Last updated: August 2, 2025
Introduction
Patent CN101068534, titled "Preparation method of compound Zhushentongxia capsule", was granted in China and pertains to a pharmaceutical formulation involving traditional Chinese medicine (TCM). The patent’s scope, patent claims, and its landscape impact are crucial for stakeholders interested in TCM development, patent enforcement, and licensing opportunities within China’s robust intellectual property framework for pharmaceuticals.
This analysis dissects the patent’s claims, assesses its innovation scope, maps its landscape relative to prior art, and discusses strategic implications for industry players.
Patent Overview
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Filing and Grant Information:
- Application Date: August 1, 2007
- Grant Date: September 22, 2008
- Applicant: Chengdu Hongxinyuan Pharmaceutical Co., Ltd.
- Patent Number: CN101068534
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Technical Field:
The patent belongs to the domain of traditional Chinese medicine formulations, specifically a preparation method for Zhushentongxia capsules, used for cardiovascular-related conditions.
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Abstract Summary:
The patent describes a preparation process involving specific extraction, mixing, and encapsulation steps to produce a compound Zhushentongxia capsule with purported enhanced efficacy.
Scope and Claims Analysis
Main Claims Overview
The patent contains fundamental claims that define the scope of protection:
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Claim 1 (Independent claim):
Outlines a method for preparing compound Zhushentongxia capsules involving specific steps, including:
- Extraction of various herbal components
- Proportional mixing
- Filtration and concentration processes
- Encapsulation techniques
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Dependent Claims:
Further specify particular ingredients, extraction solvents, process parameters, and formulations such as:
- Use of particular traditional herbs (e.g., Danshen, Honghua)
- Extraction conditions (temperature, duration)
- Dosage ratios and formulation specifics
Scope Assessment
- The scope is predominantly process-oriented – claiming a specific preparation methodology rather than the composition itself.
- It covers combination extraction and formulation procedures tailored for Zhushentongxia, aligning with China's emphasis on process patents in herbal medicine.
- The claims are narrowly tailored to the disclosed method, possibly enabling competitors to develop alternative extraction processes or formulations outside the outlined protocol.
Strengths and Limitations
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Strengths:
- The detailed process claims can deter direct copying of the preparation method.
- Coverage extends to the particular herbal components and extraction conditions, which are critical in TCM formulations.
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Limitations:
- The absence of claims on the composition itself limits protection against independent development of similar formulations using alternative methods.
- Narrow process claims can be circumvented by designing different extraction or formulation techniques.
Patent Landscape
Comparison with Prior Art
- Traditional Chinese Medicine Patents:
Similar patents have emerged in China, emphasizing process innovations for herbal extracts (e.g., CN101200617, CN101200786).
- Novelty and Inventiveness:
The patent’s process steps, specifically tailored extraction sequences and ingredient ratios, appear to be novel relative to earlier disclosures, especially given the integration for cardiovascular therapeutics.
- Existing Patents and Cited Art:
The patent references prior formulations and processing methods, but distinguishes its claims through specific procedural innovations.
Patent Family and Related Patents
- No family members or international applications are directly associated with CN101068534, indicating regional focus.
- However, similar patents in the TCM extraction domain suggest an active patenting environment focused on herbal extracts and capsule formulations.
Legal and Commercial Implications
- Freedom to Operate (FTO):
Given its process specificity, competitors must evaluate whether their extraction or formulation methods infringe on this patent before commercialization.
- Potential Licensing:
The patent’s detailed methodology is valuable for licensing within China, especially for companies aiming to produce Zhushentongxia capsules or similar compounds.
Strategic Patent Considerations
- Protection Strength:
The process-focused claims are adequately tailored but can be circumvented via alternative extraction methods, common in TCM patent strategies.
- Barrier to Entry:
The patent constrains competitors from deploying the PTO’s disclosed process, offering leverage for the patent holder.
- Lifecycle and Enforcement:
As a 2008 patent, it still holds substantial enforceability in China until 2028, barring challenges or patent term extensions.
Conclusion
Patent CN101068534 offers a focused process patent for a traditional Chinese medicine capsule preparation, characterized by detailed extraction and formulation steps. Its scope primarily covers specific procedural methods for manufacturing Zhushentongxia capsules, providing tangible protection against direct copying but with limitations against alternative processes.
The patent landscape in China reflects robust innovation in TCM formulations, with process patents serving as a strategic tool to safeguard proprietary extraction techniques. For industry players, understanding the nuances of such patents is critical to navigating the competitive Chinese herbal medicine market, balancing innovation with infringement risks.
Key Takeaways
- The patent’s claims are narrowly focused on specific preparation steps, which optimize protection yet may be circumvented by alternative methods.
- Its landscape is typical of Chinese TCM process patents, emphasizing extraction techniques and formulation specifics.
- Companies seeking to develop similar herbal capsules must analyze this patent’s scope thoroughly to avoid infringement.
- Licensing opportunities exist for the patent holder, given the strategic importance of Zhushentongxia formulations in cardiovascular health.
- Continuous monitoring of subsequent patents and prior art is essential for maintaining competitive advantage in China’s dynamic IP environment.
FAQs
1. Does Patent CN101068534 protect the composition of the Zhushentongxia capsule itself?
No. The patent focuses on the preparation process, not the biological or chemical composition of the final product, limiting protection to its method of production.
2. How can competitors circumvent this patent?
By developing alternative extraction and formulation methods not covered by the specific claims, such as using different herbs, extraction solvents, or processes.
3. Is this patent enforceable outside China?
No. It is a Chinese national patent; enforcement is limited to China unless it is part of a broader patent family with international filings.
4. What is the potential for licensing this patent in China?
High, especially for companies producing TCM capsules targeting cardiovascular diseases, given the patent’s detailed process claims.
5. How does this patent landscape influence R&D strategies in Chinese herbal medicine?
It emphasizes the importance of process innovation and detailed claims to secure robust protection while encouraging alternative extraction and formulation research to avoid infringement.
Sources
[1] State Intellectual Property Office of China (SIPO). Patent CN101068534.
[2] IP China Database. Patent landscape reports on Chinese TCM patents.
