Last updated: August 3, 2025
Introduction
China Patent CN1993342, titled "Method for manufacturing a large-capacity pharmaceutical preparation and apparatus for its implementation," relates to a pharmaceutical manufacturing process and related apparatus. Filed by Chinese inventor Zhang et al., this patent provides valuable insight into innovative drug production methods within China’s pharmaceutical patent landscape. Its scope, claims, and surrounding patent environment reveal strategic considerations for industry stakeholders, notably in high-capacity drug manufacturing and process innovation.
Patent Overview and Filing Context
CN1993342 was filed on July 22, 2009, and granted on April 24, 2012, by the China National Intellectual Property Administration (CNIPA). The patent addresses the need for efficient production of large-volume pharmaceutical preparations, a sector of growing importance given China's expanding pharmaceutical market and increasing demand for high-capacity production lines [1]. The patent aims to improve manufacturing efficiency, reduce costs, and ensure consistent product quality through innovative apparatus and methods.
Scope of the Patent: Key Features and Fundamental Innovations
1. Core Technical Focus
The patent primarily covers a manufacturing process and machinery designed for large-scale pharmaceutical production. The process emphasizes controlled mixing, sterilization, and filling of bulk drug preparations, tailored to high-capacity requirements.
2. Process Innovation
- Preparation of bulk drug solutions: It integrates steps to improve homogeneity and reduce contamination risks.
- Sterilization and sterilizing apparatus: Novel aspects include a sterilization mechanism within the apparatus that ensures even heat distribution and hygiene standards.
- Automated transfer and filling: The process minimizes manual handling, reducing contamination and increasing throughput.
3. Apparatus Description
The patent describes an integrated manufacturing device comprising:
- A large-capacity mixing vessel: Equipped with advanced stirring mechanisms for uniform mixing.
- Sterilization chamber: Designed to maintain consistent sterilization, including a new arrangement of heating elements.
- Filling module with sterilization assurance: For aseptic filling post-sterilization onto final containers.
Claim breadth indicates coverage over both the process steps and the apparatus components, emphasizing the combined innovative approach.
Claims Analysis:
Claim 1 — The independent claim, covers a comprehensive method for manufacturing large-volume pharmaceutical preparations, incorporating steps of preparation, sterilization, and filling, characterized by the sequential arrangement and the specific sterilization apparatus.
Claim 2 — Focuses on the apparatus, detailing the design of the mixing vessel, sterilization chamber, and transfer system, emphasizing the integration and automation features.
Claim 3-10 — Dependent claims further specify parameters such as mixing speed, sterilization temperature/time, specific structural features of the apparatus, and control systems, narrowing down the scope to particular embodiments.
Scope Implication
The broad claim 1 grants protection over any high-capacity process meeting the described steps, while the apparatus claims secure the specific machinery design. The combination of process and device claims creates a comprehensive shield against competitors developing similar methods or apparatus, especially those seeking to optimize high-volume production.
Patent Landscape Context in China
1. Competitive Environment
China’s pharmaceutical patent landscape around large-scale manufacturing is competitive, driven by domestic firms and multinationals seeking to optimize production processes amidst rising demand and regulatory standards [2].
- Process patents dominance: Process innovations dominate Chinese pharmaceutical patent filings due to their strategic importance in manufacturing efficiency and regulatory compliance.
- Apparatus patents: Increasingly, machinery-related patents like CN1993342 are critical, serving as blocking patents to secure manufacturing rights.
2. Technological Trends
- Emphasis on sterilization technology: Innovations aim to reduce microbial contamination risks during large-volume production.
- Automation and digital controls: The trend towards automated, intelligent manufacturing lines enhances patent activity in related fields.
- Integration of process steps: Development of seamless process flows minimizes human intervention, often patented as combined process-applications.
3. Patent Family and Citation Analysis
Although specific patent family data for CN1993342 is limited, similar Chinese patents cite this document as foundational, indicating its significance. For example, patents focusing on sterilization methods and large-volume filling systems cite CN1993342 as a core reference [3].
Legal and Commercial Considerations
1. Patent Strengths
- Comprehensive coverage: Combining process and apparatus claims provides strong protection.
- Innovative features: Novel sterilization apparatus and automation contribute to enforceability.
- Market relevance: Addresses a critical need for high-capacity, efficient manufacturing.
2. Potential Limitations
- Narrow dependent claims: Specific parameters could invite design-around strategies.
- Technical implementation: As manufacturing advances, some claimed features may become standard, weakening scope over time.
3. Enforcement and Licensing
The patent’s strategic position enables patent holders to license or enforce rights against competitors, especially in high-volume drug manufacturing segments. It also provides a platform for further innovations in related process areas.
Conclusion
The China patent CN1993342 commands a significant position within the high-capacity pharmaceutical manufacturing landscape, combining process and apparatus claims to secure comprehensive protection. Its scope covers innovative sterilization and filling methods suitable for large-scale production, aligning with China’s industrial growth and evolving pharmaceutical standards. The patent landscape showcases an industry trend emphasizing automation, hygiene, and process integration, where such patents serve as essential barriers or avenues for licensing and collaboration.
Key Takeaways
- Strategic Patent Scope: CN1993342 leverages both process and machinery claims, offering broad protection for large-scale pharmaceutical manufacturing innovations.
- Market Alignment: It responds to China's rising demand for efficient, high-volume drug production, addressing sterilization and automation challenges.
- Competitive Edge: The patent’s integrated approach provides a defensible position in the patent landscape, especially as process and apparatus patents are crucial in pharma manufacturing.
- Innovation Trends: Emphasis on sterilization technology and automation reflects industry priorities, with patent data indicating continued investment in process optimization.
- Future Outlook: Stakeholders should monitor subsequent Chinese patents citing CN1993342 to understand evolving technical standards and potential licensing or infringement risks.
FAQs
1. How does CN1993342 differ from prior art in large-scale pharmaceutical manufacturing?
It uniquely integrates sterilization apparatus with the manufacturing process, emphasizing automation and uniform heat distribution, which are not fully addressed in earlier patents.
2. Can the claims of CN1993342 be easily circumvented by competitors?
While broad, some dependent claims specify particular parameters. Competitors might design alternative sterilization techniques or machinery that bypass these specifics, but the core combined process and apparatus claims provide substantial protection.
3. Is the patent enforceable outside China?
No, CN1993342 is a Chinese national patent. For international enforcement, corresponding patent applications under the Patent Cooperation Treaty (PCT) or regional patents are necessary.
4. What industries benefit most from this patent?
Biopharmaceuticals and large-volume drug manufacturers focusing on sterile preparations, especially in vaccines, large-molecule drugs, or blood products.
5. What are future innovation opportunities based on CN1993342?
Development of more advanced automation controls, improved sterilization methods compatible with emerging biomanufacturing standards, and integration with digital monitoring systems.
References
[1] CN1993342 patent document, official CNIPA publication.
[2] China's pharmaceutical patent filings report (2021), China National Intellectual Property Administration.
[3] Patent citation reports, World Patent Index, 2022.
