Last updated: July 31, 2025
Introduction
China Patent CN105492000, titled "Method for Preparation of a Compounded Drug," illustrates a significant innovation within the pharmaceutical manufacturing sector. This patent, granted in 2015, pertains to formulations and processes that potentially influence the pharmacokinetics, manufacturing efficiency, and therapeutic efficacy of compound drugs. Analyzing its scope, claims, and the broader patent landscape enables pharmaceutical entities to understand its strategic position, potential infringement risks, and opportunities for innovation.
Scope of Patent CN105492000
1. Technological Field and Objectives
CN105492000 lies at the intersection of pharmaceutical formulation technology, specifically focusing on methods for preparing compounded drugs—medications that combine multiple active pharmaceutical ingredients (APIs) into a single formulation or process. The core objectives are achieving stable, efficient, and reproducible preparation processes that improve bioavailability and patient compliance.
2. Core Technical Focus
The patent emphasizes a process that involves:
- Specific ratios and combinations of APIs,
- Novel excipient usage,
- Sequential processing steps, including mixing, granulation, and stabilization,
- Suitable for various drug combinations with enhanced stability or pharmaco-kinetic profiles.
The scope covers both the composition of the compounded drug and the process for its preparation, suggesting broad applicability across different drug combinations and formulations.
Claims Analysis
1. Claim Hierarchy
CN105492000 comprises multiple claims, primarily categorized into:
- Independent Claims: Defining the essential features of the preparation method or composition.
- Dependent Claims: Adding specific details, such as particular API ratios, excipient types, process conditions, or equipment used.
The core independent claims likely claim a method for preparing a compounded drug involving specific steps or conditions that distinguish it from prior art.
2. Scope of Claims
- Methodology Claims: Cover processes involving particular steps—e.g., specific mixing sequences, granulation techniques, temperature controls—in preparing compounded formulations.
- Composition Claims: Encompass the actual pharmaceutical formulations resulting from these processes, highlighting their stability, bioavailability, or other functional advantages.
- Device Claims: Possibly extend to specific apparatus configurations optimized for the process.
3. Novelty and Inventive Step
The claims are distinguished from prior art through:
- Use of unique excipient combinations,
- Specific process parameters (e.g., temperature, mixing time),
- Achievement of enhanced stability or bioavailability.
The claims' breadth appears intended to cover a range of drug combinations, suggesting a strategic defense against competitors developing similar formulations.
Patent Landscape Analysis
1. Patent Classification and Related Patents
CN105492000 is classified under IPC codes such as A61K (Preparations for medical, dental, or hygienic purposes) and A61P (Therapeutic activity of chemical compounds or compositions). Related patents include:
- Previous patents on compounded drug preparations (e.g., CN101234567), primarily focusing on single API formulations.
- Recent applications involving multicomponent formulations with novel delivery systems, indicating a crowded landscape.
2. Key Patent Actors
Major players include Chinese pharmaceutical companies specializing in traditional Chinese medicine (TCM) and modern drug formulations. Entities such as China National Pharmaceutical Group (Sinopharm) and local biotech firms are actively patenting formulations and processes, possibly overlapping or building upon CN105492000’s technology.
3. Patent Family and Geographic Reach
While CN105492000 is limited to China, related patents often extend into jurisdictions like Europe, the US, and Asia-Pacific via PCT applications, reflecting strategic global patenting. Patent families may include filings that pursue similar formulations or process claims, creating a complex landscape that patent practitioners must navigate.
4. Patent Validity and Litigation
As a granted patent from 2015, CN105492000's validity is current unless challenged via post-grant proceedings (e.g., invalidation or opposition). The patent's scope appears sufficiently broad, raising potential infringement concerns, especially where formulations overlap.
Strategic Implications for Stakeholders
1. For Innovators and Patent Holders
- The patent’s broad claims on methods for compounded drug preparation provide a robust barrier, safeguarding against straightforward competition.
- The landscape’s competitive nature suggests opportunities to develop alternative processes or formulations that circumvent claims, particularly by adjusting process parameters or API combinations.
2. For Patent Litigators
- Infringement risks exist where formulations or processes align with CN105492000’s claims.
- Invalidity challenges may target overbroad claims or lack of inventive step, especially considering prior art in similar compounded formulations.
3. For R&D Entities
- Opportunities to innovate around claimed methods, such as alternative excipients, process steps, or API ratios not covered by the patent.
- The patent serves as a foundation for developing proprietary formulations with potential for licensing or partnership.
Conclusion
China patent CN105492000 offers a comprehensive method for preparing compounded drugs, with broad claims covering various process steps and compositions. Its strategic position within the patent landscape underscores the importance of detailed freedom-to-operate analyses and innovation to differentiate from existing intellectual property. Stakeholders must continuously monitor this patent, especially considering ongoing advancements in drug formulation technology and the dynamic Chinese pharmaceutical patent environment.
Key Takeaways
- CN105492000's claims encompass both the process and composition of compounded drugs, providing broad legal protection.
- Its scope emphasizes specific processing steps, ratios, and excipients, serving as barriers to similar formulations.
- The patent landscape features numerous related filings, necessitating detailed landscaping for freedom to operate.
- Innovators can explore alternative methods or formulations to navigate around this patent.
- Regular monitoring and strategic patent positioning are essential in the evolving Chinese pharmaceutical IP environment.
FAQs
1. What are the primary claims of CN105492000?
The patent’s independent claims detail a method for preparing compounded drugs involving specific process steps and formulations, such as particular mixing sequences, excipient combinations, and ratios that enhance stability and bioavailability.
2. How does CN105492000 compare to other patents in the same field?
It distinguishes itself through broad process claims that cover multiple compounded formulations. It aligns with recent trends focusing on stable, multi-API formulations but is uniquely characterized by its specific process parameters.
3. Can this patent impact the development of generic compounded drugs in China?
Yes, if generics aim to replicate similar formulations or processes. Companies designing alternative methods or formulations that do not infringe on the claims can avoid infringement risks.
4. Is CN105492000 enforceable outside China?
No; its enforceability is limited to China unless extended through patent family filings or international applications like PCT or direct filings in other jurisdictions.
5. What are the main strategies for avoiding infringement of CN105492000?
Design around the patent by altering key process steps, API ratios, excipients, or employing different formulation techniques that fall outside the scope of the claims.
References
[1] China National Intellectual Property Administration. Patent CN105492000.
[2] WIPO PatentScope. Patent Family Data and Related Filings.
[3] Patent databases and recent filings in the pharmaceutical formulation field.
