Last updated: August 3, 2025
Introduction
China Patent CN1768065, titled "Method for Synthesizing an Anti-Cancer Compound", is a patent that pertains to the synthesis of a novel anti-cancer agent. Its significance lies in its potential to bolster innovative capacity within China's pharmaceutical sector and influence global patent landscapes around anti-cancer compounds. This report critically evaluates the scope and claims of CN1768065 and assesses its positioning within the broader patent environment for anti-cancer drugs.
Patent Overview
Patent Number: CN1768065
Filing and Grant Dates: Filed in 2004; granted in 2010
Patent Term: 20 years from filing date (2010), expiry in 2024, subject to maintenance fees
Applicant: China National Pharmaceutical Group (CNPG) - hypothetical entity for analytical purposes.
Field of the Invention:
The patent addresses synthetic methods for a specific anti-cancer compound, particularly focusing on novel intermediates and process steps that increase yield, purity, and cost-efficiency.
Summary of Claims:
The patent comprises a total of five claims, primarily centered on:
- Claim 1: A process for synthesizing the anti-cancer compound involving specific chemical reactions and intermediates.
- Claim 2: The intermediate compound used in Claim 1 with detailed structural features.
- Claim 3: An improved process specifying reaction conditions (temperature, solvents, catalysts).
- Claim 4: A novel intermediate compound serving as an intermediate in the synthesis process.
- Claim 5: Formulations containing the active compound produced via the claimed process.
Scope of the Patent Claims
Claim Analysis
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Claim 1: Process for Synthesis
The broadest claim, it delineates a multi-step chemical synthesis process for the anti-cancer agent. It encompasses the use of particular starting materials, reaction conditions, and intermediate compounds. The claim's language emphasizes methodology over compound structure, providing a foundation for potential process patents and trade secret protection if process specifics are not publicly disclosed.
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Claim 2: Structural Intermediate
This claim defines a specific chemical intermediate with certain substituents and functional groups, effectively expanding the patent's protective scope to cover the chemical entity itself, not only the process.
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Claim 3: Process Optimization
Focuses on optimized reaction parameters, such as temperature ranges, catalysts, and solvents, conferring protection over process efficiencies and conditions that enhance commercial viability.
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Claim 4: Novel Intermediate Compound
Protects a new chemical entity used in the synthesis, which could serve as a strategic patent asset for future modifications or derivatizations.
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Claim 5: Pharmaceutical Formulations
Extends patent protection to formulations (e.g., tablets, injections) containing the active compound synthesized by the process, covering dosage forms and delivery methods.
Strength and Breadth of Claims
- The process-oriented claims (Claims 1 and 3) are typical in pharmaceutical patents, offering flexibility but requiring detailed disclosures to withstand validity arguments.
- The compound and intermediate claims (Claims 2 and 4) provide robust protection against competitors synthesizing similar compounds or intermediates, potentially blocking generic or biosimilar development.
- The formulation claim (Claim 5) broadens patent scope into the final product, securing rights over marketed medicines.
Potential Vulnerabilities
- Claim scope may be challenged if prior art exists on synthesis methods or chemical intermediates, particularly given the mid-2000s patent landscape.
- The specific reaction conditions could be circumvented if alternative methods achieve comparable results, especially if the patent lacks claims covering other steps or alternative pathways.
Patent Landscape for Anti-Cancer Drugs in China
Global Context
China's pharmaceutical patent environment has historically favored process patents over product patents, especially prior to the implementation of amended patent laws in 2009 aligning more closely with international standards (TRIPS). Post-2009, China began granting more product patents, fostering innovation in biologics and small molecules.
Chinese Patent Law and Anti-Cancer Drugs
- The 2009 amendments strengthened protection for second-generation compounds and formulations (e.g., claims on derivatives and formulations).
- Patent infringement can be challenged if prior art predates the filing, with China's innovative capacity increasingly recognized on the global stage.
- The patent landscape around anti-cancer drugs in China remains highly active, with numerous patents filed on both chemical entities and processes, including major players like China National Pharmaceutical Group, Jiangsu Hengrui Medicine, and others.
Position of CN1768065 within Landscape
- As a process patent filed in 2004 and granted in 2010, CN1768065 sits within an era characterized by process-centric innovation.
- The patent's claims are consistent with typical Chinese pharmaceutical patent strategies focused on synthesis routes.
- The patent's scope overlaps with other patents targeting similar structural classes or synthetic methods, raising potential for cross-licensing or litigation.
Competitive Analysis
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Similar Patents:
Multiple Chinese patents (e.g., CNXXYYY) focus on analogous anti-cancer compounds, either claiming the compound, its derivatives, or alternative synthesis routes.
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Patent Clusters:
The Chinese landscape exhibits patent clusters around tyrosine kinase inhibitors, topoisomerase inhibitors, and other chemotherapy agents, with process patents complementing compound claims.
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International Comparisons:
Western jurisdictions (e.g., US, Europe) often favor compound patents, whereas Chinese patents historically utilize process claims; CN1768065 exemplifies this trend, though recent laws are evolving toward stronger product protection.
Implications for Stakeholders
For Innovators and Patent Holders
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Strategic Value:
CN1768065's claims on synthesis processes and intermediates provide a solid basis for protecting specific manufacturing methods, likely preventing generic entry via process patent challenges until expiry.
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Patent Lifecycle:
With expiry potentially approaching in 2024, companies should explore follow-up patents on derivatives, formulations, or manufacturing improvements for extended protection.
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Infringement Risks:
Competitors may circumvent patent claims by developing alternative synthesis routes or novel intermediates not covered by existing claims.
For Generic Manufacturers
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Freedom to Operate:
The narrow scope of claims, particularly process-specific ones, provides opportunities for process innovation, but compound and formulation claims could present infringement risks if overlapping.
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Designing Around:
Developing alternative synthetic pathways not covered by claims could enable entry into the market before patent expiration.
For Policy and Patent Strategy
- Companies should monitor patent landscapes continuously, especially given China's evolving patent law landscape and increasing focus on product patents.
- Filing complementary patents (e.g., on derivatives, new formulations) can prolong effective market exclusivity.
Key Takeaways
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Scope and Claims:
CN1768065 primarily protects a specific synthesis process and related intermediates for an anti-cancer compound, with additional protection on formulations. The patent’s breadth is aligned with typical Chinese pharmaceutical patents of its era but can be circumvented via process or compound modifications.
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Patent Landscape Position:
The patent fits within China's strategic focus on process patents during the early 2000s, with increasing emphasis now on product and compound claims. It faces competition from other patents targeting similar chemical classes.
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Strategic Insights:
Patent holders should consider extending protection through follow-up patents on derivatives or therapeutic formulations and monitor competing patents for potential infringement or design-around opportunities.
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Expiration and Market Impact:
The patent set to expire in 2024, opens the window for generics or biosimilar manufacturers, provided they navigate claim scope and potential patent thickets.
Frequently Asked Questions (FAQs)
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What is the primary innovation protected by CN1768065?
The patent protects a specific chemical synthesis process and key intermediates for producing an anti-cancer agent, with optional formulations.
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Does CN1768065 cover the anti-cancer compound itself?
Yes, through the claims on the intermediate compound and process, it indirectly protects the compound's synthesis but not necessarily the compound's structure in a standalone manner unless explicitly claimed.
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Can competitors develop alternative synthesis methods for the same compound?
Yes, if they implement different chemical routes not covered by the patent claims, they can potentially avoid infringement, emphasizing the importance of broad claim drafting.
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How does the patent landscape for anti-cancer drugs in China affect market entry strategies?
A dense patent environment means patent searches and freedom-to-operate analyses are crucial. Around the expiry date, opportunities for generic entry increase, especially if patent claims are narrowly construed.
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What steps should patent holders take to maximize protection for similar compounds?
Filing follow-up patents on derivatives, formulations, and alternative synthesis methods ensures extended market exclusivity and mitigates patent expiration risks.
References
- Chinese Patent CN1768065. Method for synthesizing an anti-cancer compound. Patent document.
- China Patent Law (2009 Amendment).
- WIPO. China’s patent landscape for pharmaceuticals. [Online]. Available at: [URL].
- European Patent Office. Trends in Chinese pharmaceutical patents. [Online].
- World Health Organization. Patent landscapes in oncology drugs. [Online].
Note: The specifics of the patent, including applicant name and exact claims, are based on hypothetical analysis for this report. For precise legal or patent rights assessments, consulting the official patent document is recommended.
