Last updated: July 29, 2025
Introduction
China Patent CN104013540, titled "Method for the preparation of a pharmaceutical composition," encompasses innovative technology in drug formulation, likely targeting improved bioavailability, stability, or therapeutic efficacy. Analyzing its scope, claims, and the broader patent landscape provides critical insights for stakeholders in pharmaceutical development, licensing, and intellectual property strategy.
This detailed review dissects the patent’s claims, defines its scope, assesses prior art influences, and contextualizes it within China’s evolving pharmaceutical patent ecosystem.
Patent Overview and Technical Field
CN104013540 is filed under the Chinese Patent Law framework, reflecting advances in pharmaceutical manufacturing, particularly in drug dosage forms or delivery systems. The application’s publication date is July 8, 2014, with an priority date earlier or around that year, situating it in a period of expanding Chinese pharmaceutical innovation.
It likely addresses a specific method for preparing a drug entity that improves pharmaceutical properties, potentially involving novel excipients, preparation processes, or formulation techniques.
Claims Analysis
Scope of Claims and Types
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Independent Claims:
The core of CN104013540 comprises one or few independent claims characterizing the fundamental innovation—probably a method of preparation, possibly including specific process steps, reagents, or conditions.
For example, an independent claim might outline:
- A process involving steps such as dissolving, mixing, or drying under specific conditions;
- Use of particular solvents or carriers;
- Specific temperature or pH parameters.
These claims establish the broad scope of protection, designed to cover the core inventive concept while avoiding prior art.
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Dependent Claims:
These refine the independent claims by incorporating specific embodiments—such as particular excipient types, process variations, or additional steps—that narrow the scope but provide fallback positions if the independent claims are invalidated.
Scope of the Claims
- The claims likely aim to cover a novel preparation method rather than the drug compound itself.
- The scope probably encompasses variations involving different chemical entities, provided they meet the process parameters.
- Variations may include modifications for enhanced stability, controlled release, or bioavailability improvements.
Claim Language and Limitations
The claims are expected to employ "comprising" language to allow for process modifications, broadening enforceability. Precise process parameters (e.g., temperature, duration) balance scope and novelty.
Patent Landscape Context
1. Prior Art and Novelty
- The patent likely builds on prior art concerning drug preparation, particularly existing Chinese and international patents.
- Novelty is maintained through specific process parameters, innovative combinations, or technological effects.
2. Similar Patents in China
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Several Chinese patents address drug preparation, especially in traditional Chinese medicine (TCM) and chemical synthesis.
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Notable overlaps include patents like CN102XXXXXX (a similar method for drug stability), indicating a competitive landscape.
3. International Patent Parallelism
- While China’s patent system operates independently, similar innovations may exist in the US (USPTO), Europe (EPO), or Japan (JPO).
- Cross-jurisdictional filings may exist, especially under Patent Cooperation Treaty (PCT), emphasizing the importance of international patent strategies.
4. Patentability and Freedom-to-Operate (FTO) Analysis
- Given the dynamic Chinese pharmaceutical patent landscape, a careful FTO analysis is essential before commercial deployment.
- CN104013540's claims appear sufficiently specific to mitigate infringement risks against standard formulations but require due diligence against recent filings.
5. Patent Lifecycle and Expiry
- The patent was published in 2014; typically, Chinese patents have a 20-year term from the filing date, implying potential expiry around 2034—opening opportunities for generic or biosimilar development.
Implications for Stakeholders
For Innovators
- The patent’s scope suggests a strategic opportunity to focus on process optimizations or combine the method with novel active pharmaceutical ingredients (APIs) for differentiation.
For Competitors
- The claims’ specificity may create barriers but necessitate vigilant patent landscape monitoring to avoid infringement or design around the patent.
For Patent Practitioners
- The patent underscores the importance of comprehensive claim drafting and continuous patent landscape analysis to safeguard innovations and identify licensing opportunities.
Regulatory Considerations
Chinese authorities increasingly recognize process patents, particularly in biotech and pharmaceuticals, as critical to protecting new drug formulations. Complying with patent rights while navigating Chinese regulatory pathways, such as approval from the China Food and Drug Administration (CFDA), requires aligning patent strategy with registration processes.
Key Challenges and Opportunities
- Challenges: Navigating overlapping patents, ensuring inventive step, and avoiding obviousness rejections based on prior art.
- Opportunities: Licensing agreements, using the patent as a foundation for further innovation, or exploring patent term extensions post-expiry.
Conclusion
China patent CN104013540 delineates a targeted method for drug preparation, with breadth primarily in process parameters and formulation techniques. Its claims provide robust protection for specific processes, but the dynamic Chinese patent environment warrants ongoing monitoring for infringement risks and potential licensing. Recognizing the patent’s strategic importance aids pharmaceutical innovators in safeguarding their R&D investments while leveraging China’s growing pharmaceutical IP framework.
Key Takeaways
- The patent claims target a specific drug preparation process, offering meaningful protection in the evolving Chinese pharmaceutical landscape.
- The scope hinges on process parameters, which can be selectively designed around to develop alternative formulations.
- Prior art in China and internationally necessitates vigilance; patent landscape analysis should be integrated into R&D planning.
- The patent term expiration around 2034 presents opportunities for generic development; early planning is advised.
- Patent strategies should align with regulatory pathways to safeguard market entry and prevent infringement.
FAQs
1. What is the primary innovation of CN104013540?
It pertains to a specific, novel process for preparing a pharmaceutical composition, emphasizing improved properties such as stability or bioavailability, defined by particular process steps and parameters.
2. How broad is the patent’s scope?
The scope primarily covers the specific process methods described, with dependent claims narrowing protection to particular variations, enabling flexible design-around strategies for competitors.
3. Can this patent hinder generic drug development?
Yes. Since it protects a process, generic developers must ensure their manufacturing methods do not infringe or look for ways to innovate around its claims post-expiry.
4. How does this patent compare to similar international patents?
While similar process patents may exist globally, CN104013540’s claims are tailored to Chinese patent law standards, but cross-referencing international patents is essential for comprehensive landscape assessment.
5. What strategic actions should innovators consider regarding this patent?
Monitoring its enforcement, exploring licensing opportunities, or developing alternative processes are recommended to mitigate infringement risks and maximize commercial value.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN104013540.
[2] World Intellectual Property Organization (WIPO). Patent Landscape Reports.
[3] Chinese Patent Law and Regulations.
[4] Industry reports on pharmaceutical patent strategies in China.
