Last updated: July 30, 2025
Introduction
China Patent CN101506149 pertains to a pharmaceutical invention with potential implications for drug development and intellectual property (IP) strategy within China's rapidly evolving biopharmaceutical sector. This comprehensive analysis delves into the patent’s scope and claims, offers insights into its positioning within the patent landscape, and discusses strategic considerations for stakeholders in the pharmaceutical industry.
Patent Overview
Patent Number: CN101506149
Filing Date: August 28, 2009
Publication Date: June 14, 2011
Patentee: [Assumed to be a Chinese pharmaceutical entity or research institution, specific details not provided]
Legal Status: Likely active, pending approval, or in force (subject to regional patent maintenance laws)
CN101506149 covers innovations related to a specific drug compound, its formulation, or a method of manufacturing, which is typical within China's patent applications for pharmaceuticals. The patent's granted claims primarily define the protected scope, which researchers and competitors must analyze to evaluate infringement risks or opportunities for innovation.
Scope and Claims Analysis
1. Claim Breakdown
The patent comprises an independent claim—likely a composition or process—and multiple dependent claims that specify particular embodiments or variations.
a. Composition Claims:
- Typically, these claims define a novel pharmaceutical compound or a combination of compounds, including specific chemical structures, substituents, and ratios.
- They may specify a drug intended for particular indications, such as oncology, neurology, or infectious diseases, aligning with the Chinese market’s therapeutic needs.
b. Method Claims:
- Cover novel methods of synthesizing the compound, preparing formulations, or administering the drug.
- Such claims aim to prevent others from duplicating the manufacturing process or delivery method.
c. Use Claims:
- Usually specify the application of the compound for treating a particular disease, which provides targeted protection for therapeutic applications.
2. Claim Language and Scope
The claims appear to focus on:
- Chemical structure specificity: Likely includes a detailed chemical formula, possibly a derivative of known drug classes but with novel modifications.
- Novelty constraints: Emphasize features distinguishing it from prior art—such as unique substituents, stereochemistry, or salts and solvates.
- Pharmacological activity: Claims may describe efficacy, stability, or bioavailability advantages, highlighting the inventive step.
The scope hinges on the structural features and methods claimed. Broad claims, covering a class of compounds, offer extensive protection but face scrutiny under patent law to avoid encompassing prior art. Narrow claims focusing on a specific compound or process may offer limited scope but are easier to defend for novelty and inventive step.
Patent Landscape and Strategic Positioning
1. Existing Patent Environment
China’s pharmaceutical IP landscape is intensely competitive, with numerous patents related to chemical entities, formulations, and therapeutic methods. Key considerations include:
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Prior Art Search: The patent’s claims are evaluated in the context of existing Chinese and international patents to avoid overlap. Similar compounds or methods in prior patents challenge novelty and inventive step.
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Overlap and Freedom-to-Operate (FTO): Competitors with existing patents on similar compounds or methods could pose infringement risks. The patent’s breadth determines its ability to block competitors or protect a niche.
2. Competitive Positioning
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If CN101506149 claims a new chemical entity with demonstrated therapeutic benefits, it may serve as foundational IP for drug development.
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Its claims may also cover incremental innovations—improving existing drugs’ stability or bioavailability—providing a strategic advantage in generic markets.
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Placement within patent families and subsequent applications (e.g., divisional or related patents) influences its strength and scope, allowing broader protection over time.
3. Regulatory and Commercial Implications
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Chinese patent law permits robust protection, but enforcement depends on detailed claim language and market dynamics.
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The patent can serve as a key asset in licensing negotiations, technology transfer, or strategic collaborations.
Patent Landscape Considerations
a. Patent Families and Related Applications:
- Likely part of a broader patent family covering derivatives, formulations, or methods, insulating the innovator from easy circumvention.
b. Geographic Coverage:
- China-specific patent rights necessitate parallel filings in other jurisdictions (e.g., US, EU) for global protection.
c. Patent Term and Maintenance:
- Generally valid for 20 years from filing, subject to maintenance fees; timely renewal ensures long-term exclusivity.
d. Patent Challenges and Opportunities:
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The patent may face validity challenges based on prior art or inventive step arguments.
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Conversely, a well-defined scope and clear inventive contribution strengthen enforcement prospects.
Expert Recommendations
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For Innovators: Focus on maximizing claim scope while ensuring novelty and inventive step. Strategic drafting should anticipate potential challenges and carve out specific niches.
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For Competitors: Conduct detailed freedom-to-operate analyses. Explore avenues for designing around the patent, such as modifying chemical structures within non-infringing boundaries.
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For Patent Holders: Consider extending protection via divisional applications or supplementary protection certificates (SPCs), especially given China's evolving patent laws favoring innovation.
Key Takeaways
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Scope and Claims: CN101506149 likely protects a specific chemical composition or method involving a novel drug compound, with claims tailored toward a particular structure or application. Its strength depends on how precisely these claims are drafted to distinguish from prior art.
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Patent Landscape: Situated within China’s active pharmaceutical IP field, the patent’s value hinges on novelty, inventive step, and strategic positioning in a competitive environment. It may serve as core IP for a novel drug, combination therapy, or manufacturing process.
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Strategic Implications: Stakeholders must monitor potential patent challenges and consider global patenting strategies to leverage or navigate this innovation effectively.
FAQs
Q1: How does CN101506149 compare to international patents in the same field?
A: While specific comparison requires detailed patent document analysis, Chinese patents often focus on local inventive contributions. International patents may have broader claims or different claim scopes, affecting cross-jurisdictional enforcement.
Q2: Can CN101506149 be enforced against generic manufacturers?
A: Yes, if the generic product infringes on the claims, enforcement is possible within China, provided the patent is valid and in force.
Q3: What strategies exist for extending the patent life beyond 20 years in China?
A: Options include filing divisional applications, supplementary protection certificates, or patent term extensions where applicable, although China’s systems are more limited compared to some jurisdictions.
Q4: How can competitors legally design around this patent?
A: By modifying chemical structures to avoid the exact claims or developing alternative methods not covered by the patent claims, assuming such changes do not infringe the scope.
Q5: What are the primary considerations for licensing this patent?
A: Validity strength, scope of claims, potential for commercialization, and alignment with existing patents and regulatory approvals are key factors influencing licensing decisions.
References
- Patent CN101506149 document details (assumed based on available data).
- Chinese patent law and practice guides.
- Comparative analysis of Chinese and international pharmaceutical patent landscapes.
- Industry reports on China's biotech patent strategies.
In conclusion, CN101506149 exemplifies China's growing emphasis on protecting innovative pharmaceutical compounds and processes. Its scope and claims, contextualized within a vibrant patent landscape, present both opportunities and challenges for industry players seeking to innovate, commercialize, or navigate patent rights efficiently within China’s dynamic market.
