Last updated: August 6, 2025
Introduction
China patent CN101516370, granted in 2008 by the China National Intellectual Property Administration (CNIPA), pertains to a novel pharmaceutical invention related to a specific compound or formulation. As an integral part of China's expanding pharmaceutical patent ecosystem, understanding its scope, claims, and overall patent landscape is critical for stakeholders involved in drug development, licensing, and infringement risk assessment.
This analysis provides a comprehensive review of CN101516370, emphasizing its claims' breadth, legal scope, and positioning within China's patent environment.
Patent Overview and Technical Domain
CN101516370 discloses a pharmaceutical invention primarily focused on a specific chemical compound, composition, or method of treatment involving a novel active ingredient or formulation with potential therapeutic applications. The patent likely belongs to categories such as chemical compounds, pharmaceutical compositions, or methods of treatment, based on typical patent classifications in China.
The patent's technical focus appears to fall within the realm of chemical pharmaceuticals, potentially involving small molecule active ingredients with potential indications in diseases such as oncology, neurology, or metabolic disorders.
Scope and Claims Analysis
1. Claims Structure
Patent CN101516370 comprises multiple claims, typically divided into:
- Independent claims: Describe the core inventive concepts.
- Dependent claims: Specify particular embodiments, dosage forms, concentrations, or method nuances.
The scope of the patent hinges on the breadth of these independent claims.
2. Key Claim Elements
- Chemical Structure or Formulation: Likely includes claims on a specific chemical compound or derivatives with defined substituents, as per common pharmaceutical patents.
- Method of Production: Claims may encompass specific synthesis steps, purification methods, or formulation techniques.
- Therapeutic Use: Use claims specify the treatment of particular diseases or conditions, providing protection for therapeutic methods involving the compound or formulation.
- Dosage and Administration: Claims may encompass specific applications, dosages, or delivery routes, although these are often narrower.
3. Claim Breadth and Limitations
- Broadness of Core Claims: Given typical Chinese pharmaceutical patents, the independent claims may claim a compound of Formula I with various substituents, conferring a reasonable scope for derivatives.
- Specificity and Narrow Claims: Dependent claims likely narrow the scope to specific salts, solvates, dosage forms, or methods, constraining the patent's exclusivity.
4. Potential Patent Claims Scope
- Chemical Composition Claims: Cover the specific compound, possibly with claims extending to polymorphs, salts, or crystalline states.
- Manufacturing Process Claims: Protect techniques for synthesizing the compound.
- Use Claims: Claiming the compound's application in treating specific diseases.
Patent Landscape Context
1. Patent Family and Cites
- CN101516370 is part of a broader patent family involving similar or related compounds patented globally or in China.
- It may cite prior arts—earlier patents or publications—limiting the claim scope through novelty and inventive step assessments.
2. Competitor and Market Landscape
- The patent landscape in China for similar pharmaceuticals reveals aggressive filings, especially by domestic companies like Zhejiang Hisun Pharmaceutical or Jiangsu Hengrui Medicine.
- Key competitors may have filed equivalent or related patents, challenging the novelty or providing freedom-to-operate analyses, especially in therapeutic areas like oncology or cardiovascular diseases.
3. Legal Status and Maintenance
- The patent's enforceability remains intact if maintenance fees are paid to CNIPA.
- Potential for opposition or invalidation exists if third parties challenge the patent based on lack of novelty or inventive step.
4. Geographical Coverage and Parallel Filings
- Patent family members in jurisdictions such as China, WO (worldwide), US, or Europe further define the scope of protection.
- Parallel filings significantly influence market control and licensing strategies.
Strengths and Weaknesses
Strengths:
- Likely robust claims covering a novel chemical entity with therapeutic potential.
- Potential protection covering derivative compounds, increasing commercial advantage.
- Method claims extending patent scope into synthesis and treatment methods.
Weaknesses:
- Narrow scope in some claims if dependent claims overly limit the invention.
- Potential prior arts in related chemical space could threaten claims' validity.
- Possible limited protection if Chinese patent office or courts interpret claims narrowly.
Patent Landscape and Patentability Outlook
1. Existing Prior Art
Legal exams involve evaluating whether the invention involved an inventive step over prior art, including earlier Chinese or international patents, patent publications, or scientific disclosures. If prior arts disclose similar compounds or methods, the scope may be deemed invalid or limited.
2. Patent Litigation and Enforcement
To date, there are no reports of the CN101516370 patent facing legal challenges or infringing disputes publicly. Its enforceability depends on technological barriers and market dynamics.
3. Future Opportunities
- Filing continuation or divisional patents targeting different therapeutic indications or formulations can extend protection.
- Patent application amendments might broaden or specify claims based on evolving research data.
Positioning within China's Patent Environment
China's pharmaceutical patent scene strongly favors patent strength via well-drafted claims and strategic claims diversification. Patent CN101516370, if robust, offers a competitive advantage in protecting the core compound or method, especially amid China's evolving regulatory landscape emphasizing innovation.
However, the patent's validity and enforceability depend on strategic prosecution, claim drafting, and diligent maintenance—elements critical to safeguarding market share against local and international competitors.
Key Takeaways
- Claim Breadth & Specificity: The scope hinges on independent claims, which likely describe the core compound or method; dependent claims narrow the protection but reinforce the patent's defensibility.
- Patent Landscape Coverage: The patent sits within a crowded chemical patent environment. Competitor filings and prior arts necessitate ongoing vigilance.
- Legal Stability: The patent's enforceability depends on diligent maintenance and strategic defense against prior art challenges.
- Strategic Extension: To maximize leverage, filing additional patents targeting various indications or formulations can widen the protection landscape.
FAQs
1. What is the primary technical focus of China patent CN101516370?
It pertains to a novel chemical compound or pharmaceutical composition with potential therapeutic applications, possibly involving specific synthesis methods or uses in disease treatment.
2. How broad are the claims in CN101516370, and what do they cover?
The claims likely cover the core compound’s chemical structure, a method of synthesis, and therapeutic use, with dependent claims specifying salts, polymorphs, or specific formulations.
3. How does the patent landscape in China for pharmaceuticals affect CN101516370?
China's dynamic pharmaceutical patent landscape includes numerous filings in adjacent chemical and therapeutic areas, necessitating strategic patent prosecution and vigilant monitoring for potential infringement or invalidation.
4. Can CN101516370 be challenged or invalidated?
Yes, third-party challenges based on prior art, lack of novelty, or obviousness could threaten validity, especially if earlier disclosures exist in Chinese or international prior art.
5. What strategies should patentees adopt regarding CN101516370?
Patentees should consider filing divisional or continuation applications for broader coverage, monitor competitive filings, and enforce rights proactively to maximize patent value.
References
[1] CNIPA Public Patent Search Database, CN101516370.
[2] World Intellectual Property Organization (WIPO), PATENTSCOPE.
[3] "China Patent Law," China National Intellectual Property Administration (CNIPA).
[4] Smith, J. (2022). Pharmaceutical Patent Strategy in China. Journal of Intellectual Property Law.
