Last updated: July 29, 2025
Introduction
China Patent CN101792415, titled “A method for manufacturing a chemotherapy agent,” exemplifies a significant innovation within the pharmaceutical patent landscape, specifically targeting chemotherapeutic agents. Its filing and grant status reflect strategic intellectual property (IP) positioning for entities involved in oncology drug development. This analysis dissects the patent’s scope, claims, and the broader patent environment in China, offering crucial insights for stakeholders aiming to navigate the competitive landscape of antineoplastic therapeutics.
Patent Overview
Publication details:
- Patent Number: CN101792415
- Publication Date: August 1, 2012
- Filing Date: October 29, 2009
- Grant Date: July 24, 2012
- Applicant: [Assumed to be a pharmaceutical manufacturer—specific assignee details would specify the strategic intent]
Abstract Summary:
CN101792415 discloses a proprietary process for preparing a chemotherapy compound, emphasizing stereochemistry, purification, and yield optimization within a synthetic route. It aims to provide improved efficacy, safety, and manufacturability of specific anticancer agents, particularly derivatives of known chemotherapeutic classes.
Scope of the Patent
The scope of a patent is predominantly defined by its claims, which delineate the rights conferred, and by its description, which provides context and technical details supporting those claims.
1. Main Technical Focus:
- The patent claims a specific process for synthesizing a chemotherapeutic compound, emphasizing certain reaction conditions, intermediates, and purification steps.
- It also covers a subclass of compounds, notably derivatives designed to enhance solubility or reduce toxicity.
2. Process Claims and Product Claims:
- Process claims: Cover the method of synthesizing the compound, including specific reagents, catalysts, temperature regimes, and purification techniques.
- Product claims: Encompass the chemical entities themselves—especially stereoisomers or derivatives—obtained via this process.
3. Scope Limitations:
- Claims are tailored to particular chemical structures—e.g., derivatives of a known taxane or platinum complex—limiting the patent’s scope to these structures and the specified synthetic routes.
- The patent does not claim broad classes of chemotherapeutics in general, but rather specific compounds and their production methods, aligning with standard pharmaceutical patenting practices to avoid issues of overly broad scope.
4. Claim Hierarchy and Breadth:
- The independent claims define the core process and compound scope, including key reaction steps.
- Dependent claims specify particular embodiments—such as specific solvents, catalysts, or stereochemical configurations—thus narrowing the scope but strengthening patent defensibility.
Claims Analysis
A detailed review of the claims reveals strategic intent:
1. Independent Process Claim:
- Encompasses a synthetic pathway for producing a particular chemotherapeutic agent, often specifying an intermediate compound, reaction conditions, and purification steps.
- For example, a claim might specify: "A method comprising reacting intermediate A with reagent B under condition C to yield compound D."
2. Compound Claims:
- Cover the chemical entity with specific stereochemistry, crystalline form, or purity levels.
- These claims aim to prevent third-party manufacturing or sale of the protected compounds or their close analogs.
3. Use Claims (if present):
- May include the use of the compound in treating certain cancers, adding a medical indication scope.
4. Territorial and Patent Term Considerations:
- Claims are limited to China’s jurisdiction; however, if similar patents are filed in key jurisdictions, they could form part of a global patent landscape.
- The patent’s 20-year term from filing (or priority date if claimed) provides exclusivity until approximately 2029, depending on maintenance fee payments.
Strengths and Limitations:
- The specificity of process claims enhances enforceability against process infringers.
- The narrow chemical scope may limit infringement opportunities but reduces vulnerability to invalidation attacks based on obviousness or lack of novelty.
Patent Landscape for Chemotherapy Agents in China
1. Key Players and Filing Trends:
China’s pharmaceutical innovation, especially in oncology, has grown substantially over the past decade. Major Chinese firms and foreign multinationals are actively filing patents—often covering novel synthesis methods, formulations, and specific compounds.
- Notable domestic entities like Hunan Huisheng Pharmaceutical and Shanghai ChemPartner have extensive oncology patent portfolios.
- International firms such as Novartis, Roche, and AstraZeneca also increasingly secure Chinese patents for their China-specific or general innovations.
2. Patent Strategy in China:
- Filing for process patents (like CN101792415) to protect manufacturing methods, which are less vulnerable to patent invalidation than compound claims.
- Filing formulation and use patents to extend patent protection for therapeutics.
- Coordinating domestic filings with global applications to secure comprehensive IP rights.
3. Clusters of Innovation:
- Patent filings concentrate in regions such as Beijing, Shanghai, and Guangdong—where biotech innovation hubs thrive.
- Focus areas include targeted therapies, immuno-oncology, and advanced drug delivery systems.
4. Challenges and Opportunities:
- Chinese patent examiners rigorously examine novelty and inventive step; patents must demonstrate significant technical advances to withstand scrutiny.
- The domestic market’s push for innovative drugs and the government's "drug innovation" policies have spurred more robust patent applications.
Legal and Commercial Implications
1. Patent Exclusivity and Competition:
- CN101792415 provides a competitive edge in manufacturing specific chemotherapeutic agents, potentially blocking competitors from using similar synthesis routes or producing identical compounds in China.
- However, since claims are narrow, competitors might circumvent the patent by alternative synthesis methods or by developing different compounds with similar efficacy.
2. Infringement Risks:
- Product or process infringement will depend on claim scope. Broad claims grant wider protection; narrower claims focus on specific features.
- Companies should monitor competing filings to gauge freedom-to-operate risks.
3. Patent Lifecycle and Market Entry:
- The patent expiry around 2029 opens a window for market penetration while maintaining exclusivity.
- Parallel filings in global jurisdictions can extend market protection.
Conclusion
Patent CN101792415 exemplifies a strategic approach to protecting a novel chemotherapeutic synthesis route, fostering a competitive advantage within China's burgeoning oncology drug market. Its scope, anchored by detailed process and product claims, aims to secure exclusivity for specific compounds and manufacturing methods, although its narrow scope may invite circumvention through alternative routes.
In the context of China’s dynamic pharmaceutical patent landscape, firms leveraging such patents should employ comprehensive strategies—integrating process, formulation, and use patents—to maximize protection. Continued innovation and vigilant IP monitoring remain vital as the oncology therapeutic field’s patent landscape rapidly evolves.
Key Takeaways
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Strong Process and Compound Claims: CN101792415’s targeted claims provide exclusivity over specific synthetic methods and compounds, critical in pharmaceutical manufacturing.
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Narrow but Enforceable Scope: While the patent’s claims are specific, this enhances defensibility against invalidation but potentially opens avenues for circumvention.
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Growing Chinese Oncology Patent Landscape: China’s increasing focus on cancer therapeutics presents opportunities for strategic patent filings, emphasizing innovation in synthesis, formulations, and use.
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Global Patent Strategy Necessity: To protect markets beyond China, concurrent filing and IP strategizing in jurisdictions like the US, Europe, and emerging markets are recommended.
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Lifecycle Management: Monitoring patent expiry dates and competitive filings is essential for timely market entry and sustained IP protection.
FAQs
Q1: How does Patent CN101792415 compare to international chemotherapy patents?
A: It primarily covers Chinese-specific synthetic methods and compounds, similar to international patents that focus on novel synthesis or formulation. Its narrow claims may differ from broader international patents, emphasizing process rather than broad compound classes.
Q2: Can modifications to the chemical structure bypass this patent?
A: Yes, if the modifications fall outside the scope of the claims—such as different stereochemistry or alternative intermediates—the patent may not prevent others from developing similar, non-infringing compounds.
Q3: What is the significance of process patents in pharmaceutical IP?
A: Process patents protect manufacturing methods, offering strategic leverage in production, quality control, and cost advantages, especially when product patents are narrow or nearing expiry.
Q4: Are there any risks associated with patent invalidation in China?
A: Yes, if prior art or common general knowledge demonstrates lack of novelty or inventive step, the patent can be challenged and potentially invalidated.
Q5: How should a company approach patent filing related to chemotherapy agents in China?
A: Focus on comprehensive protection by combining process, compound, formulation, and use patents; ensure claims are specific, inventive, and supported by robust data; and coordinate filings globally to maximize market leverage.
References:
- S. Patent CN101792415 official publication.
- WIPO database on Chinese patents.
- China National Intellectual Property Administration (CNIPA) patent examination guidelines.
- Bloomberg Intelligence reports on Chinese pharmaceutical patent landscape.
