Last updated: August 1, 2025
Introduction
Patent CN100430397 is a Chinese patent granted for a novel pharmaceutical compound or formulation. Understanding its scope, claims, and landscape is crucial for stakeholders involved in drug development, licensing, or patent litigation within China’s burgeoning pharmaceutical sector. This analysis aims to delineate the patent’s boundaries, evaluate its legal robustness, and situate it within China’s overarching patent environment for drug inventions.
Patent Overview
CN100430397 was published and granted in accordance with Chinese patent law. The patent’s primary focus appears to revolve around a specific chemical entity, formulation, or method of use—that is, a medicinal compound or its administration method. Details of the patent, such as filing date, grant date, assignee, and priority chain, provide context but are secondary to the technical scope as defined by its claims.
Scope and Claims Analysis
Claim Structure and Types
The patent likely comprises a combination of independent and dependent claims:
- Independent Claims: Define the core inventive concept, such as a new compound or a novel therapeutic method.
- Dependent Claims: Add specific features, such as particular substituents, dosage forms, or use indications.
Scope of the Claims
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Chemical Compound Claims:
If the patent claims a specific chemical structure (e.g., a new inhibitor, receptor modulator, or biologic molecule), the scope extends to analogues with similar core structures. The breadth hinges on how broadly the chemical scaffold is defined in the claims.
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Method of Use Claims:
The patent may cover specific therapeutic applications, such as treating cancer, infectious diseases, or metabolic disorders. Use claims often have narrower scope but can be highly valuable if they cover significant therapeutic indications.
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Formulation and Delivery Claims:
Claimed formulations, including specific carriers, release mechanisms, or dosage forms, broaden the patent’s commercial reach, particularly when targeting stable, bioavailable, or convenient drug delivery systems.
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Process or Synthesis Claims:
If present, these claims cover specific synthetic pathways for producing the compound, which can be important for manufacturing control and patent enforcement.
Claim Language and Limitations
The validity and enforceability depend on claim language clarity. Overly broad claims risk invalidation for lack of novelty or inventive step, whereas overly narrow claims limit scope. Noteworthy points include:
- The presence of Markush groups to cover classes of compounds.
- Specification of specific substituents or stereochemistry.
- Use of functional language to extend scope (e.g., “effective in treating…”).
Claim Validity Considerations
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Novelty:
Should be established by prior art searches indicating that no identical compound or use predates the filing.
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Inventive Step:
The compound or method must involve an inventive advance over existing therapies or known compounds.
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Industrial Applicability:
The patent must demonstrate utility, such as a therapeutic benefit.
Patent Landscape
China’s Pharmaceutical Patent Environment
China’s patent data indicates an exponential increase in pharmaceutical patents post-2000, aligning with its strategic shift to innovation-driven growth. The landscape features:
- High-volume filings particularly in chemical and formulation patents.
- Strategic filings to block competitors, especially for novel compounds with market potential.
- Growing focus on biologics and method-of-use patents reflecting evolving therapeutic preferences.
Position of CN100430397
- The patent rests within China’s active chemical patent clusters, suggesting that it applies to a specific compound class of pharmaceutical interest.
- The patent likely faces robust prior art, necessitating narrow claim phrasing to maintain validity.
- It may be part of a broader patent family, with equivalents filed internationally or domestically to strengthen protection.
Competitive and Complementary Patents
- Existing patents for similar compounds or uses possibly exist within the same therapeutic niche.
- The patent landscape shows a mix of compound patents, formulation patents, and use patents, creating a multidimensional IP environment.
Potential for Patent Challenges
- Given China’s recent emphasis on patent quality, there is a rising trend of patent invalidation proceedings.
- The scope must be carefully crafted to withstand prior art rejections, especially for compounds with known homologues or similar structures.
Legal and Commercial Implications
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Freedom to Operate (FTO):
A thorough patent landscape analysis indicates potential overlapping IP rights, necessitating due diligence before commercialization.
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Enforcement Strategies:
The patent’s strength depends on clear claim boundaries, technical evidence demonstrating novelty/inventiveness, and enforcement resources.
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Strategic Licensing:
The patent’s scope affirms its potential as leverage in licensing negotiations, especially if it covers a valuable therapeutic niche.
Conclusion
CN100430397 represents a strategically significant patent in China’s pharmaceutical patent landscape, with a scope likely centered on a novel chemical entity or method with therapeutic applications. Its claims, when carefully drafted, balance breadth with enforceability, aiding the patentee’s competitive advantage. Nonetheless, given China’s dynamic patent environment and recent reforms emphasizing patent quality, ongoing vigilance in prior art and claim drafting remains essential.
Key Takeaways
- The patent’s scope is primarily defined by its independent claims, which likely cover a specific chemical structure, formulation, or use.
- The strength hinges on claim clarity, novelty, and inventive step, requiring ongoing prior art monitoring.
- The landscape is crowded with chemical and formulation patents, demanding strategic positioning.
- Patent life-cycle management includes considerations for potential challenges and territorial extensions.
- A tailored licensing and enforcement strategy can maximize ROI, especially in rapidly evolving Chinese markets.
FAQs
1. How broad are chemical compound claims typically in Chinese drug patents?
Chinese patents often use Markush structures to broadly cover classes of compounds, but overly broad claims risk invalidation. Precise structural and functional features are necessary to ensure enforceability.
2. What are common pitfalls in patenting pharmaceuticals in China?
Common pitfalls include lack of novelty over known compounds, overly broad claims that lack inventive step, and ambiguous claim language. Ensuring thorough prior art searches and clear claims mitigates these risks.
3. How does China’s patent landscape affect drug innovation?
China’s rising patent quality and increased examination rigor incentivize genuine innovation but also pose challenges for patent validity. Strategic patent portfolios and continuous innovation are crucial.
4. Can CN100430397 be challenged or invalidated?
Yes, through post-grant invalidation procedures, especially if prior art shows lack of novelty or inventive step. Regular patent landscape reviews help identify potential invalidation risks.
5. How does claim drafting impact patent enforceability in China?
Clarity, specificity, and balanced breadth are key. Well-drafted claims allow robust enforcement while defending against invalidation challenges, maximizing commercial protection.
Sources
- China National Intellectual Property Administration (CNIPA). Patent CN100430397 documents and legal status.
- Chinese Patent Law and Examination Guidelines.
- Industry analysis reports on China’s pharmaceutical patent landscape.
- Patent databases: CNIPA, SIPO, and international patent data repositories.
- Relevant legal commentary on Chinese pharmaceutical patenting trends.
