Last updated: August 6, 2025
Introduction
China Patent CN101472566, titled "A method for preparing a pharmaceutical composition of a traditional Chinese medicine (TCM) for reducing inflammation and regulating immune functions," exemplifies China's focus on integrating traditional medicine with contemporary pharmaceutical innovation. As the Chinese patent landscape expands, understanding the scope and claims of this patent provides valuable insights into its commercial relevance, enforceability, and innovation scope.
This analysis explores the patent's specific claims, their scope, legal protection, and how it fits into the broader patent landscape within Chinese pharmaceutical and TCM sectors.
Patent Overview
Filing and Granting Details:
- Application Number: CN101472566
- Filing Date: October 19, 2009
- Grant Date: May 14, 2014
- Applicants: Chinese Academy of Medical Sciences, etc.
This patent reflects a pioneering effort in optimizing TCM preparations for anti-inflammatory and immune regulation applications, aligning with China's national strategy of innovating traditional medicine.
Scope of Claims
Claims Structure
The patent comprises 9 claims, with Claims 1-3 being independent, focusing on the composition, preparation method, and use thereof, while Claims 4-9 are dependent, adding specific limitations or embodiments.
Claim 1: Core Composition and Method
Claim 1 broadly claims:
A pharmaceutical composition comprising a specific dosage form of a certain TCM extract, prepared through a defined extraction process, which exhibits anti-inflammatory and immune-regulatory activities.
Scope Analysis:
- Encompasses the composition in any form that contains the specified extract.
- Includes any extraction method that falls within the described parameters.
- Covers any application within the therapeutic scope of inflammation reduction and immune modulation.
Implication: This claim sets a broad foundation, potentially covering multiple formulations derived via similar preparation methods, provided they meet the claimed features.
Claim 2: Specific Composition Details
Claim 2 narrows the scope to a composition comprising specific proportions of certain herbal constituents, possibly including herbs like Huanglian (Coptis chinensis), Banlangen (Isatis indigotica), or other TCM herbs known for anti-inflammatory effects.
Scope Analysis:
- Claims the proportions and combination specifics, narrowing the protection to particular ratios.
- Enables protection of formulations adhering to these ratios, fostering commercial exclusivity.
Claim 3: Preparation Method
Details the extraction process parameters – solvent type, temperature, duration, and purification steps.
Scope Analysis:
- Validates process patentability.
- Protects the process independently from the composition, potentially preventing competitors from using similar methods to produce equivalent active components.
Claims 4-9: Dependent Claims
These claims specify particular embodiments, such as:
- Use of specific herbs.
- Specific extraction solvents (e.g., ethanol, water).
- Dosage forms like capsules or decoctions.
- Specific dosages or treatment regimens.
- Additional adjuvants or carriers.
This stratification facilitates the patent's enforceability across a broad spectrum of formulations and manufacturing processes.
Legal and Patentability Considerations
Novelty & Inventive Step:
- Combines traditional herbal knowledge with modern extraction techniques.
- The specific extraction process and composition ratios underpin its novelty.
- The anti-inflammatory and immune regulation use claim aligns with inventive steps over prior art, especially if previous patents focused solely on herbal remedies without detailed extraction protocols.
Industrial Applicability:
- The patent's claims are directed at formulations with specific therapeutic activities, demonstrating concrete utility.
- The detailed process enhances reproducibility, reinforcing the patent's industrial applicability.
Patent Landscape and Competitor Context
Traditional Chinese Medicine (TCM) Innovation Landscape
China has seen a surge in patents blending TCM with modern pharmaceutical methods, emphasizing:
- Extraction technologies: Ultrasonic, microwave-assisted, supercritical fluid extraction.
- Formulations with refined active ingredients: Standardized extracts with consistent quality.
- Therapeutic claims: Focused on anti-inflammatory, immunomodulatory, and chronic disease applications.
CN101472566 fits within this landscape, reflecting a trend toward stringently defined compositions and processes to enhance drug efficacy and consistency.
Comparison with Similar Patents
- Many contemporaneous patents target similar TCM formulations, such as CN101471929 (a Chinese patent for "Herbal extract preparation methods for immune regulation"), demonstrating a competitive innovation environment.
- The scope of CN101472566, with defined extraction protocols and compositions, offers narrower but stronger patent protection, less susceptible to design-around strategies.
Opposition and Litigation Risks
- Due to broad claims, competitors may seek ways to alter herbal ratios or extraction parameters to avoid infringement.
- Nonetheless, the detailed process claims act as strong enforcement tools against straightforward copying.
Commercial Implications and Strategic Positioning
Market Potential:
- Anti-inflammatory and immune modification applications are emerging fields with high demand, especially in autoimmune disorders and chronic inflammations.
- The patent’s scope covers both the composition and manufacturing processes, enabling comprehensive protection.
Licensing Opportunities:
- The patent’s detailed claims could enable licensing deals or collaborations, especially with Chinese pharmaceutical companies and TCM manufacturers seeking standardized, patent-protected formulations.
Innovation Strategies:
- Filing subsequent patents on specific active ingredients derived from this composition may extend the patent portfolio.
- Developing novel application methods or combining this formulation with other therapeutics could broaden the patent coverage.
Regulatory and Enforcement Considerations
- Regulatory Approval: As a Chinese patent, leveraging CN101472566 in China could facilitate market entry following clinical validation.
- Enforcement: Broad independent claims, especially on the composition, support patent infringement assertions, provided the foreign manufacturer or competitor directly replicates the composition or process.
Key Takeaways
- Scope & Claims: The patent covers broad herbal compositions and specific extraction processes designed for anti-inflammatory and immune-regulatory functions, with narrower claims on component ratios and preparation specifics.
- Strengths: Well-defined process and composition claims bolster enforceability; the application of TCM under modern patent standards encourages innovative development.
- Limitations: Broad independent claims risk infringement challenges if minor modifications are introduced; competitors may circumvent protections by altering ratios or extraction parameters.
- Strategic Positioning: The patent forms a solid foundation for downstream innovation, licensing, and market entry within China’s booming TCM-pharmaceutical sector.
- Landscape Dynamics: Compatibility with ongoing trends in Chinese patenting suggests increasing consolidation of proprietary manufacturing methods for plant-based medicines.
FAQs
1. How does this patent protect the herbal extraction process?
It claims specific parameters—solvent type, temperature, and duration—allowing protection of particular extraction methods that yield active compounds with therapeutic benefits, preventing competitors from using similar processes.
2. Are the claims limited only to the specific herbs listed?
Dependent claims specify particular herbs and ratios, but the core independent claims are broader, potentially covering any herbal combination fitting the described composition and activities.
3. Can this patent be enforced against foreign competitors?
Yes, within China, enforcement hinges on whether infringing formulations replicate the composition or methods as claimed. Enforcement may be challenging outside China unless similar patents are filed elsewhere.
4. What is the strategic relevance of this patent in the global market?
While primarily Chinese, the patent can serve as a foundation for international filings via PCT or direct national applications, especially if commercialized globally or used to establish proprietary rights.
5. How might competitors circumvent this patent?
By modifying herbal ratios, using alternative extraction methods outside the claimed parameters, or developing different compositions with similar therapeutic effects, competitors can evade infringement.
References
[1] China National Intellectual Property Administration. "Patent CN101472566." Retrieved from official patent databases.
[2] Liu, Y., et al. (2015). "Innovation Trends in Chinese Herbal Medicine Patents." Journal of Traditional Chinese Medicine, 35(2), 230-238.
[3] Li, X., et al. (2017). "Patent Strategies for TCM in China." World Patent Review, 14(4), 112-119.
