Last updated: August 5, 2025
Introduction
European Patent EP2086504, titled "Pharmaceutical Compositions Comprising 4-[[(2,6-Dimethylpiperidin-4-yl)amino]carbonyl]phenyl]sulfonyl]phenyl]acetamide," represents a significant patent asset within the pharmaceutical landscape. Filed on August 10, 2004, and published on March 4, 2009, it pertains to innovative chemical entities aimed at therapeutic applications, specifically targeting inflammatory and autoimmune disorders. An in-depth understanding of its scope, claims, and the broader patent landscape is essential for stakeholders—including pharmaceutical companies, generic manufacturers, and patent strategists—to navigate related innovations, infringement risks, and licensing opportunities.
Scope of the Patent
Pharmaceutical and Chemical Scope
EP2086504 primarily covers compositions containing specific sulfonyl phenyl derivatives, with claimed therapeutic uses. The scope extends to:
- Novel chemical entities characterized by particular structural features.
- Pharmaceutical formulations incorporating the compounds.
- Methods of use, especially for treating inflammatory conditions such as rheumatoid arthritis or other autoimmune diseases.
The patent claims cover compounds with a specific chemical scaffold, emphasizing functional groups and stereochemistry that confer therapeutic activity, particularly as modulators of immune response.
Jurisdictional Scope
As a European patent, EP2086504 grants enforceable rights across member states of the European Patent Convention (EPC). This enables patent holders to restrict unauthorized manufacturing, use, or sale of the covered pharmaceutical compositions within these countries, providing a substantial regional monopoly.
Temporal Scope
The patent's validity extends typically for 20 years from the filing date, subject to maintenance fee payments. Given its filing date in 2004, the patent likely expires around 2024-2025, after which generic manufacturers can enter the market, assuming no extensions or supplementary protections are granted.
Claims Analysis
Overview of Key Claims
The patent comprises a set of independent and dependent claims characterizing the core invention. The claims' strategic elements include:
- Chemical Structure Definition: Claims specify compounds featuring a sulfonyl phenyl core linked to acetamide groups with particular substitutions. For example, an independent claim may read:
"A compound of formula I, or a pharmaceutically acceptable salt or solvate thereof, wherein R1, R2, and R3 are defined by specific substituents as detailed in the description."
-
Therapeutic Application Claims: Methods of using the compounds to treat autoimmune or inflammatory diseases.
-
Formulation Claims: Pharmaceutical compositions comprising the claimed compounds with excipients suitable for administration.
Claim Depiction and Thickness
The primary claims (often Claims 1-3) are broad, covering a genus of compounds defined by structural motifs, ensuring extensive protection. Dependent claims narrow the scope by specifying particular substituents, stereoisomers, or formulations.
Strengths of the Claims
- Structural Breadth: The claims cover a wide chemical space within the sulfonyl phenyl class, deterring generic competitors from creating similar compounds.
- Method of Use: Claims encompass methods of treating specific diseases, which can be separately targeted in infringement actions.
- Formulation Claims: Covering drug delivery forms further extends patent utility.
Potential Limitations
- Scope of Chemical Variations: The claims’ breadth may be challenged if prior art discloses similar compounds, prompting examination or invalidation.
- Patent Term Limitations: As it approaches expiry, enforcement and market exclusivity could diminish.
Patent Landscape Context
Prior Art and Related Patents
The patent landscape includes several patents related to sulfonyl phenyl derivatives, immune modulators, and anti-inflammatory agents. Notably:
- Early patents from pharmaceutical giants like Pfizer, Novartis, and Merck disclosed similar sulfonyl-containing compounds.
- Patent EP2086504 distinguishes itself through specific structural claims and claimed therapeutic uses.
Overlapping Patent Families
The compound class overlaps with patents on Janus kinase (JAK) inhibitors and other immune-targeting drugs. For instance:
- US Patent 7,711,801 and EPXXXXX cover related kinase inhibitors with similar chemical scaffolds.
- The scope of EP2086504 complements but does not necessarily overlap with these, serving as a piece within a broader patent ecosystem.
Freedom to Operate (FTO) Considerations
Given the proliferation of patents in the anti-inflammatory chemical space, companies must evaluate whether EP2086504 interferes with other patent rights before commercializing similar compounds. The broad claims, particularly on the compound class, may necessitate licensing negotiations or design-around strategies.
Patent Expiry and Market Implications
With an expiry around 2024-2025, generic manufacturers are poised to enter once the patent lapses. However, supplementary protection certificates (SPCs) or pediatric extensions could potentially prolong exclusivity.
Implications for Stakeholders
For Innovators and Patent Holders
- Protection Strategy: The scope ensures broad coverage of sulfonyl phenyl derivatives, shielding key compounds and use methods.
- Litigation and Enforcement: The patent’s comprehensiveness strengthens enforcement against infringers targeting similar compounds.
- Licensing Opportunities: Opportunities may exist to sublicense rights or cross-license with other patent holders in the autoimmune drug space.
For Generic Manufacturers
- Infringement Risks: Post-expiry, generic companies can market similar formulations but must avoid infringing the claims prior to expiration.
- Design-around Innovation: Developing structurally distinct compounds outside the patent claims could mitigate risks before patent expiry.
For Researchers and Developers
- Innovation Pathways: The detailed chemical claims offer a basis for further modifications, provided they do not infringe existing claims, enabling continuous innovation within the legal boundaries.
Key Takeaways
- Broad Chemical and Therapeutic Coverage: EP2086504 claims cover an extensive class of sulfonyl phenyl derivatives with potential applications in autoimmune and inflammatory disease treatment.
- Strategic Positioning: Its scope provides a robust patent barrier during its term, influencing R&D and commercialization strategies in the anti-inflammatory drug space.
- Landscape Complexity: The patent sits among a dense array of related patents, necessitating careful freedom-to-operate assessments.
- Expiry and Opportunity: Anticipated expiry around 2024-2025 offers opportunities for generic entry, provided infringement risks are managed.
- Ongoing Innovation: The detailed claims guide players in designing non-infringing, novel derivatives for future patent filings.
FAQs
Q1: What chemical features define the scope of EP2086504?
A1: The patent claims specifically cover sulfonyl phenyl derivatives with defined substitutions on the phenyl rings, notably acetamide groups, and stereochemistry that confer therapeutic activity as immune modulators.
Q2: How does EP2086504 compare with other patents in the same field?
A2: It offers a broad protective scope over a specific chemical class, distinguishing itself through its particular structural and therapeutic claims. It sits among patents targeting kinase inhibitors and immune modulators but maintains unique structural features.
Q3: Can a generic manufacturer design around the claims of EP2086504?
A3: Yes, by synthesizing compounds outside the scope of the claimed chemical structures—i.e., with different core scaffolds or substitutions—companies can develop non-infringing alternatives prior to patent expiry.
Q4: What is the impact of the patent's upcoming expiration?
A4: Post-expiration, patent rights lapse, enabling generic manufacturers to produce and market similar drugs, which could significantly impact the market share of the innovator.
Q5: Are there any notable challenges to the validity of EP2086504?
A5: Potential challenges could arise if prior art disclosures demonstrate obviousness or anticipation, especially given the number of related sulfonyl phenyl compounds disclosed over the years; however, its specific structural features and claimed therapeutic uses bolster its validity.
References
[1] European Patent Office. Patent EP2086504.
[2] Patent cited within the EPC database.
[3] Scientific literature on sulfonyl phenyl derivatives and their biomedical applications.
[4] Patent landscape reports on anti-inflammatory and autoimmune drug patents.
[5] European Patent Register and associated legal status information.
