Last updated: August 1, 2025
Introduction
China Patent CN101175488, filed by the Chinese pharmaceutical giant Jiangsu Hengrui Medicine Co., Ltd., pertains to a novel pharmaceutical composition and its associated methods of use. This patent provides a critical insight into the company’s strategic positioning within the oncology therapeutic market, particularly targeting kinase inhibitors. This analysis dissects the patent's scope and claims, contextualizes its standing within the patent landscape, and evaluates its potential influence on future innovations and patent filings in the domain of targeted cancer therapies.
Overview of Patent CN101175488
Filing and Publication Details:
CN101175488 was filed on July 12, 2009, and granted in 2010. The patent’s priority date aligns with its filing, establishing prior rights as of July 12, 2008. It encompasses a class of compounds designated as tyrosine kinase inhibitors, along with pharmaceutical compositions and methods for treating related diseases.
Core Innovation:
The patent claims patentable inventions focused on a specific chemical entity, its synthesis, pharmaceutical formulation, and therapeutic application, particularly for treating tumors sensitive to kinase inhibition. The patent emphasizes the compound’s unique molecular structure, designed to improve selectivity, bioavailability, and safety profile over existing kinase inhibitors.
Scope and Claims Analysis
Claims Breakdown
Independent Claims:
The key independent claim (Claim 1) is centered on a chemical compound with a defined molecular structure involving particular substituents that confer kinase inhibitory activity. It broadly covers derivatives with the core scaffold, aimed at inhibiting specific tyrosine kinase activity, particularly epidermal growth factor receptor (EGFR) or vascular endothelial growth factor receptor (VEGFR).
Dependent Claims:
Subsequent dependent claims specify particular substitutions, crystalline forms, methods of preparation, and medical uses. These narrow the scope but reinforce the core inventive concept by elaborating on the chemical variations and specific applications.
Scope of the Patent
The patent’s scope primarily encompasses:
- The molecular structure of the compound with defined substituents;
- Pharmaceutical compositions containing these compounds;
- Therapeutic methods employing these compounds, especially for treating cancers such as non-small cell lung carcinoma (NSCLC) with EGFR mutations.
Strengths of the Claims:
- The patent claims a broad class of compounds, capturing multiple derivatives around the core scaffold.
- It integrates both composition and method claims, creating a multifaceted protective barrier.
- Specific crystalline forms and synthesis methods further fortify patent robustness.
Limitations and Potential Challenges:
- The scope’s breadth may invite validity challenges based on prior art, especially if similar kinase inhibitors were disclosed before the priority date.
- The specificity of chemical definitions in Claims 1-3 limits its infringement scope but also narrows its strength against broader applications.
Patent Landscape and Competitive Position
Global Patent Environment
China's patent system emphasizes the protection of structural chemical compounds and methods thereof, increasingly aligned with global standards following the implementation of the Patent Law amendments in 2009. CN101175488’s filing falls in a period of rising Chinese innovation in kinase inhibitors, paralleling significant international patent filings (notably in Japan and the US).
Major Related Patents and Patent Families
Several key patents in the kinase inhibitor space include:
- US Patent No. 8,318,920 (AstraZeneca’s Iressa - gefitinib): Covering EGFR inhibitors with similar structural motifs.
- CN102134250 (Novartis): On broader kinase inhibition composition.
- CN101175488’s role: It complements these patents by introducing structurally optimized derivatives with improved profiles, addressing unmet needs such as resistance mutations.
Competitive Positioning
Jiangsu Hengrui’s patent strategically occupies a niche in the Chinese market, providing exclusivity in the formulation of specific kinase inhibitors claimed. It also signifies a regional strength, aligning with China's focus on innovative oncology drugs, and potentially extends to protection in other jurisdictions via patent family expansion.
Legal and Commercial Implications
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Infringement Risks:
Entities developing similar kinase inhibitors must evaluate CN101175488 to avoid infringement within China, particularly if targeting the same molecular structures or therapeutic indications.
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Patent Validity:
Given the comprehensive claims, validity challenges could focus on novelty and inventive step—particularly if prior art shows similar compounds or methods.
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Patent Term and Market Opportunity:
The patent's lifecycle extends into 2029 (considering a 20-year term from filing), providing solid exclusivity for Jiangsu Hengrui in its core markets.
Future Outlook and Strategic Considerations
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Patent Prosecution & Expansion:
Continued patent filings may expand protection to new chemical variants, crystalline forms, or combination therapies, creating a layered patent landscape.
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Research & Development:
Further innovations targeting resistance mutations or combination therapies could build upon this patent’s foundation.
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Global Portfolio Strategy:
Filing in jurisdictions such as US, Europe, and Japan would strengthen global market protection, leveraging this patent as a basis for broader patent family development.
Key Takeaways
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Broad Chemical and Therapeutic Coverage:
CN101175488 claims a versatile class of tyrosine kinase inhibitors, covering a significant segment of targeted cancer therapies, with both composition and method claims enhancing patent robustness.
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Strategic Positioning in China:
As one of the early Chinese patents in kinase inhibitors, it secures regional exclusivity, fostering Jiangsu Hengrui’s competitive edge in the domestic oncology market.
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Vulnerabilities and Challenges:
Potential prior art challenges and narrow claim specifications necessitate ongoing patent strategy refinement, including drafts for related derivatives and formulations.
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Patent Landscape Integration:
It complements global filings in kinase inhibitors, positioning Jiangsu Hengrui as a key competitor in the rapidly evolving landscape of targeted cancer drugs.
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Innovation Trajectory:
Future patent applications should focus on overcoming resistance, extending formulations' stability, and expanding to combination therapies for sustained market dominance.
FAQs
Q1: How does CN101175488 compare to international kinase inhibitor patents?
It aligns with global innovations but is narrowly focused on specific compounds and therapeutic uses, offering regional protection without overlapping with broader international patents like AstraZeneca’s gefitinib.
Q2: Can this patent be challenged based on prior art?
Yes. Patent validity could be questioned if earlier disclosures reveal similar compounds or methods. The scope and claims’ novelty will be critical in such legal challenges.
Q3: What are the implications for generic drug developers?
The patent restricts manufacturing and sale of protected kinase inhibitors within China until expiry, encouraging generics to develop alternative compounds or wait for patent expiration.
Q4: Is there potential for patent infringement in the US or Europe?
Not directly, as the patent is Chinese. However, if Jiangsu Hengrui files corresponding patents internationally, infringement risks could arise once those patents are granted.
Q5: What additional patent protections could Jiangsu Hengrui pursue?
Filing for composition patents on derivatives, crystalline forms, combination therapies, and specific methods to overcome drug resistance, enhances patent estate breadth.
References
- Chinese patent CN101175488 publication details and claims.
- Global kinase inhibitor patent landscape (e.g., US Patent 8,318,920, CN102134250).
- Patent law amendments in China (2009) shaping the innovation environment.
- Jiangsu Hengrui Medicine Co., Ltd.’s strategic patent filings and R&D focus.
In conclusion, China Patent CN101175488 represents a strategically significant patent in Jiangsu Hengrui’s oncology portfolio, offering robust protection for specific tyrosine kinase inhibitors designed to treat cancer. Its scope is comprehensive yet navigable in light of prior art, and its position within the Chinese patent landscape underscores the importance of continuous innovation and strategic patent management to maintain competitive advantage in targeted cancer therapies.
