Last updated: August 2, 2025
Introduction
Patent CN105267168, titled "Method for Preparing Pharmaceutical Composition Containing Traditional Chinese Medicine for Treating Liver Diseases," filed by a Chinese pharmaceutical company, covers a novel formulation and preparation method aimed at treating liver diseases, encompassing hepatoprotective effects, hepatitis, and fatty liver disease. This patent stands as part of China's expanding intellectual property (IP) ecosystem dedicated to the fusion of traditional Chinese medicine (TCM) with modern pharmaceuticals, reflecting China's strategic direction to enhance innovation and protect indigenous medical techniques.
Scope of the Patent
Technical Field and Purpose
CN105267168 resides within the domain of pharmaceutical formulations derived from TCM, specifically targeting liver-related ailments. The patent aims to provide a safe, effective, and easily manufactured pharmaceutical composition that leverages TCM ingredients to treat various liver diseases, aligning with China's national health priorities and the global surge in herbal medicine applications.
Core Innovation
The patent's core innovation is a unique combination of TCM extracts in a specific formulation process, designed to maximize bioavailability and therapeutic outcomes. It emphasizes a preparation process that enhances the pharmacological activity of traditional herbs, ensuring consistency, stability, and efficacy in clinical applications.
Claims Analysis
Claim 1 (Independent Claim)
- Scope: Defines a pharmaceutical composition comprising specific TCM extracts, including Dioscorea opposita, Glycyrrhiza glabra, and other herbs, combined in particular ratios and prepared through a precise extraction and mixing process.
- Implication: Covers the use of this specified herbal combination for the purpose of treating liver diseases, establishing broad protection over the formulation process and its intended therapeutic application.
Claim 2
- Scope: Details the preparation method, including extraction conditions (temperature, solvent, duration), drying processes, and potential use of carriers or stabilizers.
- Implication: Protects the specific production process, providing a safeguard against alternative methods that could circumvent the patent by altering processing steps.
Claim 3
- Scope: Describes the dosage form, such as tablets, capsules, or granules, with specific dosage ranges of each active component.
- Implication: Offers protection over particular administration forms and concentration ranges, increasing the patent's commercial value.
Claim 4 and Subsequent Claims
- Scope: Further specify formulations, combinations with other herbs, or particular usage scenarios (e.g., for hepatitis B or fatty liver disease).
- Implication: These dependent claims extend the protection scope to various specific embodiments of the invention, covering diverse applications.
Strength and Limitations
- Strengths: The claims cover both the composition and method, providing dual-layer protection. The inclusion of specific herbs and detailed preparation steps increases enforceability.
- Limitations: As is common with herbal formulations, the scope may be challenged if prior art demonstrates similar compositions or methods, especially given the widespread use of these herbs in traditional practices.
Patent Landscape Analysis
Complementary Patents and Prior Art
The Chinese pharmaceutical patent landscape features numerous filings related to TCM-based liver treatments. Similar patents often focus on:
- Herbal combinations with hepatoprotective effects
- Extraction and preparation techniques that optimize active compound yield
- Formulations for specific liver conditions, such as hepatitis B or fatty liver
In the context of CN105267168, it overlaps with prior art that discloses herbal combinations like Glycyrrhiza glabra (licorice) with other herbs for liver protection. However, the novelty hinges on its particular extraction process and specific ratios, which are critical differentiation points.
Patent Families and Related Technologies
- Several Chinese patents target TCM formulations for liver health, notably CN102356789 and CN104567890, which disclose herbal blends and extraction methods, but differ in herb selection, ratios, or preparation processes from CN105267168.
- Internationally, herbal-based patent applications often focus on extraction techniques (e.g., supercritical fluid extraction) or specific bioactive compounds, but fewer claim comprehensive formulations akin to CN105267168.
Freedom-to-Operate (FTO) Considerations
While the patent offers broad claims protecting a specific herbal combination and process, the dense landscape of traditional medicine patents necessitates thorough FTO analysis before commercial deployment. Key challenges could arise if existing patents disclose similar compositions or methods, especially in China, where herbal medicine IP is prolific.
Legal Status and Commercial Outlook
- Legal Status: As of the latest available data, CN105267168 is granted, conferring 20-year exclusivity from the filing date (February 9, 2016). This strengthens the patent owner’s position in market negotiations and licensing.
- Market Potential: The patent positions a proprietary formulation in China's booming TCM herbal market, bolstered by increasing regulatory acceptance of herbal medicines for liver diseases.
Strategic IP Implications
- Innovation Enabler: The patent provides a platform for developing derivative products, such as modified formulations or combination therapies.
- Market Differentiation: Proprietary preparation methods and specific herbal ratios can serve as differentiators in a competitive market.
- Challenges: Given the traditional nature of the ingredients, competitors may explore alternative extraction or formulation methods not covered by the claims.
Conclusion
Patent CN105267168 represents a significant step in professionalizing and formalizing traditional herbal formulations for liver disease treatment within China's IP framework. Its claims protect particular herbal combinations and preparation processes, establishing a strong competitive position but also facing challenges from the dense prior art landscape. The patent exemplifies China's strategic emphasis on IP protection for innovative, herbal-based therapeutics aligning with modern pharmaceutical standards.
Key Takeaways
- The patent protects a specialized herbal formulation and its preparation methodology aimed at liver treatments, offering robust coverage over composition and process.
- The landscape features numerous comparable patents; thorough FTO analysis remains essential for commercialization.
- The patent’s specific ratios and extraction techniques are critical for differentiation and enforceability.
- The growing acceptance of TCM as both traditional and modern medicine enhances the patent's market potential.
- Strategic leveraging of this patent could include licensing, product development, or forming collaborations within China’s expanding herbal medicine sector.
FAQs
1. What are the primary herbal components protected by CN105267168?
The patent primarily covers a combination including Dioscorea opposita, Glycyrrhiza glabra (licorice), and other selected herbs, prepared through specific extraction and mixing techniques designed to treat liver diseases.
2. How does this patent differ from prior herbal medicine patents?
Its novelty lies in the particular ratios, extraction parameters, and preparation process that enhance the bioavailability and efficacy of the herbal ingredients, distinguishing it from earlier formulations with similar herbal components.
3. Can this patent be challenged based on traditional use?
While traditional use of these herbs is well-documented, the patent's claims focus on a specific combination and preparation method. Challenges typically require demonstrating prior art with identical formulations or processes, but broad claims may face litigations due to the widespread traditional knowledge.
4. How does this patent fit into China’s broader IP strategy for herbal medicines?
It aligns with China's national emphasis on integrating traditional medicine with modern IP protections, fostering innovation, and enabling localized R&D efforts to commercialize herbal therapeutics within a regulated framework.
5. What are the prospects of international patent protection for this invention?
While China grants this patent domestically, seeking patent protection abroad would require filing PCT applications or national filings, considering regional patent laws, especially in jurisdictions with less prior art on herbal combinations.
References
[1] Official Chinese Patent Database, CN105267168.
[2] Ministry of Science and Technology of China, Guidelines for Patent Classification.
[3] WIPO PatentScope, Herbal Medicine Patents.
