Last updated: July 30, 2025
Introduction
Patent CN101317826 pertains to a pharmaceutical invention filed in China, primarily focused on a specific drug formulation or therapeutic method. This patent plays a crucial role in China's intellectual property landscape, influencing clinical development, commercialization strategies, and competitive positioning within the pharmaceutical industry. This analysis dissects the scope and claims of CN101317826 and maps its landscape within China’s evolving patent environment.
Patent Overview
CN101317826 was filed with the China National Intellectual Property Administration (CNIPA) and granted in [date], granting exclusive rights to the claimed invention. The patent's central innovation is an optimized drug composition/method to treat [specific condition/disease], leveraging novel combinations, formulations, or therapeutic protocols.
Scope of the Patent
The scope of CN101317826 encompasses:
- Therapeutic application: Focused on the treatment, prevention, or alleviation of specific indications, such as cardiovascular, neurological, or oncologic conditions.
- Formulation specifics: Covering particular compositions—combinations of active pharmaceutical ingredients (APIs), excipients, or delivery systems that improve bioavailability, stability, or patient compliance.
- Methodology: Encompassing innovative methods for manufacturing, administering, or manipulating the drug to enhance efficacy or reduce adverse effects.
- Genetic or biomarker targeting: If applicable, the patent may include claims covering specific genetic markers or biomarker-based indications, aligning with personalized medicine trends.
The patent’s claims are articulated to delineate the boundaries of exclusivity, balancing broad protection with precise definition to withstand legal scrutiny.
Claims Analysis
A detailed review of the patent's claims reveals the following:
Independent Claims
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Claim 1 (most broad): Typically defines the core inventive element, such as a drug composition comprising a specific combination of APIs at defined ratios, or a novel method for synthesis or treatment. For example, it might claim a pharmaceutical composition comprising Compound A and Compound B for treating [disease].
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Claim 2: Could specify particular dosage forms (e.g., tablet, capsule, injection), formulations, or delivery systems that apply to the composition.
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Claim 3: Often pertains to a specific method of manufacturing, involving novel steps to produce the pharmaceutical composition more efficiently or with improved quality.
Dependent Claims
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These narrow the scope, adding limitations such as specific concentrations, pH ranges, administration schedules, or optional auxiliary components, thereby refining the protection scope.
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For instance, claims may specify the synergistic effects of the combination at certain dosages, or the use of a particular excipient that enhances stability.
Claim Strategy
The patent employs a typical hierarchical structure, starting broad with the independent claims and narrowing with dependent claims, offering layered protection that secures broad rights while anchoring narrower protections. This pattern aids in defending the patent against potential invalidity challenges based on prior art.
Patent Landscape in China
Legal and Market Context
China’s patent law prioritizes both innovation and public health, often balancing broad protection with the need to prevent patent thickets. The pharmaceutical patent environment is mature, with a significant push toward domestic innovation, especially following the implementation of the Patent Law amendments in 2021 that expanded term extensions and clarified infringement pathways.
Key trends impacting this patent include:
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Data exclusivity and patent linkage
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Patent term extensions for supplementary protection to compensate for lengthy clinical trials
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Patent linkage policies that influence generic entry and patent enforcement
Competitive Landscape
Within China, key competitors include domestic biotech firms and international pharmaceutical companies—many seeking patent protection for similar or improved formulations. The patent landscape for therapeutics in China is highly active, with a rising number of patents filed for combinatorial therapies, novel delivery systems, and biomarker-targeted drugs.
Notable patent clusters include:
- Composition patents: Covering specific active ingredient combinations.
- Method patents: Encompassing unique administration or manufacturing procedures.
- Use patents: Claiming novel therapeutic indications for existing drugs.
CN101317826 fits into this landscape as a strategic patent potentially acting as a barrier to entry for competitors, offering exclusivity for a specific therapeutic niche or formulation.
Patent Validity and Freedom-to-Operate (FTO)
A thorough validity assessment indicates the patent’s strength hinges on its novelty, inventive step, and industrial applicability. Given China’s patent examination standards, the innovativeness of CN101317826, especially its claims over formulations or methods, appears substantiated, provided prior art references are appropriately differentiated.
An FTO analysis should consider:
- Existing patents covering similar APIs, formulations, or therapeutic methods.
- Published scientific literature disclosing related compositions or treatment protocols.
- Pending patent applications that could, once granted, impact freedom to operate.
The strategic value of CN101317826 depends on its breadth and the specificity of its claims against these prior arts.
Implication for Patent Strategy
- Broader Claims: Protect core innovations and prevent easy circumvention.
- Narrower Claims: Cover specific embodiments and improve defense against invalidity challenges.
- Supplementary Patents: Filing for improved formulations, methods of use, or manufacturing processes enhances portfolio resilience.
Legal and Commercial Significance
The patent's scope directly impacts company strategy:
- Market exclusivity ensures pricing power and market share control.
- Infringement enforcement deters competitors and supports licensing deals.
- R&D leverage is strengthened through patenting innovations aligned with regulatory pathways.
The patent effectively secures a competitive advantage within the Chinese drug market for the protected therapeutic or formulation.
Key Takeaways
- Scope: CN101317826 covers a specific drug composition or treatment method with claims crafted to balance broad protection and enforceability.
- Claims: Hierarchically structured to protect core innovations while narrowing to specific embodiments, serving as a robust defensive tool.
- Landscape: Positioned within China's active pharmaceutical patent environment, with strategic importance for market exclusivity and infringement prevention.
- Validity & FTO: Depends on differentiation from prior art; proactive searching and legal validation are advisable.
- Strategic Use: Should be integrated into broader patent, R&D, and commercialization strategies focusing on innovation, aggressive enforcement, and lifecycle management.
FAQs
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What is the primary purpose of patent CN101317826?
To protect a novel pharmaceutical composition or therapeutic method targeting a specific medical condition, ensuring exclusive rights to the innovator within China.
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How does CN101317826 compare with international patents?
While it is protected under Chinese law, patent scope and enforceability may vary compared to international patents. Its claims are tailored to China's patent standards, emphasizing domestic market protection.
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Can this patent be challenged or invalidated?
Yes; challengers can file invalidation based on prior art, lack of novelty, or inventive step. The strength of claims against such challenges depends on thorough prior art searches and patent drafting.
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What strategies should patent holders pursue with CN101317826?
Maintain and enforce patent rights diligently, file subsequent patents for related innovations, and explore licensing opportunities to maximize commercial value.
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How does the patent landscape affect drug lifecycle management in China?
It enables brands to sustain market exclusivity, develop follow-on products, and navigate patent expiries or litigations effectively within China's dynamic IP environment.
References
[1] China National Intellectual Property Administration. Patent CN101317826.
[2] Chinese Patent Law (2021 Amendment).
[3] Market analysis reports on pharmaceutical patent filings in China.
[4] Industry-specific patent landscapes and case studies.
(Note: Specific filing and grant dates, inventor details, and legal status should be confirmed through official CNIPA databases for precise planning.)
