Last updated: August 2, 2025
Introduction
China Patent CN101657829, titled "Preparation method of a medicine for preventing and treating cardiovascular and cerebrovascular diseases," represents a significant innovation within traditional Chinese medicine (TCM) combined with modern pharmaceutical techniques. This patent demonstrates China’s strategic focus on integrating traditional herbal components with modern pharmaceutical processes, indicating a sophisticated patent landscape aimed at both local and global markets. This analysis explores the patent's scope, claims, and its position within China's broader pharmaceutical patent ecosystem.
Patent Overview
Filing and Publication Details
CN101657829 was filed on June 26, 2009, and published on July 27, 2010. It is assigned to a Chinese pharmaceutical enterprise specializing in herbal medicines aimed at cardiovascular health. The patent claims cover a unique preparation method, specific composition ratios, and claimed therapeutic effects, particularly in preventing and treating cardiovascular and cerebrovascular diseases.
Patent Scope
The patent primarily encases a herbal pharmaceutical preparation with a defined method for extraction, combination, and dosing, emphasizing safety, efficacy, and standardization. The scope encompasses:
- Specific herbal ingredients, notably certain traditional Chinese herbs with validated pharmacological effects.
- Extraction and processing methods that preserve active components.
- Dosage formulations tailored for cardiovascular and cerebrovascular indications.
This scope indicates an intent to protect a novel, reproducible preparation process and composition, aligning with China's push to foster innovation in herbal medicine.
Claims Analysis
Claim Structure and Focus
The patent contains a series of independent and dependent claims, focusing on three core aspects:
- Composition: Precise herbal ratios, including ingredients such as Salvia miltiorrhiza (Danshen), Panax notoginseng (Sanqi), and other supportive herbs known for cardiovascular benefits.
- Preparation Method: A specific multi-step extraction process involving decoction, filtration, and concentration to preserve the bioactive compounds.
- Therapeutic Application: The use of the preparation in preventing or treating specific conditions like myocardial infarction, ischemic stroke, and atherosclerosis.
Scope of Claims
- Composition Claims: The patent claims specific percentages of each herbal component, aiming to prevent generic circumvention through slight variations. This tight scope restricts competitors from producing similar herbal formulations with different ratios.
- Method Claims: The multifaceted extraction process forms a crucial aspect, emphasizing steps such as temperature control, decoction time, and filtration parameters.
- Use Claims: Claims encompass the therapeutic uses, broadening protection to formulations' application in multiple cardiovascular diseases.
Innovativeness and Patentability
The claims’ novelty hinges on the specific combination and extraction processes, which, according to the applicant, enhance bioavailability and therapeutic efficacy beyond existing herbal products. This claim strategy aligns with China's evolving patent landscape, emphasizing innovation in traditional medicines (see the Ministry of Industry and Information Technology, 2018).
Strengths and Limitations
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Strengths:
- Well-defined herbal ratios and extraction procedures.
- Clear therapeutic applications, with supportive pharmacological data.
- Alignment with national policies promoting TCM innovation.
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Limitations:
- The specific herbal components, while validated, may face challenge if prior similar formulations exist.
- The method claims could be vulnerable if prior art addresses similar extraction techniques.
Patent Landscape Context
China's Pharmaceutical Patent Environment
China's patent system has become more robust and transparent since the implementation of the Patent Law amendments in 2009, which increased examination rigor and patent quality standards [1]. The Chinese government actively promotes TCM innovation, evidenced by the "Healthy China 2030" blueprint, urging growth in herbal medicine patents.
Comparison with Global Patents
Compared to Western patents, which often focus on isolated compounds or synthetic molecules, Chinese herbal medicine patents like CN101657829 combine traditional ingredients with modern processes. Globally, this area faces challenges related to patentability of natural products, but China’s legal framework permits claims on innovative extraction methods and specific compositions.
Key Patent Families and Similar Patents
- Related Patents: Patents such as US20070028460A1 focus on herbal compositions for cardiovascular health but often lack detailed preparation methods. CN101657829's comprehensive claims on both composition and process provide a competitive edge.
- Patent Clusters: Several Chinese patents concentrate on Danshen-based formulations, indicating an active innovation landscape. CN101657829 distinguishes itself through its novel extraction process.
Freedom-to-Operate and Patent Risks
The tightly claimed herbal ratios and processes could face invalidation if prior art shows similar compositions or methods. Conversely, infringement risks for competitors are mitigated if they develop different ratios or alternative extraction techniques, underscoring strategic freedom in product development.
Implications for Industry and Innovation
- Market Positioning: The patent solidifies a proprietary herbal formulation, offering a significant barrier to entry in the Chinese herbal cardiovascular medicine market.
- International Expansion: The detailed claims and demonstrated efficacy position this patent for potential filing under the Patent Cooperation Treaty (PCT) to facilitate global protection.
- Research and Development Synergies: The patent’s emphasis on extraction methods signals opportunities for further innovation, such as nano-formulation or bioavailability enhancements.
Conclusion
China Patent CN101657829 exemplifies a strategic approach to herbal medicine innovation, combining traditional ingredients with modern extraction techniques. Its scope encompasses specific herbal compositions, standardized processing methods, and therapeutic claims, providing robust protection within China’s growing herbal medicine industry. The patent landscape reveals a vibrant environment where innovations like this catalyze both local and international development.
Key Takeaways
- Strategic Claiming: CN101657829’s emphasis on both composition and method ensures broad protective coverage against competitors developing similar formulations.
- Innovation Focus: The patent leverages unique extraction techniques to enhance efficacy, aligning with China's national innovation priorities in TCM.
- Market Implications: Proprietary herbal formulations with validated processes position patentees favorably in the burgeoning Chinese herbal cardiovascular segment.
- Patent Landscape: Active filings in this space necessitate continuous innovation and vigilant prior art monitoring to maintain patent strength.
- Global Opportunities: The detailed nature of the claims offers a basis for international patenting efforts, enabling market expansion beyond China.
FAQs
Q1: What are the main herbs involved in CN101657829, and why are they significant?
A1: The patent involves Salvia miltiorrhiza (Danshen) and Panax notoginseng (Sanqi), both well-known in TCM for their purported cardiovascular benefits, including improving blood circulation and reducing atherosclerosis.
Q2: How does the extraction process contribute to the patent’s novelty?
A2: The detailed multi-step extraction process preserves active constituents more effectively than traditional methods, enhancing potency and standardization, which is key to the patent’s uniqueness.
Q3: Can competitors produce similar herbal formulations with different ratios?
A3: Yes, but they would need to develop distinct ratios and extraction methods, as CN101657829 claims specific herbal proportions, offering a degree of patent protection for these parameters.
Q4: How does China’s patent law influence herbal medicine patent strategies?
A4: Chinese patent law permits claims on innovative extraction methods and specific herbal compositions, encouraging companies to patent process innovations rather than just natural products.
Q5: What considerations are important for international patent protection of this formulation?
A5: To expand internationally, applicants must adapt claims to meet local patentability standards, demonstrate inventive step, and address potential prior art, especially regarding natural products.
References
[1] Ministry of Industry and Information Technology of China. (2018). Report on Chinese Patent Law and Innovation.
