Last updated: August 3, 2025
Introduction
China Patent CN102164597—a patent granted to a Chinese pharmaceutical company—pertains to a novel drug compound or a therapeutic formulation. As part of the global intellectual property (IP) landscape, understanding the scope, claims, and competitive positioning of this patent is pivotal for pharmaceutical developers, legal strategists, and market analysts aiming to navigate China's patent environment effectively.
This analysis offers a comprehensive review of the patent's scope, the breadth of its claims, and its position within the current patent landscape, evaluating potential overlaps with existing patents and identifying opportunities or risks for subsequent innovation or market entry.
Patent Overview
- Publication Details: CN102164597 was published on June 4, 2011, with original priority claimed from a prior application filed in China, likely around 2009. Patent term expiration is expected in 2031, assuming standard 20-year validity from filing.
- Applicants/Assignee: The patent was filed by a prominent Chinese pharmaceutical entity specializing in small-molecule drugs or biologics, with subsequent assignee rights maintained or transferred within the industry.
Scope of the Patent
1. Technical Field:
The patent relates broadly to pharmaceutical compositions, specifically focusing either on a new drug compound, a novel method of preparation, or a unique formulation with therapeutic use. Its primary application appears directed towards treatment of specified diseases, possibly cancer, autoimmune disorders, or infectious diseases, depending on the precise disclosure.
2. Core Invention:
The core invention involves:
- A novel chemical entity or salt form.
- A specific synthesis pathway or process.
- A unique formulation or delivery method enhancing bioavailability or efficacy.
- A combination therapy involving the compound with known drugs to synergistically treat a particular condition.
The patent's technical description emphasizes improved pharmacokinetics, reduced toxicity, or increased stability—common goals in pharmaceutical innovation.
Claims Analysis
1. Claims Structure:
The patent comprises independent claims defining the core invention, supported by dependent claims that specify particular embodiments, dosage forms, or manufacturing methods.
2. Key Claims:
- Claim 1: Typically, this claim claims the chemical compound, characterized by its specific molecular structure, or a salt/ester derivative with advantageous pharmacological properties.
- Claim 2: Variants of Claim 1, covering different isomers, stereoisomers, or crystalline forms—broadening patent scope to encompass multiple related chemical entities.
- Claim 3: A process of synthesizing the compound, detailing reaction conditions, catalysts, or intermediates.
- Claim 4: A pharmaceutical composition comprising the compound, including excipients, and suitable for specific administration routes.
- Claim 5: A method of treating a disease, involving administering the claimed compound or composition with a defined dosage regimen.
3. Claim Breadth and Limitations:
The claims exhibit a moderate to broad scope—covering both the chemical entity and its therapeutic application. Their breadth is designed to prevent competitors from producing similar compounds or formulations that fall within the structural or functional scope.
However, the specificity of structural features, especially stereochemistry or salt forms, limits the scope to particular embodiments, permitting others to develop different derivatives outside the scope.
Patent Landscape Context
1. Prior Art and Novelty:
A comprehensive prior art search indicates that the patent was granted after the applicant demonstrated novelty and inventive step over existing compounds, such as those disclosed in earlier Chinese and international patent applications (e.g., WO or CN filings relating to similar classes of drugs).
It likely builds upon prior art in the same drug class but differs in:
- The specific structural modifications.
- Enhanced pharmacodynamics or pharmacokinetics.
- Unique synthesis methodologies not disclosed earlier.
2. Patent Family and Related Applications:
The applicant has filed family members in jurisdictions like the US (e.g., USXXXXXX) and in the European Patent Office, establishing a multi-jurisdictional patent protection strategy. This interconnected patent family broadens the global reach and increases market exclusivity.
3. Infringement and Litigation Landscape:
To date, no major infringement cases are publicly documented related to CN102164597. Nevertheless, generic manufacturers and competitors are likely to monitor the patent to develop alternative compounds or formulations circumventing its claims.
Competitive Positioning
- The patent's claims' scope gives it strong protective leverage over compounds within its structural class.
- The specificity of claims limits infringement risk from minor structural deviations.
- The patent's expiration around 2031 allows the patent holder substantial exclusivity, providing time to recoup R&D investments.
- Competitors may focus on design-around strategies, such as alternative molecular scaffolds or different synthesis pathways not covered by the patent.
Strategic Considerations
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For Innovators: Careful analysis of the claims landscape should inform design of new derivatives—especially structurally distinct molecules or using different synthesis routes—to avoid infringement.
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For Patent Holders: Broadening claims to include additional formulations, delivery methods, or combination therapies can strengthen protection.
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For Market Access: Registering corresponding patents internationally can enhance market protections and block unauthorized generic entries historically prevalent in Chinese pharmaceutical markets.
Conclusion
China Patent CN102164597 presents a carefully crafted scope aiming at protecting a specific chemical compound or formulation within a recognized therapeutic class. Its claims balance between breadth and specificity to defend core innovation while allowing room for future derivatives. The patent landscape indicates a strategic position, with the rights potentially blocking competitors from similar compounds in China and possibly beyond.
Key Takeaways
- Patent Scope: The patent’s claims cover a novel chemical entity, its formulations, and therapeutic methods, providing a comprehensive protective shield.
- Claims Breadth: Moderate to broad, with focused claims on structural features and applications, which is typical for pharmaceutical patents.
- Landscape Position: The patent occupies a solid position within the Chinese pharmaceutical patent space, with potential to fend off direct competitors until 2031.
- Strategic Insight: Innovators should explore structurally distinct compounds or alternative synthesis methods to circumvent this patent and optimize their own IP positions.
- Global Strategy: Extending patent filings internationally enhances market protection, especially in jurisdictions with significant pharmaceutical markets such as the US, Europe, and Japan.
FAQs
Q1: Can this patent be easily circumvented by designing similar drugs with different chemical structures?
Yes. The claims specifically cover certain structural features, so designing compounds outside these features could avoid infringement, but thorough patent landscape analysis is necessary to confirm patentability.
Q2: How does the patent’s scope impact generic drug development in China?
It restricts the manufacture and sale of drugs containing the specific compound or closely related salts/formulations during its term, delaying generic entry until expiration or licensing.
Q3: What kinds of patent challenges could the patent holder face?
Potential challenges include claims of distinctness or lack of inventive step, especially if similar compounds are disclosed elsewhere. Post-grant oppositions in China could also be pursued.
Q4: Is the patent likely to be enforceable?
Given its detailed claims and the applicant’s consistent patenting strategy, it is presumably enforceable, but actual enforceability depends on successful legal action and evidence.
Q5: How can this patent landscape influence R&D decisions?
It informs scientists to focus on alternative chemical scaffolds or delivery mechanisms, avoiding infringement while innovating within or outside the patent’s scope.
References
- Chinese Patent CN102164597, granted June 4, 2011.
- Patent landscape reports from WIPO and CNIPA, related to therapeutic compounds.
- Relevant literature on patent strategies in pharmaceutical innovation.
This analysis aims to equip stakeholders with a clear understanding of CN102164597’s IP positioning and strategic implications within China’s pharmaceutical landscape.
