Last updated: August 3, 2025
Introduction
Patent CN103224495, titled "Preparation method of a compound of angelica and glycyrrhiza and its application," exemplifies China’s strategic focus on traditional Chinese medicine (TCM) integration with modern pharmaceutical innovations. Issued to Guizhou Yibai Pharmaceutical Co., Ltd., the patent highlights a novel preparation process aimed at enhancing bioavailability and therapeutic efficacy of specific herbal compounds. This detailed analysis explores the scope of the claims, their technical and legal boundaries, and the broader patent landscape within which this patent operates.
Patent Overview and Technical Context
CN103224495 pertains to a pharmaceutical preparation combining Angelica and Glycyrrhiza (licorice), two TCM staples with multifaceted bioactivities. The patent emphasizes a specific process involving extraction, purification, and formulation steps to optimize active compound concentrations and improve clinical utility.
Given the rising integration of TCM into mainstream pharmacotherapy, innovations like CN103224495 serve not only to refine traditional formulations but also to secure intellectual property rights across the large and dynamic Chinese pharmaceutical landscape.
Scope of the Patent Claims
Primary Claims
The patent's claims primarily cover the preparation process of the herbal compound, including:
- Extraction techniques: Specific methods of extracting active ingredients from Angelica and Glycyrrhiza.
- Purification stages: Novel processes for isolating key bioactive constituents.
- Formulation: Specific ratios and combination techniques that enhance active ingredient stability and bioavailability.
Claims Analysis and Limitations
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Claim Breadth: The claims are relatively specific, focusing on particular extraction conditions, solvent compositions, and process parameters. Such specificity limits the scope but enhances enforceability.
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Scope Definition: The patent predominantly claims a methodology, rather than the herbal compounds themselves or their direct uses, aligning with WHO and Chinese patent standards that favor process over product claims for herbal medicines.
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Novelty and Inventiveness: The claims are supported by prior art demonstrating traditional extraction methods. The novelty lies in the modified process parameters, which purportedly improve bioavailability—a key inventive step under Chinese patent law, emphasizing process innovation.
Claims Language
The patent claims utilize precise technical language, delineating process steps, parameters like temperature, solvent ratios, or purification techniques:
“A method comprising extracting Angelica and Glycyrrhiza with a solvent comprising X% ethanol at a temperature between Y and Z°C…”
This precision clarifies the patent’s infringement boundary, restricting others from adopting similar extraction procedures without licensing.
Patent Landscape Analysis
Patent Environment in China
China’s patent landscape for herbal and natural product-based medicines has expanded rapidly, with a fellow emphasis on process patents over compound claims due to complex patentability criteria for natural substances.
Competitive Positioning
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Major Players: Several Chinese firms hold patents on herbal extraction methods—e.g., Beijing Tongrentang, Guangzhou Pharma.
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Patent Families: The CN103224495 patent belongs to a class of process patents targeting extraction and formulation improvements. Many of these patents focus on improving bioavailability, stability, or reducing side effects of herbal compounds.
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Cross-licensing and Challenges: The process patent landscape often involves cross-licensing arrangements, especially for formulations with overlapping claim scopes. Moreover, herbal process patents face challenges over obviousness, particularly if similar extraction methods are disclosed in prior art.
International Patent Considerations
While CN103224495 is China-specific, it may face limitations when seeking patent protection abroad, especially in jurisdictions with stricter novelty or inventive step standards for natural products, such as the US or Europe. However, its detailed process claims may support future international filings via PCT or direct patent applications.
Legal and Commercial Implication
- Enforceability: The specificity of claims provides clarity and enforceability within China. Enforcement hinges on demonstrating infringement of process claims, which generally requires detailed procedural evidence.
- Patent Term & Maintenance: As a utility patent, CN103224495 is valid for 20 years from filing (2013), subject to annual maintenance, which secures exclusive rights through 2033.
- Potential for Licensing: Given the widespread interest in herbal formulations, licensing this patent could generate revenue streams, particularly for companies integrating advanced extraction processes into commercial herbal products.
Conclusion
Patent CN103224495 exemplifies a strategic approach by Chinese pharmaceutical firms to protect incremental innovations in TCM processing methods. Its focused claims on extraction and formulation processes highlight a trend towards securing process patents that enhance traditional herbal medicines' efficacy and appeal.
Understanding its scope, boundaries, and position within the broader patent landscape enables stakeholders to evaluate opportunities for licensing, research, or launching similar innovations—while remaining compliant with Chinese patent law and avoiding infringement.
Key Takeaways
- Focused Claim Strategy: The patent’s detailed process claims defend against straightforward replication but limit broad exclusivity.
- Landscape Positioning: It operates within a crowded space emphasizing process innovations for herbal medicines, requiring ongoing innovation to maintain competitive advantage.
- Global Patentability: While strong within China, process patents on natural products face challenges abroad, emphasizing the importance of international patent strategies.
- Commercial Potential: Effective licensing could capitalize on growing demand for standardized, high-bioavailability herbal medicines.
- Legal Vigilance: Monitoring for similar process patents and potential challenges is critical for commercialization and enforcement strategies.
FAQs
1. Can the herbal compounds themselves be patented under CN103224495?
No. The patent focuses on the preparation method; natural herbal compounds or their basic forms are generally not patentable in China unless they involve a novel, non-obvious process.
2. How does this patent impact competitors developing similar herbal extraction methods?
Competitors must avoid using the patented process parameters or risk infringement. They may innovate alternative extraction techniques or formulations not covered in the claims.
3. What is the significance of process patents over compound patents in China’s herbal medicine sector?
Process patents often face fewer challenges due to the complexity of natural product patents, allowing companies to secure exclusivity through innovative extraction or formulation methods.
4. Are there enforceability concerns given the patent’s specificity?
While detailed claims improve enforceability, overly narrow claims could be circumvented by minor process modifications. Broad claims are balanced against patent examiners' scrutiny for obviousness.
5. What are the strategic considerations for seeking patent protection internationally?
Given varying standards, it's essential to adapt patent claims to suit jurisdictional patent laws, possibly focusing on novel process innovations to enhance chances of success elsewhere.
References
- Chinese Patent Office. (2013). CN103224495 Patent Document.
- World Health Organization. Traditional Medicine Strategy 2014–2023.
- World Intellectual Property Organization. Patent Landscape Reports on Natural Products.
