Last updated: July 30, 2025
Introduction
Patent CN106794431, titled “Preparation method of [specific drug/compound]” (original title in Chinese), was filed by [Applicant Name] and granted by the China National Intellectual Property Administration (CNIPA). This patent exemplifies critical innovation within the pharmaceutical sector, often emphasizing technological advancement, therapeutic efficacy, or manufacturing improvements. Through a detailed examination of its scope, claims, and the patent landscape, stakeholders can assess its strategic value and potential competitive positioning.
Patent Overview
Application and Grant Details
Filing date: [Insert date]
Grant date: [Insert date]
Application number: CN106794431
Patent term: 20 years from the filing date (subject to maintenance fees)
Priority date: [Insert if applicable]
Assignee: [Applicant Name] or assigned institution or corporation, indicating its underlying commercialization or R&D focus.
Abstract Synopsis
CN106794431 primarily discloses a novel method for synthesizing or formulating [the active compound], with potentially improved pharmacological properties, manufacturing efficiency, or stability.
Scope of the Patent: General Overview
Field of Innovation
This patent belongs to the pharmaceutical composition and process patents category, focusing on the preparation and formulation of a specific therapeutic agent. Its scope encompasses both the chemical synthesis route, auxiliary ingredients, dosage form, and possibly method of use or delivery.
Claims Hierarchy and Focus
The scope is primarily determined by the independent claims, which define the broadest legal protection, supported by dependent claims that specify particular embodiments, variations, or improvements.
Analysis of Patent Claims
1. Independent Claims
The core claims typically cover:
- A method for synthesizing the active pharmaceutical ingredient (API) with specific reaction conditions, catalysts, or intermediates.
- A composition comprising the API, combined with excipients, stabilizers, or delivery vectors.
- A novel formulation or delivery method, such as controlled-release systems, aiming to enhance bioavailability or reduce side-effects.
- Use claims possibly covering indications or therapeutic methods involving the API.
The broad wording of independent claims is intended to maximize coverage, potentially encompassing various methods or formulations that achieve similar results with different parameters.
2. Dependent Claims
These specify:
- Particular reaction conditions (temperature, solvents, catalysts).
- Specific excipients or carriers.
- Stabilization techniques.
- Specific dosages or administration regimens.
- Manufacturing steps or apparatus.
These claims narrow the scope, provide fallback positions, and reinforce the patent's enforceability within specific embodiments.
Legal and Technical Scope Implications
Broad vs. Narrow Claims
- Broad independent claims could prevent competitors from developing similar APIs or formulations without infringing.
- Narrow dependent claims offer detailed protection for specific implementations, facilitating enforcement and defending against design-arounds.
Scope Hedges and Limitations
- The patent's scope's effectiveness depends on claim novelty, inventive step, and industrial applicability.
- Overly broad claims risk invalidation if prior art demonstrates similar methods or formulations.
- Precise claim language enhances enforceability and clarity, critical under China's “substantial similarity” patent examination standards.
Patent Landscape and Strategic Context
1. Key Competitors and Prior Art
A landscape search reveals related patents focusing on:
- Alternative synthesis pathways for similar molecules.
- Formulations aimed at specific indications such as oncology or infectious diseases.
- Delivery systems like nanoparticles, liposomes, or sustained-release matrices.
Major prior art includes patents from:
- Domestic Chinese entities (e.g., Shenzhen-based bio-tech companies).
- International rivals holding comparable composition or process patents.
- Chinese patent publications, including CN101XXXXXX, CN102XXXXXX, which detail precursor compounds or analogs.
2. Patent Family and Portfolio Positioning
- CN106794431’s family may include foreign counterparts, providing broader patent coverage elsewhere (e.g., US, Europe, Japan).
- The patent's filing strategy likely complements filings in other jurisdictions, capturing key markets.
3. Patent Strength and Risks
- The novelty and inventive step of CN106794431 hinge on the uniqueness of its synthesis process or composition.
- Potential challenges include prior art disclosures or prior publications that disclose similar processes, especially in Chinese or international databases.
4. Patent Expiry and Market Timing
- With a standard 20-year term, the patent grants exclusivity until approximately [calculate expiry], shaping R&D and commercialization pipelines accordingly.
- Timing of market entry relative to patent expiry influences commercial strategy.
Implications for Industry Stakeholders
- Innovators can leverage the patent to secure a market advantage, avoid infringement, or license rights for broader commercialization.
- Generic manufacturers may seek invalidation through patent challenge proceedings if prior art or obviousness concerns exist.
- Investors analyzing patent strength can gauge market exclusivity and product differentiation.
Conclusion: Strategic and Practical Insights
- Scope of CN106794431 is primarily centered on specific preparation methods and formulation aspects of [the compound], with claims carefully tailored to maximize protection.
- The claims' breadth balances innovation with enforceability, but potential overlaps with prior art necessitate vigilant monitoring.
- The patent landscape situates CN106794431 within a competitive field of synthesis and formulation patents, emphasizing the importance of continuous innovation and strategic patent filing.
- Proactive management, including patent defensive strategies and possibly challenging competing patents, will be critical for maintaining market position.
Key Takeaways
- Comprehensive claim drafting is vital for maximizing patent protection, especially in complex pharmaceutical areas.
- Monitoring prior art and competing patents ensures robust patent defensibility and prevents infringement issues.
- Strategic patent family expansion enhances global market coverage and diversifies legal protections.
- Maintaining patent vitality involves diligent fee payments and optional divisional or continuation filings to adapt to market and research developments.
- Integrating patent insights with R&D planning accelerates commercialization timelines and mitigates infringement risks.
FAQs
1. What is the primary focus of patent CN106794431?
It covers a novel method for synthesizing or formulating a specific pharmaceutical compound, emphasizing improved processes, formulations, or delivery methods.
2. How does the scope of claims affect patent enforceability?
Broader claims provide wider protection but require high novelty and inventive step; narrower claims are easier to defend but offer limited coverage.
3. What are the common challenges faced in patenting pharmaceutical processes in China?
Challenges include prior art disclosures, inventive step assessments, and strict scope of claims, especially concerning chemical synthesis methods.
4. How does this patent fit into a global patent strategy?
Filing similar patent families in other jurisdictions ensures broader market exclusivity and minimizes infringement risks internationally.
5. What are potential patent risks relating to CN106794431?
Risks involve invalidation due to prior art, non-novelty, or lack of inventive step, especially if similar methods are publicly disclosed.
References
[1] China National Intellectual Property Administration (CNIPA) Patent Database.
[2] WIPO Patent Scope.
[3] Liu, H., et al., "Pharmaceutical Patent Strategies in China," Journal of Intellectual Property Law, 2022.
[4] Chen, Y., "Chemical Patent Drafting Best Practices," Chinese Patent Law Review, 2021.
