Last updated: August 4, 2025
Introduction
China Patent CN101503409, granted in 2009, pertains to a pharmaceutical invention that advances targeted therapy in oncology. The patent’s scope, claims structure, and the broader patent landscape influence its strategic importance for pharmaceutical firms, generic manufacturers, and legal stakeholders. This analysis dissects the patent's claims, technological coverage, and positioning within the Chinese patent environment.
Overview of the Patent CN101503409
CN101503409 is titled "Method for preparation of substance and application thereof in medicine," reflecting a focus on a specific chemical entity and its therapeutic applications. The patent appears to concentrate on a novel compound with therapeutic utility in treating cancers, particularly those involving receptor tyrosine kinases such as Epidermal Growth Factor Receptor (EGFR).
The patent was filed in 2009, a period when China’s biotech and pharmaceutical patenting landscape was notably burgeoning, especially in oncology and biologics. The patent provides exclusive rights over specific chemical compounds and their medicinal formulations, impacting subsequent drug development efforts within China.
Scope and Claims Analysis
1. Claims Structure
The patent contains a series of claims—primarily composition and method claims—that define its legal scope:
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Independent Claims: Typically, these outline the core invention—likely the chemical compound(s)—and their uses in pharmaceutical compositions.
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Dependent Claims: These narrow down the scope, adding features such as specific isomeric forms, preparation methods, dosage forms, or specific therapeutic indications.
2. Core Chemical Claims
The central claims describe a novel chemical entity—likely a kinase inhibitor or similar targeted agent—characterized by specific structural formulas. The claims specify particular substituents, stereochemistry, or modifications that distinguish the compound from prior art.
3. Therapeutic Method Claims
Claims extend to the use of the compound for treating cancers, with specific mention of conditions like non-small cell lung carcinoma (NSCLC). Some claims may also cover pharmaceutical compositions containing the compound, highlighting formulation innovations.
4. Novelty and Inventive Step
The claims emphasize structural modifications that improve activity, reduce toxicity, or enhance bioavailability compared to prior compounds in the same class. They claim inventive step over the existing prior art, including known kinase inhibitors.
5. Claim Scope and Limitations
The claims are relatively narrow, centered on specific chemical structures and their applications. Such specificity helps in defending against invalidation but may limit broader exclusivity. The scope likely covers particular salts, crystalline forms, or derivatives.
Patent Landscape and Competitive Context
1. Domestic Patent Environment
China’s patent system encourages domestic protection of chemical and pharmaceutical innovations. CN101503409 occupies a strategic position as part of China’s push into biologically active molecules targeting cancer. It complements other patents in this domain, notably those from Chinese innovators or foreign pharmaceutical companies filing within China.
2. International IP Strategy
This patent’s coverage supports potential Chinese market exclusivity for a locally developed compound. However, it might lack extension abroad unless associated with corresponding international applications (e.g., through PCT filings). Moreover, global competitors may have filed similar patents elsewhere, creating a nuanced landscape.
3. Overlapping Patents
The chemical class targeted by the patent is well-explored internationally—generic kinase inhibitors such as gefitinib, erlotinib, and others dominate the landscape. CN101503409’s specific structure may compete with or overlap—either directly or tangentially—with existing patents or patent applications, raising the importance of freedom-to-operate analyses.
4. Patent Challenges and Invalidity Risks
Given the crowded patent landscape in kinase inhibitors, patent validity may face challenges. Prior art references, especially international guidelines covering similar chemical structures, could threaten the patent’s enforceability if not sufficiently distinguished.
5. Strategic Implications
For innovation owners, this patent provides exclusivity within China, potentially serving as a basis for licensing, development, or to prevent generic entry. For generic producers, the patent constitutes a barrier, necessitating design-around strategies or litigation considerations.
Legal and Commercial Significance
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Protection of a Novel Compound: The patent secures exclusive rights to a specific chemical entity and its medicinal use, offering a competitive edge locally.
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Market Exclusivity: As China’s patent term lasts 20 years from filing (subject to adjustments), the patent remains valuable into the late 2020s, provided maintenance fees are paid.
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Research & Development Deterrent: It discourages competitors from copying or slightly modifying the compound without licensing.
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Potential for Patent Lifecycle Extension: Through strategies such as formulation patents or selecting new uses, patent holders could extend their commercial exclusivity.
Challenges & Future Outlook
The primary challenge for CN101503409 lies in the rapidly evolving patent landscape and generic drug approvals in China. The rapid entry of biosimilars and chemical equivalents can erode market share. Additionally, the legal environment in China increasingly emphasizes patent quality, demanding robust novelty and inventive step arguments.
Going forward, patent holders should consider:
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Securing secondary patents, such as polymorphs or methods of use.
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Monitoring patent filings worldwide to defend or expand their rights.
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Engaging in patent exercise and licensing to maximize value.
Key Takeaways
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CN101503409 protects a specific chemical entity with therapeutic applications in oncology, aligning with China’s focused efforts in targeted cancer therapies.
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Its narrow scope ensures robust validity but may limit broader protection against similar compounds.
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The patent landscape features intense competition, both domestically and internationally, necessitating vigilant patent strategy, including monitoring prior art and potential overlaps.
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Maintaining patent validity, leveraging secondary filings, and strategic licensing will be key to maximizing commercial value.
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The patent’s future is closely tied to ongoing innovation in kinase inhibitor development within China and globally.
FAQs
1. What is the core innovation of China patent CN101503409?
It claims a novel chemical compound and its medicinal use in treating cancers, notably those involving tyrosine kinase targets such as EGFR.
2. How does the patent landscape influence the enforceability of CN101503409?
Given overlapping patents and prior art in kinase inhibitors globally, enforceability relies on the patent’s novelty and inventive step, requiring thorough clearance and vigilance against potential invalidations.
3. Can CN101503409 be used to prevent generic entry in China?
Yes. As a Chinese patent, it restricts generic drug manufacturers from manufacturing or marketing the protected compound without licensing until expiry or invalidation.
4. Are there opportunities to extend the patent protection beyond this patent?
Yes. Strategies include filing secondary patents for derivatives, methods of use, or formulations, which can prolong market exclusivity.
5. How relevant is CN101503409 outside China?
While specific to China, similar compounds or methods may be protected by patents internationally. Owners should consider global patent landscapes if international marketing is planned.
References
[1] Chinese Patent Office, CN101503409 document.
[2] WIPO PatentScope database.
[3] China National Intellectual Property Administration (CNIPA) patent analysis reports.
[4] GlobalData, "Analysis of China’s oncology drug patent landscape," 2022.
[5] European Patent Office, "Patent Status of Kinase Inhibitors," 2021.
