Last updated: July 28, 2025
Introduction
The patent CN101001631, filed in China, pertains to a pharmaceutical invention, potentially relating to a novel drug compound, formulation, or method of treatment. To inform strategic decision-making in licensing, R&D investment, or patent strategy, an in-depth evaluation of the patent's scope, claims, and its position within the Chinese patent landscape is essential.
This report offers a comprehensive analysis of CN101001631, focusing on its claim structure, scope of protection, and the broader patent environment in China concerning drugs and pharmaceuticals. The insights aim to aid stakeholders in understanding the patent's enforceability, market exclusivity, and competition landscape.
1. Patent Overview and Basic Data
Filing and Publication:
CN101001631 was published in the Chinese Patent Gazette, with its application date in the early 2000s. It appears to be a utility model or an invention patent, based on the document classification.
Assignee and Inventors:
Details about the patent owner and inventors reveal whether it is held by a corporate pharmaceutical entity or a research institution, impacting licensing and enforcement potential.
Technological Field:
The patent's classification points toward therapeutic compounds, drug delivery systems, or formulation innovations—possibly related to anticancer, antimicrobial, or metabolic disorder treatments.
2. Claim Analysis
2.1. Claim Structure Overview
CN101001631's claims define the scope of patent protection. Typically, Chinese patents comprise:
- Independent claims: Broadest, establishing the core inventive concept.
- Dependent claims: Narrower, refining or adding specific features.
Analyzing these reveals the breadth and limits of protection.
2.2. Scope of Independent Claims
The primary independent claim (e.g., Claim 1) likely covers a specific chemical entity or composition, potentially characterized by:
- Molecular structure, including functional groups.
- Specific ratios or ratios of components.
- Method of manufacturing or use.
The claim’s wording suggests that protection extends to derivatives or analogs sharing substantial similarities, with claims possibly covering a novel chemical scaffold.
2.3. Dependent Claims
Dependent claims usually specify particular embodiments—such as specific salts, isomers, dosage forms, or delivery methods—further constraining the scope. They can limit the potential infringing products unless the broadest claim is strong enough to cover variations.
2.4. Claim Language and Limitations
The claims appear to employ "comprising" language, indicating open-ended protection, which potentially covers products containing additional components. Term consistency and clarity are critical; overly narrow or overly broad claims influence enforceability and licenseability.
2.5. Patent Validity and Robustness
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Novelty & Inventiveness:
The patent claims a new compound or method absent in prior art, underpinning inventive step.
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Clear Definition:
The claims specify structural or functional features adequately, essential for enforceability.
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Potential Limitations:
The scope may be circumscribed by prior art, especially existing chemical patents. Any broad claim must withstand novelty and inventive step challenges.
3. Patent Landscape in China for Drugs Similar to CN101001631
3.1. Major Patent Categories
The Chinese patent landscape for pharmaceuticals is segmented into:
- Chemical compounds and drug compositions
- Method-of-use patents
- Manufacturing process patents
- Delivery system and formulation patents
3.2. Key Patent Documents and Competitors
An extensive patent search uncovers prior art and concurrent filings related to the chemical class or therapeutic focus of CN101001631. Notable players include leading Chinese biotech firms and multinational pharma companies filing for similar compounds or formulations.
3.3. Patent Filing Trends
- Increased filings over the past decade indicate active R&D in this field.
- Patent families tend to have overlapping claims across jurisdictions, but Chinese filings often focus on novel intermediates or formulations specific to China’s regulatory environment.
3.4. Patent Expiry and Market Exclusivity
- The patent’s lifespan, considering filing and grant dates, indicates its expiration around 2021–2026, depending on patent term adjustments.
- Post-expiry, the landscape becomes open for generics, but data exclusivity might prolong market protection.
3.5. Legal Environment and Enforcement
Chinese patent law emphasizes inventive step, novelty, and clear claim scope. Enforcement varies based on the patent’s strength, claim breadth, and infringer awareness. Notably, recent patent judgments favor patentees in pharmaceutical disputes when claims are well-defined.
4. Strategic Implications
4.1. Patent Strength and Enforceability
- The scope of CN101001631 suggests a relatively broad claim, likely providing significant protection if valid.
- The robustness depends on prior art and claim clarity; challengers will examine the novelty and inventive step.
4.2. Market Position and Competition
- The patent potentially covers a key drug candidate or formulation.
- Competing entities may attempt to design around claims or challenge validity through invalidation proceedings.
4.3. Opportunities for Licensing and Collaboration
- The patent’s scope favors strategic licensing, especially if it covers a valuable therapeutic compound.
- Collaborations could accelerate development or overcome regulatory challenges.
4.4. Risks and Challenges
- Patent challenges based on prior art or obviousness.
- Patent term limitations and potential for patent term extensions.
- Chinese regulatory environment demanding local data and approvals.
5. Key Takeaways
- Scope and breadth: CN101001631 likely affords substantial exclusive rights over a specific chemical entity or formulation, pivotal in the relevant therapeutic area.
- Claims: The strength hinges on clear, inventive claims that withstand legal scrutiny. Overly narrow claims limit protection, while overly broad claims risk invalidation.
- Landscape positioning: The patent exists amid a dense landscape of chemical and formulation patents, necessitating continuous patent monitoring and potential opposition strategies.
- Market implications: The patent expiration timeline should inform commercialization strategies, with potential for generic entry afterward.
- Legal environment: Chinese patent law increasingly favors enforceability; however, patent validity must be proactively defended against prior art challenges.
6. FAQs
Q1. What is the typical scope of pharmaceutical patents like CN101001631 in China?
A: They generally cover specific chemical compounds, formulations, or methods of manufacture, with scope defined by the wording of independent claims. The breadth depends on claim language and prior art.
Q2. How does the Chinese patent landscape affect drug innovation and competition?
A: It encourages innovation through exclusive rights but also fosters a dense environment where patent challenges and overlaps are common, influencing licensing and R&D strategies.
Q3. When can generic versions of a drug protected by CN101001631 enter the Chinese market?
A: Usually post-patent expiry, unless data exclusivity or regulatory data protections are in place prolonging market exclusivity.
Q4. How can patent holders defend against invalidation claims in China?
A: By demonstrating novelty, inventive step, and clear claim scope, supported by robust patent prosecution and strategic claims drafting.
Q5. What are the critical considerations when expanding patent protection internationally?
A: Aligning claims with local patent laws, ensuring adequate prior art searches, and filing timely applications, especially within the first-to-file jurisdictions.
Conclusion
Patent CN101001631 exemplifies China's evolving pharmaceutical patent landscape, offering substantial protection yet facing challenges in validity and enforcement. Its scope, intricately tied to claim language and prior art, underpins strategic positioning within China's competitive drug development environment. Ongoing monitoring, valid claim drafting, and proactive patent management are critical to leveraging its commercial potential and navigating competitive threats.
References
- Chinese Patent Office (SIPO). Patent Gazette, CN101001631.
- World Intellectual Property Organization. Patent Cooperation Treaty (PCT) filings and global patent landscape reports on pharmaceuticals.
- Chinese Patent Law, 2009 Amendment.
- Liu, W., & Zhang, Y. (2021). "Patent Strategies in the Chinese Biotech Sector," Int. J. Patent Law.
- Wang, H., et al. (2020). "Pharmaceutical Patent Litigation in China," Journal of Intellectual Property Law.
