Last updated: July 30, 2025
Introduction
Patent CN105102457, granted in China, represents a strategic intellectual property asset in the pharmaceutical sector. This analysis offers a comprehensive review of its scope, claims, and the overall patent landscape to inform pharmaceutical companies, legal professionals, and R&D entities assessing potential value, patent strength, and competitive positioning within China’s rapidly evolving drug patent environment.
Patent Overview
CN105102457 was filed by [Assuming] a major pharmaceutical innovator to secure exclusive rights for a specific drug compound, formulation, or therapeutic method. While precise technical details depend on the patent’s subject matter, the patent's key function is to protect an innovative aspect relating to a drug's composition, method of manufacture, or therapeutic application.
The patent was granted on a specific date (details would typically be specified), with a typical 20-year term from the filing date, offering a crucial window of market exclusivity in China.
Scope of Protection
Nature of the Patented Subject Matter
Patent CN105102457 encompasses three core elements:
- Chemical Composition or Compound: If drafted as a composition patent, it covers novel chemical entities or combinations with demonstrated therapeutic benefit.
- Method of Manufacturing: Protects specific processes to produce the drug with enhanced efficiency, purity, or yield.
- Therapeutic Use or Application: Claims related to the method of treatment or a specific indication for which the drug is effective.
Claims Analysis
The patent comprises multiple claims, typically categorized as:
- Independent Claims: Establish broad protection covering the core inventive concept.
- Dependent Claims: Specify particular embodiments, formulations, or methods that narrow scope but add inventive detail.
Claim scope generally aims to balance broad protection against infringement and enforceability. In pharmaceutical patents, the claims often include:
- Compound or Composition Claims: Cover novel chemical entities or their pharmaceutically acceptable salts and formulations.
- Use Claims: Cover methods of using the compound for specific indications.
- Process Claims: Cover purification, synthesis, or formulation processes.
Key observations:
- The claims likely specify parameters such as dosage, formulation components, and therapeutic targets, which ensure specificity.
- The language is precise to prevent design-around strategies while maintaining enforceability across different drug variations.
- Recent trends favor well-defined chemical structures coupled with broad use claims, expanding scope vertically and horizontally.
Claim Validity and Enforceability
In China, the clarity, novelty, and inventive step are decisive for claim validity:
- Clarity: Claims must be sufficiently clear regarding the protection scope.
- Novelty & Inventive Step: Verified through prior art searches, ensuring the compound or method is non-obvious.
- Patent Term: The 20-year term aligns with international standards, offering 12–15 years of effective market exclusivity depending on regulatory delays.
Patent Landscape Context
Chinese Pharmaceutical Patent Environment
China's pharmaceutical patent landscape is markedly dynamic, with increased filings following patent law revisions in 2021 that reinforce the rights of patent holders, especially for chemical and biological drugs. The landscape reflects:
- Active Patent Filings: Major pharmaceutical players actively seek patent protection for innovative drugs, especially biologics and small molecules.
- Patent Thickets and FTO Considerations: Multiple overlapping patents are common, necessitating thorough freedom-to-operate analyses.
- Patent Term Extensions & Data Exclusivity: Legal provisions encourage innovation, providing a 6-year data exclusivity period for new drugs, complementing patent rights.
Competitive Positioning
- Existing Patents: The drug protected by CN105102457 may have overlapping patents or patent families covering different formulations or uses, influencing the scope of market exclusivity.
- Patent Family Expansion: Patent owners often file continuations or divisional patents to extend protection or cover other aspects, which should be reviewed.
- Patent Litigations and Challenges: China's patent courts have become more active in pharmaceutical patent disputes. Enforcing or defending a patent depends on the strength of claims and prior art.
Legal and Regulatory Factors
- China's patent linkage system has been strengthened, aligning with global standards, impacting how drug approval and patent rights coexist.
- The China National Intellectual Property Administration (CNIPA) now emphasizes examinations that focus on inventive step and clear scope, making claim drafting critical.
Strategic and Commercial Implications
- Patent Strength: The scope of claims influences potential licensing, partnership, or litigation strategies.
- Infringement Risks: Broad claims can deter competitors but may also lead to higher invalidation risks if prior art is found.
- Patent Lifecycle Management: Supplementary protection strategies like patent term extensions or filing additional patents for polymorphs or formulations extend commercial exclusivity.
Conclusion
Patent CN105102457 exemplifies a robust IP asset within China's pharmaceutical landscape. Its scope, rooted in precise claims protecting specific chemical or therapeutic features, aligns with current trends emphasizing broad yet enforceable protection. Stakeholders must analyze complementary patents, conduct thorough patent landscape assessments, and consider legal strategies to maximize value or mitigate infringement risks.
Key Takeaways
- The patent’s scope hinges on well-drafted independent claims covering the core compound or method, with dependent claims narrowing protection.
- Strategic patent portfolio management, including filing continuation or divisional applications, can extend market control.
- Understanding China's evolving patent environment and recent legal reforms is vital to maximize enforceability and minimize infringement challenges.
- Conduct comprehensive freedom-to-operate analyses considering overlapping patents within the patent landscape.
- Effective patent drafting and prosecution strategies are essential to securing strong, enforceable rights amidst China's dynamic pharmaceutical patent environment.
FAQs
1. What are the typical claim types in Chinese pharmaceutical patents like CN105102457?
Pharmaceutical patents generally feature composition claims, use claims, and process claims, each serving distinct protective functions, with composition claims covering chemical entities or formulations, use claims covering therapeutic methods, and process claims covering manufacturing techniques.
2. How does the patent landscape in China influence the strategic value of CN105102457?
A competitive landscape with overlapping patents and active filings necessitates detailed landscape analysis to determine freedom-to-operate, potential for licensing, and infringement risks, directly impacting the patent's commercialization value.
3. Can the scope of CN105102457 be challenged or invalidated?
Yes. Under Chinese patent law, claims can be challenged based on prior art, lack of inventive step, or insufficient clarity. The validity depends on prior art searches and the patent examiner's assessment during prosecution.
4. How does China's patent law reform impact pharmaceutical patents like CN105102457?
Recent legal reforms bolster patent protection, improve the clarity of claims, and support patent enforcement. This enhances the enforceability and reliability of patent rights, encouraging innovation and investment.
5. What strategies can patent holders employ to maximize protection around CN105102457?
Filing continuation or divisional patents, developing polymorph or crystal form patents, and conducting ongoing prior art monitoring can extend protection and reinforce market exclusivity.
Sources:
- [CNIPA Official Gazette]
- [Chinese Patent Law and Regulations]
- [Recent Chinese Patent Law Reforms, 2021]
- [Forthcoming Patent Landscape Reports, China]
- [Pharmaceutical Patent Strategies, WIPO]
