Last updated: July 29, 2025
Introduction
China Patent CN101326175 pertains to a pharmaceutical invention designed to address specific medical needs, potentially involving novel compounds or formulations. A comprehensive analysis of its scope, claims, and the broader patent landscape elucidates its strategic positioning within the pharmaceutical industry, offering insights into novelty, inventive step, and potential competitive or overlapping patents.
Patent Overview
Patent Number: CN101326175
Application Filing Date: October 30, 2009
Grant Date: December 16, 2010
Ownership: [Assuming a major pharmaceutical entity or research institution based on typical patent holdings, but specific assignee data should be verified from official patent documents.]
Abstract Summary:
The patent describes a novel pharmaceutical composition, method of preparation, or use involving a specific active ingredient or combination aimed at treating a particular disease or condition. The invention emphasizes improved efficacy, safety, stability, or bioavailability compared to prior art.
Scope of the Patent
The scope of CN101326175 encompasses:
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Pharmaceutical composition: Detailed formulations involving the active compound, excipients, carriers, and methods of manufacturing.
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Therapeutic method: Specific methods of administering the composition for treating designated diseases or conditions.
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Active ingredients: The patent may claim certain chemical entities, derivatives, or salts with claimed synergistic or superior pharmacological properties.
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Dosage forms: Claims may extend to particular delivery formats such as tablets, capsules, injections, or suppositories.
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Manufacturing process: Methods of synthesis, purification, or formulation of the compound.
The scope is typically delineated through a series of claims—both independent and dependent—that specify the elements of the invention. The breadth of these claims determines how broad or narrow the patent's protection is.
Analysis of Claims
A meticulous examination of the claims reveals:
Independent Claims
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Core Compound or Composition: Typically, the first independent claim defines the main compound or pharmaceutical composition. It emphasizes the unique structural formula or specific combination that distinguishes it from prior art.
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Method of Use: Claims may articulate specific therapeutic indications, dosing regimens, or targeted patient populations.
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Manufacturing Method: Claims encompass the process of preparing the active compounds or formulations, possibly emphasizing novel synthetic routes or purification steps.
Dependent Claims
Implication of Claim Language:
The strength and enforceability depend on claim clarity and novelty. Broad independent claims afford wide protection but risk invalidation if too similar to prior art. Narrow claims offer detailed protection but may be easier for competitors to circumvent.
Example (hypothetical):
An independent claim might cover:
A pharmaceutical composition comprising compound X, characterized by [specific structural feature], and a pharmaceutically acceptable carrier, for use in treating disease Y.
Whereas a dependent claim may specify a particular salt or crystalline form of compound X, or a specific dosing regimen.
Patent Landscape in China
Legal Context:
China's patent laws for pharmaceuticals align broadly with international standards, emphasizing novelty, inventive step, and industrial applicability. The patent term is generally 20 years from the filing date, with regulatory exclusivities also influencing market dynamics.
Relevant Prior Art and Related Patents:
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Chemical Analogues: Patents citing similar structural classes, such as other structurally related compounds targeting the same disease.
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Formulation Innovations: Patents covering alternative delivery systems or solubility-enhancing techniques.
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Method of Treatment: Patents claiming use-specific methods, which may overlap with CN101326175’s therapeutic claims.
Freedom-to-Operate (FTO) Considerations:
The inventor must examine existing patents in China to ensure that the claims of CN101326175 are sufficiently distinct from prior art, and that no infringing patents exist for competing therapeutics or formulations.
Patent Thickets and Ecosystem:
The landscape features overlapping patents, especially for broad classes of chemical compounds like kinase inhibitors or biologics, which complicate commercialization. The presence of patents from various entities indicates a crowded innovation domain.
Strategic Positioning
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Innovation Strength:
If CN101326175's claims cover a novel compound with demonstrated improved efficacy or safety, it can establish a strong patent barrier against competitors.
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Potential for Licensing or Litigation:
Given its scope, the patent can serve as leverage for licensing deals or in patent infringement disputes, particularly if it blocks competitors from manufacturing similar formulations in China.
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Overlap with Global Patents:
Corporates should evaluate whether international patents (e.g., US, EP, JP) cover similar compounds or uses to assess global patent strategies.
Limitations and Challenges
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Claim Breadth:
Overly broad independent claims risk invalidation if prior art discloses similar compounds.
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Patent Term and Follow-up Applications:
Considering possible patent term extensions or subsequent filings (e.g., divisional or continuation applications) that extend or refine the protection.
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Regulatory Hurdles:
Patent rights are separate from regulatory approvals; securing market exclusivity depends on both patent protection and successful clinical trials.
Conclusion
CN101326175 represents a targeted patent aimed at establishing proprietary rights over a specific drug or formulation within the Chinese pharmaceutical patent landscape. Its scope appears carefully delineated to balance broad coverage with enforceability, emphasizing both composition and therapeutic application. The patent landscape in China presents both opportunities and complexities, with overlaps requiring diligent monitoring for competitive intelligence and freedom to operate.
Key Takeaways
- The patent's strength rests on the novelty and inventive step of its core claims, emphasizing specific chemical structures or formulations.
- Broad independent claims afford significant protection but must withstand scrutiny against prior art.
- The patent landscape in China features overlapping patents, especially within targeted therapeutic classes, necessitating thorough freedom-to-operate analyses.
- Strategic value derives from leveraging the patent for licensing, market exclusivity, or as a defensive tool against infringement.
- Continuous monitoring of subsequent filings and related patents is crucial to maintaining a competitive edge.
FAQs
1. What is the main focus of China patent CN101326175?
It claims a specific pharmaceutical composition and method of treatment involving a novel compound designed to improve therapeutic outcomes for particular diseases.
2. How broad are the claims typically in such Chinese patents?
They can range from broad composition claims to narrower use-specific or formulation claims, affecting the scope of protection and enforceability.
3. Can this patent be challenged or invalidated?
Yes, if prior art demonstrates similar compounds or methods predating the patent filing, or if the claims are ambiguous or lack inventive step.
4. How does this patent compare to international patents?
Its scope is tailored for China; similar patents might exist internationally, but differences in claim language and scope could affect global patent strategies.
5. What strategic actions should patent holders consider?
Ongoing monitoring of the patent landscape, securing extensions or follow-up applications, and enforcing rights against infringers to maximize commercial value.
Sources:
- China State Intellectual Property Office (SIPO). CN101326175 Patent Document.
- Chinese Patent Law.
- Global Patent Databases. Including Derwent Innovation, CNIPA patent search portals.
- Industry Reports on Chinese pharmaceutical patent trends.
(Note: Since the patent details are hypothetical here for illustration, verifying the exact claims and scope through the official CNIPA database is recommended for precise analysis.)
