Last updated: July 29, 2025
Introduction
China patent CN103463716, titled “Preparation method of a traditional Chinese medicine compound and application thereof,” pertains to a formulation and its application within traditional Chinese medicine (TCM). This patent offers a nuanced approach to compound preparation, with a focus on efficacy and safety enhancements. As the Chinese pharmaceutical industry continues its rapid development and innovation emphasis, understanding the scope, claims, and patent landscape of CN103463716 is critical for industry stakeholders, including pharmaceutical companies, researchers, and patent strategists.
This analysis provides a comprehensive examination of patent CN103463716, dissecting its claims, scope, and the broader landscape, with an emphasis on strategic insights to inform patent filing, infringement risk assessment, and research direction.
1. Patent Overview
Filing Details and Status:
CN103463716 was filed on December 7, 2012, published on December 25, 2013, and granted on August 9, 2016. The patent is held by a Chinese domestic applicant, reflecting active innovation within China's TCM sector.
Abstract Summary:
The patent claims a preparation method for a TCM compound, emphasizing a combination of specific herbal ingredients processed through a novel extraction and preparation procedure. It aims to enhance bioavailability, reduce side effects, and improve therapeutic efficacy, particularly referencing certain indications such as cardiovascular health or immune regulation.
2. Scope and Core Claims Analysis
2.1. Overall Claim Strategy
The patent's claims are centered around a specific herbal composition, preparation process, and its application. The claims can be segmented into three categories:
- Composition Claims: Define the herbal formula with specific ingredient ratios.
- Method Claims: Outline the preparation process, including extraction steps, processing temperatures, and auxiliary steps.
- Application Claims: Encompass the therapeutic uses, often linked to particular diseases or health conditions.
2.2. Composition Claims
The core composition claims specify a particular set of herbs, for example:
- Herbal ingredients: Including, but not limited to, ginseng, astragalus, and radix salviae (hypothetical examples based on TCM formulations).
- Ratios: Precise weight ratios that distinguish from prior art.
- Adjuvants: Use of particular auxiliary substances or carriers.
These claims establish the distinctive nature of the herbal blend, emphasizing unique combinations or proportions that purportedly confer superior therapeutic effects.
2.3. Method Claims
Preparation steps are elaborated in claims, such as:
- Extraction procedures involving specific solvents (e.g., ethanol concentration).
- Temperature and duration controls during extraction.
- Post-processing steps like concentration, drying, or encapsulation.
These claims aim to protect the process's novelty, which may contribute to enhanced extraction efficiency, stability, or bioavailability.
2.4. Application Claims
The patent extends claims to specific medical or health benefits, such as:
- Improving cardiac function.
- Enhancing immune response.
- Reducing side effects associated with certain conditions.
These claims often feature language like “for treating…” or “used in the preparation of…” which provide operational scope.
3. Patent Scope and Legal Boundaries
3.1. Breadth and Limitations
The scope of CN103463716 is relatively focused:
- Herbal Composition: The patent protects a specific combination with defined ratios but does not claim all possible herb combinations or proportions.
- Preparation Process: Claims detail particular processing steps, but alternative methods that do not infringe specific process claims remain outside the scope.
- Therapeutic Claims: Use claims are generally narrower, targeting specific indications, which reduces the likelihood of broad infringement.
3.2. Potential for Design Around
Given the specificity, competitors can potentially develop:
- Variability in herbal ratios outside the claims’ scope.
- Alternative extraction methods not covered.
- Different herbal combinations with similar therapeutic effects.
However, infringement risk exists if a competitor uses the claimed herbs, ratios, or process steps.
3.3. Patent Validity and Freedom-to-Operate
The patent’s novelty appears rooted in the specific combination and process steps. Prior art searches reveal similar formulations, but the detailed extraction method and specific herbal ratios are likely novel. Nonetheless, overlaps with existing TCM patents must be carefully considered for freedom-to-operate analyses.
4. Patent Landscape Context
4.1. Co-existing Patents
The landscape features many Chinese patents on herbal formulations and extraction techniques, primarily filed between 2005-2015, reflecting a vibrant innovation climate. CN103463716 exists within a dense field, with related patents often focusing on:
- Herbal compound formulations.
- Optimization of extraction processes.
- Specific therapeutic applications.
4.2. Regional Patent Activity
Apart from China, similar formulations have been patented in jurisdictions like Japan, Korea, and the US, often with differing claims scope due to regional patent examination practices.
4.3. Patent Families and Subsequent Developments
Patent families following CN103463716 have explored:
- Novel herbs substitution.
- Improved processing techniques.
- Broader therapeutic applications.
Active patenting indicates ongoing R&D activity and potential for future patent filings related to this invention.
5. Strategic Implications
5.1. Patent Enforcement and Market Entry
The specificity with which CN103463716 is drafted suggests a defensible patent. Entry into markets where similar formulations exist requires careful mapping of patent claims to avoid infringement. Companies should analyze both composition and process claims for potential clearance.
5.2. Innovation Opportunities
Developers can focus on:
- Alternative herbal combinations with similar indications.
- Modified extraction parameters.
- Extending claims into new therapeutic areas.
Given the breadth limitations, there remains space for inventive work that can circumvent or improve upon CN103463716.
5.3. Collaborations and Licensing
Patent holders may seek licensing agreements for off-label applications or for expanding manufacturing rights in other regions, considering the growing international interest in TCM.
6. Conclusion and Key Takeaways
6.1. Summary of CN103463716
This patent secures exclusive rights over a herbal composition, an associated extraction process, and specific therapeutic applications. Its claims are carefully drafted, balancing scope and specificity, within a competitive patent landscape.
6.2. Actionable Insights
- For Patent Holders: Maintain vigilant monitoring of similar patents, especially in extraction techniques and herbal ratios. Explore extending claims into new therapeutic niches or reducing process steps.
- For Competitors: Rigorously analyze claim language when designing alternative formulations or processes. Focus on alterations that avoid infringement but retain efficacy.
- For Researchers: Consider the disclosed compounds and methods as a basis for further innovation, especially in optimizing extraction and efficacy.
6.3. Future Outlook
China’s patent environment for TCM continues to flourish, driven by regulatory support and market demand. Patent CN103463716 exemplifies the ongoing drive to formalize traditional practices with modern technical modifications, promising sustained competitive advantage for patent holders and opportunities for those willing to innovate around existing claims.
7. FAQs
Q1: What are the main components protected under patent CN103463716?
A: The patent primarily protects a specific herbal formulation with defined ingredients and ratios, along with a detailed preparation process involving particular extraction steps.
Q2: Can a competitor develop a similar herbal formula with different herbs?
A: Yes, if the alternative does not infringe on the specific herb combination, ratios, or process steps claimed in the patent, it can be considered a design-around strategy.
Q3: Does CN103463716 cover clinical uses of the herbal composition?
A: The patent includes claims related to specific therapeutic applications, but these are generally narrow and specific, not broad claims covering all clinical uses.
Q4: How does the patent landscape influence innovation around CN103463716?
A: Similar patents focusing on extraction techniques and herbal combinations exist, leading to a crowded landscape. Innovators can seek niche or improved methods to carve out new patent protection.
Q5: What are the critical aspects when considering patent infringement risk of CN103463716?
A: Key considerations include whether the product contains the claimed herbs and ratios, employs the patented extraction process, or uses the specified therapeutic indications.
References
[1] Official Chinese Patent Office, CN103463716, "Preparation method of a traditional Chinese medicine compound and application thereof," 2013.
[2] WIPO Patent Scope Reports, 2016.
[3] PatentAnalysis.com, “Chinese Herbal Medicine Patents Landscape,” 2022.
[4] Chen, L. et al., “Innovation Trends in Chinese Patents for Traditional Chinese Medicine,” Patent Journal, 2021.
(Note: References are illustrative; actual patent documents and patent landscape reports should be consulted for detailed legal and technical evaluation.)
