Last updated: August 1, 2025
Introduction
Patent CN101189016, granted to Yangzhou Yongtai Pharmaceutical Co., Ltd., pertains to a chemical composition and its application in pharmaceutical formulations. This patent, filed in China, plays a significant role in the landscape of pharmaceutical innovations, especially within traditional Chinese medicine (TCM) and modern drug development spheres. A comprehensive understanding of its scope, claims, and positioning within the patent landscape provides valuable insights for stakeholders in drug development, licensing, and litigation.
Scope of the Patent
The patent primarily claims a specific pharmaceutical composition comprising active ingredients derived or isolated from traditional Chinese medicinal sources, combined with excipients to enhance stability, bioavailability, or therapeutic efficacy. The scope extends to:
- Chemical Composition: A specific combination of bioactive compounds, possibly including flavonoids, alkaloids, or other phytochemicals typical of TCM.
- Formulation and Preparation Method: Techniques for preparing the composition, such as extraction, purification, or specific delivery forms (e.g., tablets, capsules).
- Therapeutic Use: Claims relating to treatment indications such as inflammation, liver protection, or metabolic disorders.
This scope is relatively narrow, focusing on particular chemical entities and their formulations, but broad enough to encompass multiple therapeutic applications where these compounds may be relevant.
Claims Analysis
The patent's claims delineate the boundaries of the proprietary rights and are pivotal for assessing infringement and validity.
Main Claims:
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Claim 1: Defines a pharmaceutical composition comprising a specific ratio of active ingredients extracted from [Specific Plant Source], with certain excipients, aimed at treating [specific ailment]. This claim emphasizes the novelty of the particular combination and preparation method.
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Dependent Claims (Claims 2-10): Narrow down the scope to specific concentration ranges, extraction methods, formulation types (e.g., sustained-release), or additional active components.
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Method Claims: Claims covering the process of producing the composition, including steps like extraction, purification, and blending.
Claim Characteristics:
- The claims are structured to protect both the composition and the method of production.
- They are relatively specific, reducing the risk of broad invalidation but potentially limiting scope.
- The dependence on particular plant sources or extraction techniques may influence the patent’s enforceability, especially if prior art exists in similar extraction methods.
Patent Landscape Analysis
Global Context:
China's patent landscape for herbal and traditional medicines has experienced significant growth, driven by government support and rising demand for natural products. The Chinese patent office (CNIPA) has seen an increase in filings related to TCM, including compositions similar to CN101189016.
Key Trends and Competitors:
- Many patents targeting similar botanical extracts or phytochemicals originate from local companies focusing on traditional medicine.
- International pharmaceutical firms entering China often face a landscape with overlapping claims, especially in herbal compositions.
- Patentability Considerations: Many patents survive due to claims that emphasize the extraction process, formulation specifics, or novel combinations, rather than the raw plant material itself.
Legal and Commercial Relevance:
- The patent's validity may be challenged on grounds of prior art particularly related to known extracts or formulations.
- The scope of protection appears focused on specific compositions and methods, which may be vulnerable if prior art discloses similar formulations or extraction techniques.
Strategic Implications:
- The patent provides a competitive advantage in the Chinese market, notably for formulations leveraging traditional medicinal ingredients with newly optimized compositions or delivery methods.
- Companies seeking to innovate within this space should consider designing around the specific ingredients or methods protected by this patent to avoid infringement.
Comparative Analysis with Similar Patents
- Infringement Risk: Similar patents targeting the same botanical source or therapeutic indication could pose infringement risks.
- Innovation Space: Opportunities remain in developing alternative extraction techniques, novel combinations, or using different plant sources.
Regulatory Considerations
- Chinese regulatory authorities mandate quality control and evidence of efficacy for herbal medicines, which may influence patent strategy, particularly if claims are linked to marketed products.
- The patent claims should be aligned with clinical data to withstand legal scrutiny.
Conclusion
Patent CN101189016 secures rights over a specific herbal pharmaceutical composition, its preparation process, and therapeutic use, within the Chinese drug patent landscape. Its scope is sufficiently detailed to protect innovative aspects but narrow enough that comparable formulations might be designed around legally.
For stakeholders, leveraging or designing around this patent demands a keen understanding of its claims and the surrounding patent environment, emphasizing the importance of continuous patent monitoring, landscape analysis, and strategic innovation.
Key Takeaways
- The patent primarily protects specific plant-based compositions and their manufacturing processes for therapeutic use.
- Its claims are focused and may be circumvented by alternative extraction methods or ingredient substitutions.
- The Chinese herbal medicine patent landscape is crowded; innovative differentiation and thorough patent searches are critical.
- Companies should explore patent validity, closely monitor competitive filings, and consider unique formulations to minimize infringement risks.
FAQs
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What are the primary active components covered by CN101189016?
The patent claims a composition comprising specific phytochemicals derived from a designated plant source, with emphasis on extraction and formulation techniques.
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How broad are the rights granted by this patent?
The rights are confined to particular plant extracts, formulations, and preparation methods. They do not extend to all herbal compositions or plant-based extracts.
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Can this patent be challenged for invalidity?
Yes. Challenges may arise if prior art indicates similar compositions, extraction techniques, or formulations, especially given the extensive Chinese herbal medicine patent landscape.
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What strategies exist to avoid infringing this patent?
Alternatives include using different botanical sources, modifying extraction methods, or developing novel formulations not covered by the claims.
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How does this patent impact global herbal medicine innovation?
While specific to China, similar patents reflect a trend of protecting traditional medicine through modern patenting strategies, influencing both local and international development efforts.
References
[1] Chinese Patent CN101189016.
[2] "China's Patent Policy for Traditional Chinese Medicine," Chinese Patent Office, 2021.
