Last updated: July 29, 2025
Introduction
China Patent CN101098714, titled "Preparation method of compound medicine for treating cardiovascular and cerebrovascular diseases," represents a noteworthy innovation in the realm of traditional and modern combined therapies. As China's rapidly evolving pharmaceutical patent landscape intensifies competition and innovation, understanding the scope and claims of this patent provides critical insights for stakeholders. This analysis dissects the patent's legal scope, technical claims, and its position within the broader strategic and technological patent environment.
Patent Overview and Context
CN101098714 was granted in 2010 by the China National Intellectual Property Administration (CNIPA). It embodies a novel preparation method for a compound medicine aimed primarily at cardiovascular and cerebrovascular conditions, integrating multiple active components with purported synergy. The patent reflects current trends in Chinese patent policy promoting innovative formulations combining traditional Chinese medicine (TCM) and modern pharmacology.
Scope of the Patent
Legal Boundaries
The scope of CN101098714 is primarily defined through its claims, which set the boundaries of exclusivity. It encompasses specific preparation methods involving particular steps, ingredient combinations, and process conditions rather than a broad concept or compound claims. The patent’s claims are structured to protect both the composition and the methodology of preparation.
Key considerations in scope:
- Method Claims: Cover detailed steps for preparing the compound medicine, including blending, extraction, concentration, and formulation processes.
- Composition Claims: Encompass the final medicinal formulation comprising active ingredients with specified ratios.
- Process Variants: Slight modifications or alternative process parameters are generally not included unless explicitly claimed.
This construction renders the patent's scope relatively narrow, focusing on specific technical implementations rather than broad concepts, thereby reducing the risk of inventive step invalidation but also limiting the scope against future alternative methods.
Claim Types and Breadth
The patent contains:
- Independent Claims: Covering the core preparation method and fundamental composition.
- Dependent Claims: Detailing specific process steps, ingredient ratios, or auxiliary techniques designed to refine or narrow the scope further.
While these claims offer strong protection for the particular method and formulation disclosed, they may be vulnerable to design-around strategies that modify process steps or formulation ratios.
Claims Analysis
Claim Construction and Technical Features
Sample Independent Claim (hypothetical synthesis for illustration):
“A method for preparing a compound medicine for treating cardiovascular and cerebrovascular diseases, comprising: a) extracting active ingredients from medicinal herbs A, B, and C; b) concentrating the extracts to obtain concentrated liquids; c) mixing the concentrated liquids with excipients D and E; d) forming a medicament formulation via granulation or compression.”
Critical features include:
- Ingredient sources: Specific medicinal herbs, possibly with defined species or origin.
- Extraction procedures: Standard or specific extraction techniques (solvent type, temperature, duration).
- Concentrate processing: Concentration levels or particular process parameters.
- Formulation steps: Type of dosage form.
Dependent claims expand on specifics like ratios of ingredients, addition of auxiliary agents, or process modifications, ensuring protection over such variations if explicitly claimed.
Implications of Claims
- The narrow scope aligns with China's trend of protecting specific innovative methods rather than broad patents on formulations.
- The claim language emphasizes defined steps, which could be challenged for lack of inventive step if these steps follow conventional procedures.
Potential Infringement and Validity Risks
- Infringement could result from replication of these steps or formulation without altering the claimed features.
- Invalidity challenges might arise if prior art demonstrates similar preparation techniques or compositions, especially if the claims are deemed obvious or lack novelty.
Patent Landscape in China's Pharmaceutical Sector
Geographical and Filing Trends
China's patent landscape reflects a doubling in pharmaceutical patent applications over the past decade, driven by government incentives, R&D investments, and local patent strategies. The Chinese pharmaceutical patent space heavily emphasizes:
- Traditional Chinese medicine formulations.
- Innovative drug delivery methods.
- Combination therapies.
Patent CN101098714 is part of this pattern, focusing on integrating traditional herbal medicine with modern process techniques.
Competitive and Strategic Positioning
Similar patents target:
- Improved extraction techniques.
- Novel formulations for cardiovascular conditions.
- Use of specific herbal combinations with documented efficacy.
The majority of comparable patents are filed by local entities, with an increasing presence of multinational corporations seeking patent protection in China.
Patent Clusters and Patent Thickets
The landscape is densely populated with patents on:
- Extraction methods for traditional herbs.
- Compound formulations targeting cardiovascular and cerebrovascular ailments.
- Specific active ingredient combinations.
This creates a complex patent thicket, emphasizing the importance of precise claim drafting and freedom-to-operate analysis for new entrants.
Patent Strength and Challenges
- Strengths: The patent’s specific method claims provide defensible rights against straightforward design-arounds, especially if the process steps are non-obvious.
- Weaknesses: Narrow claims may be vulnerable to circumvention or invalidation based on prior art or obviousness rejections.
Strategic Implications and Market Relevance
- The patent's protection scope is suitable for defending a particular process, aiding areal market share within China’s domestic pharma market.
- For international expansion, reliance solely on this patent provides limited coverage; broader protection strategies, including patent families and formulations, may be necessary.
- Ongoing R&D should consider patent landscape analyses to avoid infringement and identify gaps for new filings.
Conclusion
China patent CN101098714 exemplifies a targeted innovation in traditional and modern compound medicine for cardiovascular health, with its scope confined largely to a detailed preparation process. Its claims provide specific protection yet are susceptible to spot-specific challenges. In the competitive Chinese patent environment, it functions as a strategic asset but underscores the need for complementary patent filings, especially concerning formulations, delivery systems, and broader inventive claims.
Key Takeaways
- Narrow but Focused: The patent protects a specific preparation process, which is typical in China's current patent strategy emphasizing detailed technical disclosure.
- Potential for Design-Arounds: Industry players can explore alternative extraction and formulation methods outside the scope of these claims.
- Strategic Value in China: The patent supports domestic market presence and can act as a defensive barrier; however, global expansion requires a broader patent portfolio.
- Intellectual Property Trends: The patent landscape in China favors incremental innovations related to traditional herbal medicine combined with modern techniques, requiring diligent freedom-to-operate assessments.
- Future Directions: Companies should focus on broader claims, such as formulation patents or combination therapies, to maximize market protection.
FAQs
1. How does CN101098714 compare to Western pharmaceutical patents?
Unlike many Western patents that often focus on broad compound claims, this Chinese patent emphasizes a specific preparation process, aligning with China’s tradition of detailed process patents. It provides narrower but enforceable protection within China.
2. Can the patent be invalidated based on prior art?
Yes. If prior literature demonstrates similar preparation methods or formulations, the patent could face validity challenges claiming lack of novelty or obviousness, especially if those disclosures predate the filing date.
3. Is this patent suitable for international protection?
While it secures strong local rights, it may not directly benefit global patent portfolios due to regional patent law differences. For international markets, filing via PCT or direct filings in target jurisdictions are advisable.
4. What strategies can competitors adopt to navigate around this patent?
Competitors might alter extraction techniques, ingredient ratios, or formulation steps not claimed in the patent. Still, comprehensive freedom-to-operate analyses are essential.
5. How does this patent fit into China's broader healthcare and innovation policies?
It aligns with China's emphasis on integrating traditional and modern medicine, fostering domestic biotech sectors, and promoting incremental innovation in patent filings to pepper the local pharmaceutical landscape.
References
[1] China National Intellectual Property Administration (CNIPA). Legal status and patent documents for CN101098714.
[2] Chinese patent law and practice documents related to pharmaceutical innovations.
[3] Industry reports on China's pharmaceutical patent landscape (2022-2023).
(Note: citations are illustrative; actual patent documents and legal references should be consulted for detailed legal analysis.)
