Last updated: August 7, 2025
Introduction
The European Patent Office (EPO) patent EP2514466, titled "Method for treatment of inflammation and pain", broadly claims a novel method concerning the treatment of inflammatory and pain-related conditions. Filed initially by AbbVie Inc., the patent plays a significant role in the landscape of pharmaceuticals targeting inflammatory disorders, especially in relation to cytokine inhibition pathways.
This analysis provides a comprehensive review of the patent’s scope, claims, and the prevailing patent landscape, facilitating strategic decision-making for stakeholders in pharmaceutical R&D, licensing, and patent management.
Scope of EP2514466
EP2514466 primarily covers a method of treating inflammatory diseases involving administration of a compound that inhibits specific cytokine pathways. It is not limited to a particular compound but rather emphasizes the therapeutic use of a class of molecules or pharmaceutical compositions capable of modulating inflammation and pain.
Core Focus
- The patent aims to protect a method of therapy, which involves administering a compound that inhibits cytokines such as TNF-α (Tumor Necrosis Factor-alpha), IL-6, or other pro-inflammatory mediators.
- The scope extends to treatments of autoimmune and inflammatory disorders such as rheumatoid arthritis, psoriasis, Crohn's disease, and other cytokine-driven conditions.
Legal Boundaries
- The scope encompasses methods of treatment rather than new chemical entities, focusing on novel uses of known compounds or specific compositions.
- It applies to any suitable pharmaceutical formulation capable of delivering the active ingredient effectively.
Claims Analysis
Claim Structure and Hierarchy
The patent features independent claims primarily directed at:
- Claim 1: A method for treating an inflammatory disorder involving administering a therapeutically effective amount of a cytokine inhibitor.
- Claim 2-10: Dependent claims that specify the class of inhibitors, dosage, formulation, and particular inflammatory diseases.
Key Elements of the Claims
- Scope of Inhibitors: The claims broadly cover inhibitors of cytokines such as TNF-α and IL-6, including monoclonal antibodies (e.g., adalimumab, infliximab), fusion proteins, or small molecules.
- Administration Regimen: Claims specify dosage ranges, frequency, and route of administration.
- Diseases Treated: The claims target a spectrum of inflammatory and autoimmune diseases, emphasizing rheumatoid arthritis, psoriasis, ulcerative colitis, and other chronic inflammatory diseases.
Novelty and Inventive Step
The claims distinguish themselves by specifically combining known cytokine inhibitors with novel administration protocols or treatment regimens, potentially providing improved efficacy, safety, or patient compliance. The inventive step hinges on this methodological combination rather than the chemical structure alone.
Patent Landscape
Prior Art and Related Patents
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Multiple patents relate to cytokine inhibitors and their therapeutic applications. Notably:
- EP 1,349,876: Discloses anti-TNF-α antibodies.
- US 7,898,091 and US 8,491,893: Cover specific monoclonal antibodies and methods for treating autoimmune diseases.
- WO 2010/142861: Describes cytokine targeting compositions.
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The prior art emphasizes chemical innovations or biological agents, whereas EP2514466 focuses on methodology—providing a patentable niche through treatment protocols.
Patent Families and Geographical Coverage
- The patent family includes multiple jurisdictions: Europe (EP), United States, Japan, and others.
- These filings ensure a broad territorial scope, capturing key markets for autoimmune and inflammatory therapies.
Competitive Positioning
- The patent's broad claims over cytokine inhibitors' use in inflammatory diseases place it centrally within the biologic therapeutics IP landscape.
- There is potential competition from existing biologic patents, but EP2514466’s specific claims on treatment protocols may offer a strategic advantage for patent enforcement and licensing.
Implications for Stakeholders
Pharmaceutical Developers
- Freedom to Operate (FTO) considerations must evaluate overlapping patents, especially concerning cytokine inhibitors such as adalimumab or tocilizumab.
- The patent provides possible pathways for developing novel treatment regimens, especially immunomodulatory protocols.
Patent Holders and Licensees
- Can leverage EP2514466 to reinforce patent portfolios or to negotiate licensing agreements.
- The patent’s scope supports combination therapies and personalized medicine approaches.
Legal and Regulatory Context
- The patent's focus on treatment methods aligns with European patent law, which permits patenting methods of medical treatment in specific circumstances.
- Ongoing legal challenges may involve public policy debates regarding patenting medical methods.
Conclusion and Future Outlook
EP2514466 exemplifies an advanced strategy in pharmaceutical patenting by focusing on methodology of treatment with cytokine inhibitors. Its broad claims concerning autoimmune and inflammatory diseases position it as a potentially cornerstone patent in biologic therapy development.
Given the evolving landscape, monitoring related patent filings, especially those involving biosimilars, combination therapies, and novel cytokine pathways, is essential. The patent’s strength derives from its broad claim scope coupled with defense against prior art, bolstering its strategic importance within the autoimmune therapeutics ecosystem.
Key Takeaways
- EP2514466 secures a broad method-of-treatment patent targeting cytokine-inhibiting therapies for inflammatory diseases.
- Its claims encompass various cytokine inhibitors, including monoclonal antibodies and fusion proteins, with specified treatment protocols.
- The patent landscape is densely populated with prior art on cytokine inhibition; however, its treatment-focused claims provide strategic leverage.
- Legal considerations: The patent’s scope supports enforcement and licensing opportunities but may face challenges over method claim patentability.
- Future growth hinges on innovative treatment regimens and combination approaches within the biologics domain.
FAQs
Q1: Can EP2514466 be used to protect new cytokine inhibitors developed after its filing?
A: No. Patent claims cover specific methods involving known cytokine inhibitors. New inhibitors introduced later would require separate patent protection.
Q2: Does EP2514466 protect chemical entities?
A: No, it primarily protects methods of administration and treatment protocols involving cytokine inhibitors, not the chemical structures of the inhibitors themselves.
Q3: How does this patent impact biosimilar development?
A3: It may pose blocking rights or foster licensing opportunities for biosimilar manufacturers seeking to develop cytokine inhibitor therapies within the patent scope.
Q4: What is the lifespan of EP2514466?
A: Typically, European patents provide 20 years from the application date, subject to maintenance fees and legal proceedings.
Q5: Are there ongoing legal disputes related to EP2514466?
A: As of now, no publicly disclosed legal disputes are associated with this patent; however, patent landscape dynamics suggest vigilant monitoring is advised.
References
- European Patent No. EP2514466.
- Prior art references related to cytokine inhibitors and autoimmune therapies.
- Patent family filings in the US, Japan, and other jurisdictions.
- Official EPO patent documentation and legal status reports.
