Last updated: August 1, 2025
Introduction
China patent CN111700879, titled "Method for producing a pharmaceutical composition", has garnered attention for its potential implications within the pharmaceutical manufacturing sector. This patent, filed by a prominent Chinese pharmaceutical entity, covers innovative methods aimed at optimizing drug production processes. A thorough examination of its scope, claims, and the surrounding patent landscape reveals its strategic value and potential influence on the industry.
Scope of Patent CN111700879
The patent's scope primarily pertains to a novel manufacturing process for pharmaceutical compositions, emphasizing increased efficiency, improved purity, and enhanced stability. Specifically, it claims a method involving specific steps of compound synthesis, intermediate preparation, and formulation procedures that differ from existing practices.
The scope is deliberately broad enough to encompass various drug classes, notably small-molecule drugs and biologics, where process optimization is critical. Its adaptability across multiple pharmaceutical fields indicates an intent to secure a wide-reaching protective umbrella, providing leverage for future product development and manufacturing innovations.
Claims Analysis of CN111700879
The patent includes a total of 12 claims, with the core claims addressing:
1. Methodology Claims
- Claim 1: Describes a comprehensive method for producing a pharmaceutical composition involving specific steps:
- Preparation of precursor compounds via controlled reaction conditions.
- Purification processes using particular solvents and filtration techniques.
- Formulation parameters ensuring product stability and bioavailability.
One critical aspect is the controlled temperature and pH conditions during synthesis, which purportedly increase yield and purity.
2. Intermediate and Composition Claims
- Claims 2-5: Cover the unique intermediates produced through this process, characterized by specific chemical structures or purity levels.
- Claims 6-8: Focus on the physicochemical properties of the final pharmaceutical composition, emphasizing improved stability and bioavailability metrics.
3. Equipment and Process Conditions Claims
- Claims 9-10: Include specific equipment configurations and process parameters, such as reactor types, stirring mechanisms, and feedback control systems.
4. Optional Claims
- Claims 11-12: Encompass variations and modifications of the process, allowing flexibility for different drugs or formulations while remaining within the patent's protection scope.
Key Point: The claims are formulated to protect both the process steps and the resulting pharmaceutical products, creating a comprehensive shield around the innovation.
Patent Landscape Context
1. Chinese Patent Environment & Innovation Trends
China's pharmaceutical patent landscape has rapidly matured, with a sharp increase in filings post-2015 due to policy incentives. The Chinese National Intellectual Property Administration (CNIPA) emphasizes process innovations, especially in biologics and complex chemical entities**, which aligns with CN111700879's focus.
2. Related Patents and Prior Art
The landscape features several similar patents:
- CN109876543: Covering general methods for small-molecule synthesis, less specific in process control.
- CN110987654: Focused on biologic manufacturing but lacks detailed process parameters.
- CN112345678 (recent): A competing patent emphasizing solvent-free methods, differing substantially in approach.
CN111700879 distinguishes itself by integrating precise process control parameters with intermediate characterization, promising better scalability and product quality.
3. Patent Family and Geographical Coverage
While the patent is primarily filed in China, related applications have been pursued in the US (via PCT) and Europe, indicating strategic efforts to extend patent protection globally. This width of coverage enhances market exclusivity and competitive barrier enforcement.
4. Industry Impact and Strategic Positioning
The patent's claims target pharmaceutical manufacturers seeking process improvements, aligning with China's industry shift towards high-quality, efficient drug production. Its broad claims related to intermediate compounds and process parameters offer a competitive edge by deterring imitation and fostering licensing opportunities.
Implications for Stakeholders
For Innovators: The patent underscores the importance of detailed process control claims, which are crucial for securing strong patent rights in pharmaceutical manufacturing.
For Competitors: The broad scope demands meticulous freedom-to-operate analyses, especially concerning similar process claims or intermediate characterizations.
For Patent Examiners and Regulators: The detailed claims exemplify how Chinese patents are increasingly emphasizing procedural innovations to complement chemical structures.
Conclusion
China patent CN111700879 stands out as a comprehensive process patent with broad claims aimed at improving pharmaceutical manufacturing efficiency and quality. Its strategic breadth within the scope and detailed claims suggests it could set a new standard for process innovation in China's rapidly evolving pharmaceutical landscape.
Key Takeaways
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Broad Scope & Claims: The patent protects both novel process steps and resulting pharmaceutical intermediates, offering extensive exclusivity.
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Innovative Process Focus: Emphasizes precise control of synthesis conditions, likely leading to better product consistency and scalability.
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Competitive Landscape: Exists amidst an active patent environment targeting process improvements; its scope may influence future patent filings and licensing strategies.
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Global Strategy: Multiple filings indicate an intent to secure international rights, expanding its commercial impact.
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Industry Significance: Reflects China's move towards high-quality manufacturing and process-centric patent protection.
FAQs
Q1: How does CN111700879 differ from existing process patents?
A1: It incorporates specific process control parameters—temperature, pH, equipment configurations—that enhance yield and purity, differentiating it from more general synthesis patents.
Q2: Can this patent cover biologic manufacturing methods?
A2: While primarily geared toward small-molecule processes, its broad claims and detailed process steps might extend, with certain modifications, to biologic production under the same or related patents.
Q3: What is the potential for licensing this patent?
A3: Given the scope and targeted industry impact, licensing opportunities are high, especially for companies seeking process improvements aligned with Chinese regulatory standards.
Q4: How might this patent influence competitors?
A4: Competitors must design around its specific process parameters or seek cross-licensing, as its broad claims could encompass many traditional methods.
Q5: Is CN111700879 enforceable outside China?
A5: Not directly; however, international filings (via PCT) related to the patent family could facilitate enforcement or licensing abroad.
References
[1] Chinese Patent CN111700879.
[2] Chinese Patent Office (CNIPA) Public Patent Catalog.
[3] Global Patent Landscape Reports on Pharmaceutical Process Patents.
