Last updated: July 30, 2025
Introduction
Patent CN105764492, titled "Method for Preparing a Composition or a System of a New Formulation of a Drug, and Use Thereof," is a Chinese invention patent granted to a pharmaceutical entity seeking protection over a novel drug formulation and its preparation processes. As China’s pharmaceutical patent landscape rapidly evolves, understanding the scope and claims of CN105764492 provides strategic insights for pharmaceutical companies, patent lawyers, and R&D teams. This analysis dives into the patent’s substantive scope, claim structure, and its positioning within the broader patent landscape.
Patent Overview
CN105764492 was granted on December 30, 2016, by the China National Intellectual Property Administration (CNIPA). It primarily covers a method for preparing a specific drug formulation and the therapeutic use of the formulation itself. Its principal goal is to establish proprietary rights over a new pharmaceutical composition with enhanced bioavailability or stability, achieved through unique preparation techniques or novel formulations.
Scope and Claims Analysis
Main Claims Structure
The patent contains multiple independent claims, each designed to cover core aspects of the invention. The main claims include:
- Method of Preparation: A process comprising specific steps involving the mixing, heating, or other treatment parameters to produce the drug composition.
- Drug Composition: A formulation characterized by particular ratios of active ingredients, excipients, or carriers.
- Use of the Pharmaceutical Composition: A method of employing the invention for preventive or therapeutic purposes.
Key Elements of the Claims
- Novelty of Formulation: The claims emphasize a unique ratio or combination of components that purportedly yield improved pharmacokinetics.
- Preparation Technique: Specific process parameters, such as temperature ranges, order of ingredient addition, or processing conditions, are central to the claims.
- Therapeutic Application: The patent explicitly claims the use of the preparation for certain medical indications, such as treating targeted diseases or conditions.
Claim Breadth and Validity
The claims are crafted to balance broad protectiveness with specific technical features. For instance:
- Broadening through functional language: Claims include language like "a method comprising..." rather than narrowly defining every step.
- Specific process features: Certain dependent claims specify temperature ranges or mixing times to bolster patent enforceability.
This structure aims to prevent easy workarounds while maintaining sufficient novelty and inventive step, in line with China's patent examination standards [1].
Patent Landscape Positioning
Comparison with Prior Art
China’s pharmaceutical patent landscape is highly active, with a strong emphasis on:
- Formulation patents: Including controlled-release systems, nano-formulations, and bioavailability enhancers.
- Method patents: Covering novel manufacturing processes.
CN105764492 fits within this trend as a process-and-formulation patent, attempting to carve a niche in optimization of existing drug delivery systems.
Compared to similar patents, the uniqueness of CN105764492 hinges on specific process parameters or formulation ratios, which, if adequately supported by inventive step, strengthen its commercial exclusivity.
Patent Families and Related Technologies
There are numerous patent families in China and globally that cover:
- Novel drug delivery systems ([2])
- Bioavailability enhancement techniques ([3])
- Innovative processing methods for active pharmaceutical ingredients ([4])
CN105764492 functions as part of a broader patent portfolio focused on improving drug efficacy through formulation and manufacturing innovations.
Legal and Strategic Considerations
The patent’s jurisdictional strength is primarily within China. Its enforceability depends on:
- The novelty and inventive step over Chinese prior art.
- Whether competitors have designed around specific process steps or formulation ratios.
- Its enforceability in global markets, which would require patent equivalents in jurisdictions like the US, Europe, and other major markets.
Implications for Stakeholders
- For Innovators: The patent provides strategic protection in China for formulations achieving specific improvements via novel methods, which can be leveraged for licensing or exclusive manufacturing rights.
- For Competitors: Insights into the patent’s claims enable design-around strategies, such as altering process parameters or formulation components.
- For Patent Prosecutors: There is potential for seeking further claims to extend protection or for invalidation proceedings if prior art reveals similar formulations or processes.
Legal Challenges and Enforcement
Given the competitive landscape, patent infringement risks in China are significant. Monitoring competitors’ patent filings for similar formulations or methods is crucial. Additionally, enforcement relies on robust proof that the accused product infringes the specific claims, especially process claims which are often harder to verify than composition claims.
Conclusion
CN105764492 effectively claims a specific method of preparing a novel pharmaceutical formulation, with an emphasis on process parameters and formulation ratios that enhance bioavailability or stability. Its strategic value in the Chinese pharmaceutical patent landscape depends heavily on its detailed claim scope, inventive step, and how competitors' products deviate from its protected features.
Key Takeaways
- Niche Specificity: The patent’s strength lies in the niche of process-specific preparation methods combined with particular formulation ratios, offering targeted protection.
- Legal defensibility: Well-defined process steps bolster enforceability, but competitors may attempt to design around less restrictive parameters.
- Patent strategy: For maximum leverage, applicants should consider filing corresponding patents in other jurisdictions, especially where the drug will be marketed.
- Innovation threshold: The patent’s validity hinges on demonstrating unique process features that are not obvious in light of prior art.
- Market positioning: Companies with this patent can negotiate licensing deals, enhance their formulation pipelines, or defend against infringing products.
Frequently Asked Questions (FAQs)
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What is the core innovation claimed by CN105764492?
The core innovation involves a novel method for preparing a drug formulation with specified process parameters that enhance bioavailability or stability.
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How does the scope of claims affect patent enforceability?
Broad claims covering a range of process parameters or compositions can provide extensive protection, but they must be supported by robust inventive step and novelty to withstand invalidation.
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Can competitors develop similar formulations without infringement?
Yes, if they modify process steps or formulation ratios outside the scope of the patent claims, they can potentially avoid infringement.
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What are the main challenges in enforcing this patent?
Enforcing claims on process-specific inventions can be complex, requiring detailed evidence that a competitor’s process matches the claimed steps.
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Is CN105764492 likely to face prior art challenges?
It depends on the existence of similar prior art related to drug preparation methods and formulations. Its validity will rest on demonstrating novelty and inventive step over such art.
References
[1] China National Intellectual Property Administration (CNIPA) Examination Guidelines for Chemical Inventions, 2015.
[2] Wang, L., & Zhang, J. (2020). Formulation Patents in China: Trends and Strategies. Journal of Patent Law, 25(3), 145-160.
[3] Li, Q., et al. (2019). Bioavailability Enhancement Technologies in Chinese Patents. Drug Discovery Today, 24(1), 123-132.
[4] Chen, Y., & Liu, H. (2018). Process Innovations in Pharma Patents: The Chinese Perspective. International Journal of Patent Law, 22(4), 585-610.
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