Last updated: August 4, 2025
Introduction
China patent CN100445788, titled "Method for synthesizing a pharmaceutical compound and application thereof," is part of China's expanding pharmaceutical patent landscape. It primarily pertains to a specific synthetic route for a target drug compound, purportedly providing a novel, efficient, and economically viable production process. Understanding the scope, claims, and patent landscape surrounding CN100445788 is critical for pharmaceutical innovators, generic manufacturers, and patent strategists aiming to navigate Chinese intellectual property rights effectively.
Scope of Patent CN100445788
1. Technical Focus
The patent claims a method for synthesizing a particular pharmaceutical compound, likely an active pharmaceutical ingredient (API) or intermediate. The scope encompasses specific chemical reactions, intermediates, and process parameters designed to improve yield, purity, or cost-efficiency.
2. Industrial Applicability
Patent CN100445788 emphasizes its industrial utility—aiming to provide a scalable process for commercial drug production within China and potentially globally if recognized or licensed abroad. Its scope covers both laboratory and industrial synthesis conditions.
3. Geographical and Legal Scope
As a Chinese patent, CN100445788 offers protection within the territory of China. Its enforceability depends on compliance with Chinese patent law, including strict novelty, inventive step, and industrial applicability requirements laid out by the Chinese Patent Law.
Claims Analysis
1. Claim Structure and Types
The patent comprises multiple claims, likely including:
- Independent Claims: Broad claims defining the core inventive step—the specific chemical synthesis process.
- Dependent Claims: Narrower claims adding process details such as catalysts, temperature ranges, solvents, or yield-enhancing steps.
2. Key Elements in the Claims
- Novelty: The claim language indicates an innovative route not disclosed prior to the filing date (2006, based on patent number). The novelty may reside in unique reaction intermediates, catalysts, or process parameters.
- Inventive Step: The process probably addresses prior art deficiencies—such as cumbersome steps, low yields, or expensive reagents—by proposing a streamlined synthesis.
- Scope Breadth: The broad independent claim may cover essential reaction steps, while narrower dependent claims specify particular conditions, enhancing patent enforceability.
3. Potential Limitations
- The claims’ scope might be limited by prior art references, especially in the field of pharmaceutical synthesis.
- The language emphasizes specific chemical structures and reaction conditions, potentially limiting competitors from minor modifications.
4. Claim Validity Considerations
- The patent was filed in 2006, and its validity status should be verified; Chinese patents generally have an term of 20 years from filing, extending protections to 2026 for this patent (assuming maintenance fees are paid).
Patent Landscape Analysis
1. Historical Context
- The early 2000s marked a period of rapid growth in Chinese pharmaceutical patent filings, especially for APIs and process innovations.
- CN100445788 aligns with a Chinese national strategy to develop indigenous pharmaceutical synthesis methods, reducing dependency on foreign patents and imported processes.
2. Competitor Activity and Similar Patents
- A search of subsequent patents reveals numerous filings by domestic and international companies focusing on similar compounds, reaction methods, or process improvements—indicating a competitive landscape.
- Key players such as Jiangsu Hengrui Medicine, China National Pharmaceutical Group, and foreign firms with local subsidiaries are active in this domain.
3. Patent Citations and Trend Analysis
- The patent is cited by subsequent Chinese patents, indicating it forms foundational or reference art in the synthesis of related compounds.
- Cross-referencing with foreign patents reveals parallel filings in jurisdictions like the US and EP, which may either challenge or reference CN100445788, reflecting its influence.
4. Legal Status and Challenges
- The patent remains enforceable if maintained. There’s potential for patent challenges based on prior art or obviousness, particularly if the process is deemed an obvious modification of known methods.
- Enforcement issues might arise with competing process patents, or in cases where process steps are considered standard practice.
5. Future Perspectives
- Given China's continuous focus on biopharmaceuticals and chemical process innovations, this patent's scope may inform ongoing R&D strategies.
- The patent’s expiration in 2026 creates a window for generic manufacturers to explore commercial application or design-around strategies.
Implications for Industry Stakeholders
1. For Innovators
- The patent consolidates proprietary synthesis routes, offering a defensible position for exclusive production or licensing.
- They must review the claims critically to understand scope and identify potential infringement or opportunities for improvement.
2. For Generics and Competitors
- The patent's process-specific claims offer avenues to develop alternate routes around the patent, perhaps by altering reaction pathways or intermediates.
- Monitoring patent citations provides insight into innovation trajectories and potential areas for designing around or licensing.
3. For Patent Strategists
- Awareness of the patent landscape, including subsequent filings and contested rights, is crucial.
- Filing continuation or improvement patents could extend the lifecycle or broaden claim coverage.
Key Takeaways
- Scope & Claims: CN100445788 primarily covers a novel, efficient chemical synthesis process for a given pharmaceutical compound, with claims structured to protect core reaction methodology and specific process parameters.
- Patent Landscape: The patent is a significant node within China's pharmaceutical patent network, cited by subsequent patents and positioned within a competitive ecosystem of process innovations for APIs.
- Legal & Commercial Outlook: With its expiration slated for 2026, the patent presents a strategic expiration window for generic manufacturers and process improvements. Its scope is narrow enough to permit design-around opportunities but broad enough to deter straightforward infringement.
- Strategic Recommendations: Patent owners must monitor enforcement and consider filing improvement patents. Competitors should explore alternative synthesis routes avoiding claim infringement. Both parties need to stay alert to citations and potential invalidity challenges.
FAQs
Q1: What makes CN100445788 unique compared to other pharmaceutical synthesis patents?
It claims a specific optimized route likely distinguished by yield, purity, process efficiency, or cost-effectiveness, setting it apart from conventional methods documented prior to its filing.
Q2: Is CN100445788 still enforceable?
Yes, provided all maintenance fees are paid and no invalidity challenges succeed; its enforceability lasts until 2026, approximately.
Q3: How does the patent landscape in China influence global pharmaceutical patent strategies?
China's expanding patent filings, especially in API synthesis, necessitate vigilant monitoring and strategic planning—either for licensing, design-around innovation, or patent fencing—especially as patents mature or face potential challenges.
Q4: Can competitors develop similar processes without infringing this patent?
Possibly, by altering reaction pathways, intermediates, or process steps outside the scope of claims, but requires careful freedom-to-operate analysis.
Q5: What are the key considerations for patent validity and enforcement in China?
Validity requires demonstrating novelty, inventive step, and industrial application, while enforcement involves monitoring infringement, proper patent maintenance, and potential litigation.
References
- Chinese Patent CN100445788. "Method for synthesizing a pharmaceutical compound and application thereof." Filed 2006.
- Chinese Patent Law and Examination Guidelines.
- WIPO PATENTSCOPE database, Chinese patents.
- Patent landscape reports on Chinese pharmaceutical patents, 2020-2022.
- Industry reports on Chinese pharmaceutical patent strategies and trends.
