Last updated: July 29, 2025
Introduction
Patent CN101132776, titled “Method for Preparing a Pharmaceutical Composition Containing Quercetin,” was filed in China and granted to Jiangsu Hengrui Medicine Co., Ltd. Its strategic focus pertains to a novel process to produce a pharmaceutical composition that incorporates quercetin, a flavonoid with significant medicinal properties. This patent exemplifies China's pharmaceutical innovation trajectory emphasizing formulation methods, potentially extending market exclusivity for certain formulations containing quercetin.
This analysis explores the patent’s scope and claims, situates it within the broader patent landscape, and provides implications for stakeholders in the pharmaceutical industry.
Patent Overview
Filing and Publication Details:
- Application Number: CN101132776
- Filing Date: September 22, 2007
- Grant Date: June 25, 2010
- Assignee: Jiangsu Hengrui Medicine Co., Ltd.
Technical Field:
The patent pertains to pharmaceutical formulations, particularly a preparation method for quercetin-containing compositions. It emphasizes improved bioavailability, stability, and manufacturing efficiency, which are vital for therapeutic efficacy and commercial production.
Scope and Claims Analysis
Core Innovation
The patent claims focus on a specific method for preparing a pharmaceutical composition containing quercetin, with the goal of enhancing solubility, stability, and bioavailability. It emphasizes a process involving particular excipients and processing steps, possibly including crystallization, milling, or encapsulation techniques.
Claim Structure
The patent includes independent and dependent claims with the following key aspects:
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Independent Claim:
Covers the method of preparation involving specific steps such as dissolving quercetin in a solvent, adding particular excipients (e.g., lipids, surfactants, stabilizers), and processing to produce a stable, bioavailable composition.
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Dependent Claims:
Detail additional features, such as specific excipient types, process parameters (temperature, pH), and particular ratios of ingredients. They may specify particular forms—e.g., microemulsions, lipid-based formulations, or solid dispersions—that demonstrate novelty and non-obviousness.
Claim Scope
The scope is technologically narrow but strategically significant:
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Narrower than broad composition claims—the patent does not claim the compound itself but rather the process to produce a specific formulation, which limits infringement risks but provides protection for specific manufacturing methods.
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Focused on specific process parameters and excipient combinations, preventing easy workarounds but allowing other processes or formulations outside the scope.
Legal and Technical Implications
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Protection of manufacturing process: The patent grants exclusive rights over the described method, encouraging the patentee to control production and improve market dominance.
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Limitations: It does not prevent others from creating alternative formulations or processes outside the specified claims, such as using different excipients or processing steps.
Patent Landscape Context
Global and Chinese Patent Environment for Quercetin
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International Patents: Several patents incorporate quercetin as an active ingredient, often focusing on derivatives, new delivery systems, or combination therapies. The landscape shows a trend toward enhancing bioavailability and reducing degradation.
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Chinese Patent Activity: China's patent authorities have granted numerous filings targeting natural alkaloids, flavonoids, and plant extracts, often emphasizing innovative preparation processes. Notably, the patent family around quercetin spans composition, extraction, and formulation patents, with CN101132776 focusing on a novel preparation method.
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Competitive Positioning: Jiangsu Hengrui’s patent fills a niche in process innovation, granting it leverage over downstream formulations and generic manufacturing.
Related Patents and Prior Art
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Prior art related to quercetin formulations often involves liposomal encapsulation, nanocrystals, or co-administration with bioenhancers.
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The patent distinguishes itself by specific process conditions designed to optimize yield, stability, and bioavailability, narrowing its scope but reinforcing its inventive step.
Strategic Implications
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For Innovators: The process-focused claims provide a pathway to develop alternative formulations but emphasize the importance of process innovation to novel patent protection.
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For Generic Manufacturers: Due to the narrow scope, there may be opportunities to develop non-infringing processes, especially with different excipients or process parameters.
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For Patent Holders: The patent’s scope facilitates market exclusivity for specific preparation methods, especially in the Chinese market, bolstering downstream product development.
Regulatory and Commercial Outlook
Given the increasing demand for natural product-based pharmaceuticals, especially in China, the patent underscores the strategic importance of process patents in herbal and nutraceutical drugs. The focus on improving bioavailability directly addresses clinical efficacy concerns.
Conclusion
Patent CN101132776 exemplifies a targeted process patent in the Chinese pharmaceutical landscape, emphasizing manufacturing innovation for quercetin formulations. Its scope is confined to specific preparation methods, offering protective leverage while allowing room for alternative approaches. Stakeholders must consider this patent within the evolving landscape of natural product formulations and process innovations to optimize R&D and market strategies.
Key Takeaways
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Narrow but impactful scope: The patent protects a specific process for preparing quercetin-containing compositions, essential for bioavailability and stability improvements.
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Process over compound claims: Focusing on manufacturing steps rather than the active ingredient itself allows strategic flexibility.
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Landscape positioning: It complements a broader patent environment emphasizing formulation techniques for natural products, providing Jiangsu Hengrui a competitive edge in China.
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Infringement strategy: Companies developing similar formulations should analyze process parameters meticulously to avoid infringement.
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Market potential: The patent underscores China’s robust focus on natural product-based pharmaceuticals, signaling regulatory and commercial opportunities.
FAQs
1. What is the primary innovation claimed in CN101132776?
It claims a specific process for preparing a stable, bioavailable pharmaceutical composition containing quercetin, involving particular excipients and processing steps designed to optimize the drug’s stability and absorption.
2. How does this patent compare with other quercetin-related patents globally?
While many patents focus on quercetin derivatives or delivery systems like liposomes and nanocrystals, CN101132776 emphasizes process innovation within specific formulation steps, making it strategically narrow but effective within China.
3. Can other manufacturers develop similar products without infringing this patent?
Yes. They can consider alternative process parameters, different excipients, or different preparation methods outside the scope of the claims, provided such modifications do not infringe the process-specific claims.
4. What impact does this patent have on the Chinese market?
It grants Jiangsu Hengrui exclusivity on certain preparation methods for quercetin-based compositions, potentially influencing generic development and market entry strategies.
5. What should patent applicants consider when drafting process patents like CN101132776?
They should define specific, inventive process steps, select unique process parameters or excipients, and clearly delineate the scope to balance protection and avoid easy workarounds by competitors.
References
[1] Jiangsu Hengrui Medicine Co., Ltd. Patent CN101132776. "Method for Preparing a Pharmaceutical Composition Containing Quercetin." 2010.
