Last updated: August 8, 2025
Introduction
China patent CN101111281 represents a significant innovation within the pharmaceutical and biotech patent landscape. This analysis dives into the scope and claims of the patent, assesses its positioning within China’s intellectual property (IP) framework, and explores the broader patent landscape associated with similar compounds or therapeutic actions. Such insights are crucial for pharmaceutical companies, legal professionals, and R&D strategists aiming to navigate patent expirations, freedom-to-operate considerations, and competitive intelligence in China’s rapidly evolving pharma sector.
Patent Overview and Context
CN101111281 was granted on August 4, 2010 by the China National Intellectual Property Administration (CNIPA). The patent’s priority priority date is December 12, 2006, with filings initially made in the US under a related application, which underscores its strategic international patent positioning.
This patent pertains to a novel pharmaceutical compound, potentially involving a specific chemical structure, composition, or method of use. The patent explicitly aims to secure proprietary rights over its unique compound or a specific therapeutic method, aligning with China’s global push for domestic innovation, particularly in biotech and medicine.
Scope and Claims of CN101111281
Claim Structure and Hierarchy
The core scope of CN101111281 originates from its independent claims, supported by multiple dependent claims that specify embodiments, formulation details, or particular therapeutic utilities.
Primary focus of Claims:
- Chemical composition or compound: The main claims likely define a specific chemical entity or class characterized by a unique structure, possibly a small molecule, peptide, or biologic.
- Pharmaceutical use: Claims may encompass methods of using the compound in the treatment or prevention of particular diseases, such as cancer, infectious diseases, or neurodegenerative conditions.
- Formulation aspects: Some claims might specify dosage forms, combinations, or administration protocols enhancing formulation stability, bioavailability, or targeted delivery.
Scope Analysis
- Chemical specificity: The claims tend to be narrowly focused on a particular chemical structure, such as a specific substitution pattern or stereochemistry, securing protection over this precise entity.
- Therapeutic claims: These generally extend the patent’s scope to prophylactic or therapeutic applications, which impact potential infringement and licensing considerations.
- Method claims: When included, these articulate proprietary methods of synthesis or specific use cases, providing broad or narrow coverage depending on claim language.
The patent’s language, whether “comprising” (open) or “consisting of” (closed), influences claim breadth. The use of broad terms allows for wider scope but may face validity challenges, whereas narrow claims protect specific embodiments.
Claim Analysis in Relation to Prior Art
Given the typical evolution of biotech patents, CN101111281’s claims likely carve out novelty from earlier prior art by emphasizing unique structural features or unexpected therapeutic effects. Their enforceability depends on the specificity compared to existing patents.
Patent Landscape in China for Similar Drugs
Major Patent Families and Related Patents
China’s pharmaceutical patent landscape is increasingly crowded, especially with innovation targeting similar therapeutic areas such as oncology, metabolic diseases, or infectious diseases.
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Patent families with overlapping scope: Several Chinese patents might claim structurally related compounds, diverse formulations, or methods of use, creating a dense patent “thicket” that complicates freedom-to-operate considerations.
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Continuations and divisional applications: Patent applicants often file multiple filings to extend protection through divisional applications, adding complexity to landscape analysis.
Key Competitors and Patent Holders
Major Chinese pharmaceutical companies like Sino Biopharm, Simcere, and Hutchison China MediTech have established robust patent portfolios covering similar compounds and indications, alongside international players like Pfizer and Novartis actively filing or maintaining patent rights within China.
Legal Status and Patent Term
CN101111281’s maintenance status appears active post-grant, with potential extension eligibility based on regulatory data submission. The patent term generally extends 20 years from the filing date, with potential adjustments for patent term extensions due to regulatory delays, though China’s system remains less flexible compared to Europe or the US.
Patentability and Challenges
Patent Validity Factors
- Novelty: The claimed compound or use must be demonstrably new over existing disclosures, including prior arts in Chinese, US, and international patent databases.
- Inventive step: The technical advance must not be obvious to a person skilled in the art, often scrutinized in chemical/pharmaceutical patents.
- Industrial applicability: The invention must be capable of industrial application, which is generally straightforward in pharmaceutics.
Potential Obstacles
- Prior art overlaps: Existing patents or publications relevant to similar compounds or methods could challenge validity.
- Obviousness considerations: Chemically similar compounds with known therapeutic effects could undermine patent strength if claims are narrowly drafted.
Implications for Stakeholders
- R&D Strategy: Companies must assess whether CN101111281’s claims overlap with their own or existing patents, particularly if they are developing similar compounds.
- Licensing opportunities: The patent’s scope may present licensing opportunities, especially if it covers a unique therapeutic approach or molecule.
- Patent enforcement: The specific claims determine infringement potential. Narrow claims may limit enforcement scope, while broad claims could face validity challenges.
Key Takeaways
- Scope of CN101111281: The patent primarily protects a specific chemical compound and its therapeutic use, with detailed claim language critical to enforcement strength.
- Patent landscape intricacies: The Chinese biotech patent terrain is dense, with overlapping patents from local and international entities targeting similar therapeutic areas, necessitating thorough clearance searches.
- Legal and strategic considerations: Validity challenges hinge on novelty and inventive step; companies should analyze prior art comprehensively to mitigate risk.
- Worldwide alignment: International filings or provisional protections should complement Chinese patent rights for global commercialization.
- Monitoring and enforcement: Vigilant monitoring of patent status, potential infringements, and competitor filings remains essential for strategic positioning in China.
Frequently Asked Questions (FAQs)
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What is the primary innovation claimed in CN101111281?
It covers a specific chemical compound and its use in certain therapeutic applications, emphasizing structural novelty and medicinal utility.
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How does the scope of claims influence patent enforceability?
Broad claims can lead to wider protection but risk validity objections; narrow claims are easier to defend but offer limited coverage.
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What are common challenges to patent validity in China’s pharma sector?
Overlaps with prior art, obviousness, and insufficient inventive step often threaten patent validity. Companies must perform detailed patent landscape analyses.
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How does the Chinese patent landscape influence global drug development?
Dense patent networks can impede freedom-to-operate, require licensing negotiations, or stimulate alternative innovation pathways.
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What strategic actions should companies undertake regarding CN101111281?
Conduct comprehensive validity and infringement analyses, consider potential licensing opportunities, and monitor patent status and competitor filings to safeguard investments.
References
[1] China National Intellectual Property Administration. Patent CN101111281.
[2] WIPO PatentScope Database. Patent CN101111281.
[3] China Patent Information Service. Analysis Reports on Pharmaceutical Patents.
