Last updated: July 30, 2025
Introduction
Patent CN101495122, filed in China, delineates a pharmaceutical innovation targeting specific therapeutic compounds or delivery mechanisms. As China emerges as a crucial hub for pharmaceutical R&D, understanding the scope, claims, and overall patent landscape of CN101495122 enables stakeholders to evaluate the scope of market exclusivity, potential infringement risks, and landscape positioning. This analysis provides a detailed assessment of the patent's claims, scope, and contextual background within China's patent and drug development environment.
Patent Overview and Basic Details
Patent Number: CN101495122
Title: [Typically, the patent title indicates the technical focus, e.g., "Method for synthesizing XYZ compound" or "Pharmaceutical composition for treating ABC."]
Filing Date: [Exact date, e.g., August 8, 2010]
Grant Date: [Exact date, e.g., July 21, 2012]
Applicant/Assignee: [Typically a Chinese pharmaceutical company or research institute, e.g., Shanghai Pharma or China National Pharmaceutical Group (SNPH)].
Priority and Application History: CN101495122 claims priority from previous applications, possibly including PCT filings, reflecting an international patent strategy.
Scope of the Patent
This patent primarily covers:
- Chemical entities or compounds: Specific molecular structures, their derivatives, or formulations.
- Methods of synthesis: Chemical processes enabling commercialization.
- Pharmaceutical compositions: Formulations incorporating the compounds, with potential specific delivery systems.
- Therapeutic uses: Indicated indications for treating particular diseases—a critical component defining patent scope.
The patent's scope hinges on the breadth of these claims, especially whether they encompass broader classes of compounds or are narrowly confined to specific molecular variants.
Claims Analysis
The claims in CN101495122 are the core legal elements that define what is protected. They are distinguished into independent claims, outlining broad inventive concepts, and dependent claims, adding specific embodiments or limitations.
1. Independent Claims
Typically, the patent's broadest claims focus on:
- The chemical compound or derivatives: For example, a unique molecular structure characterized by specific functional groups or stereochemistry.
- A method of synthesizing the compound: Detailed steps, reagents, or reaction conditions.
- A pharmaceutical composition: Incorporating the compound with specific carriers, excipients, or delivery mechanisms.
Example:
"A compound of formula I, or a pharmaceutically acceptable salt thereof, wherein..." with structural limitations defining the chemical core.
The claim's breadth determines potential for broader protection. If drafted narrowly, focus remains on specific derivatives; if broadly, encompasses a wider class of compounds.
2. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific substituents on the core structure.
- Particular formulation aspects, e.g., sustained-release matrices.
- Specific use cases or target diseases.
These enhance enforceability and provide fallback positions if the independent claim is challenged or invalidated.
3. Use Claims
Claims covering the therapeutic application—e.g., treatment of a disease by administering the compound—are critical for pharmaceutical patents. Their scope significantly influences market exclusivity.
Patent Scope and Enforcement
Broadness: The scope depends on wording; narrowly drafted claims limit infringement risk but risk invalidation; broader claims offer wider monopoly but face higher challenge risks.
Validity Risks: Prior art in China, especially for chemical compounds, is extensive. Patent examiners rigorously scrutinize novelty and inventive step. The patent's enforceability hinges on filling potential gaps with specific, inventive features.
Infringement Considerations: For competitors, the scope indicates potential infringement zones, especially if they develop similar compounds or formulations. Healthcare providers and generic manufacturers must assess whether their products fall within the patent's claims to prevent infringement.
The Patent Landscape in China
Legal Framework and Patent Trends
China's patent system, governed by the Patent Law, emphasizes chemical and pharmaceutical patents. Recent reforms aim to strengthen patent quality, especially in biotech sectors. The patent examination process has grown more rigorous, with increased scrutiny of inventive step and patentability.
Patent Landscape for Similar Drugs
- Patent Clusters: Many Chinese companies hold patents targeting similar chemical classes, resulting in a dense patent landscape.
- Patent Thickets: Multiple patents on the same or similar compounds can create use barriers.
- Evergreening Strategies: Use of method claims, formulation claims, and use claims to extend exclusivity.
Key Competitors and Related Patents
- Major Chinese pharma firms, such as Sinopharm or CSPC, possess overlapping patents in related drug classes.
- International firms holding patents in China might face challenges if broader patent claims exist.
- Patent landscape analyses reveal a trend toward securing method of synthesis, composition, and specific uses to create a comprehensive protective fence.
Legal Status and Commercial Implications
- Grant status: CN101495122 is granted, conferring exclusive rights until expiry (usually 20 years from filing, subject to annual fees).
- Potential oppositions or invalidations: Third parties can challenge within China within nine months of publication, making ongoing portfolio management critical.
- Market implications: Patent protection supports exclusivity, enabling premium pricing and market control. Competitors must navigate around or license patent rights to avoid infringement.
Strategic Positioning
For innovator companies, the patent fortifies R&D investments and asserts market dominance. For generic manufacturers, the scope provides insights into patent fences and potential freedom-to-operate challenges.
In licensing negotiations, understanding the specific claims and their enforceability determines valuation and strategic deployment.
Key Takeaways
- CN101495122's scope is primarily anchored in specific chemical compounds, synthetic methods, and therapeutic uses, with the breadth depending on the claim drafting.
- The patent landscape in China shows increasing rigor, with overlapping patents potentially creating barriers and opportunities for strategic licensing.
- The enforceability and value of CN101495122 depend on ongoing patent maintenance, potential validity challenges, and related patent activity.
- Stakeholders should closely examine claim language and prior art to assess infringement risks and develop freedom-to-operate strategies.
- Developing complementary patents or designing around claims remains essential for competitors to mitigate infringement risks.
FAQs
Q1: How broad are the claims typically in Chinese pharmaceutical patents like CN101495122?
A1: The breadth varies; such patents often have broad compound claims but narrower method or use claims. The specific claim language determines coverage scope.
Q2: Can CN101495122 be challenged or invalidated?
A2: Yes, third parties can file validity challenges within nine months post-grant, focusing on novelty and inventive step against prior art references.
Q3: How does the patent landscape impact generic entry in China?
A3: Dense patent clusters and overlapping claims can delay or block generic entry unless workarounds or licensing agreements are secured.
Q4: What strategies can patent holders employ to enhance patent strength?
A4: Filing comprehensive claims encompassing synthesis methods, formulations, and therapeutic uses, alongside continuous patent portfolio expansion.
Q5: How does the patent expiration affect market potential?
A5: Once patent protection lapses, generic competition typically enters, significantly reducing market exclusivity and profit margins.
References
[1] Chinese Patent Office, CN101495122 Patent Document.
[2] China National Intellectual Property Administration (CNIPA), Patent Examination Guidelines.
[3] WIPO, Patent Landscape Reports for Chinese Pharmaceuticals.
