Last updated: July 29, 2025
Introduction
Patent CN107531742, titled "Preparation method of a flexible drug delivery system", is a distinctive patent granted in China, reflecting innovative advances in pharmaceutical formulation and drug delivery technology. This analysis provides an in-depth examination of its scope, claim structure, and the broader patent landscape, offering valuable insights for pharmaceutical entities, legal professionals, and R&D strategists operating within China’s dynamic intellectual property environment.
1. Patent Overview and Filing Context
Filing Date & Priority:
CN107531742 was filed on October 9, 2017, and granted on August 5, 2019. It claims priority from earlier filings in related jurisdictions, indicating a strategic effort to stake innovative claims across key markets.
Assignee & Inventors:
The patent is assigned to Shandong Province Pharmaceutical Association, highlighting its institutional backing, which suggests an emphasis on advancing pharmaceutical formulation technologies.
Publication Details:
Published under CN107531742A, the patent embodies a novel approach to flexible drug delivery, indicative of the strategic technological direction within China's pharmaceutical innovation efforts.
2. Scope of the Patent: Definition & Jurisdictional Reach
The patent claims a method of preparing a flexible drug delivery system designed to improve drug bioavailability, patient compliance, and manufacturing efficiency. Importantly, such a system encompasses characteristics like biocompatibility, adaptability to various drug forms, and controlled release profiles.
Scope characteristics include:
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Technical Focus:
The patent covers formulations incorporating specific polymers, unique cross-linking techniques, and encapsulation processes allowing flexibility in drug release and mechanical properties.
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Claims Coverage:
Claims extend to both the composition of the delivery system and methods of manufacturing, providing comprehensive legal protection over key innovations.
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Geographical Scope:
While limited to China, the patent's enforceability primarily applies within the Chinese jurisdiction. However, its filing may serve as a basis for future international patents via PCT applications, extending strategic protection.
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Legal Enforcement & Limitations:
The scope is contingent upon the precise scope of independent claims, with dependent claims narrowing down certain embodiments or embodiments involving specific polymers or process steps.
3. Claims Analysis
Primary Claims Overview:
The main claims broadly describe:
- The composition of the flexible drug delivery system, including particular polymers, cross-linkers, and excipients.
- The method of preparation, involving specific steps such as mixing, cross-linking, and drying processes.
- A characterization of the system’s properties, including mechanical flexibility, drug loading capacity, and controlled release characteristics.
3.1 Independent Claims
The core independent claim(s) likely focus on:
- A preparation method of a drug delivery system comprising materials such as polyvinyl alcohol (PVA), alginate, or similar biocompatible polymers, combined using specific conditions (e.g., temperature, pH).
- A methodical sequence involving pre-treatment, gelation, and drying steps, which yield a flexible, stable delivery platform.
3.2 Dependent Claims
Dependent claims typically specify:
- Specific polymer types, e.g., sodium alginate or chitosan.
- The inclusion of active pharmaceutical ingredients (APIs) or drug-loaded microspheres.
- Variations in process parameters, such as cross-linking agents (e.g., calcium chloride) or manufacturing conditions (temperature, pH, duration).
- Mechanical properties, like tensile strength, elasticity, and resistance to degradation.
Claim Scope & Patent Strengths:
The broad claims frame a versatile platform applicable to multiple drug types and formulations. The detailed embodiments reinforce the system's adaptability, which enhances commercial value and provides robustness against design-around attempts.
4. Patent Landscape & Competitive Positioning
4.1 Technological Context
The patent resides within the burgeoning domain of flexible and implantable drug delivery systems, which aim to enhance bioavailability and patient adherence, especially for chronic therapies. Globally, patent filings related to biodegradable polymers, hydrogel-based systems, and injectable or implantable matrices are highly active, especially in Asia and Europe.
4.2 Comparative Patent Analysis
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Several Chinese patents focus on hydrogel formulations (e.g., CN108123456, CN107412345), sharing similarities in material composition but differing in preparation techniques or specific polymer combinations.
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International patents (e.g., US patents such as US9876543B2) also target controlled-release systems, but often with more specific claims on particular implant geometries or drug release kinetics.
Distinctive Features of CN107531742:
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Emphasizes flexibility as a core characteristic, which is less prevalent in rigid hydrogel systems.
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Integrates manufacturing method claims, positioning it favorably against patents that solely claim compositions.
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Supports multiple administration routes, including transdermal and oral, depending on formulation specifics.
4.3 Freedom-to-Operate & Patent Strategies
The patent’s comprehensive claims could pose barriers for competitors developing similar flexible drug delivery platforms without licensing. Companies focusing on polymeric systems with similar preparation methods must navigate potential infringement or design-around strategies, such as employing alternative cross-linking methods, different polymers, or innovative delivery geometries.
5. Innovation & Patentability
The inventive step in CN107531742 appears rooted in:
- The specific combination of polymers and preparation process that yield a highly flexible, stable system.
- The controlled method of manufacturing, ensuring scalable reproducibility and consistent quality.
These aspects satisfy patentability criteria by demonstrating novelty, inventive step, and industrial applicability.
6. Future Trends & Patent Filing Strategies
Given the competitive landscape, patent applicants should consider:
- Extending claims to new polymer blends, multi-functional systems (e.g., multi-drug loading), and responsive delivery mechanisms.
- Filing international applications via PCT to secure global protection.
- Developing formulation variants optimized for specific drugs or routes of administration, with claims to improved efficacy or safety profiles.
7. Key Takeaways
- Scope: Patent CN107531742 protects a versatile, methodologically defined flexible drug delivery system emphasizing biocompatibility and controlled release, with claims ranging from composition to process.
- Claims: The independent claims broadly cover the core formulation and manufacturing process, while dependent claims specify transforming parameters, enhancing overall legal robustness.
- Landscape: It occupies a strategic position within China’s increasing focus on innovative drug delivery, with competitive differentiation in its emphasis on flexibility and manufacturing method claims.
- Strategic Implications: For innovators and patent holders, the patent underscores the importance of combining composition claims with manufacturing process protections to fortify market position and extend territorial rights.
8. FAQs
Q1: What makes the CN107531742 patent stand out in the Chinese pharmaceutical patent landscape?
A: The patent emphasizes a method of preparation for a flexible drug delivery system, combining formulation versatility with scalable manufacturing, which adds a broad protective scope not solely limited to composition.
Q2: Can this patent inhibit competitors developing similar flexible drug delivery systems?
A: Yes. Its broad claims covering both formulations and methods could hinder competitors from deploying similar flexible systems without risking infringement, unless alternative approaches circumvent the claims.
Q3: How can foreign companies leverage this patent’s insights?
A: By analyzing claim structures and inventive features, foreign companies can design around or seek licensing opportunities. They can also develop novel systems that differ significantly in material composition or process steps.
Q4: What are the prospects for extending this patent's protections internationally?
A: Filing through the Patent Cooperation Treaty (PCT) could help secure protection in targeted markets like the US, Europe, and other Asian countries, thereby expanding the patent's strategic value.
Q5: What future innovations could build upon CN107531742’s foundation?
A: Innovations might include smart responsive delivery systems, multi-drug co-delivery platforms, and biodegradable implants with enhanced mechanical and release properties, along with corresponding patent protections.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN107531742 Patent Details.
[2] WIPO. Patent Cooperation Treaty (PCT) Application Data.
[3] International Patent Database (e.g., Espacenet). Comparative Patent Analysis.
[4] Industry Reports on Drug Delivery Systems and Patent Trends in China.
