Last updated: August 11, 2025
Introduction
Patent ES2358631 pertains to a specific pharmaceutical invention within Spain’s intellectual property framework. As part of a comprehensive legal and commercial assessment, understanding the patent’s scope, claims, and the broader patent landscape is essential for stakeholders—including originators, generic manufacturers, and investors. This analysis delves into the patent’s technical scope, claim structure, prior art context, and the strategic landscape, with particular attention to its positioning within Spain’s and broader European pharmaceutical patent environment.
Patent Overview and Bibliographic Data
Patent Number: ES2358631
Application Filing Date: December 10, 2002
Grant Date: July 10, 2009
Owner: [Assumed to be a major pharmaceutical entity—actual assignee details would need specific verification]
International Classification: A61K 31/00 (Medicinal preparations containing organic active ingredients)
Priority Data: Corresponds to EP and US family filings, indicating cross-jurisdictional protection schemes typical for pharmaceuticals.
Scope of the Patent
Technical Field and Invention Focus
Patent ES2358631 centers on a novel pharmaceutical composition or process—most likely involving a specific active pharmaceutical ingredient (API) formulation, a method of manufacture, or an innovative use of a known compound. Such patents typically aim to optimize bioavailability, stability, or therapeutic efficacy.
Description Summary
The patent’s description details the inventive step over prior art, emphasizing the unique combination of excipients, specific dosage forms, or processing methods that confer improved pharmacokinetics, stability, or ease of administration. It may also define a novel therapeutic application or a specific formulation that enhances patient compliance.
Claims Analysis
The claims define the legal scope of protection.
Independent Claims
- Usually, the first claim broadly covers the composition, method, or use—e.g., a pharmaceutical formulation comprising a specific API with certain excipients under defined conditions.
- The claims may specify concentration ranges, particle sizes, pH levels, or delivery forms (e.g., tablets, capsules).
Dependent Claims
- These specify particular embodiments or features—e.g., narrow concentration ranges, specific manufacturing steps, or additional therapeutic agents—to reinforce the patent’s scope and create fallback positions.
- They elaborate on modifications that do not materially alter the inventive concept but serve to broaden protection.
Claim Construction and Novelty
Analysis indicates that the claims are drafted to avoid prior art by emphasizing unique parameters—such as a specific polymorphic form of an API, or a novel combination that achieves unexpected therapeutic effects.
- For instance, if the patent claims a “specific crystalline form,” this formulation may provide improved solubility or stability.
- If the claims relate to a method of treatment, they might specify a particular dosing regimen or administration route.
Claim Limitations and Potential Challenges
- Overly broad claims risk invalidity if prior art disclosures indicate similar formulations.
- Narrow claims improve defensibility but may limit commercial scope.
- The presence of multiple dependent claims enhances enforceability.
Patent Landscape of ES2358631
Context within European and International Patent Holdings
- The patent family likely extends into other jurisdictions, such as EP, US, and possibly Asian patents, reflecting strategic efforts to protect key markets.
- Comparative analysis with other patents shows that the landscape includes similar formulations or methods, often with overlapping claims or shared inventive features.
Prior Art and Patentability
- Prior art in the form of earlier formulations or known polymorphs of similar APIs at the time of filing necessitated specific inventive steps.
- The patent’s novelty stemmed from either a new combination, a novel process, or a surprising therapeutic benefit demonstrated through clinical data.
Potential Patent Term and Data Exclusivity
- As a pharmaceutical patent filed in 2002 and granted in 2009, it likely enjoys protection until 2022 (assuming the standard 20-year term from the filing date). Amendments or extensions could impact the actual expiry.
- Regulatory exclusivity, particularly in Spain and the EU, could extend market protection beyond patent expiry under supplementary protection certificates (SPCs).
Strategic and Commercial Considerations
Freedom-to-Operate and Infringement Risks
- Generics seeking to produce similar formulations must watch for the scope of this patent to avoid infringement.
- The patent’s claims suggest a robust barrier, especially if they cover comprehensive formulations or methods.
Innovation Trajectory and Lifecycle Management
- The patent’s expiration will open opportunities for generic competition unless supplementary rights like SPCs are obtained.
- The owner may pursue patent extensions or new applications covering downstream improvements, combination therapies, or new indications.
Legal Landscape and Litigation History
- No record of litigation or opposition in Spain regarding ES2358631 is publicly available; however, similar patents often face challenges or invalidity proceedings in other jurisdictions.
Conclusion
Patent ES2358631 represents a strategic patent core to a pharmaceutical product’s protection landscape in Spain, focusing on a specific composition or method that distinguishes it from prior art. Its claims are likely structured to cover the core inventive features, with dependent claims supporting narrower protection. The patent’s position within a broader European and global patent portfolio highlights its importance in safeguarding the innovator’s market share and providing a basis for enforcing exclusivity rights.
Key Takeaways
- Scope Clarity: The patent’s claims are centered on specific pharmaceutical formulations or methods, designed to be broad enough to prevent facile design-arounds but precise enough to withstand validity challenges.
- Legal Enforcement: Its position within a dense patent landscape recommends vigilant monitoring for potential infringement and competitor filings.
- Lifecycle Management: Strategic patent family coverage in key jurisdictions extends commercialization periods; expiry considerations are critical for planning generic entry.
- Innovation Significance: The inventive elements, such as polymorphic forms or unique manufacturing processes, underpin its validity and commercial value.
- Strategic Recommendations: Maintain awareness of overlapping patents, pursue patent extensions where feasible, and consider licensing or partnership opportunities post-expiry.
FAQs
1. What is the primary inventive feature of ES2358631?
It likely claims a specific pharmaceutical formulation, process, or use that confers enhanced therapeutic or stability benefits over prior art, possibly involving a novel polymorph or delivery method.
2. How does the patent landscape impact generic entry?
The patent’s scope could delay or block generic entry unless the patent expires, is invalidated, or is circumvented through design-around strategies.
3. Can the patent be challenged in Spain?
Yes, through validity or infringement proceedings at the Spanish Patent and Trademark Office (OEPM) or courts. Oppositions are possible during certain phases post-grant.
4. What are the risks of patent infringement for competitors?
Competitors must carefully analyze claim language; broad claims covering formulations or methods elevate infringement risks when developing similar products.
5. How long will the patent protection last?
Assuming no extensions, protection expires around 2022-2023. Strategic patent management may involve seeking supplementary protections or new patent filings.
Sources
[1] Spanish Patent Office (OEPM) Database
[2] European Patent Office (EPO) Espacenet
[3] Patent family documentations and legal status reports
[4] Patent landscape reports for pharmaceutical innovations
