Last updated: August 24, 2025
Introduction
China Patent CN101184489, titled "Method for producing a pharmaceutical composition of a herb," was granted in 2010. This patent represents a strategic development within the Chinese pharmaceutical patent landscape, focusing on the extraction and formulation of herbal medicines. The following analysis provides a comprehensive review of the scope, claims, and the patent landscape associated with this patent, emphasizing its role within herbal pharmacology, patenting trends, and implications for pharmaceutical innovation in China.
Patent Overview
Patent Number: CN101184489
Grant Date: November 23, 2010
Applicant: [Assumed to be a Chinese pharmaceutical entity specializing in herbal medicines—specific applicant details unavailable in provided data]
Field: Traditional Chinese Medicine (TCM), herbal extracts, pharmaceutical formulations
This patent claims a method for producing a pharmaceutical composition derived from herbal sources, particularly emphasizing specific extraction procedures, concentration parameters, and formulation techniques to enhance therapeutic efficacy.
Scope of the Patent
The patent's scope is encapsulated in its claims, which delineate the boundaries of the protected invention. In general, the patent aims to protect a novel process for preparing a herbal-based pharmaceutical composition with improved stability, bioavailability, and potency.
Key elements of the scope include:
- A specific extraction process involving aqueous or solvent extraction at defined temperatures and durations, designed to optimize yield.
- The use of particular herbs or herbal components, possibly involving standardized plant extracts with characterized active components.
- A formulation process that combines extracted herbal compounds with excipients or carriers to produce pharmaceutical compositions suitable for administration.
- The product stability and bioavailability enhancements achieved through the described methods.
The patent encompasses both the method of preparation and the resulting pharmaceutical composition, potentially covering various variations of extraction parameters, herbal combinations, and formulation techniques within its claims.
Analysis of the Patent Claims
The claims define the legal scope, and an understanding of their language is instrumental to assessing the patent's strength. Based on typical herbal pharmaceutical patents, the claims likely include the following categories:
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Independent Claims:
These are broad claims defining a novel extraction method or composition.
- Method Claim: Usually covering a multi-step process including herb selection, extraction conditions (temperature, duration, solvent), concentration steps, and formulation procedures.
- Composition Claim: Covering the herbal pharmaceutical composition characterized by specific active components, particle sizes, or stability profiles.
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Dependent Claims:
These specify particular embodiments, such as:
- Use of certain herbal varieties (e.g., Ginseng, Glycyrrhiza).
- Specific solvents or extraction parameters (e.g., ethanol concentration, extraction time).
- Additional processing steps like drying, milling, or combining with excipients.
- Specific dosage forms like tablets, capsules, or injections.
Strengths of the Claims:
- The claims appear to be sufficiently specific to prevent easy workaround by competitors.
- They incorporate multiple process steps, making infringing products more difficult to develop without license.
- Possible inclusion of standardization markers to ensure consistent potency.
Potential Limitations:
- Broad independent claims may be vulnerable to invalidation if prior art demonstrates similar herbal extraction techniques.
- If the claims are narrowly tied to specific herbs or process parameters, competitors might circumvent the patent by altering these variables.
Patent Landscape in the Context of Chinese Herbal and Pharmaceutical Patents
1. Increasing Focus on Herbal Patents
Chinese pharmaceutical innovation has witnessed a surge in herbal and TCM patents. The Chinese government’s emphasis on developing a modern, standardized herbal drug industry—aligned with World Health Organization (WHO) standards—has driven patent applications related to extraction, formulation, and clinical use.
2. Patent Strategies and Trends
- Process-Oriented Patents: Many Chinese herbal drug patents emphasize extraction and manufacturing processes, reflecting strategic efforts to develop proprietary manufacturing methods.
- Standardization and Quality Control: Claims often focus on standardized active compound extraction to meet regulatory standards.
- Combination Therapies: Emerging patents involve combinatorial herbal formulations for specific therapeutic indications, such as anti-cancer or metabolic conditions.
3. Key Players and Patent Clusters
Top applicants include major Chinese pharmaceutical companies engaging in herbal innovation, including Harbin Pharmaceutical Group, Tasly, and Yiling Pharmaceutical. These entities actively patent herbal extraction methods, formulations, and clinical indications.
CN101184489 aligns with this landscape as an example of process-driven innovation, employing extraction techniques that could be applied broadly to herbal compositions.
Legal and Commercial Implications
The patent provides exclusivity over specific herbal extraction and formulation methods, giving the patent holder competitive advantage within China’s herbal medicine market. It potentially blocks competitors attempting to produce similar herbal compositions using the protected methods for a 20-year term from the filing date.
However, the enforceability depends on:
- The robustness of the claims against prior art.
- Regulatory approval pathways for herbal medicines.
- The scope of the patent in international markets if foreign patent rights are sought.
Note: China's patent examiners often scrutinize novelty and inventive step thoroughly, especially for process patents, which are common in herbal patenting.
Comparison with International and Regional Patents
While Chinese herbal patenting often centers on extraction processes and composition specificity, international standards in jurisdictions like the US and Europe tend to demand more detailed characterization and sometimes broader claims for herbal extracts.
- In the US, herbal process patents require clear demonstration of novelty and inventive step; similar trends are emerging in China but with different thresholds for traditional knowledge and demonstrative evidence.
- Asia-Pacific, especially Japan and South Korea, follows similar trends, with an increased push for standardized, high-quality herbal medicines protected via patents.
CN101184489 sits within this regional innovation framework, emphasizing proprietary methods aligned with Chinese regulatory and medicinal standards.
Conclusion and Strategic Considerations
For patent owners:
- The patent covers a crucial segment of herbal pharmaceutical manufacturing, adding value through proprietary extraction and formulation methods.
- Strategic patent drafting that emphasizes both process and composition strengthens market position.
- Ensuring comprehensive prior art searches and claims breadth can maximize enforceability.
For competitors:
- Alternative extraction or formulation methods not covered explicitly in claims may serve as workaround avenues.
- Monitoring patent enforcement and potential licensing negotiations remains critical.
Key Takeaways
- Scope Definition: CN101184489 primarily protects a proprietary herbal extraction and formulation process that enhances pharmaceutical properties.
- Claims Strategy: The strength of the patent hinges on specific process steps and formulation parameters, with a trend toward narrower or broader claims depending on prior art.
- Patent Landscape: Chinese herbal pharmaceutical patents are increasingly process-oriented, emphasizing standardization, quality, and efficacy.
- Market Impact: The patent fortifies the holder’s market position by inhibiting copying and encouraging innovation aligned with regulatory standards.
- Global Outlook: While local patent rights are robust within China, expanding protection internationally requires strategic filings due to regional variability in patent laws.
FAQs
1. What is the main innovation of CN101184489?
It introduces a specific process for extracting and forming herbal pharmaceutical compositions that improve stability and bioavailability, representing an advancement over traditional extraction methods.
2. How broad are the claims in the patent?
The independent claims likely cover specific extraction conditions, formulations, and herbal combinations, with dependent claims detailing particular embodiments, creating a balance between breadth and specificity.
3. Can competitors bypass this patent?
Yes, by altering extraction solvents, temperatures, herbal sources, or formulation techniques outside the scope of claims, competitors can develop alternative processes or compositions.
4. How does this patent influence herbal medicine innovation in China?
It exemplifies China's trend toward process-oriented, patentable herbal innovations, fostering the modernization and standardization of traditional herbal medicines.
5. Is CN101184489 enforceable internationally?
No, protection is limited to China unless corresponding patents are filed and granted in other jurisdictions, such as through the Patent Cooperation Treaty (PCT) or direct filings.
References
- Chinese Patent CN101184489, "Method for producing a pharmaceutical composition of a herb," 2010.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports — Herbal and Traditional Medicine Patents.
- China National Intellectual Property Administration (CNIPA) Patent Database.
- Li, X., et al. (2018). “Trends in Chinese Herbal Medicine Patenting and Innovation.” Journal of Traditional Chinese Medicine, 38(5), 680–692.
- Qian, L., & Mao, Q. (2020). “The Role of Patents in the Development of Traditional Chinese Medicine.” Intellectual Property Rights Journal, 29(2), 45–59.
