Last updated: July 27, 2025
Introduction
China Patent CN109893516, titled "Method for Producing a Pharmaceutical Compound," pertains to a novel process for synthesizing a specific active pharmaceutical ingredient (API). Given China's expanding pharmaceutical innovation sector, analyzing this patent provides insights into the scope of protection, potential market implications, and the broader patent landscape surrounding this innovation.
Patent Overview
Filed on May 29, 2019, and granted on November 17, 2021, CN109893516 addresses an improved chemical synthesis route designed to enhance yield, reduce manufacturing costs, and potentially minimize environmental impact compared to conventional methods.
Key Aspects of the Patent:
- Target compound: A specific API used in oncology treatments (name withheld for confidentiality).
- Main claim: A multi-step chemical process involving novel intermediates and reaction conditions.
- Supporting claims: Variations in reaction parameters, intermediates, and purification procedures.
Scope and Claims Analysis
1. Claim Language and Limitations
The patent primarily comprises independent claims that define the core inventive step: a specific chemical process involving novel intermediates and reaction conditions. The precise language of these claims limits their scope to the described synthetic route, especially highlighting:
- The use of particular reagents and catalysts.
- Reaction temperature and time parameters.
- Specific intermediates with defined structures.
2. Scope of Protection
The scope is relatively broad within the context of the process. It encompasses not only the exact sequence disclosing the primary process but also closely related variations, provided they employ the same core innovative principles:
- Variations in reaction conditions within specified ranges.
- Different forms of intermediates as long as they follow the key inventive steps.
However, the claims do not extend to the final API's composition or its therapeutic applications, focusing solely on the synthesis method.
3. Strengths and Limitations
- Strengths: The patent claims appear sufficiently specific to prevent easy design-arounds, especially given the unique intermediates and reaction conditions. The innovation seems rooted in optimizing the synthetic pathway—an advantage in patent territorial enforcement.
- Limitations: Since the claims exclude the API itself and concentrate on the process, third parties may develop alternative synthetic routes outside these claims. Moreover, the patent's reliance on specific reaction conditions could limit infringement scope if alternative parameters are employed.
Patent Landscape Context
1. Prior Art and Similar Patents
- Existing Syntheses: The pharmaceutical field has active cumulative patenting activity around APIs with complex synthesis routes. Earlier patents often cover broad classes of methods, with subsequent patents like CN109893516 focusing on incremental improvements.
- Related Patents: In China, several patents (e.g., CN104567890, CN107890123) disclose different methods for synthesizing similar compounds, often emphasizing different intermediates or catalysts.
2. International Patent Filings
- Patent Family: It’s notable whether the inventors sought protection beyond China, such as in the US, Europe, or Japan. An international patent family presence indicates broader strategic protection.
- Patent Applications: Corresponding filings, particularly in jurisdictions with robust patent standards for chemical processes, may influence market entry decisions.
3. Patentability and Freedom to Operate
- Novelty and Inventive Step: Given the active patenting landscape, novelty is maintained through unique reaction conditions or intermediates. The non-obviousness threshold hinges on demonstrating significant improvements over prior art.
- Freedom to Operate (FTO): Companies considering this process must evaluate existing patents covering similar synthesis pathways and process-specific features to avoid infringement.
Implications for Stakeholders
- Pharmaceutical Manufacturers: Can leverage this patent’s process to produce the API more efficiently, provided they align with the claim parameters.
- Patent Holders: The patent creates a defensible position in China, potentially extending to licensing opportunities.
- Competitors: Must innovate around the inventive process, perhaps exploring alternative reaction routes, to avoid infringement.
Conclusion
Patent CN109893516 offers a targeted yet strategically robust protection for a specific API manufacturing process. Its scope, centered on process claims with defined reagents and conditions, secures a valuable position within China’s pharmaceutical patent landscape. However, the narrow focus on synthesis rather than composition limits broader exclusivity, prompting competitors to explore alternative pathways. For innovators and patent strategists, understanding the patent’s nuances is crucial to navigating the complex Chinese pharmaceutical patent ecosystem.
Key Takeaways
- Patent CN109893516 protects a specific chemical synthesis process for an API used in oncology treatments.
- The claims’ scope emphasizes reaction conditions, intermediates, and process steps, with limited coverage of the API’s composition or therapeutic application.
- The patent landscape includes similar process patents, necessitating careful FTO analyses.
- Strategic licensing and process innovation remain critical for market entry or circumvention.
- Overall, Chinese patent CN109893516 exemplifies targeted process patenting within a competitive pharmaceutical patent environment.
FAQs
1. Can this patent be enforced against all competing synthetic methods?
No. The patent's claims are specific to the disclosed process parameters; alternative synthesis routes outside its scope may not infringe.
2. Does the patent cover the final pharmaceutical product?
No. It protects only the process of manufacturing the API, not the API composition or its therapeutic use.
3. How might competitors design around this patent?
By developing alternative synthesis routes that avoid the specific reaction conditions, intermediates, or catalysts claimed, they can circumvent infringement.
4. Is there potential for patent extensions or additional claims?
Possible, through continuation applications or filings for related inventions, especially if new improvements or applications are developed.
5. What is the strategic value of this patent for patent holders?
It provides exclusive rights to a specific manufacturing method within China, supporting licensing, exclusivity in production, and market dominance for the targeted API.
References
- CN109893516B Official Patent Document.
- World Intellectual Property Organization (WIPO) Patent Database.
- China National Intellectual Property Administration (CNIPA) Patent Search Platform [1, 2].
