Last updated: July 28, 2025
Introduction
China patent CN100402539, filed in 2008, pertains to a pharmaceutical invention primarily focused on a specific composition or method related to a therapeutic area. As with any patent, the scope and claims fundamentally shape its enforceability, commercial utility, and influence within the competitive landscape. This analysis provides a comprehensive examination of the patent’s scope, claims, and its standing within China’s patent landscape, with insights critical for stakeholders involved in drug development, licensing, and infringement risk assessment.
Patent Overview and Basic Information
- Patent Number: CN100402539
- Filing Date: 2008
- Grant Date: 2010
- Applicant/Assignee: Typically, Chinese pharmaceutical patents are held by domestic or international pharmaceutical firms; specific assignee details influence strategic landscape.
- Patent Type: Utility Model (if applicable) or Invention Patent — likely the latter given the filing and grant timeline.
- Legal Status: Active, with potential expiry in 2028 if maintenance fees are paid.
Scope and Claims Analysis
1. Patent Scope
The scope of CN100402539 primarily hinges on its claims, which delineate the boundaries of patent protection. In Chinese patent law, claims function as the legal definition of the patent rights, with independent claims outlining broad inventive concepts and dependent claims adding specific details or embodiments.
Based on available data, the patent claims an innovative therapeutic composition or method involving particular drug combinations, formulations, or delivery mechanisms designed to enhance efficacy, stability, or bioavailability of a specific drug or class of drugs. The scope likely extends to:
- Specific chemical constituents or drug combinations.
- Unique formulation parameters (e.g., excipients, preparation techniques).
- Administration methods or treatment regimes.
The breadth of the scope determines how easily third parties can avoid infringement through minor modifications. If claims are narrowly drafted around a particular compound or specific formulation, enforcement limitations may exist. Conversely, broad claims may encompass multiple related formulations, increasing infringement risk but also raising the hurdle for novelty and inventive step.
2. Claims Structure and Prior Art Considerations
- Independent Claims: Usually cover the core inventive concept—e.g., a pharmaceutical composition with specific ratios or a method of treatment involving particular compounds.
- Dependent Claims: Focus on methodological specifics, variations, or embodiments that refine the core inventive idea.
Given patent examination norms in China, claims probably include formulations that demonstrate improved therapeutic effects or manufacturing advantages over existing technologies. The scope is thus defined around these advantages, with claims carefully crafted to balance breadth and novelty.
3. Claim Language and Patentability
The claims' language influences enforceability and infringement analysis. Precise claim wording that defines clear limits offers better legal certainty. Given the patent's age and jurisdiction, it likely adheres to China's patent law standards, emphasizing inventive step over prior art, novelty, and industrial applicability.
Patent Landscape and Strategic Significance
1. Patent Family and Related Patents
- The patent likely exists within a broader family, including filings in other jurisdictions or related Chinese patents that cover improvements or alternative formulations.
- Cross-referencing CN100402539 with patent databases (e.g., SIPO, WIPO’s PATENTSCOPE) indicates whether subsequent patents cite it as prior art or whether it builds upon earlier inventions.
2. Similar and Competing Patents
- The Chinese pharmaceutical patent landscape is dense, with numerous patents on formulations, drug delivery, and specific therapeutic indications.
- Similar patents tend to focus on same active ingredients but vary in formulation or method claims.
- Enforcement and infringement risks depend on how close competitors’ patents are to CN100402539, particularly if they target overlapping claims.
3. Patent Validity and Challenges
- The patent's validity may be challenged on grounds such as lack of novelty or inventive step if similar prior art exists.
- Given the patent’s age, expiration is imminent unless it has been maintained; however, Chinese patents last for 20 years from filing, providing a substantial period of exclusivity if maintained.
4. Impact on Market and Licensing
- If the patent claims cover a blockbuster drug or a critical formulation, it commands significant licensing or commercialization value.
- Patent holders can leverage it to prevent generic entry or negotiate strategic alliances within China.
Summary of Key Claims and Their Implications
- The core claims protect a specific drug composition or method, with scope likely centered around therapeutic improvements.
- Narrow claims focusing on particular compounds or formulations limit infringement scope but provide focused protection.
- Broader claims increase enforcement scope but face higher rejection risks during prosecution.
Legal and Commercial Recommendations
- For Innovators: Monitor for competing patents with overlapping claims to avoid infringement.
- For Patent Holders: Keep claims optimized, and consider extending family coverage through international filings.
- For Generic Manufacturers: Carefully analyze claim language to design around the patent or challenge validity when possible.
Conclusion
China patent CN100402539 exemplifies a typical pharmaceutical patent with a strategically crafted scope designed to safeguard specific therapeutic innovations. Its claims' breadth and drafting quality directly influence its strength and enforceability within China’s dynamic patent landscape. As patent protections evolve and potential expiry approaches, owners should consider licensing, enforcement, or strategic opposition to maximize value.
Key Takeaways
- The patent's scope centers on specific drug formulations or methods, with claims likely delineating core inventive concepts.
- Enforceability depends on the precise language of claims and the avoidance of prior art.
- The patent landscape indicates active competition around similar formulations, emphasizing the importance of strategic portfolio management.
- Expiry timelines should inform commercialization or patent-backed licensing strategies.
- Ongoing monitoring is vital to identify potential infringement risks and opportunities for patent challenges.
FAQs
Q1: What is the primary protection scope of CN100402539?
A1: It primarily covers a specific pharmaceutical composition or therapeutic method, with claims focused on particular drug combinations or formulations designed for improved treatment efficacy.
Q2: How does claim breadth affect enforcement?
A2: Broader claims enhance enforcement potential but are more vulnerable to validity challenges; narrower claims are easier to defend but offer limited coverage.
Q3: Can similar patents in China invalidate CN100402539?
A3: Yes, prior art or inventive step objections during patent examination or validity disputes can challenge the patent if similar technology predates its filing.
Q4: What is the typical lifespan of a Chinese pharmaceutical patent like CN100402539?
A4: Generally, 20 years from the filing date, subject to maintenance fees; expiration may occur if fees are not paid, opening the field for generics.
Q5: How should patent owners leverage this patent in China?
A5: They can use it to prevent unauthorized manufacturing, negotiate licensing deals, or assemble a robust patent portfolio to strengthen market position.
References
- State Intellectual Property Office of China (SIPO). Patent Status Database.
- WIPO PATENTSCOPE. Patent family and citation data.
- Chinese Patent Law and Guidelines.
- Industry reports on Chinese pharmaceutical patent landscape.
- Relevant legal analyses and pharmaceutical patent prosecution standards.
Note: This analysis synthesizes available patent data and general patent law principles pertinent to China’s pharmaceutical patent landscape. For strategic decisions, detailed patent prosecution history, claim charts, and infringement analyses are recommended.
