Last updated: August 8, 2025
Introduction
Patent CN101939020, filed by Jiangsu Hengrui Medicine Co., Ltd., pertains to a novel pharmaceutical invention primarily related to a class of compounds or formulations intended for therapeutic applications. As part of an in-depth analysis, this review assesses the scope of the patent claims, the specific technological coverage, and the overall patent landscape relevant to this patent. Such insights are critical for pharmaceutical companies, legal professionals, and R&D entities to navigate intellectual property rights, monitor competitors, and evaluate patent infringement risks in China’s dynamic drug patent environment.
Patent Overview and Context
CN101939020 was filed in 2010 and granted in 2013, reflecting Jiangsu Hengrui’s strategic effort to protect innovative pharmaceutical compounds. This patent covers certain chemical entities, their preparation methods, pharmaceutical formulations, and therapeutic uses, likely related to oncology or anti-inflammatory agents, consistent with Hengrui’s core research focus.
The patent landscape in China for pharmaceutical compounds is characterized by a dense network of patents covering chemical structures, methods of synthesis, formulations, and therapeutic claims. This patent's core contribution resides in its claims, which delineate protection boundaries and influence market exclusivity for its proprietary compounds.
Scope of Patent Claims
Claims Structure
The patent features two main categories of claims:
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Compound Claims: These specify chemical structures with particular substituents, stereochemistry, and functional groups. The claims aim to capture a broad class of structurally similar molecules with potential pharmacological activity.
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Method and Use Claims: These cover methods of synthesizing the compounds, pharmaceutical compositions containing these compounds, and their therapeutic applications, particularly specific indications such as cancers or inflammatory diseases.
This combination aims to secure comprehensive protection around the chemical entities and their practical use, effectively deterring generic entry and encouraging license negotiations.
Key Elements of the Claims
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Chemical Structure Definition: The core claims outline a general chemical scaffold with various permissible substitutions, defining the scope of protected variants. For example, a heteroaryl core linked to specific side chains, with scope for modifications.
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Pharmacological Application: Uses of the compounds in treating particular diseases, such as solid tumors, are explicitly claimed, aligning with the needs for medicinal patent protection.
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Preparation Method: Claims describe synthesis pathways or intermediates, crucial for controlling manufacturing techniques and preventing copying of proprietary processes.
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Formulation Claims: Pharmaceutical compositions are claimed in terms of excipients, dosages, or delivery mechanisms, further fortifying exclusivity.
Claim Breadth and Limitations
The claims appear to balance breadth and specificity. Broad compound claims cover chemically similar structures, but they are likely bounded by structural definitions to prevent invalidation. Use claims authorized for specific diseases extend the patent’s commercial value, especially if the compound demonstrates significant therapeutic benefits.
However, overbroad claims risk invalidation under the Chinese patent law, which emphasizes inventive step and novelty. The claims must sufficiently distinguish over prior art, especially from existing chemical patents in China and internationally.
Patent Landscape and Prior Art Considerations
Comparative Analysis
The patent exists within a dense landscape of similar pharmaceutical patents, particularly from Chinese competitors aiming at targeted therapies or kinase inhibitors (e.g., Hengrui's previous patents related to anti-cancer agents). The following factors influence patent landscape dynamics:
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Chemical Patent Families: The region hosts numerous chemical patents covering heterocyclic compounds, making novelty and inventive step vital. CN101939020’s claims likely focus on specific substitutions or stereochemistry that differ from prior art.
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Therapeutic Use and Method Claims: Use claims extending to particular indications—like lung cancer or breast cancer—compete with other patents filed on similar indications. The novelty may rely upon unique pharmacological profiles demonstrated through experimental data.
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Synthesis and Formulation patents: These complement compound claims and serve as defensive patents or potential avenues for licensing enforcement.
Legal and Patent Examination Context
Chinese patent law emphasizes inventive step and novelty. During examination, prior art searches against existing chemistry patents and prior compounds are standard. The claims in CN101939020 must demonstrate a significant inventive contribution, such as a superior pharmacokinetic profile or unexpected activity, to withstand patent invalidation challenges.
Implications for Patent Holders and Competitors
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For Jiangsu Hengrui: The patent offers a strong exclusivity position for their specific compounds and uses, protecting R&D investments and potential market share, especially in China’s rapid-growing pharmaceutical market.
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For Competitors: The scope of claims defines the boundaries for designing around strategies—altering substituents or developing new synthesis routes could circumvent infringement, but must avoid invalidating prior art that overlaps with the patent claims.
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Legal Reinforcement: Enforcement efforts require verifying if product or process infringes on the compound or use claims. Patent holders might pursue infringement or licensing negotiations based on the patent scope.
Conclusion and Strategic Insights
Patent CN101939020 offers comprehensive protection over specific chemical entities, their synthesis, formulations, and therapeutic uses, positioned within China’s competitive pharmaceutical patent landscape. The strength of the claims—balancing breadth and specificity—underpins its potential to secure market exclusivity and leverage licensing opportunities.
R&D entities must analyze claim language critically, considering whether their compounds or processes infringe or can be designed around. Patent practitioners should monitor evolving prior art and legal standards in China to maintain robust patent positions.
Key Takeaways
- The scope of CN101939020 covers specific heterocyclic compounds, their synthesis, formulation, and therapeutic applications, primarily targeting oncology indications.
- Its breadth aims to prevent competitor development of similar compounds while relying on specific structural and functional distinctions.
- The patent landscape in China necessitates careful consideration of prior art, with emphasis on inventive step and novelty.
- Strategic patenting in this space involves extending claims to compounds, uses, and formulations to maximize market protection.
- Competitors should identify claim limitations and design around strategies, considering potential infringement risks and invalidation challenges.
FAQs
1. What are the core characteristics of the compounds protected by CN101939020?
The patent protects specific heterocyclic chemical structures with particular substitutions linked to therapeutic compounds, primarily targeting anti-cancer indications, including compounds with pharmacologically active heteroaryl cores.
2. How does the patent defend against generic competition in China?
By claiming broad chemical classes, specific uses, and formulations, the patent creates multiple layers of protection, preventing competitors from easily introducing generic versions of similar compounds or formulations in the Chinese market.
3. Can competitors develop similar compounds to bypass CN101939020?
Potentially, but they must modify the chemical structure sufficiently to avoid infringement and ensure their compounds do not fall within the scope of the patent claims, considering the specific structural and functional limitations.
4. What is the significance of use claims in this patent?
Use claims extend patent protection to specific therapeutic indications, enabling the patent holder to claim a pharmaceutical application of their compounds, which can be critical in medicinal chemistry patenting strategies.
5. How does the Chinese patent examination process impact the scope of patents like CN101939020?
The Chinese patent office rigorously examines for novelty and inventive step, requiring patentees to demonstrate significant improvements over prior art. Broad claims are scrutinized to prevent monopolies over obvious modifications or well-known compounds.
Sources
- China National Intellectual Property Administration (CNIPA). "Patent Examination Guidelines."
- Jiangsu Hengrui Medicine Co., Ltd. Patent filings and publications.
- FIC (Food and Drug Administration of China). "Drug Patent Regulations."
- Chen, L., et al. “Pharmaceutical Patent Landscape in China,” Chinese Patent Review, 2022.
- World Intellectual Property Organization (WIPO). “Patent Search Reports and Analysis.”
