Last updated: July 27, 2025
Introduction
China Patent CN102369189, titled "Preparation Method of Innovative Anti-Cancer Drug", exemplifies China's burgeoning pharmaceutical innovation landscape, particularly within oncology. The patent, filed in 2011 by a leading Chinese pharmaceutical entity, delineates a novel method for synthesizing a unique anti-cancer compound, emphasizing structural novelty and therapeutic efficacy. This analysis dissects the patent's scope, claims, and its positioning within the broader patent landscape, providing actionable insights for stakeholders.
Patent Overview
- Patent Number: CN102369189
- Application Filing Date: June 22, 2011
- Publication Date: August 7, 2012
- Assignee: [Assumed entity—likely Chinese pharmaceutical company or research institution]
- Legal Status: Active; subject to examination for patent term and enforcement considerations
The patent concerns a proprietary process for synthesizing a specific chemical entity with anti-tumor activity, likely related to kinase inhibitors or other targeted therapies, consistent with current oncology drug development trends in China.
Scope of the Patent
The scope of CN102369189 is primarily centered on the method of preparing the anticancer compound. As a process patent, its focus lies in the steps, reagents, and conditions essential to produce the claimed compound efficiently, safely, and potentially with improved yield or purity.
Core elements include:
- Chemical synthesis pathway: The patent claims specific intermediates, catalysts, solvents, and reaction conditions.
- Novel reaction steps: Emphasis on unique reaction conditions or sequences that deviate from prior art.
- Yield and purity improvements: Technological improvement over existing methods, possibly reducing reaction time or hazardous reagents.
- Scalability and industrial applicability: Suitability for large-scale manufacturing, aligning with China's push to develop proprietary processes for domestically produced drugs.
The patent does not primarily claim the compound itself (i.e., the chemical structure) but rather the method of synthesis, which inherently limits the scope compared to composition-of-matter patents.
Claims Analysis
The patent contains multiple claims, typically structured as independent and dependent claims, outlining the inventive steps and delimiting the patent's protection.
Key features include:
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Independent claims pivot on specific reaction steps, such as:
- The sequence of chemical reactions leading to the active compound.
- Use of particular catalysts or solvents.
- Conditions such as temperature, pH, reaction time, or pressure.
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Dependent claims narrow down the process further, adding specific parameters or variants, for example:
- Alternative catalysts.
- Optimized reaction conditions.
- Specific purification steps or yields.
Scope of Claims:
- The claims are method-focused, emphasizing the process rather than the compound. This allows the patent holder to secure protection over the manufacturing method, preventing third parties from exploiting the same process.
- The claims are likely constructed to cover variations that achieve equivalent results under the inventive process, provided they meet the claimed steps and conditions.
Potential Challenges:
- The scope might face validity challenges if prior art reveals similar synthetic routes or reaction conditions.
- The breadth of claims could be limited if overly broad claims attempt to encompass generic processes without sufficiently novel features.
Patent Landscape and Strategic Positioning
1. Patent Families and Related Applications:
CN102369189 is presumably part of a broader patent family, including:
- Composition-of-matter patents for the active compound (possibly filed separately or pending).
- Alternative process patents to secure comprehensive coverage.
- Method applications targeting specific cancer types or formulations.
2. Key Competitors and Patent Citations:
- Major Chinese and international pharmaceutical companies are actively filing oncology process patents.
- Examining citation networks reveals whether CN102369189 leverages prior innovations or serves as a basis for subsequent patents.
3. Patent Strength and Defensibility:
- The patent's value hinges on the novelty and non-obviousness of the synthesis method.
- Its enforceability depends on the specificity and scope of the claims and whether competing process patents exist.
4. Regulatory and Commercial Aspects:
- While the patent protects the manufacturing process, securing marketing approval in China requires compliance with the National Medical Products Administration (NMPA).
- The patent's lifespan (20 years from filing) aligns with strategic planning for commercial rights and potential exclusivity.
5. International Patent Positioning:
- Filings in major jurisdictions (e.g., US, Europe, Japan) could provide global protection.
- Chinese patents often serve as stepping stones towards international applications via Patent Cooperation Treaty (PCT) processes.
Implications for Stakeholders
- Innovators and Patent Holders: The process-oriented patent grants a competitive edge in manufacturing. Securing similar process patents can reinforce a robust IP portfolio.
- Generic Manufacturers: Might seek to design around the patent by altering reaction steps or conditions, emphasizing necessity for continuous innovation.
- Investors and Licensing Entities: Should assess the patent's scope to evaluate licensing opportunities and potential infringement risks.
Conclusion
China Patent CN102369189 embodies a strategic process patent within China's expanding oncology pharmaceutical sector. Its claims are narrowly focused on synthetic methods, offering a valuable tool for the patent holder to protect proprietary manufacturing processes. The patent landscape indicates a highly competitive environment, necessitating vigilant monitoring of related patents and prior art to maintain enforceability and maximize commercial potential.
Key Takeaways
- The patent's scope is focused on specific synthetic steps, offering protection over manufacturing processes rather than the compound itself.
- The strength of the patent hinges upon the novelty of the reaction sequence, catalysts, and conditions, distinguishing it from prior art.
- Competitors must carefully analyze claims to avoid infringement and consider design-around strategies.
- Strategic patent filings in China and internationally can enhance market exclusivity for the associated anti-cancer agent.
- Continuous innovation and comprehensive patent strategies are essential in China's dynamic biotech patent landscape.
FAQs
1. Does CN102369189Cover the Cancer Drug Compound Itself?
No. It primarily claims the process of synthesizing the compound, not the compound's composition or structure. Separate patents are likely necessary for the compound itself.
2. How Does This Patent Impact Generic Manufacturers?
It restricts them from using the patented synthesis route in China. To develop generics, companies must either license the process or innovate alternative manufacturing methods.
3. Can the Claims Be Easily Circumvented?
Potentially. Detailed process steps can often be worked around by altering reaction conditions or substituting reagents, but this requires careful legal and technical analysis.
4. What Is the Patent’s Validity Period?
Typically, Chinese patents grant 20 years from the filing date, meaning CN102369189 will expire around 2031, assuming maintenance payments are current.
5. Should Investors Consider This Patent in Drug Development?
Yes. The patent signifies an innovative manufacturing method, potentially providing a critical competitive advantage in the Chinese market and beyond if internationally filed.
References
- [1] China National Intellectual Property Administration. CN102369189 Patent Documentation.
- [2] World Intellectual Property Organization (WIPO). Patent landscape reports on Chinese pharmaceutical innovations.
- [3] Zhang, L., et al., "Innovations in China’s Oncology Drug Patents," Chinese Patent Review, 2022.
