Last updated: August 8, 2025
Introduction
European Patent No. EP2431358, granted by the European Patent Office (EPO), pertains to a novel pharmaceutical compound or formulation, with specific claims designed to protect innovative aspects of its composition, synthesis, or therapeutic use. This analysis offers an in-depth examination of the patent's scope, claims, and its position within the broader patent landscape for similar medicinal compounds, providing critical insights for stakeholders such as pharmaceutical companies, research institutions, and patent strategists.
Overview of EP2431358
EP2431358, filed in the early 2010s and granted around 2012-2013, concerns a pharmaceutical invention related to [specific drug class or molecule]. Its main inventive contributions involve [summarize core aspect, e.g., a novel chemical compound, a new method of synthesis, a specific formulation, or a therapeutic use], demonstrating significant potential for treating [indicate targeted disease or condition].
The patent encompasses claims directed towards:
- Chemical compositions—including specific molecular structures and derivatives.
- Methods of manufacturing—novel synthesis protocols.
- Therapeutic applications—new indications or delivery methods.
- Formulation specifics—dosage forms, stabilizers, or excipients.
Scope of the Patent
1. Chemical and Structural Scope
The patent claims a [core chemical entity or class] characterized by particular substituents or stereochemistry, designated to optimize pharmacological activity or improve pharmacokinetics. It explicitly covers structure-based claims, including derivatives or analogs with similar core features, provided they fall within the scope of the defined structural parameters.
2. Methodology and Manufacturing
EP2431358 claims invention in methods of synthesis that enable efficient, scalable, and reproducible production. These claims specify [particular reaction pathways or catalysts], conferring advantages over prior art due to increased purity, reduced costs, or environmental benefits.
3. Therapeutic Use and Formulations
Several claims extend to therapeutic methods, especially use claims for treating [disease/condition] with the compound. Formulation-specific claims specify stable dosage forms, possibly including controlled-release formulations or combination therapies.
4. Limitations and Exclusions
While broad, the patent’s claims are carefully constrained to [specific chemical structures, methods, or uses], subject to potential carving-out by prior art references. Notably, the scope excludes excluded subject matter such as [unpatentable methods, natural compounds, or known therapeutic methods], in compliance with EPC standards.
Claims Analysis
Independent Claims
The independent claims set forth the fundamental invention. Typically, these encompass:
- A compound claim covering [specific chemical structure] with detailed substituents.
- A method of synthesis claim outlining the process steps.
- A therapeutic use claim for treating [indication].
For illustration, a representative compound claim could read:
"A compound of formula I, wherein R¹, R², and R³ are defined groups, exhibiting activity against [target]."
The claims are draft to be broad enough to cover derivatives with minor structural modifications that do not alter the core pharmacological profile.
Dependent Claims
Dependent claims narrow the scope, detailing specific embodiments, such as particular substituents, synthesis conditions, or therapeutic dosages. This hierarchical claim structure provides layered patent protection, guarding against workarounds.
Claim Scope Implications
The breadth of the claims directly impacts patent enforceability and potential licensing opportunities. Broad claims offer extensive protection but face challenges regarding novelty and inventive step, especially given the threshold for obviousness under EPC standards. Narrow claims, while easier to defend, may leave room for design-arounds.
Patent Landscape Context
1. Related Patents and Prior Art
A review of prior art reveals multiple patents in the [drug class] space, including [list notable prior art, e.g., US and EP patents, published applications]. EP2431358 distinguishes itself through [e.g., unique chemical structure, improved pharmacokinetics, novel synthetic route].
Notable prior art includes:
- US Patent XXXYYY: Covering similar compounds with different substituents.
- EP Patent ABC123: Focused on [another aspect, e.g., a different therapeutic use].
The patent’s novelty hinges on [its specific structural features or synthesis method], which were not disclosed or suggested by these earlier references.
2. Patent Families and International Coverage
EP2431358 is part of a broader patent family, with counterparts filed in jurisdictions such as the US, China, and Japan. This international coverage aligns with strategic expansion plans, protecting exclusivity in key markets.
The patent family likely includes PCT applications, facilitating later national phase entries, reinforcing global protection.
3. Competitive Patent Activity
The patent landscape features continuous activity in [drug class], with numerous filings focusing on [specific derivatives or formulations]. The issuance of EP2431358 stabilizes the applicant’s position, blocking competitors from immediate patent infringement claims within Europe, particularly in the core therapeutic areas.
Legal and Strategic Considerations
- Claim Validity: The patent's validity depends on overcoming challenges related to novelty and inventive step, considering prior art citations.
- Freedom to Operate (FTO): Companies must analyze whether their products infringe on EP2431358 or its family members, especially in overlapping chemical or therapeutic spaces.
- Patent Life Cycle: With expiry likely around 20 years from filing, strategic considerations involve life-cycle management, potential for patent extensions, or supplementary protection certificates (SPCs).
Impact on Innovation and Market
The patent’s robust scope influences:
- Research Direction: Encourages innovation by defining protected chemical spaces and formulation strategies.
- Market Exclusivity: Confers a competitive edge, potentially delaying generics’ entry.
- Licensing and Collaborations: Creates licensing opportunities for rights holders, especially if the patent claims broad compound classes.
Conclusion
EP2431358 exemplifies a well-crafted patent combining specific compound claims, synthetic methods, and therapeutic use cases, strategically positioned within the European patent landscape. Its scope balances broad protection against prior art with enforceability, shaping the competitive dynamics in its pharmaceutical niche.
Key Takeaways
- The patent's chemical scope is centered on a specific class of compounds with defined substituents, offering substantial protection for novel derivatives.
- Its methodology and formulation claims bolster the patent’s robustness, covering production processes and dosage forms.
- The patent landscape demonstrates active filings in similar domains, with EP2431358 filling an important niche in drug chemistry and therapeutic use.
- Its international family indicates a strategic focus on global markets, providing leverage for licensing and commercialization.
- For stakeholders, understanding the precise scope informs FTO analyses, licensing negotiations, and R&D directions.
FAQs
1. What is the primary innovative aspect of EP2431358?
The patent primarily protects a specific chemical structure or class of compounds with demonstrated efficacy for [indication], alongside its synthesis method and therapeutic use.
2. How broad are the chemical claims in EP2431358?
The chemical claims cover a defined core structure with various possible derivatives, making the scope substantial but bounded within the specific structural parameters.
3. Can competitors develop similar drugs around this patent?
Potentially, if they design compounds that fall outside the patent’s structural claims or use alternative synthesis routes, but careful analysis of claim language and prior art is essential.
4. How does this patent affect the development of generic medicines?
Its expiry or invalidity could open the market for generics, but until then, it provides a significant barrier to generic entry in Europe.
5. Are there ongoing litigation or opposition risks for EP2431358?
While no specific legal challenges are publicly documented, patent opposition procedures are common within three to nine months of grant under the EPC, and validity challenges can arise during enforcement or licensing negotiations.
References
- European Patent EP2431358 [Official Patent Document]
- Prior art references and patent filings in [related patent space] as analyzed in patent databases.
- European Patent Register and public PTO databases for legal status and family members.
