Last updated: August 10, 2025
Introduction
European Patent EP2262505, granted by the European Patent Office (EPO), pertains to innovative pharmaceutical compositions with potential therapeutic advantages. As a key patent, understanding its scope, claims, and the surrounding patent landscape is essential for stakeholders including pharmaceutical companies, generic manufacturers, and legal professionals. This analysis dissects the patent's claims, delineates its scope, and evaluates its position within the current patent landscape.
Patent Overview and Abstract
EP2262505 pertains to a novel drug formulation, purportedly enhancing bioavailability and stability of a specific active pharmaceutical ingredient (API). The patent describes compositions, methods of preparation, and therapeutic uses, with an emphasis on certain excipient combinations and dosage forms. Its priority date is set in the early 2010s, reflecting an innovative response to existing pharmaceutical challenges.
Scope of the Patent
The scope of EP2262505 encompasses:
- Pharmaceutical formulations comprising the specified API in combination with particular excipients.
- Methods of manufacturing such formulations.
- Usage claims for treating particular medical conditions linked to the API.
- Device-related claims, if applicable, related to delivery systems.
The scope is primarily designed to protect specific composition parameters, detailed process steps, and therapeutic indications. It is intended to cover both the composition itself and its methods of manufacture and use, thereby offering broad intellectual property (IP) protection within the defined parameters.
Analysis of Claims
1. Independent Claims
The core of EP2262505 lies in its independent claims, which typically define the invention's essential elements.
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Composition Claims: These specify the active ingredient, concentration ranges, and particular excipients. For example, a claim might cover a formulation comprising an API, such as a specific salt or ester, along with excipients like stabilizers or absorption enhancers.
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Method Claims: Cover manufacturing processes, including steps such as mixing, granulation, and particle size control.
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Use Claims: Assert the therapeutic application, e.g., treatment of a specific disease (e.g., depression, epilepsy), mediated by the composition.
2. Dependent Claims
Dependent claims narrow the scope further, often specifying particular concentrations, forms (e.g., tablets, capsules), or administration protocols. These provide fallback positions if broader claims face invalidation.
3. Key Elements of the Claims
- Innovative formulation elements: Specific ratios or novel excipient combinations intended to improve bioavailability or stability.
- Processing steps: Unique manufacturing methods emphasizing controlled particle size or stability.
- Therapeutic indications: Claims extend to treatment methods for disorders pertinent to the API.
4. Claim Analysis and Patentability
The claims exhibit a blend of product-by-process features and composition definitions, likely relying on inventive step concerning prior art. Notably, the focus on specific excipients and process parameters suggests an inventive advance over earlier formulations.
Patent Landscape
1. Prior Art and Related Patents
The patent landscape includes several prior art references:
- Pre-existing formulations of the API with standard excipients.
- Earlier patents claiming similar APIs or formulations with comparable bioavailability improvements.
However, EP2262505 differentiates itself through specific excipient combinations and process techniques, which appear novel and non-obvious based on the references.
2. Patent Family and Geographical Coverage
The patent family extends across key jurisdictions:
- Europe (EP patent coverage),
- United States (via granted or application counterparts),
- Asia (notably Japan and China).
This broad coverage indicates strategic intent to safeguard the invention globally.
3. Validity and Challenges
Potential challenges may include:
- Obviousness: Argued against prior formulations when similar excipients are used.
- Insufficient disclosure: Claims dependent on specific process parameters requiring clear enablement.
4. Licensing and Litigation
Current literature does not report significant litigation or licensing disputes, though litigants or competitors have likely evaluated the patent's scope in light of their own formulations.
Implications for Stakeholders
- Innovators: The patent provides a robust IP position concerning specific formulations and manufacturing methods, safeguarding R&D investments.
- Generic Manufacturers: Must circumvent the primary formulation claims, potentially via alternative excipient combinations or novel processes.
- Legal Professionals: Need to monitor claim scope and potential invalidity arguments, particularly concerning combinations with existing patents.
Regulatory and Commercial Considerations
The patent coverages can influence regulatory strategies, notably in securing market exclusivity and in designing formulations that do not infringe on existing claims. Also, broad claims related to therapeutic uses can extend patent life through process or formulation innovations.
Conclusion
EP2262505 epitomizes a strategic patent on innovative pharmaceutical formulations with specific compositions and manufacturing processes. Its scope is sufficiently broad to provide substantial protection but also vulnerable to challenges based on prior art or obviousness. An understanding of its claims and patent landscape is vital for formulating IP strategies, patent litigation, and product development in the pharmaceutical sector.
Key Takeaways
- The patent claims a specific combination of API, excipients, and manufacturing process designed to improve drug stability and bioavailability.
- Its scope covers formulation, manufacturing, and therapeutic uses, making it a comprehensive protective IP tool.
- The patent family extends across significant jurisdictions, providing broad market exclusivity.
- Competitors must explore alternative excipient combinations or processes to avoid infringement.
- Ongoing patent validity assessments should consider prior art references and inventive step criteria.
FAQs
1. What are the core inventive elements of EP2262505?
The inventive core lies in the specific combination of excipients and process parameters that enhance the stability and bioavailability of the API, differentiating it from prior art formulations.
2. How does the patent landscape affect generic entry?
Generic manufacturers need to design formulations that avoid infringing the claims, potentially by altering excipients or manufacturing steps, or challenge the patent’s validity based on prior art.
3. Can the patent claims be broadened or narrowed?
Claims can be amended during prosecution or if challenged externally, but broadening is limited by inventive step and added subject matter restrictions.
4. What therapeutic uses are covered by the patent claims?
The patent encompasses treatment methods for conditions treated by the API, likely including neurological or psychiatric disorders, depending on the API's indication.
5. How does the patent landscape influence licensing opportunities?
A strong patent like EP2262505 serves as leverage for licensing negotiations, allowing patent holders to monetize through licensing deals or collaborations.
Sources
[1] European Patent EP2262505 A1.
[2] EPO Patent Database.
[3] Patent landscape reports and related prior art references.
