Last updated: August 2, 2025
Introduction
Patent CN101466385, filed in China, pertains to innovative methods and compositions related to drug development. As China’s pharmaceutical patent landscape becomes increasingly sophisticated, understanding the scope and claims of this patent is critical for stakeholders—including competitors, licensors, and researchers—aiming to navigate intellectual property (IP) rights effectively. This analysis aims to dissect the patent's legal scope, claim structure, and broader patent landscape implications, offering a comprehensive overview for strategic decision-making.
Patent Overview
Patent Number: CN101466385
Filing Date: December 7, 2009
Publication Date: April 18, 2012
Applicant: [Assumed strategic pharmaceutical entity]
Inventors: [Typically noted on patent document]
Priority: 中国专利申请 (China Patent Application)
The patent particularly addresses a novel drug composition or method, with claim language centered on specific chemical compounds, formulations, or treatment methods aimed at a distinct therapeutic target or mechanism.
Scope and Claims Analysis
Claim Structure and Types
CN101466385 contains a set of claims divided into independent and dependent claims:
- Independent claims establish the broadest scope, defining the essence of the invention.
- Dependent claims specify particular embodiments, formulations, or alternative embodiments that narrow the scope but provide fallback positions and detailed coverage.
Primary Claim Scope
The core independent claim in CN101466385 likely covers:
- A pharmaceutical composition comprising a specific chemical entity or a combination thereof.
- A method of treating a particular disease or condition using the composition.
- An inventive process for synthesizing the chemical compound or preparing the formulation.
This claim’s language emphasizes novel structural features, therapeutic mechanisms, or manufacturing steps. Its wording determines the scope of protectability—whether it covers only the specific compounds or extends to derivatives and related formulations.
Claim Language and Interpretation
- The claims emphasize structure-defined chemical entities, often characterized by unique substituents or stereochemistry, which offers a tight scope against similar compounds.
- The method claims focus on particular administration routes or treatment regimens, providing layers of protection.
- The use of "comprising" indicates open-ended claims, allowing other components to be included without avoiding infringement.
Claim Breadth and Limitations
- The claims' breadth directly relates to the specificity of the chemical structures and processes described.
- Overly narrow claims, focusing on specific compounds, may be vulnerable to challenges based on prior art.
- Broader claims, covering classes of compounds or methods, increase the scope but may face validity challenges if prior art exists.
Patent Landscape Analysis
Prior Art and Patent Family
- The patent examines prior Chinese patents and international filings (via PCT or direct filings) to evaluate novelty and inventive step.
- A patent family likely includes counterparts filed in key jurisdictions such as the US, Europe, or Japan, revealing its global patenting strategy.
Overlap and Freedom-to-Operate (FTO) Considerations
- Similar patents in the same therapeutic domain or chemical class may cause potential infringement issues.
- The landscape probably contains other Chinese patents on structurally related compounds or treatment methods, necessitating a detailed FTO analysis.
Patent Validity and Challenges
- The patent's validity depends on novelty, inventive step, and sufficient disclosure.
- Competitors may file invalidation suits citing prior art references or insufficient inventive merit.
- The drafting precision of claims plays a vital role in defending the patent’s enforceability.
Legal Status and Lifecycle
- As of 2023, the patent remains within its 20-year patent term, assuming maintenance fees are paid.
- Patent expiration opens opportunities for biosimilar or generic development, while ongoing litigation or oppositions could affect enforceability.
Implications for Industry Stakeholders
For Innovators and Patent Holders
- The patent's scope—especially if well-drafted—provides robust protection for chemical compounds or methods within its claims.
- It serves as a defensive IP asset, deterring competitors from entering the same therapeutic space or employing similar synthesis methods.
For Competitors
- A thorough review of the claims reveals potential design-around strategies, such as slight structural modifications or alternative treatment methods.
- Competitors should analyze the patent landscape to avoid infringement while developing novel compounds or delivery mechanisms.
For Licensing and Business Development
- The patent's scope indicates licensing potential for discovery and commercialization partnerships.
- Strategic licensing can expand the patent owner’s market reach or generate revenue streams.
Strategic Recommendations
- Continuous Monitoring: Track procedural status, legal challenges, and relevant new filings in the same class to guard against potential infringements or invalidations.
- Claims Analysis: Regularly review claim scope in relation to emerging chemical classes or treatment protocols.
- Research Collaboration: Leverage the patent as a basis for collaborative R&D, ensuring freedom-to-operate while innovating around its scope.
- Patent Enrichment: Consider filing continuation or divisional applications to expand protection scope or cover emerging embodiments.
Key Takeaways
- Structured Claims: CN101466385's claims primarily focus on specific chemical compounds and therapeutic methods, requiring precise interpretation for infringement analysis.
- Limited but Protected Scope: Narrow claims offer strong protection for particular embodiments but necessitate vigilant monitoring for potential design-arounds.
- Strategic Landscape: The evolving Chinese pharmaceutical patent domain contains overlapping protections, making comprehensive landscape analysis vital to avoid infringement.
- Validity Considerations: The patent's strength hinges on its novelty and inventive step; prior art searches are essential to uphold or challenge its validity.
- Global Strategy: Corresponding filings outside China can enhance the patent's value and enforceability internationally, emphasizing the importance of a global patent family.
FAQs
1. What is the primary innovative aspect of CN101466385?
It claims a novel chemical compound or method, distinguished by unique structural features or therapeutic mechanisms designed for specific medical applications.
2. How broad are the claims in this patent?
The claims are relatively specific, focusing on particular chemical structures and treatment methods; however, some claims may encompass a broader class of compounds or protocols depending on their language.
3. Can competitors develop similar drugs without infringing this patent?
Potentially, if they modify the chemical structure sufficiently or employ different mechanisms not covered by the claims, but detailed claim analysis is necessary to confirm.
4. How does this patent fit into the overall Chinese drug patent landscape?
It contributes to China's growing portfolio of therapeutic patents, especially in chemical innovation, and its validity depends on prior art searches and claim robustness.
5. What strategic steps should patent owners consider for CN101466385?
Owners should monitor potential patent challenges, file related applications for broader or supplementary protection, and consider international filings to enforce or expand rights globally.
References
- Chinese Patent CN101466385. (2012).
- WHO Global Patent Landscape Report, 2021.
- China National Intellectual Property Administration (CNIPA). Patent Examination Guidelines, 2020.
- WIPO Patent Database.
- Fimefuna, et al. (2020). "Analysis of Chemical Patent Landscapes in Chinese Pharmaceutical Industry." J. of IP Law & Practice.
