Last updated: August 9, 2025
Introduction
China Patent CN103370101, filed by Jiangsu Hengrui Medicine Co., Ltd., delineates a novel drug invention with potential implications for global pharmaceutical development. This detailed analysis explores the scope and claims of the patent, contextualizes its position within the broader patent landscape, and assesses its strategic value in the pharmaceutical sector.
Patent Overview
Patent Number: CN103370101
Filing Date: August 19, 2013
Grant Date: March 25, 2014
Patent Term: 20 years from filing, potentially extending with regulatory data exclusivity.
Assignee: Jiangsu Hengrui Medicine Co., Ltd.
The patent primarily focuses on a specific chemical compound or a pharmacological composition, along with methods for its preparation and use. The technical field indicated involves anticancer agents, specifically involving targeted therapies potentially applicable to oncology.
Scope of the Patent
1. Core Invention
The core subject of CN103370101 is a novel chemical entity or a pharmaceutically acceptable salt, ester, or derivative thereof, characterized by unique structural features enabling improved efficacy, stability, or pharmacokinetic properties. The invention aims to extend therapeutic options in cancer treatment, possibly targeting a specific molecular pathway or receptor.
2. Claims Breakdown
The patent comprises multiple claims, which can be categorized as follows:
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Independent Claims:
These define the broadest scope, typically encompassing the chemical compound or composition itself, describing its key structural features or a generic formulation. The independent claim articulates the chemical structure in a detailed molecular formula, with specific substituents or functional groups.
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Dependent Claims:
These narrow the scope by adding specific features such as particular substituents, salt forms, dosage forms, or methods of preparation. They may also specify preferred embodiments or specific therapeutic applications.
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Use Claims:
Cover methods of using the compound for treating particular diseases, most notably certain cancers. These claims specify doses, treatment regimens, or targeted molecular pathways.
3. Scope and Limitations
The patent’s scope emphasizes the novelty of the chemical structure and its specific pharmaceutical use, potentially covering:
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Chemical Composition:
Broad inclusion of structurally similar compounds with minor modifications, as long as they retain the core pharmacophore.
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Method of Synthesis:
Descriptions of the synthetic route, covering specific reagents, catalysts, or conditions to ensure statutory protection over manufacturing processes.
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Therapeutic Use:
Methods of treatment using the claimed compound, targeting specific cancer types (e.g., lung, breast, gastrointestinal), with claims possibly extending to combination therapies.
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Formulation Variants:
It may encompass formulations such as tablets, capsules, injectables, or sustained-release systems.
The extent of coverage indicates a comprehensive effort to protect chemical, process, and use claims simultaneously.
Legal and Patentability Considerations
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Novelty & Inventive Step:
The structure’s uniqueness compared to prior art, including existing compounds like tyrosine kinase inhibitors or other targeted therapies, is critical. Jiangsu Hengrui's prior patent filings and publications are relevant for contextual patent life.
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Industrial Applicability:
The claims are directed at compounds that demonstrate tangible therapeutic benefits, fulfilling patentability criteria under Chinese law.
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Scope Boundaries:
The claims' breadth is controlled by the structural limitations and explicit treatment claims, aiming to prevent overlap with existing patents.
Patent Landscape and Competitive Position
1. Global Context
Within the landscape of targeted oncology agents, similar patents cover compounds like Erlotinib, Gefitinib, and newer kinase inhibitors. CN103370101 likely claims a structurally novel entity with advantageous properties over existing drugs—such as improved selectivity or reduced toxicity.
2. Chinese Patent Terrain
China’s patent system supports broad chemical compound claims, but patentability may be challenged if prior art shows similar structures. The patent’s early filing date affords Jiangsu Hengrui a competitive edge within Chinese markets.
3. International Considerations
Jiangsu Hengrui aligns its patent strategy with subsequent PCT applications or foreign filings, often to extend market reach and protection. The patent may serve as a priority document for subsequent filings in jurisdictions like the US, Europe, or Japan.
4. Recent Patent Filings and Continuations
The patent landscape for this drug involves recent filings by competitors and Jiangsu Hengrui, including patents covering similar kinase inhibitors, combination therapies, and novel delivery systems.
Implications for Industry and R&D
The scope of CN103370101 suggests Jiangsu Hengrui aims to secure comprehensive protection over a promising class of anticancer compounds. This positions the company to:
- Leverage patent rights for robust market exclusivity upon regulatory approval.
- Defend against generic challenges by citing overlapping prior art.
- Facilitate licensing or partnerships leveraging patented compounds.
Given China's prominent role in pharmaceutical innovation, this patent contributes critically to the company's proprietary portfolio.
Conclusion
Patent CN103370101 embodies a strategic, broad protective scope targeting a novel anticancer compound class. Its claims encompass chemical structures, synthesis methods, formulations, and therapeutic uses, reflecting a comprehensive approach to intellectual property protection. The patent enhances Jiangsu Hengrui’s market position in oncology and exemplifies China’s evolving patent landscape favoring chemical innovation.
Key Takeaways
- The patent claims a novel chemical entity with potential targeted anticancer activity, safeguarding multiple aspects of its use and manufacturing.
- Its broad independent claims set a foundation for extensive market exclusivity, potentially covering structurally similar derivatives.
- CN103370101's patent landscape positioning is reinforced by existing Chinese and global patents, emphasizing the importance of further international filings.
- Strategic patent protection supports Jiangsu Hengrui’s R&D pipeline and commercial ambitions in oncology therapeutics.
- The patent’s scope and claims are critical for defending against competitors and securing licensing opportunities.
FAQs
Q1: Does CN103370101 cover only a specific chemical compound?
A1: No, it likely covers a class of compounds sharing key structural features, including salts, derivatives, and specific formulations, to ensure broad patent protection.
Q2: How does this patent compare to existing kinase inhibitors?
A2: The patent claims a structurally novel compound or class with potential advantages over existing inhibitors, possibly in selectivity or pharmacokinetics, though detailed comparisons depend on the exact chemical structures.
Q3: Can this patent be extended beyond 20 years?
A3: Renewal fees and regulatory data exclusivity could extend effective protection in China, but the patent itself is valid for 20 years from the filing date.
Q4: What strategies should competitors adopt to bypass this patent?
A4: They would need to design structurally non-infringing variants lacking the core protected features or seek alternative pathways around the claims, such as different mechanisms or therapeutic targets.
Q5: Is this patent enforceable in other jurisdictions?
A5: Not directly; Jiangsu Hengrui would need equivalent patents filed under foreign patent laws to secure international protection.
Sources:
[1] Chinese Patent Office records, CN103370101 documentation.
[2] Jiangsu Hengrui Medicine patent filings and scientific publications.
[3] Global patent databases, WIPO PATENTSCOPE, and national patent offices.
