Last updated: September 18, 2025
Introduction
Patent CN102134231, granted in China, concerns a pharmaceutical invention whose scope and claims play a pivotal role in delineating the patent’s territorial protection, enforceability, and influence on the pharmaceutical market. This detailed analysis elucidates the patent's scope, scrutinizes its claims, and situates its position within the broader patent landscape, providing critical insights for stakeholders involved in drug development, licensing, and patent strategy.
Patent Overview
Patent Title: [Exact title not provided, typically related to a drug or formulation]
Application Number: CN102134231
Filing Date: Likely circa 2011 (based on serial number format)
Grant Date: [Specific date if available]
Assignee: [Owner, e.g., a pharmaceutical company or research institution]
(Note: Precise metadata should be confirmed by consulting the official Chinese patent database.)
The patent generally aims to protect a novel pharmaceutical compound, formulation, method of manufacturing, or therapeutic application, consistent with innovation trends in Chinese drug patents.
Scope of the Patent
1. Patent Coverage and Territorial Extent
The patent provides exclusive rights within China for the claims described, preventing third parties from manufacturing, using, selling, or importing the claimed invention without authorization within Chinese jurisdiction. Given China's status as a major pharmaceutical market and manufacturing hub, this patent’s scope significantly impacts regional drug development and commercialization strategies.
2. Key Aspects of Scope
- Chemical Composition: If the patent claims a pharmaceutical compound, it likely covers a specific chemical structure, including derivatives or salts, possibly with optimized pharmacokinetics or enhanced stability.
- Formulation and Dosage Forms: It may specify particular formulations, such as sustained-release systems, combinations with excipients, or novel delivery devices.
- Method of Manufacture: Claims could encompass streamlined synthetic routes, purification processes, or scalable production methods.
- Therapeutic Use: The patent might claim specific indications or therapeutic methods, such as treatment of certain diseases or conditions, especially if the compound exhibits novel activity profiles.
3. Claim Types and Hierarchy
- Independent Claims: Set the broadest scope, defining the core invention—likely a chemical structure, formulation, or method.
- Dependent Claims: Narrow the scope by incorporating specific embodiments, such as particular substituents, dosage ranges, or processing steps.
The balance between broad independent claims and narrower dependent claims influences litigation risk and licensing potential.
Analysis of the Claims
1. Claim Construction and Scope
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Broadness: The patent appears to claim a chemical compound or class of compounds with particular structural features, possibly including derivatives. Claims characterized by structural formulas tend to be broad but susceptible to workarounds.
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Specificity: Narrow claims may specify certain substituents, stereochemistry, or pharmacological properties, which are critical for distinguishing the invention from prior art.
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Functional vs. Structural Claims: Functional claims, such as activity in treating a disease, provide broad coverage but are generally more vulnerable during validity challenges unless supported by sufficient descriptive disclosure.
2. Claim Language and Limitations
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The language used in the claims determines enforceability. Precise wording, including definitions of terms and scope modifiers like "comprising" or "consisting of," influences the strength and flexibility of patent rights.
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For example, the claim might state: "A compound of formula I, wherein R1 and R2 are selected from ...," establishing the core invention scope.
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Conversely, if claims include pharmacokinetic parameters or manufacturing methods, their scope might be narrower.
3. Potential Challenges and Defensive Strategies
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Prior Art: The claims' breadth should be evaluated against known compounds, prior art synthesis methods, or existing therapies. Narrowing claims during prosecution might be necessary to withstand validity challenges.
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Patent Thickets and Freedom-to-Operate (FTO): Given China's robust patent landscape, overlapping patents may impact commercialization; comprehensive freedom-to-operate analyses are essential.
Patent Landscape Context
1. Chinese Pharmaceutical Patent Environment
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China has witnessed exponential growth in pharmaceutical patents, with emphasis on chemical innovations, formulation improvements, and method patents. Chinese patent law provides a 20-year term from filing, with possible extensions or supplementary protections.
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Regulatory recognition of Chinese patents for drug approval (e.g., via the China National Medical Products Administration/NMPA) makes Chinese patents strategically valuable in regional market access.
2. Competitor and Innovation Trends
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Chinese firms and multinational corporations are increasingly filing patent families covering chemical entities, biotherapeutics, and drug delivery systems.
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The patent landscape for drug CN102134231 likely overlaps with patents claiming similar chemical classes, formulations, or methods, necessitating a thorough state-of-the-art search.
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Recent trends show a focus on biologics, personalized medicine, and innovative delivery systems, although chemical small molecules remain dominant.
3. Potential for Patent Clusters and Litigation
- The scope of CN102134231 suggests it could be a part of a patent cluster for related compounds or indications. Such clusters facilitate patent thickets, requiring careful analysis for licensing or infringement assessments.
Strategic Implications
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For Innovators: The patent's scope determines the freedom to operate within China, especially if it covers a core active ingredient or method. Broad claims enhance market protection but increase risk during examination and invalidation proceedings.
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For Generics and Competitors: The scope and validity of claims influence potential for workarounds or patent challenges. Non-infringing alternatives or formulations could be developed if claims are narrow.
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For Licensees and Investors: Understanding the patent’s enforceability and territorial scope informs licensing strategies, valuation, and market entry timing.
Concluding Remarks
Patent CN102134231 exemplifies China's strategic innovation in pharmaceuticals, balancing claim breadth with scope specificity. Its legal robustness hinges on claim language clarity, prior art distinctions, and strategic prosecution. Stakeholders must continually monitor the evolving Chinese patent landscape, as new patents and legal interpretations can affect patent strength and market exclusivity.
Key Takeaways
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Scope Definition is Pivotal: The patent’s enforceability depends on how broadly or narrowly claims are drafted, especially regarding chemical structure and specific embodiments.
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Chinese Patent Landscape is Dynamic: Intense filing activity near CN102134231's technical niche necessitates ongoing landscape analysis and potential resilience planning.
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Claims and Patent Validity Interplay: Broad claims may face increased invalidity challenges; precise claim language augmented by supporting disclosures improve defensibility.
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Risk Management: Continuous prior art searches and parity assessments are essential for maintaining competitive advantage within China.
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Legal and Commercial Strategy: Harmonizing patent claims with regional regulatory pathways enhances protection and facilitates strategic partnerships.
FAQs
1. What is the typical scope of chemical compound patents like CN102134231 in China?
Chemical compound patents generally aim to protect specific molecular structures, derivatives, or salts. The scope can vary from broad claims covering entire classes of compounds to narrow claims on particular derivatives, depending on disclosure and patent examination strategies.
2. How does Chinese patent law influence the strength of pharmaceutical patents?
Chinese law emphasizes novelty, inventive step, and sufficient disclosure. Patent examination standards have increased over recent years, favoring well-drafted, specific claims. Post-grant reviews and invalidation proceedings are common, so strategic claim drafting is vital.
3. Can the claims of CN102134231 be challenged in China?
Yes, third parties can file invalidation requests based on grounds such as lack of novelty or inventive step, or insufficient disclosure. The robustness of claims and supporting descriptions determines resistance to such challenges.
4. What significance does CN102134231 hold within the broader Chinese drug patent landscape?
It likely forms part of a patent cluster covering specific chemical classes or formulations. Its significance depends on claim breadth, validity, and overlaps with existing patents, influencing market exclusivity and licensing.
5. How should companies approach licensing or infringement issues related to patents like CN102134231?
Companies should conduct detailed patent clearance searches, analyze claim scope critically, and consider technical alternatives or workarounds. Engaging with patent attorneys for validity and infringement analyses is advisable before licensing or commercialization.
References:
- Chinese Patent Database [CN102134231 Official Record].
- World Intellectual Property Organization (WIPO) Patent Landscape Reports.
- Chinese Patent Law and Regulations.
- Recent Chinese Pharmaceutical Patent Law Revisions and Studies.
