associated with aberrant cell proliferation.
Scope of the Patent
Core Focus
The patent primarily discloses methods for treating cancer by therapeutically targeting the Notch signaling pathway, notably via DLL4 (Delta-like ligand 4) inhibition. This pathway plays a pivotal role in tumor angiogenesis and cancer stem cell maintenance, underpinning the patent's emphasis on anti-DLL4 agents as therapeutic strategies.
Claims Declared
The patent's claims can be categorized into the following groups:
- Method-of-treatment claims, involving administering specific anti-DLL4 antibodies or other Notch pathway modulators.
- Composition claims, covering pharmaceutical formulations comprising anti-DLL4 antibodies.
- Use claims, directed to using anti-DLL4 antibodies for treating cancers characterized by certain biomarkers or pathological features.
Scope Analysis
-
Claim Breadth: The claims are drafted broadly, covering various anti-DLL4 agents, including monoclonal antibodies, fragments, and possibly other antagonists of DLL4. This coverage extends to multiple cancer types, such as solid tumors, metastatic cancers, and potentially combination therapies.
-
Limitations: Some claims are narrowed by specific dosage regimes, disease markers, or particular antibody characteristics, such as binding epitopes or isotype specificity.
-
Legal Scope: The claims' broad language encompasses pre-clinical and clinical applications, potentially allowing coverage of a wide array of anti-DLL4 therapeutic agents and treatment regimens.
Claim Construction & Key Elements
Independent Claims
The independent claims broadly define:
- The method of treating cancer by the administration of an anti-DLL4 antibody (or fragment thereof) effective to inhibit DLL4 activity.
- The composition of an anti-DLL4 antibody for use in treating cancer, emphasizing the therapeutic utility.
Dependent Claims
Dependent claims specify:
- Specific antibody structures, such as humanized or fully human antibodies.
- Dosage ranges, formulation specifics.
- Target indications, including particular tumor types or disease states.
- Combination therapy aspects, involving other anti-tumor agents.
This layered approach enhances the patent's robustness, providing fallback positions for potential patent challenges.
Patent Landscape Context
Competitive Forces and Prior Art
The anti-DLL4/Notch pathway has been a prolific area of research and patenting activity around 2010-2020, fueled by its crucial role in tumor angiogenesis and resistance mechanisms.
- Major Players: Besides OncoMed, other biotech giants like Genentech (with anti-DLL4 antibodies), Pfizer, and Novartis have initiated filings targeting similar mechanisms.
- Pre-existing Patents: The landscape includes various patents on anti-Notch and anti-DLL4 antibodies, their compositions, and use in cancer therapy (e.g., US patents on anti-DLL4 antibodies, such as US8,557,420).
Patent Families and Freedom-to-Operate (FTO)
EP2493466 exists within a crowded patent space focusing on Notch pathway modulation, which introduces potential FTO considerations. The broad claims might overlap with earlier filings, emphasizing the necessity of thorough patent clearance, particularly regarding antibody epitope specificity and treatment indications.
Innovation and Differentiation
OncoMed's patent distinguishes itself through claims encompassing multiple anti-DLL4 agents, broad therapeutic indications, and compositions, potentially outpacing narrower prior art. Yet, the substantial patenting activity in this domain increases the risk of licensing dependencies or infringement considerations.
Legal and Strategic Implications
- Defensibility: The broad scope of the claims demands attention to prior art challenges post-grant. The specificity of antibody claims and their functional activity generally offer some defensibility.
- Patent Lifecycle & Extension: Strategies such as filing divisional or continuation applications could prolong patent coverage around specific antibody modifications or combination therapies.
- Market Relevance: Given the pivotal role of Notch inhibitors in ongoing clinical trials, patent protection confers a substantial advantage in commercial negotiations and licensing.
Conclusion and Key Takeaways
European Patent EP2493466 signifies a robust intellectual property position targeting anti-DLL4 antibodies for cancer therapy. Its broad language confers extensive coverage over therapeutic methods and compositions, aligning with the strategic interests of biotech firms aiming to solidify rights in a competitive anti-cancer space.
However, the complex patent landscape necessitates vigilant freedom-to-operate analyses. The overlapping patents and ongoing research in anti-Notch therapeutics underscore the importance of continuous landscape monitoring and precise claim drafting.
Key Takeaways
- EP2493466 provides broad patent coverage for anti-DLL4 antibodies in cancer treatment, emphasizing its strategic importance.
- The patent’s claims encompass various antibody formats, indications, and use cases, enhancing its market security.
- The anti-DLL4/Notch pathway remains a hotly contested area, with multiple overlapping patents requiring careful navigation.
- Companies should conduct comprehensive FTO analyses considering existing patents targeting similar mechanisms.
- Ongoing developments in antibody engineering and combination therapies could challenge or extend the patent scope, necessitating continual innovation.
FAQs
1. How broad are the claims within EP2493466?
The claims are broad, covering various anti-DLL4 antibodies, their uses in treating cancers, and formulations, providing extensive scope to the patent holder.
2. Does the patent cover all anti-DLL4 therapies?
While broad, the patent specifically targets antibodies and similar agents that inhibit DLL4 activity, but not necessarily all forms (e.g., small molecules) unless explicitly claimed.
3. How does EP2493466 fit within the current patent landscape?
It exists amidst multiple patents on anti-Notch and anti-DLL4 agents. Its broad claims may overlap with prior art, requiring careful legal navigation and potential licensing.
4. Can this patent be enforced against other anti-DLL4 antibody developers?
Yes, if the other developers' molecules fall within the scope of the claims, especially regarding the antibody structure and therapeutic use.
5. What are the implications for companies developing DLL4/Notch pathway therapies?
They must perform detailed patent landscape analyses and consider licensing or designing around existing patents to mitigate infringement risks.
References
- European Patent EP2493466.
- "Anti-Delta-like ligand 4 (DLL4) antibodies in cancer therapy," Journal of Hematology & Oncology, 2016.
- Patent landscape reports on anti-DLL4 and Notch pathway modulators, 2020–2022.
- US Patent US8,557,420 on anti-DLL4 antibodies.
