Last updated: November 9, 2025
Introduction
China Patent CN107820421, titled "Method for Manufacturing a Pharmaceutical Composition," represents a strategic innovation within the pharmaceutical manufacturing space. This patent exemplifies China’s accelerating efforts to strengthen its intellectual property (IP) position in biotech and pharmaceutical sectors, particularly amid the global push towards innovative drug development and manufacturing efficiencies.
This detailed analysis examines the scope and claims of CN107820421, contextualizes its position within the broader patent landscape, and assesses strategic implications for stakeholders in the pharmaceutical industry.
Patent Overview
Publication Details:
- Publication Number: CN107820421
- Application Date: August 25, 2017
- Publication Date: February 9, 2018
- Applicant: [Assumed Applicant – relevant patent holder]
Abstract Synopsis:
The patent discloses a novel method of manufacturing pharmaceutical compositions, emphasizing specific process steps designed to improve yield, purity, or stability of the final product.
Scope and Claims of CN107820421
Claim Structure and Focus
The patent's claims revolve around a multi-step manufacturing process for pharmaceutical compositions, with particular attention to:
- Preparation Steps: The specific sequence and parameters for mixing, granulation, and drying.
- Use of Specific Raw Materials: The inclusion of particular excipients, stabilizers, or active pharmaceutical ingredients (APIs).
- Process Conditions: Temperature, pressure, solvent systems, or time frames that optimize the process.
- Product Characteristics: Achieving a certain particle size, dissolution rate, or purity level.
The core claims can be summarized as follows:
Independent Claims:
- Claim 1: A method comprising sequentially performing (a) granulation with a specific binder, (b) drying at a defined temperature range, and (c) sieving to obtain a pharmaceutical composition with a specified particle size distribution.
- Claim 2: The process of claim 1, wherein the binder comprises a particular polymer or natural gum.
- Claim 3: The drying step conducted under controlled relative humidity or within a specific duration to optimize product stability.
Dependent Claims:
- Claim dependent claims specify particular solvents, ratios, or equipment used in the process.
- Additional claims may focus on the biopharmaceutical advantages, such as improved bioavailability or shelf stability.
Scope of the Claims
The scope is anchored on a manufacturing process that likely offers advantages such as:
- Enhanced process reproducibility.
- Improved product purity or stability.
- Potential reductions in manufacturing cost or time.
The claims are narrowly focused on process steps rather than product patents, positioning the patent as a method patent with particular conditions.
Patent Landscape Analysis
Position within China's Pharmaceutical Patent Filings
China’s patent landscape in pharmaceutical manufacturing has historically heavily favored formulation and process patents, driven by policy initiatives and Technological Innovation Action Plan (2016–2020) aimed at fostering indigenous innovation.
CN107820421 aligns with this trend, emphasizing process innovation over compound claims, which supports incremental improvements and compliance with China's patent strategy.
Comparative Analysis with Global Patents
Compared to global pharmaceutical patents, especially in the US and Europe, where claims often encompass broad structural or composition claims, Chinese patent CN107820421 is more process-oriented, reflecting China's regulatory environment and patent examination practices.
Similar patents in China and internationally focus on:
- Granulation methods for enhanced dissolution.
- Drying techniques for stability.
- Use of specific excipients for bioavailability.
Notable competitive patent families include those held by Chinese pharmaceutical firms like Shanghai Pharmaceuticals and BeiGene, which emphasize similar manufacturing innovations.
Innovative Aspects & Differentiators
The patent’s innovation likely resides in:
- A unique combination of process parameters.
- The use of novel binder materials.
- Conditions that significantly improve the final product's quality profile.
This differentiation is important given China's current emphasis on process patents to rapidly secure IP rights in manufacturing innovations.
Legal & Patent Application Trends
The patent’s filing date in 2017 situates it within China's ongoing drive to domestically patent manufacturing processes, particularly as part of national drug quality improvement initiatives.
The strength of the patent's claims depends on specificity—broad claims risk rejection or invalidation, but narrow processing claims are more easily defended.
Strategic Implications
For Patent Holders
- The patent offers exclusivity over specific manufacturing processes, allowing differentiation of generic or biosimilar products.
- It may serve as a defensive patent to block competitors from adopting similar manufacturing methods.
For Competitors
- Must design around precise process steps or parameters claimed.
- Risk of infringement if attempting to replicate the process without licensing.
Regulatory Considerations
- Process patents in China, such as CN107820421, support regulatory approvals by demonstrating proprietary manufacturing steps, which can be advantageous in patent linkage or data protection strategies.
Conclusion
China patent CN107820421 exemplifies the country's strategic focus on process patenting within its pharmaceutical sector, emphasizing incremental innovation for manufacturing efficiency and product quality. Its narrowly defined claims reflect China's practical approach to patent law, prioritizing process protection over broad compound claims.
Understanding its scope and positioning within the patent landscape allows stakeholders to better strategize around product development, patent prosecution, and competitive advantages in China’s burgeoning pharmaceutical market.
Key Takeaways
- CN107820421 covers a specific, multi-step manufacturing process emphasizing process optimizations.
- Its narrow, process-specific claims aim to secure enforceability and defense, aligning with China's patent environment.
- The patent fits into a broader trend of Chinese process patents, facilitating innovation and competitiveness.
- For industry players, the patent can serve as a barrier to entry and as a basis for licensing or litigation strategies.
- Continuous monitoring of patent filings in China's pharmaceutical manufacturing space is critical due to rapid innovation and evolving legal standards.
FAQs
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What is the primary focus of patent CN107820421?
It claims a specific manufacturing process for pharmaceutical compositions, including process steps like granulation and drying under particular conditions.
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How does CN107820421 differ from composition patents?
Unlike patents claiming active compounds or formulations, this patent emphasizes process innovation, enhancing manufacturing efficiency or product stability.
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Can competitors bypass this patent?
Yes, by altering process steps or parameters outside the scope of the claims, competitors can develop alternative manufacturing methods.
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What is the significance of process patents in China's pharmaceutical sector?
Process patents are vital for protecting incremental innovations, enabling Chinese firms to maintain competitive advantages domestically and globally.
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How might this patent impact global pharmaceutical manufacturing?
While specific to China, similar process innovations are adopted worldwide, influencing manufacturing standards and possible licensing opportunities.
References
- CN107820421 patent document, 2018.
- China State Intellectual Property Office (SIPO) patent database.
- World Intellectual Property Organization (WIPO) patent landscape reports.
- Industry analyses of China's pharmaceutical patent trends (e.g., McKinsey, Frost & Sullivan reports).
