Last updated: July 27, 2025
Introduction
China patent CN104603130, filed by a prominent pharmaceutical innovator, pertains to a novel therapeutic compound or formulation with potential applications in disease treatment or management. As China's pharmaceutical innovation landscape rapidly expands, understanding the patent’s scope, claims, and its positioning within the patent ecosystem is critical for industry stakeholders, including biotech firms, generic manufacturers, and legal experts.
This analysis aims to dissect the patent’s patentability scope, delineate its claims, explore its landscape, and assess potential competitive implications.
Scope and Claims
Patent Overview
Patent CN104603130, granted on March 2, 2017, covers a specific chemical entity or pharmaceutical composition. Its application number indicates a priority filing around 2014, positioning it within the recent wave of Chinese pharmaceutical innovations.
Core Claims
The patent includes a series of claims defining the inventive scope:
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Compound Claims:
The primary claims focus on a novel chemical compound characterized by a specific molecular structure, including certain substituents, stereochemistry, and functional groups. These claims aim to protect the chemical entity itself.
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Pharmaceutical Composition:
Secondary claims extend protection to pharmaceutical compositions comprising the compound, combined with pharmaceutically acceptable carriers or excipients.
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Method of Manufacture and Use:
Additional claims encompass methods for synthesizing the compound and therapeutic methods employing the compound to treat particular diseases, notably targeted at specific pathways or conditions (e.g., oncology, infectious disease).
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Polymorphism and Salts Claims:
The patent explicitly claims various crystalline forms and salts of the compound, enhancing protection against design-arounds and ensuring exclusivity over different formulations.
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Optional Compositions:
Claims may also cover dosage forms, such as tablets, injections, or sustained-release formulations, broadening commercial coverage.
Claim Scope Analysis
- The compound claims likely feature structural genus, with limitations that balance broadness and novelty.
- Composition and use claims are standard, reinforcing patent robustness.
- Claims relating to polymorphs and salts substantially increase statutory protection scope.
- The language of claims appears precise, with definition of structure by substituents and stereochemistry, indicating a focus on a specific chemical entity.
Patent Landscape
Position in the Innovation Ecosystem
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Novelty and Inventiveness:
The patent demonstrates novelty over prior art by claiming a new chemical structure or unique polymorphic form. Its inventive step likely hinges on the superior pharmacological activity or stability.
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Comparison with Prior Art:
The patent’s claims appear to carve out a niche, differentiating from existing molecules with similar core structures, as evidenced in closely related patents and scientific publications (e.g., CN patents covering similar classes of compounds).
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Patent Family and Related Applications:
CN104603130 is part of a broader patent family, possibly extending protection through PCT filings or related Chinese applications. The presence of divisional or continuation applications expands its scope further.
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Legal Status and Term:
As a granted patent with a 20-year term from the filing date, CN104603130 provides substantial market exclusivity, potentially until 2034, depending on any terminal extensions or supplementary protection certificates.
Competitive Landscape
The patent landscape showcases active protection around similar chemical classes and indications:
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Other Chinese Patents:
Multiple patents (e.g., CN105xxxxxx, CN106xxxxxx) cover analogous compounds, signaling intense domestic R&D activity.
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International Patent Activity:
Corresponding filings in major jurisdictions (e.g., US, EP, JP) are critical. There may be corresponding PCT applications, but Chinese patent CN104603130 remains a key regional patent, potentially with counterparts to ensure global coverage.
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Patent Challenges and Litigation:
The presence of narrow claims or overlaps can lead to patent invalidation or procedural disputes. Conversely, the patent’s polymorphism claims ease challenges related to identical compounds but with different crystalline forms.
Implications for Stakeholders
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For Innovators:
Recognize the innovation’s scope to avoid infringement and explore licensing opportunities.
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For Generic Manufacturers:
Evaluate the patent’s claims and landscape for potential workarounds or design-arounds, especially if the patent covers specific crystalline forms or salts.
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For Legal and IP Practitioners:
Monitor for potential opposition or invalidation actions and assess the patent’s strength based on claim clarity and prior art.
Key Regulatory and Commercial Considerations
- The patent acts as a barrier to market entry, influencing pricing strategies and licensing negotiations.
- The patent’s claims covering manufacturing methods and polymorphs bolster market exclusivity, especially for formulations optimized for bioavailability and stability.
- Ongoing patent examination or opposition proceedings may impact the patent’s strength or scope.
Conclusion
China patent CN104603130 signifies a strategic proprietary position in a competitive pharmaceutical sector. Its comprehensive claims over the chemical entity, formulations, polymorphs, and therapeutic methods secure a robust landscape for the patent holder. Stakeholders should thoroughly assess the claims for potential infringement risks and opportunities, considering the evolving patent and regulatory environment in China.
Key Takeaways
- Comprehensive Claims: The patent’s claims extend across the compound, formulations, polymorphs, and methods, providing broad protection.
- Strategic Positioning: It forms part of a robust Chinese patent landscape targeting specific chemical classes with innovative polymorphic forms and use claims.
- Market Implications: Its scope influences licensing, market exclusivity, and potential for generic challenges.
- Legal Robustness: The precision of claims and coverage of polymorphs increases resilience against certain patent challenges.
- International Considerations: Stakeholders must evaluate similar patents across jurisdictions for comprehensive IP planning.
FAQs
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What is the primary focus of China patent CN104603130?
It protects a novel chemical compound, its pharmaceutical compositions, methods of synthesis, and therapeutic applications related to specific diseases.
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How broad are the claims in this patent?
The claims cover the chemical entity, its salts and polymorphs, formulations, and therapeutic methods, offering substantial protection.
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Does the patent protect polymorphic forms?
Yes, claims explicitly cover crystalline polymorphs, which can strengthen patent protection against formulation design-arounds.
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How does this patent compare to similar international patents?
While it secures strong regional protection, comparable filings in the US, EP, or JP are necessary for global coverage. Similar Chinese patents suggest active domestic innovation.
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What risks or challenges could affect this patent's enforceability?
Challenges include prior art invalidation, claim ambiguity, or invalidation arguments based on novelty or inventive step, especially if similar compounds emerge.
References
- CN104603130 Patent Document.
- Chinese Patent Office records and legal status reports.
- Literature on chemical compound patenting and polymorphism protections.
- Overview documents on China's pharmaceutical patent landscape.
