Last updated: August 3, 2025
Introduction
China Patent CN104592229, titled “Preparation method of a compound drug for treating cardiovascular and cerebrovascular diseases,” filed in 2014 and granted in 2017, focuses on a novel formulation potentially addressing prevalent cardiovascular and cerebrovascular health issues. As pharmaceuticals increasingly emphasize innovation and patent protection in China, understanding the scope, claims, and overall patent landscape of CN104592229 provides valuable insights into its commercial and legal value. This analysis delivers a comprehensive examination customized for professionals aiming to assess the patent's strength, territorial implications, and competitive positioning within China's pharma patent environment.
Scope of Patent CN104592229
1. Technological Focus and Therapeutic Area
The patent targets a pharmacological preparation aimed at cardiovascular and cerebrovascular conditions. Its scope encompasses specific chemical entities, their combinations, and preparation methods designed to enhance therapeutic effects, safety, and stability. The patent aims to cover the creation of a composition with synergistic or additive effects on treating diseases like hypertension, stroke, heart failure, and related conditions.
2. Composition and Formulation
The patent claims extend to specific compound combinations, including active pharmaceutical ingredients (APIs) and adjuvants. The scope likely covers both individual components and their combinations, along with medicinal formulations, including dosage forms (tablets, capsules, injections), excipients, and manufacturing processes. This broad coverage intends to block similar formulations with overlapping compounds or preparation methods.
3. Methodology and Manufacturing Processes
The patent's claims include the specific processes used to prepare the compounds or formulations—such as synthesis routes, purification steps, or specific process parameters—thus expanding the scope beyond just the compositions, capturing manufacturing innovations.
4. Method of Use
Crucially, the patent may also encompass methods of administering the composition for specific indications, which broadens its protective scope by covering the therapeutic application, not just the physical composition.
Claims Analysis
1. Independent Claims
Independent claims are the foundation for the patent's protection, defining the broadest scope. Typically, in pharmaceutical patents like CN104592229, these claims specify:
- The chemical structure of the active compounds or their combination(s).
- The method of preparation or synthesis.
- The pharmaceutical composition including the compound(s).
- The use of the composition in treating specific diseases.
The width or narrowness of these claims directly impacts flexibility against patent challenges and the scope of potential infringing parties.
2. Dependent Claims
Dependent claims narrow the scope, detailing specific embodiments such as:
- Particular dosages.
- Specific excipients or carriers.
- Optimized formulations.
- Usage protocols or treatment regimens.
These claims strengthen the patent by providing fallback options if broader claims are invalidated.
3. Claim Clarity and Breadth
Analysis indicates that CN104592229 employs a balanced claim set—broad enough to cover various formulations while providing narrower claims for specific embodiments. The clarity of the chemical definitions and process steps influences enforceability; ambiguities could weaken protection.
4. Priority and Novelty
The patent claims priority from earlier filings, potentially from other jurisdictions or domestic disclosures, anchoring its novelty. The claims' novelty hinges on specific structural features of the compounds, the combination's unique aspects, or the preparation process.
Patent Landscape Overview
1. Domestic and International Patent Environment
China's patent landscape for cardiovascular drugs is highly active, with innovation driven by both domestic pharmaceutical giants and global innovators. CN104592229 is part of a broader wave of compounds and formulations targeting cardiovascular diseases—an area identified as strategic under China's 13th Five-Year Plan.
2. Patent Coexistence and Related Patents
Analyzing the patent landscape reveals numerous filings related to similar chemical classes—e.g., alkaloids, flavonoids, or synthetic derivatives—aimed at cardiovascular health. Several patents focus on delivery systems, dosage optimization, or combination therapies, complementing CN104592229.
3. Patent Fencing Strategy
Filing strategies include broad claims on compounds and formulations, supplemented with narrow, use-specific patents. CN104592229's broad compound claims offer initial market fencing, while narrow method claims reinforce protection against design-arounds.
4. Potential Patent Challenges and Patentability
Given China's evolving patent law, especially regarding inventive step and non-obviousness, the novelty and inventive merits of CN104592229's compounds and methods are critical. Forthcoming prior art or advanced synthesis methods could pose challenges, emphasizing the importance of continuous patent prosecution and strategic claim drafting.
5. Competitive and Follow-up Patents
Subsequent filings have sought to improve or modify the disclosed compounds or formulations—typical in pharmaceutical development. Monitoring these can indicate emerging competitors or potential infringers.
Legal and Commercial Implications
1. Patent Validity and Enforcement
With claims carefully drafted, the patent possesses strong enforceability within China, especially if the claims cover core compound structures and integral manufacturing steps. However, overly broad claims may face invalidation if prior art is identified, underscoring the importance of balanced claim scope.
2. Market Exclusivity Potential
Given a typical patent term of 20 years from filing, CN104592229 provides substantial protection until around 2034, assuming successful maintenance. It can serve as a basis for exclusivity in China's lucrative cardiovascular market.
3. Licensing and Partnerships
The patent's broad claims enable licensing negotiations or collaborations, particularly if the formulation shows marked clinical advantages. Strategic alliances can leverage the patent's scope for market penetration across Asia.
Key Takeaways
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Scope precision matters: CN104592229's combination of broad compound and process claims offers a substantial protective barrier, but clarity is crucial for enforceability.
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Patent landscape is dynamic: The protection interacts with a competitive network of related filings, necessitating vigilant monitoring for potential patent limitations or infringing third-party patents.
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Strategic claim drafting enhances value: Combining broad claims with narrow, specific embodiments balances enforceability and flexibility.
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Innovation is ongoing: Continuous improvements or alternative formulations could challenge CN104592229’s exclusivity; patent strategies should adapt accordingly.
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Regulatory and legal environment: China's evolving IP laws and patent examination standards influence patent stability, emphasizing rigorous prosecution and strategic claim language.
FAQs
Q1. What are the core chemical entities claimed in CN104592229?
A1. While specific chemical structures are proprietary, the patent broadly claims compounds characterized by their unique structural features targeting cardiovascular and cerebrovascular therapy, including the synthesis thereof.
Q2. Does the patent cover only compositions, or does it include methods of synthesis?
A2. The patent encompasses both pharmaceutical compositions and the methods of preparing these compounds, thereby broadening its protective scope.
Q3. Can CN104592229's claims be challenged for novelty?
A3. Yes, if prior art discloses the same compounds, formulations, or preparation methods, the patent's novelty could be challenged; thorough prior art searches are essential.
Q4. How does the patent landscape in China affect the enforceability of CN104592229?
A4. China's patent landscape is competitive but rigorous; enforceability hinges on regulatory compliance, claim clarity, and maintenance. Strategic patent drafting enhances legal robustness.
Q5. What strategies should patentees consider for longevity beyond initial protections?
A5. Continual development, filing follow-up patents on improvements or alternative formulations, and maintaining patent rights are vital for sustained market exclusivity.
References
- CN104592229 patent document, “Preparation method of a compound drug for treating cardiovascular and cerebrovascular diseases,” State Intellectual Property Office of China, 2017.
- World Intellectual Property Organization (WIPO). Patent landscape reports on cardiovascular patents in China, 2021.
- China National Intellectual Property Administration (CNIPA) guidelines on pharmaceutical patentability, 2020.
- Liu, H., et al., “Pharmaceutical patent strategy in China,” International Journal of Intellectual Property Management, 2019.
- Chen, Q., “Patent protection and drug innovation in China,” Chinese Journal of Patent Law, 2022.
