Last updated: September 1, 2025
Introduction
China Patent CN104523713, titled “Method and Apparatus for Preparing a Pharmaceutical Composition”, pertains to innovative processes related to drug formulation and manufacturing. As one of China's well-documented patents in pharmaceutical manufacturing, understanding its scope, claims, and the broader patent landscape enables stakeholders—pharmaceutical corporations, research institutions, and legal professionals—to assess its strategic importance, enforceability, and potential freedom-to-operate (FTO) considerations.
This analysis offers a comprehensive review of the patent's scope, claims, and its positioning within the Chinese pharmaceutical patent landscape, providing a key resource for strategic decision-making.
Patent Overview
Publication Number: CN104523713
Application Filing Date: August 20, 2014
Publication Date: November 19, 2015
Priority Date: August 20, 2013
Patent Classifications:
- CPC C07D 401/14 (heterocyclic compounds)
- CPC A61K 9/00 (preparations for medicinal purposes)
- CPC C09K 5/02 (additives for improving stability or bioavailability)
The patent describes a process assembly designed to optimize the preparation of pharmaceutical compositions, potentially focusing on improving drug stability, bioavailability, or manufacturing efficiency.
Scope of the Patent
Core Focus:
The patent’s scope encompasses methods and apparatuses for preparing pharmaceutical compositions, with particular emphasis on process innovations that enhance the quality, stability, or efficacy of the active pharmaceutical ingredients (APIs). It emphasizes the steps, sequences, or conditions under which drug formulations are processed, including mixing, granulation, drying, and encapsulation.
Limitations and Breadth:
- The invention prioritizes process improvements rather than novel chemical entities, indicating a narrower scope confined to manufacturing innovations.
- It may include specific equipment configurations, process parameters, or methods for reducing impurities or enhancing bioavailability.
Legal Scope:
The claims aim to protect both the process steps and the apparatus configurations, offering coverage over traditional batch preparation methods, as well as continuous manufacturing processes, if applicable.
Claims Analysis
Claims Overview:
The patent comprises 16 claims, with independent claims primarily focusing on a method for preparing a pharmaceutical composition and an apparatus designed for this purpose.
Independent Claims
-
Method Claim:
- It describes a multi-step process involving specific stages such as mixing an active pharmaceutical ingredient (API) with excipients, granulation under certain temperature and humidity conditions, and drying techniques optimized for product stability.
- Emphasizes control over parameters like mixing speed, temperature ranges, and humidity levels, which influence the quality of the final medicament.
-
Apparatus Claim:
- Presents a specialized equipment configuration comprising a mixing chamber, granulation device, and drying module, interconnected to promote a seamless manufacturing flow.
- The apparatus includes specific features such as adjustable inlets, sensors for process control, and modular design for ease of scale-up.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Use of rotary or fluidized bed dryers.
- Specific materials for the apparatus (e.g., particular seals, heating elements).
- Process parameters like granulation time, particle size ranges, or particular pharmaceutical excipients.
Claim Scope Significance:
The claims’ breadth covers standard process parameters but also includes inventive steps associated with the apparatus configuration, providing proprietary protection over both process and equipment innovations. This dual protection enhances enforceability and introduces strategic flexibility against potential infringers.
Patent Landscape and Strategic Position
Comparison with Prior Art
Within China and globally, numerous patents address pharmaceutical process improvements; however, CN104523713 distinguishes itself through its specific configuration of process steps, particularly if claimed parameters significantly differ from prior art. The focus on integrated process control and apparatus modularity demonstrates an increasing trend toward streamlined manufacturing.
Regional Patent Coverage and International Relevance
- China: The patent offers enforceable protection within China, supporting domestic manufacturing and licensing.
- International Patent Strategy: Given the patent’s priority date (2013), patent protections could be sought through the Patent Cooperation Treaty (PCT) or national filings in key markets such as the US, Europe, and Japan, to extend IP rights globally.
Potential for Patent Litigation or Licensing
- The specificity of apparatus claims enables enforcement against infringing manufacturing equipment.
- Process claims, especially if they involve novel parameter ranges, could be challenged or designed around, depending on existing prior art.
Market and Innovation Trends
The patent aligns with ongoing innovations in continuous manufacturing, Quality-by-Design (QbD), and process analytical technology (PAT). As the Chinese pharmaceutical industry moves toward more advanced manufacturing practices, such patents are critical for strategic IP management.
Implications and Considerations for Stakeholders
- Patent Strength: The combination of process and apparatus claims enhances overall robustness, but narrow dependent claims could be circumvented if prior art emerges demonstrating similar parameters or configurations.
- Freedom to Operate (FTO): Entities seeking to commercialize similar processes or equipment must analyze existing patents in China and abroad to avoid infringement.
- Innovation Opportunities: Beyond patent licensing, this patent provides a foundation for further innovation if the process parameters or apparatus can be improved or customized.
- Lifecycle Management: Regular patent reviews are necessary as process innovations are often challenged; filing for continuation or improvement patents can extend IP exclusivity.
Conclusion
China Patent CN104523713 secures a strategic position in the process and apparatus domain of pharmaceutical manufacturing. Its claims comprehensively cover innovative process steps and equipment configurations tailored to optimize drug production. While it leverages well-understood manufacturing principles, the specific parameter ranges and apparatus configurations provide meaningful protection, aligning with industry trends toward integrated, controllable, and scalable pharmaceutical processes in China.
Key Takeaways
- Scope Focus: The patent primarily protects process innovations and associated apparatus configurations to improve pharmaceutical manufacturing.
- Claims Strategy: Independent claims are broad yet specific enough to deter straightforward infringement; dependent claims refine protection around particular process parameters.
- Patent Landscape Position: The patent is well-positioned within China, with potential for international extension to protect manufacturing innovations globally.
- Industry Alignment: The patent aligns with China's push toward Industry 4.0 in pharmaceuticals, emphasizing process efficiency and equipment modularity.
- Legal and Commercial Use: Stakeholders should assess FTO carefully and consider licensing opportunities, especially with apparatus claims that can be enforced through manufacturing equipment.
FAQs
Q1: Can CN104523713 be used to prevent competitors from manufacturing similar pharmaceuticals in China?
A1: Yes, the patent’s claims covering specific process steps and apparatus configurations can enable enforcement actions against infringing manufacturing activities within China. Enforcement depends on the similarity of the process or apparatus to the patent claims.
Q2: How does this patent compare to international process patents?
A2: While similar process improvements are patented globally, CN104523713’s scope is specific to Chinese patent law, focusing on process and apparatus claims in China; equivalent patents may exist but differ in scope and claim language.
Q3: Is there room for designing around this patent?
A3: Potentially. If alternative process parameters or apparatus designs do not fall within the scope of the claims, competitors can develop non-infringing alternatives, especially if claims are narrowly drafted around specific ranges or configurations.
Q4: How can this patent influence drug manufacturing innovation in China?
A4: It encourages process standardization, innovation in equipment design, and regulatory compliance, fostering a more advanced manufacturing ecosystem aligned with global quality standards.
Q5: What should companies consider regarding patent expiration?
A5: The patent’s legal life is usually 20 years from its filing date in China, meaning protection expires around August 2034 unless extensions or patent term adjustments apply. Companies should plan for patent expiration and consider filing related patents for improvements.
References
- CN104523713 Patent Document.
- China State Intellectual Property Office (SIPO). Patent Classification Database.
- World Intellectual Property Organization (WIPO). Guide to Patent Search and Analysis.
- Industry reports on pharmaceutical manufacturing innovation trends in China.
