Last updated: September 8, 2025
Introduction
China Patent CN112638384, titled "Method for Preparing a Pharmaceutical Compound," is a recent patent of significance within the pharmaceutical innovation landscape. This patent encompasses a novel method that potentially enhances the synthesis efficiency, purity, and yield of specific pharmaceutical compounds, underpinning its strategic importance in drug manufacturing and development. This report provides a comprehensive analysis of the patent’s scope, claims, and its position within the broader patent landscape in China.
Scope of Patent CN112638384
Technical Field and Background
The patent belongs to the chemical and pharmaceutical manufacturing sector, specifically focusing on synthetic methods for active pharmaceutical ingredients (APIs). It aims to address limitations associated with existing synthetic routes, such as complex reaction steps, low yields, or impurity formation.
Core Innovation
The patent claims a novel, optimized process for preparing a pharmaceutical compound—potentially an API or a precursor—using specific reaction conditions, catalysts, intermediates, or purification techniques. The process emphasizes improving efficiency and product quality, aligning with industry goals of cost reduction and higher purity standards.
Operational Environment
The patented method is suited for industrial-scale synthesis, designed to be scalable, safe, and compliant with Chinese regulatory standards for pharmaceuticals. The description suggests compatibility with existing manufacturing lines, providing incremental innovation rather than a fundamental overhaul of chemical synthesis.
Claims Analysis
Overview of Claims
The patent contains multiple claims—both independent and dependent—that define the scope of protection. Typically, Chinese chemical and pharmaceutical patents focus on process claims, product claims, or a combination of both.
Independent Claims
The independent claims most likely specify a method involving a sequence of steps, including:
- Reactant selection: Specific chemical compounds or intermediates.
- Reaction conditions: Temperature, pressure, solvents, catalysts, or additives.
- Process parameters: Reaction times, pH levels, or purification steps.
For example, an independent claim may state:
"A method for synthesizing compound X, comprising reacting compound A with compound B under conditions C to yield compound X with improved purity and yield."
Or, it might describe a particular catalytic process that reduces impurities or reaction time.
Dependent Claims
Dependent claims narrow the scope by specifying particular embodiments, such as:
- Use of specific catalysts or solvents.
- Variations in reaction temperature or pressure.
- Additional purification or isolation techniques.
- Modified intermediates or alternative reaction pathways.
Claim Strength and Breadth
Chinese patents often aim at balancing breadth with defensibility. The claims likely claim a specific process, with some scope for variations, yet ensuring core innovation remains protected. The breadth of claims directly impacts the patent's ability to deter competitors and support licensing strategies.
Patent Landscape Context
Existing Patents and Similar Technologies in China
The CFD (Chinese Patent Database) reveals a dense landscape of similar patents related to pharmaceutical synthesis—particularly for APIs used in oncology, cardiovascular, or infectious disease treatments. Notable overlaps include patents on:
- Catalytic intermediates for pharmaceutical synthesis.
- Purification methods improving API purity.
- Novel solvents or reaction steps for complex molecules.
Competitive Positioning
CN112638384’s novelty resides in specific process optimizations—possibly innovative catalysts, conditions, or intermediates—that distinguish it from prior art. Its filing date and examination history indicate a focus on securing broad yet defensible claims, relevant given the proliferation of similar patents.
Legal and Strategic Significance
Given China's active patent environment, CN112638384’s strength depends on the novelty and inventive step. It offers potential leverage for pharmaceutical companies or generic manufacturers to control manufacturing processes, defend against infringement, or develop new formulations.
It also forms part of a broader patent portfolio that could encompass diverse synthetic routes or applications related to the core compound.
Implications for Industry and Patent Strategy
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For Innovators: The patent provides a protected process that could streamline manufacturing, reducing costs and time to market.
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For Competitors: The scope may necessitate designing around specific steps or conditions claimed, or pursuing alternative synthesis routes.
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For Patent Holders: Strategic enforcement and licensing negotiations depend on the robustness of claims and the patent’s validity, considering prior art.
Regulatory and Commercial Considerations
The patent’s focus on improved synthesis aligns with Chinese regulatory priorities—higher purity, fewer impurities, and process robustness—facilitating approval pathways for generics or novel drugs.
Conclusion
CN112638384's scope appears centered on a refined synthetic method with specific process parameters, emphasizing efficiency and purity. Its claims are likely carefully crafted to protect key inventive steps while allowing some flexibility. The patent landscape indicates a competitive environment, with ongoing innovation in pharmaceutical synthesis in China.
Key Takeaways
- The patent offers a targeted process innovation with industrial relevance for pharmaceutical manufacturing.
- Its claims, focusing on specific reaction conditions, may be strategically crafted to balance scope and robustness.
- Competition in the Chinese pharmaceutical patent space remains fierce, highlighting the importance of patent strength and diligence.
- The patent supports strategic positioning for manufacturers aiming to optimize production pipelines.
- Continued patent filings in this sector underscore China’s commitment to advancing pharmaceutical synthesis and process innovation.
FAQs
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What types of inventions does CN112638384 claim?
The patent primarily claims a specific synthetic process—detailing reaction steps, conditions, and intermediates—to produce a pharmaceutical compound efficiently and with high purity.
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How does this patent fit into China's broader pharmaceutical patent landscape?
It complements existing innovations focused on API synthesis and purification, contributing to a competitive environment emphasizing process efficiency and quality improvements.
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Can the claims be circumvented by alternative synthesis routes?
While the claims protect specific process steps and conditions, competitors may design around by altering reaction parameters or employing different chemical pathways not covered by the patent.
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What strategic benefits does this patent offer to its holder?
It enables control over the manufacturing process, facilitating licensing, reducing competition in the protected process, and strengthening market positioning.
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How can companies ensure their innovations harmonize with patents like CN112638384?
By conducting thorough freedom-to-operate analyses, exploring alternative synthesis strategies, and monitoring patent claims and legal developments in China.
References
- [1] China National Intellectual Property Administration (CNIPA). Official patent filing and publication records for CN112638384.
- [2] Patent landscape reports on pharmaceutical synthesis innovations in China, available through patent analytics platforms.
- [3] Chinese Patent Law and Examination Guidelines, relevant sections on process claims and inventive step analysis.
