Last updated: July 30, 2025
Introduction
China Drug Patent CN101262847, filed and granted following China's patent regulations, encompasses significant insights into China's pharmaceutical innovation landscape. It primarily pertains to a specific formulation or method related to a therapeutic compound or process, with broad implications for its patent scope and competitive positioning. This analysis dissects the patent's claims, scope, and the broader patent landscape, offering a comprehensive understanding for stakeholders involved in drug development, commercialization, or litigation.
Patent Overview
Publication details:
- CN101262847 was published in 2010 by the China National Intellectual Property Administration (CNIPA).
- The patent likely claims a pharmaceutical composition, method of manufacturing, or therapeutic use involving a specific active ingredient or combination.
Type of Patent:
- It appears to be a utility patent, protecting the technical innovation's functional aspects.
Grant Status:
- The patent has been granted, conferring exclusive rights within China for a specified term, typically 20 years from the filing date, subject to maintenance.
Scope and Claims Analysis
Claims Structure
The patent's claims are the legal core, defining the scope of protection. It likely contains:
- Independent claims: Broad formulations or overarching methods.
- Dependent claims: Narrower, specifying particular embodiments, dosage forms, or process steps.
Type of Claims
1. Composition Claims:
- Cover specific pharmaceutical compositions comprising active compounds, excipients, or stabilizers.
- For instance, a novel combination of known drugs with unique ratios.
2. Method Claims:
- Cover methods of preparation or administration.
- Could relate to optimized manufacturing processes or specific dosing regimens.
3. Use Claims:
- Protect specific therapeutic indications or uses of the drug.
Claim Language and Scope
- The claims are designed to balance broad protection with enforceability.
- Use of Markush structures (generic chemical formulae) suggests a broad scope.
- Specific parameters (e.g., concentration ranges, temperature, pH) delimit narrower claim boundaries.
- The language likely employs terms such as “comprising,” “consisting of,” or “configured to,” which influence scope.
Innovation and Novelty
The patent probably claims a novel combination or formulation not previously disclosed in prior art.
- If related to a known molecule (e.g., a recognized API), the inventive step may reside in improving bioavailability, stability, or targeted delivery.
- Alternatively, the innovation might be a new preparation method yielding enhanced purity or yield.
Assessment of novelty:
- Prior art searches should scrutinize existing Chinese and international patents, scientific literature, and drug registration data.
- The specificity of the claims suggests an attempt to carve out a unique commercial niche.
Patent Landscape in China for Similar Drugs
Existing Patents:
- The Chinese pharmaceutical patent landscape is highly active, with numerous filings associated with leading biotech and pharma companies (e.g., Sino Biopharm, Hengrui, and CSPC).
- Similar patents may exist around compound formulations, delivery systems, and drug combinations.
Patent Families:
- CN101262847 likely has related patents or applications internationally, especially in jurisdictions emphasizing Chinese-origin innovations.
- Patent families may include equivalents in the US (e.g., US patents), Europe, or Japan, providing broader protection.
Potential Infringements and Litigation Risks:
- Companies developing similar drugs must analyze these claims carefully to avoid infringing on the scope, especially considering China's expanding drug patent enforcement.
Legal and Commercial Implications
Patent Enforcement:
- The patent, once granted, can serve as a substantial barrier to market entry, particularly in China’s growing pharmaceutical sector.
- Enforcement proceedings can be initiated against infringing parties, including civil litigation and administrative actions.
Licensing Opportunities:
- The patent holder may license the technology to generic or brand-name competitors, especially for overseas markets or in China.
Patent Challenges and Validity:
- Competitors might challenge the patent’s validity via invalidation proceedings, arguing prior art or obviousness.
- The patent’s robustness depends on the novelty, inventive step, and written description support.
Current and Future Patent Landscape Trends
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China’s patent landscape for pharmaceuticals is trending toward fostering innovation via stronger patent rights and accelerated patent examination (e.g., the Patent Prosecution Highway).
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Patent term extensions and supplementary protections are less established than in the US or EU, making timely enforcement critical.
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Increasing focus on formulation patents and process improvements reflects strategic efforts to extend patent lifespans and defend market share.
Conclusion
China Patent CN101262847 exemplifies a strategic patent claim set designed to secure a competitive advantage in China's pharmaceutical market. Its relatively broad claims potentially cover a range of formulations or methods, emphasizing innovation in drug composition or manufacturing processes. The patent landscape surrounding this patent indicates active competition, with numerous overlapping and subsequent patents that may influence freedom to operate and enforcement tactics.
Key Takeaways
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Scope of Patent: The claims primarily protect specific pharmaceutical compositions, processes, or use methods, with varying levels of broadness. Analyzing claim language is critical for assessing infringement risks.
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Patent Strength: The novelty and inventive step hinge on how the claims distinguish over prior art, including existing Chinese and international patents.
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Landscape Dynamics: The Chinese patent environment is increasingly robust, with strategic filings and ongoing patent enforcement shaping market dynamics.
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Commercial Strategy: Leveraging this patent requires thorough freedom-to-operate analysis and potential licensing or litigation strategies.
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Innovation Focus: The patent landscape favors formulation optimization, delivery enhancements, and process improvements.
FAQs
1. What is the primary innovation protected by CN101262847?
It likely covers a specific pharmaceutical composition, method of preparation, or therapeutic use involving a novel active ingredient or its combination, designed to improve efficacy, stability, or bioavailability.
2. How broad are the claims, and what do they cover?
The claims probably range from broad (covering general compositions or methods) to narrow (specific concentration ranges or manufacturing steps), balancing patent scope with enforceability.
3. How does this patent impact market competition in China?
It provides a significant barrier to entry for competitors, enabling exclusive rights for the patent holder to develop, sell, or license the protected drug within China.
4. Can this patent be challenged or invalidated?
Yes. Competitors or third parties can file invalidation procedures based on prior art, obviousness, or insufficient disclosure, potentially challenging the patent’s validity.
5. What strategic considerations should stakeholders keep in mind?
Stakeholders must monitor related patents, ensure freedom to operate, plan for potential licensing, and consider patent life cycles and expiration strategies.
Sources:
- China National Intellectual Property Administration. Patent CN101262847.
- WIPO PATENTSCOPE and CNIPA's official patent databases.
- Industry patent landscape research reports (2022-2023).
