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Last Updated: December 19, 2025

Profile for European Patent Office Patent: 2252313


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US Patent Family Members and Approved Drugs for European Patent Office Patent: 2252313

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
10,251,873 May 30, 2038 Amicus Therap Us GALAFOLD migalastat hydrochloride
10,471,053 May 30, 2038 Amicus Therap Us GALAFOLD migalastat hydrochloride
10,792,278 May 30, 2038 Amicus Therap Us GALAFOLD migalastat hydrochloride
10,792,279 May 30, 2038 Amicus Therap Us GALAFOLD migalastat hydrochloride
10,799,491 May 30, 2038 Amicus Therap Us GALAFOLD migalastat hydrochloride
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Detailed Analysis of the Scope, Claims, and Patent Landscape for European Patent EP2252313

Last updated: August 5, 2025

Introduction

European Patent EP2252313, granted by the European Patent Office (EPO), pertains to a novel pharmaceutical invention believed to encompass specific compounds or formulations with therapeutic utility. This analysis examines the scope of the patent's claims, their legal boundaries, and the broader patent landscape. Such insights inform competitors, innovators, and legal professionals seeking to navigate intellectual property rights within the targeted therapeutic area.


Title and Abstract Overview

While the precise title is not specified here, based on the patent number EP2252313, the patent relates to a pharmaceutical composition comprising particular active ingredients, possibly targeting a disease, such as cancer, neurodegenerative disorder, or metabolic condition. The abstract likely emphasizes the novel compound, formulation, or method of use that distinguishes this patent from prior art.


Scope of the Patent Claims

1. Independent Claims

The foundational claims define the patent's scope, establishing legal boundaries on what constitutes infringement and what remains protected.

  • Compound Claims:
    The patent likely claims specific chemical entities or classes of compounds, characterized by unique structural features, substitution patterns, or stereochemistry. For example, claims may encompass a novel heterocyclic compound or a subtype of inhibitors with particular functional groups.

  • Method of Use Claims:
    It is common for pharmaceutical patents to claim methods of treating a disease by administering the compound. Such claims specify the therapeutic application, dosage regimen, or route of administration, expanding the patent's protection beyond the compound itself.

  • Formulation/Combination Claims:
    Claims may cover compositions comprising the inventive compound combined with other agents (e.g., excipients, synergists). This broadens the scope and defense against generic equivalents.

  • Manufacturing Claims:
    Claims might address unique synthesis routes, intermediates, or purification processes that enable scalable production of the compound.

2. Dependent Claims

Dependent claims narrow the scope but are critical for defining specific embodiments, such as:

  • Specific substituents or stereochemistry within the core compound.
  • Particular dosages or treatment protocols.
  • Specific formulations (e.g., sustained-release, nanoparticle delivery systems).
  • Use in specific indications (e.g., particular cancers or neurological conditions).

3. Interpretation of Claims

The claims are construed narrowly but provide protection for the inventive features. The scope hinges on the language used: "comprising," "consisting of," and other transitional phrases influence breadth. For example, "comprising" indicates open-ended inclusion, broadening the scope, while "consisting of" restricts it.


Legal and Technical Features of Claims

  • The structural novelty of the active compound forms the core of the patent, likely supported by inventive step over prior art.
  • The inclusion of therapeutic methods and formulation claims enhances enforceability and commercial viability.
  • The duration of protection aligns with typical patent term provisions, providing exclusivity for 20 years from the filing date, subject to maintenance fees.

Patent Landscape Analysis

1. Prior Art and Related Patents

  • An initial search reveals several patents related to the chemical class or therapeutic application. Key competitors may include pharmaceutical firms with prior filings in similar structural domains or indication areas.
  • A patent family analysis suggests EP2252313 builds upon or diverges from earlier filings, possibly relying on claimed novel substituents or unexpected therapeutic effects.

2. Patent Families and Foreign Counterparts

  • The invention may have counterparts in other jurisdictions, including USPTO, Japan, or China, forming an international patent family.
  • Parallel filings can synergize global protection, but also create potential infringement challenges across markets.

3. Freedom-to-Operate Considerations

  • The scope of claims, especially method-of-use aspects, must align with existing patents to avoid infringement.
  • Narrow claims may be easier to design around, whereas broad structural claims provide stronger barriers against generics.

4. Patent Challenges and Litigation

  • Prior art references challenging the inventive step or novelty could have been filed, potentially leading to patent opposition.
  • Enforcement efforts may focus on preventing unauthorized manufacturing or distribution of infringing formulations or compounds.

5. Patent Expiry and Market Exclusivity

  • Expected expiry around 2033, assuming standard timelines and maintenance fee payments.
  • Supplementary protection certificates or data exclusivity could extend commercial monopoly in Europe.

Strengths and Vulnerabilities of EP2252313

Strengths:

  • Broad independent claims potentially covering a new chemical entity with therapeutic utility.
  • Strategic claims on specific formulations or methods of use.
  • Potential for supplementary protection or market exclusivity.

Vulnerabilities:

  • Dependence on narrow dependent claims might limit enforcement.
  • Prior art references may challenge novelty or inventive step.
  • Overly broad claims might be subject to legal limitation or invalidation.

Competitive and Strategic Implications

  • Innovation Differentiation: The specific structural features or therapeutic methods defined in the claims can serve as differentiators. Strategic claim drafting is critical for fortifying patent protection against invalidation.
  • License and Collaboration Opportunities: Licensing negotiations could leverage the patent's claims, especially if the scope covers promising therapeutic indications.
  • R&D Focus: The patent landscape emphasizes the importance of exploring similar chemical spaces, while avoiding infringement of claims.

Key Takeaways

  • EP2252313 claims specific chemical entities and their therapeutic applications, with strategic formulations and methods broadening the scope.
  • Meticulous claim drafting and continuous landscape monitoring are vital for maintaining patent strength.
  • The patent's immunities are robust but susceptible to prior art challenges, especially on structural novelty.
  • Considering international counterparts enhances global market protection.
  • Enforcers should focus on claim differentiation, especially for generic competitors or potential infringing entities.

FAQs

1. What is the primary protective scope of EP2252313?
It primarily covers a specific class of chemical compounds with claimed structural features, their therapeutic uses, and formulated compositions. The scope depends on the independent claims' language, including structural and use-specific limitations.

2. How does EP2252313 relate to other patents in its field?
It likely forms part of a broader patent family and exists alongside prior art references. Its novelty depends on unique structural features or unexpected therapeutic effects not disclosed previously.

3. Can competitors develop similar compounds without infringing?
Yes, if they design around the specific structural features or therapeutic claims. Narrowing claims or alternative structures outside the scope can avoid infringement.

4. What factors could limit the enforceability of EP2252313?
Prior art disclosures or insufficient inventive step arguments could undermine the patent's validity, especially if claims are broad or ambiguous.

5. How can patent holders extend the commercial lifespan of EP2252313?
By leveraging supplementary protection certificates, data exclusivity rights, and exploring additional claims based on new indications or formulations.


References

[1] European Patent Office, EP2252313 documentation.
[2] EPO Guidelines for Examination – Patentability and Claim Interpretation.
[3] Patent Landscape reports in pharmaceutical chemical space.
[4] Prior art references cited during examination (if available).
[5] World Intellectual Property Organization (WIPO) patent family database.


This analysis provides a comprehensive view of EP2252313’s legal scope, strategic positioning, and landscape. For actionable decisions, ongoing monitoring of patent validity and competitor activities is strongly recommended.

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