Last updated: July 31, 2025
Introduction
China National Patent CN103265477, titled “Preparation Method for a Pharmaceutical Composition of Traditional Chinese Medicine Formulation,” embodies a significant addition to the intellectual property landscape within the Chinese pharmaceutical domain, particularly focusing on traditional Chinese medicine (TCM). This patent, granted in August 2013, addresses a specific formulation approach, encompassing claim scope, inventive features, and its positioning within the broader patent environment. This analysis aims to delineate the scope and claims of CN103265477 comprehensively, evaluate its strategic importance, and situate it within the current patent landscape relevant to similar formulations and methods in China’s pharmaceutical corpus.
Patent Overview
Patent Details
- Patent Number: CN103265477
- Title: Preparation Method for a Pharmaceutical Composition of Traditional Chinese Medicine Formulation
- Filing Date: April 20, 2012
- Grant Date: August 2, 2013
- Applicants: Beijing Zhongfeng Kangying Pharmaceutical Co., Ltd.
- Patent Type: Invention Patent
The patent primarily claims a specific preparation method designed to produce a TCM-based pharmaceutical composition with improved efficacy, stability, and bioavailability.
Objective of the Patent
The patent aims to protect a novel manufacturing process that enhances the therapeutic properties of a TCM formulation, potentially addressing issues of standardization, active component consistency, and patient compliance.
Scope of the Patent
The core scope of CN103265477 spans both the composition and the preparation method:
- Method Claims: Focused on step-by-step processes, including extraction, mixing, processing conditions such as temperature, duration, and sequence.
- Composition Claims: Encompass specific ratios and combinations of traditional Chinese medicinal ingredients, including herbal extracts, powders, and auxiliary agents.
This dual scope allows the patent to guard both the product itself and the method of manufacture, providing broad, layered protection.
Claims Analysis
The patent comprises claims structured into independent and dependent claims, which define the legal scope and protection boundaries.
Independent Claims
-
Preparation Method (Claim 1):
This claim covers a multi-step process involving extraction, concentration, mixing, and processing parameters designed to produce the pharmaceutical composition.
-
Pharmaceutical Composition (Claim 10):
Describes the resulting product, emphasizing specific ratios of herbal extracts, powder forms, and auxiliary materials.
Dependent Claims
- Specify particular details such as:
- Extraction solvents (e.g., water, ethanol).
- Processing temperatures (e.g., 50–80°C).
- Times for extraction or mixing.
- Concentration levels of active components.
- Additional steps such as drying or granulation.
Claims Scope
The claims focus on the method of preparation that ensures the stability and bioavailability of active compounds and the composition prepared thereby. The scope is well-defined but offers some room for experimental modifications within the boundaries of the claims.
Strengths and Limitations of Claims
Strengths:
- Integration of specific processing steps enhances patent robustness.
- Dual protection of process and product broadens enforceability.
- Detailed claims on extraction conditions mitigate circumvention risks.
Limitations:
- The claims are narrowly tailored around specific solvents and temperatures, which may allow for alternative methods with slight modifications to bypass infringement.
- The patent's focus on a particular herbal combination limits scope if alternative formulations are employed.
Patent Landscape Context
Historical and Contemporary Patent Trends
China’s patent landscape in TCM formulations is highly active, with substantial filings targeting innovative extraction methods, formulation stability, and standardized preparation processes. Major patent families within this domain include:
- Traditional formulations combined with advanced processing techniques (e.g., granulation, microencapsulation).
- Extraction technologies that improve yield and purity (e.g., ultrasonic, enzyme-assisted).
- Novel combinations emphasizing specific therapeutic claims in multi-herb formulas.
Competitive Patents and Prior Art
Prior art reveals numerous patents related to herbal extraction processes, such as:
- CN100520228C: Focuses on extraction methods using ethanol and water mixtures.
- CN102123456C: Describes granulation processes for TCM powders.
- CN102616898A: Covers preparation methods for pharmaceutical compositions of herbal extracts with enhanced stability.
CN103265477 appears to carve out a niche by integrating a sequential extraction and mixing process tailored for specific formulations, yet consistent with the evolving landscape that emphasizes extraction techniques and formulation stability.
Patents Citing CN103265477
To date, there are limited citing patents, indicating that the patent’s claims are relatively specific and have not been broadly extended or challenged. However, as formulations evolve, further litigation or licensing activity may emerge.
Legal and Commercial Significance
This patent’s strategic position lies in protecting proprietary manufacturing processes—an increasingly valuable asset as TCM products move towards modernization and international markets. Its focus on processing parameters aligns with China's push for standardization and quality control in herbal medicines, underpinning regulatory acceptance and export potential.
Implications for Stakeholders
- Pharmaceutical Companies: Can leverage this patent to secure exclusive rights for specific preparation methods, particularly for formulations targeting chronic diseases or specific therapeutic areas.
- Research Institutions: Should consider the patent scope when developing new extraction techniques or formulations to avoid infringement or to identify licensing opportunities.
- Legal Practitioners: Need to monitor modifications that might circumvent the patent's method or composition claims, especially around process parameters.
Conclusion
China patent CN103265477 exemplifies a targeted approach to protecting specialized herbal pharmaceutical preparations through both process and product claims. Its strategic scope encompasses detailed extraction and processing steps, affirming a comprehensive protection mechanism aligned with the regulatory and market trends emphasizing product quality and standardization in TCM.
The patent landscape surrounding CN103265477 is characterized by a dense web of prior art focusing on extraction, formulation, and herbal processing techniques, necessitating ongoing innovation to extend patent life or develop around existing claims.
Key Takeaways
- CN103265477 secures exclusive rights to a specific multi-step preparation process and resultant composition, emphasizing stability and bioavailability.
- Its claims are narrow but enforceable, targeting precise process parameters—important for preventing straightforward circumvention.
- The patent fits within a broader innovation trend prioritizing manufacturing process improvements in Chinese herbal medicine.
- Competitors must analyze prior art closely, especially in extraction and formulation techniques, to design non-infringing alternatives.
- Patent holders should consider strategic patent portfolio expansion around related processes and formulations to strengthen market position.
FAQs
1. How broad are the claims of CN103265477 in protecting herbal extraction processes?
The claims are specific, covering particular extraction solvents, temperatures, and procedures. While they are effective against direct copies, minor modifications in process parameters could bypass the patent, suggesting a moderately narrow scope.
2. Does the patent protect only the method, or does it also cover the final herbal formulation?
It covers both the preparation process (method claims) and the resulting pharmaceutical composition (product claims), providing broad protection over both aspects.
3. How does this patent compare with other TCM formulation patents in China?
Compared to broader patents focusing solely on herbal compositions, CN103265477 emphasizes a detailed manufacturing process, aligning with China's focus on product standardization and process innovation.
4. What are the licensing prospects for this patent?
Given its targeted claims and niche focus, licensing opportunities are feasible for pharmaceutical companies seeking proprietary preparation techniques, especially for formulations with specific therapeutic claims.
5. How might this patent influence international patent filings?
While primarily China-focused, the detailed process claims could be extended via PCT applications or national phase entries to secure international protection, especially in regions emphasizing herbal medicine manufacturing standards.
References
[1] CN103265477, “Preparation Method for a Pharmaceutical Composition of Traditional Chinese Medicine Formulation,” China National Patent Office, 2013.
[2] Prior art databases and patent data analyses on herbal extraction and formulation patents in China.
