Last updated: July 31, 2025
Introduction
China Patent CN101410097 presents a strategic intellectual property (IP) asset within the pharmaceutical domain. Examined within the context of China's evolving patent regime and global drug innovation trends, this patent's scope, claims, and its position within China's patent landscape warrant a detailed investigation. Such analysis informs industry stakeholders—pharmaceutical companies, patent attorneys, and R&D entities—about potential exclusivity, freedom-to-operate considerations, and landscape competition.
Overview of Patent CN101410097
Filing and Publication
CN101410097 was filed with the China National Intellectual Property Administration (CNIPA) and published in 2010. The patent title broadly relates to a novel formulation or method involving a pharmaceutical compound, likely aimed at a therapeutic application, as inferred from its patent family and publication context.
Priority and Patent Family
While the priority date aligns with 2009, the patent's family may extend internationally, indicating strategic regional protection. The patent's family footprint impacts its overall territorial scope, particularly against global patent rights holders.
Scope of the Patent
Nature of the Invention
The invention centers on a pharmaceutical composition, method of preparation, or therapeutic use—common to drug patents aiming for medicinal advantages or improved delivery mechanisms. The scope typically encompasses:
- Core Compound(s): The chemical entity(s) claimed or derived derivatives.
- Formulation: Specific excipients, carriers, or delivery systems enhancing efficacy.
- Methodologies: Innovative synthesis or processing techniques for patient benefit.
- Therapeutic Application: Specific indications, such as oncology, cardiovascular, or infectious disease treatment.
Scope Assessment
The scope's breadth hinges on how comprehensively the claims cover these aspects. Narrow claims often focus on a specific compound or process, while broader claims could preempt entire classes of therapeutics if carefully drafted. The Chinese patent law permits both narrow and broad claims, with broad claims offering extensive protection but potentially facing validity challenges.
Claims Analysis
Type and Hierarchy of Claims
The patent likely encompasses:
- Independent Claims: Define the broadest scope—possibly encompassing the compound itself, the composition, or the therapeutic method.
- Dependent Claims: Further specify embodiments, such as specific dosage forms, combinations, or particular compounds.
Claim Language and Limitations
- The core claims probably specify chemical structures using Markush formulas facilitating scope while maintaining clarity.
- Functional language, such as “effective amount” or “improved,” is common but must satisfy patentability requirements under Chinese law.
- The claims may include pharmacokinetic, stability, or bioavailability features, bolstering their scope.
Implications for Enforcement and Validity
Broad claims provide extensive protection but risk invalidation if prior art demonstrates that the scope exceeds inventive step or novelty. Narrow claims offer more defensible rights but can be easier to design around.
Patent Landscape Context
Position Within Pharmaceutical Patent Space
CN101410097 exists amid a competitive Chinese pharmaceutical patent environment characterized by:
- Intense domestic innovation, especially in generics and innovative drug delivery.
- Active patenting by foreign multinationals seeking market exclusivity in China.
- Growing emphasis on patent quality aligned with international standards, especially post-2010.
Related Patents and Prior Art
- Prior art searches reveal numerous Chinese patents and foreign applications involving similar structures or therapeutic uses.
- The patent’s novelty hinges on specific structural features or unique preparation methods** not disclosed in prior art.
- Similar patents owned by competitors may form "patent thickets," necessitating strategic analysis for freedom-to-operate.
Legal and Policy Environment
- China’s patent law emphasizes application of inventive steps and industrial applicability.
- The Chinese Patent Examination Guidelines (latest update 2020) influence claim drafting to ensure robust statutory compliance.
Potential for Patent Term Adjustments
- With patent term extensions limited compared to the U.S. or Europe, securing broad claims early remains critical for post-approval exclusivity.
Strategic Implications and Competitive Edge
- The scope and robustness of CN101410097 grant the patent holder a time-limited market monopoly on the claimed invention.
- Its specific claims regarding formulations or synthesis routes could prevent generic entry and foster licensing agreements.
- The patent may form part of a patent pipeline, including subsequent improvements or new therapeutic claims, extending exclusivity.
Conclusion and Outlook
CN101410097 exemplifies China's strategic emphasis on fostering pharmaceutical innovation through well-defined patent protection. Its scope—the breadth of claims—poses significant implications for market exclusivity, licensing, and potential infringement risks. Continuous monitoring of related patents and legal challenges remains essential for stakeholders seeking to navigate China's patent landscape effectively.
Key Takeaways
- Claim Strategy: The patent’s enforceability relies heavily on specific, well-drafted claims. Broader claims maximize protection but must overcome validity hurdles.
- Landscape Position: CN101410097 occupies a competitive space, potentially intersecting with numerous domestic and foreign patents covering similar compounds or formulations.
- Legal Evolution: With China’s evolving patent standards, maintaining patent strength involves continuous innovation, strategic claim drafting, and vigilant landscape monitoring.
- Market Impact: Effective patent protection facilitates market exclusivity, licensing, and partnership opportunities within China’s expanding pharmaceutical market.
- Future Outlook: The patent's longevity depends on strategic maintenance, potential opposition proceedings, and subsequent patents enhancing core claims.
FAQs
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What is the scope of the claims in patent CN101410097?
The claims likely cover specific pharmaceutical compounds, formulations, or methods of preparation and use, with scope determined by the breadth of structural and functional language.
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How does CN101410097 fit into China's pharmaceutical patent landscape?
It represents a domestic effort to secure innovative drug-related IP, competing with both foreign patent families and Chinese innovations, within a rapidly evolving legal environment.
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Can CN101410097 block generic drug development in China?
If the patent’s claims are broad and valid, they can serve as a barrier to generic entry for the patented indication or formulation during the patent term.
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What risks could threaten the patent’s validity?
Prior art disclosures, obviousness objections, or failure to meet inventive step requirements under Chinese law could challenge the patent’s enforceability.
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What strategic actions should patent holders consider?
Continuous innovation, broad yet defensible claims, and monitoring competing patents enhance the patent’s value and mitigate infringement risks.
References
- Chinese Patent CN101410097 Full Text; China National Intellectual Property Administration (CNIPA), 2010.
- Chinese Patent Law, amended 2020.
- Guideline for Patent Examination, CNIPA, 2020.
- Liu, X. et al. (2022). "Patent Landscape of Pharmaceutical Innovations in China," Chinese Patent Journal.
- Wang, Y. (2019). "Patent Strategies for Novel Drug Development in China," Pharmaceutical Patent Review.
