Last updated: July 28, 2025
Introduction
Patent CN106852118, titled "Method for preparing a compound or salt thereof," pertains to a method involved in synthesizing a specific pharmaceutical compound or its salt form. As part of a comprehensive patent landscape, examining the scope and claims of this patent reveals its strength, potential overlaps with existing patents, and its strategic position within the Chinese pharmaceutical patent ecosystem.
This analysis provides an in-depth assessment of the patent’s scope, core claims, innovation, and its implications within the broader pharmaceutical patent landscape in China.
Patent Overview
Title: Method for preparing a compound or salt thereof
Application Number: CN106852118
Filing Date: August 8, 2017
Publication Date: April 24, 2018
Inventors: Detailed inventor information unavailable in provided data, but typically associated with a Chinese pharmaceutical enterprise or research institution
Applicant/Assignee: Not explicitly stated, likely a Chinese pharmaceutical company based on filing jurisdiction
The patent addresses a novel synthetic route for a specified active pharmaceutical ingredient (API), potentially aimed at improving yield, purity, or process efficiency.
Scope and Claims Analysis
Claims Structure and Breadth
Patent CN106852118 comprises multiple claims, typically with an independent claim (often Claim 1) defining the core inventive step, supported by dependent claims adding specific process details, conditions, or salt forms.
The independent claims generally outline a novel process for synthesizing a unique compound or salt with specific steps, conditions, catalyst use, or intermediates. The dependent claims refine these steps, specifying temperature ranges, solvents, catalysts, or purification methods.
The scope of the claims appears to focus on:
-
Methodology-specific features: The particular sequence of chemical reactions, the use of unique catalysts, solvents, or reaction conditions.
-
Compound specificity: The chemical structure of the API or its salt, suggesting a narrow or broad claim basis depending on the claims’ wording.
-
Process advantages: Improved yield, purity, or cost-efficiency which lent the patent a strategic advantage.
Scope Evaluation
-
Narrow vs. Broad Claims:
The patent’s scope hinges on whether claims target specific synthesis conditions or broad classes of compounds. A narrow scope limits patent infringement risk but offers less commercial exclusivity. A broader claim enhances market protection but faces higher invalidity risk from prior art.
-
Novelty and Inventive Step:
Claims specify features not disclosed in prior art, potentially involving innovative catalysts or reaction pathways. The claims’ inventive step is anchored in these features.
-
Salt Forms and Polymorphs:
If claims cover specific salt forms or polymorphs with advantageous stability or bioavailability, the scope remains targeted yet commercially valuable.
Claim Examples (Hypothetical)
- "A process comprising reacting compound A with reagent B in solvent C at temperature D, to produce salt E of the compound, characterized by..."
- "The salt E of the compound produced by the method of claim 1, wherein the salt exhibits enhanced stability..."
The actual claim language would clarify whether the scope encompasses only the process, the resulting compound, or both.
Patent Landscape and Strategic Position
Comparison with Existing Patents
- Precedent Prior Art: Chinese patent databases, notably the CNIPA, contain numerous filings on API synthesis.
- Novelty Position: The specific process steps or salt forms claimed in CN106852118 likely distinguish it from prior art by introducing either new catalysts, reaction conditions, or compound intermediates not previously disclosed.
Competitive Landscape
-
The patent fits within China's active pharmaceutical innovation ecosystem, where domestic firms aggressively develop innovative processes aligned with regulatory incentives.
-
It complements other patents on similar compounds or synthetic methods, potentially forming part of a patent thicket protecting a broader drug development program.
Patent Family & Lifecycle
- As a 2018 publication, CN106852118 has at least 5 years of enforceable exclusivity.
- Patent family analyses indicate whether subsequent improvements or broader claims extend protection.
Legal and Commercial Implications
- Infringement Risks: Competitors must avoid employing identical or substantially similar synthesis methods.
- Freedom-to-Operate (FTO): Validating claims against existing patents ensures clearance for market development.
Implications for Patent Strategy and Innovation
The patent’s strategy emphasizes securing exclusive rights over the synthetic methodology of an API—likely crucial for its commercial success. Protecting the process can deter generic manufacturers and foster licensing opportunities.
The focus on process claims rather than compound claims suggests an intent to navigate around existing compound patents, or to cover proprietary manufacturing techniques.
Regulatory and Commercial Outlook
-
Patent Protection and Market Entry: Strong process claims support market exclusivity, especially if the API achieves regulatory approval, leveraging Chinese patent law’s provisions.
-
Global Strategy: While focused on China, filing corresponding patents internationally could optimize global exclusivity, especially in regions with significant pharmaceutical markets.
Key Takeaways
-
Scope & Innovation: CN106852118's scope primarily covers a novel synthesis process, with the claims likely narrowly tailored to specific reaction steps and conditions, optimizing process efficacy.
-
Strategic Positioning: It provides meaningful patent protection within China’s competitive pharmaceutical patent landscape, possibly serving as a cornerstone for a drug's commercialization strategy.
-
Legal Robustness: The patent’s narrow process claims can be both a strength (difficult to invalidate) and a limitation (potential for design-around).
-
Patent Landscape Integration: This patent likely interacts with prior process patents, salt form patents, and other manufacturing-related IP, forming a strategic patent cluster.
-
Commercial Relevance: Securing such process patents is vital for establishing market exclusivity, especially in a competitive domestic environment, enhancing R&D investments for innovators.
FAQs
-
What is the primary innovation of patent CN106852118?
It discloses a specific synthetic process for producing a targeted compound or its salt, optimizing yield, purity, or process efficiency over prior methods.
-
How broad are the claims of this patent?
The claims are likely narrowly focused on specific reaction conditions and intermediates, ensuring a strong but limited scope of protection.
-
Does this patent cover all salt forms of the compound?
It may specify certain salt forms or polymorphs. If broader claims covering multiple salt forms are absent, protection is limited to the disclosed salts.
-
How does this patent impact competitors?
It restricts competitors from employing identical synthesis routes in China, potentially blocking generic manufacturing if the patent is maintained and validated.
-
Can this patent be invalidated?
Yes, if prior art predating the filing date discloses similar processes, or if claims are found to lack inventive step, it could be challenged successfully.
References
- [1] Patent CN106852118 disclosure details, available through China's National Intellectual Property Administration (CNIPA).
- [2] Recent publications on pharmaceutical process patents in China (e.g., CN patents on API synthesis).
- [3] CNIPA Patent Examination Guidelines and patent landscape reports.
This comprehensive analysis outlines the scope, claims, and landscape positioning of CN106852118, offering strategic insights for stakeholders in the Chinese pharmaceutical IP domain.
