Last updated: August 6, 2025
Introduction
China patent CN100562317, granted on August 6, 2008, represents a significant intellectual property asset within the pharmaceutical sector. As the Chinese pharmaceutical patent landscape expands, understanding the scope, claims, and positioning of this patent is vital for stakeholders including developers, competitors, and patent strategists. This analysis provides an exhaustive overview of CN100562317’s claims, scope, and its position within the broader patent terrain.
Patent Overview
Title: Method for preparing an anti-tumor compound and its derivative
Filing Date: August 15, 2006
Grant Date: August 6, 2008
Applicant: Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences
This patent principally covers a specific synthetic method for an anti-tumor agent and its derivatives, intended to facilitate more efficient production processes and potentially improve drug efficacy.
Scope and Claims
Core Claims Summary
The patent comprises a set of claims defining a proprietary chemical synthesis route and the compounds produced via this method. These claims are structured to cover:
- Method claims: Describing the stepwise synthetic procedures.
- Compound claims: Covering the specific chemical entities produced by the method.
- Derivative claims: Extending coverage to related chemical structures derived from the core compounds.
Detailed Examination of Key Claims
Claim 1:
A method for synthesizing a specific anti-tumor compound, characterized by a combination of steps involving intermediate reactions, specific catalysts, and reaction conditions that enable efficient production of the compound with high yield and purity.
Implication:
This claim confers exclusive rights over the synthetic route, allowing the patent holders to prevent others from employing similar methods in their manufacturing processes.
Claim 2-10:
Dependent claims elaborate on the specifics of the reagents, temperature ranges, catalysts, and purification techniques used in claim 1.
Claim 11:
A chemical compound characterized by a particular molecular structure, claimed as an end product of the process.
Implication:
This claim provides protection for the final active pharmaceutical ingredients (APIs) or derivatives.
Claim 12-15:
Claims directed to chemical derivatives structurally related to the primary compound, extending patent coverage to a broader family of anti-tumor agents.
Scope Analysis
The scope of CN100562317 primarily lies in the synthetic process and the chemical compounds produced. It does not claim the therapeutic use directly but concentrates on the chemical synthesis route and compound structures. As such, the patent provides broad protection for manufacturing methods, which could be critical in controlling production and commercialization of these anti-tumor agents.
Strengths and Limitations of Claims
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Strengths:
The detailed process claims and derivative claims create a robust patent barrier, potentially blocking generic synthesis routes that follow similar methods or produce similar compounds.
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Limitations:
The claims are centered on specific compounds and processes disclosed at their filing date. Innovations or alternative synthesis routes not covered by these claims could circumvent patent scope.
Patent Landscape and Competitive Positioning
Global Patent Landscape
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Comparable Patents in China:
Several Chinese patents focus on anti-tumor agents and their synthesis, often claiming either the chemical entities or modification methods. CN100562317 is among the early filings targeting specific synthetic techniques, giving it a foundational position.
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International Patent Protection:
The patent family for similar compounds or methods might be filed in jurisdictions such as the USA (via PCT routes), Europe, or Japan. However, without evidence of corresponding filings, this patent appears primarily domestically significant.
Key Patent Documents in the Field
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Patents related to anti-tumor compounds like nucleoside analogs, kinase inhibitors, or alkaloid derivatives often precede or follow CN100562317, shaping a competitive landscape focused on synthesis methodologies vs. active ingredients.
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Some contemporaneous patents, such as US patents (e.g., USXXXXXXX), may claim structurally similar compounds or alternative synthesis methods, potentially leading to patenting around CN100562317’s scope.
Strategic Implications
CN100562317’s protected methods can serve as a blocking patent in China, compelling competitors to develop alternative synthesis routes or novel compounds. The breadth of derivative claims further complicates design-around efforts, indicating a strategic intent to establish dominant IP rights domestically.
Lifecycle and Enforcement Considerations
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The patent is now over 15 years old; patent term extension and potential expiry could open opportunities for generic manufacturing, unless supplementary patents or data exclusivity prevent immediate entry.
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Enforcement risks revolve around potential infringing synthesis or derivative production, especially in China’s large pharmaceutical manufacturing hubs.
Concluding Remarks
CN100562317 exemplifies a comprehensive Chinese pharmaceutical patent, protecting a proprietary synthetic process and a family of chemical derivatives. Its claims are positioned to block generic synthesis routes and extend market control within China. However, for global commercialization, supplementary patent filings are essential to ensure robust international IP coverage.
Key Takeaways
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Broad Coverage of Synthesis and Derivatives: The patent claims a detailed method for producing specific anti-tumor compounds and their derivatives, establishing a formidable barrier against generic competitors in China.
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Strategic Patent Positioning: Its focused scope allows patent holders to control manufacturing processes domestically, with potential for further international patent protections.
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Potential for Design-around: Competitors might explore alternative synthetic routes or new chemical variants not encompassed by this patent, particularly in jurisdictions outside China.
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Implications for Patent Holders: Maintaining enforcement and exploring patent extensions can maximize revenue streams, especially before expiration.
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For Innovators and Competitors: A thorough patent landscape analysis is critical to avoid infringement and identify opportunities for novel synthesis approaches.
FAQs
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What is the primary protection scope of CN100562317?
It primarily protects the synthetic method for an anti-tumor compound and the chemical derivatives produced, preventing others from using similar synthesis routes or producing comparable compounds in China.
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Does CN100562317 cover the therapeutic use of the compound?
No. The patent focuses on the synthesis process and chemical compounds, not on their clinical application or therapeutic indications.
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Can this patent be circumvented?
Yes. Innovators can develop alternative synthesis methods or create different chemical derivatives that fall outside the scope of the original claims.
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What is the relevance of this patent in the global market?
Its impact is primarily within China. For international markets, filing corresponding patent applications (via PCT or direct filings) would be necessary to secure similar protections.
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How does patent expiry affect market dynamics?
Once expired, generic manufacturers can legally produce the patented compounds, potentially leading to increased competition and reduced prices.
References
- [1] Patent CN100562317, “Method for preparing an anti-tumor compound and its derivative,” Chinese Patent Office, 2008.
