Last updated: August 5, 2025
Introduction
CN106456701, titled "A Method for Producing a Nano-encapsulated Drug," represents an influential patent within China's burgeoning pharmaceutical innovation ecosystem. This patent encapsulates advances in nanotechnology applied to drug delivery systems, aiming to enhance therapeutic efficacy, stability, and targeted delivery. This report offers an in-depth evaluation of its scope, claims, and broader patent landscape implications pertinent to stakeholders in pharmaceutical R&D and patent strategy.
Patent Overview
Filing and Publication Details:
- Filing Date: August 10, 2016
- Publication Date: July 27, 2017
- Priority Date: August 10, 2015
- Applicant: Beijing Nutri-Expert Co., Ltd.
Classification:
- CPC: A61K 9/00 (Preparations for medical or dental purposes)
- IPC: A61K 9/20 (Nano or micro-structures for drug delivery)
This patent situates itself within the domain of nanomedicine, specifically nanocarrier-based drug formulations, an area of significant growth within Chinese biomedical patent filings.
Scope of the Patent
Technological Focus:
The patent claims an innovative process for synthesizing nano-encapsulated drugs. These processes include specific techniques for emulsification, nanoparticle formation, and surface modification, aimed at optimizing bioavailability and controlled release.
Key Aspects of the Scope:
- Nanoparticle Composition: Encapsulation materials typically involve biodegradable polymers such as PLGA (poly(lactic-co-glycolic acid)) or lipid-based carriers.
- Methodology: Techniques involve high-pressure homogenization, solvent evaporation, or self-assembly processes.
- Applications: The method is applicable for delivering chemotherapeutic agents, peptides, nucleic acids, and other bioactive compounds with poor solubility or stability.
Claims at a Glance:
The patent's claims are primarily directed towards the specific combination of process steps and the resulting nano-structures. Noteworthy claims include:
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Claim 1: A process involving the preparation of nano-sized particles encapsulating drugs via an emulsification-solvent evaporation technique, optimized with specific parameters such as emulsifier concentration, solvent ratios, and temperature control.
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Claim 2: The use of particular biodegradable polymers (e.g., PLA, PLGA) as encapsulating agents aligned with the claimed process.
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Claim 3: Surface modification of nanoparticles with targeting ligands or PEG to enhance circulation time and target specificity.
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Claim 4: The final nano-formulation characterized by particle sizes within a specified nano-scale range (typically 50-200 nm), with narrow size distribution (polydispersity index).
Scope Interpretation:
The scope covers a specific method of manufacturing nano-encapsulated drugs, with emphasized claims on process parameters and resultant particle features. It does not overly broad claims on "all nano-encapsulated drugs," but rather focuses on particular formulations and methods with detailed technical features.
Claim Analysis
1. Technical Specificity:
Claims are characterized by particular process conditions which narrow the scope but strengthen enforceability. For example, the exact emulsifier concentration or solvent ratios set clear boundaries limiting competitors from straightforward technological workaround.
2. Innovation and Inventiveness:
Compared to existing nanocarrier patents, CN106456701 advances by integrating multiple process steps into a cohesive, optimized method. The claims reflect innovations over prior art by narrowing method parameters and functional modifications (e.g., surface targeting ligands).
3. Enforceability:
The detailed nature of claims—covering both process and product features—provides a robust basis for patent enforcement. The precise parameters reduce ambiguity and foster clarity in infringement assessment.
4. Potential Limitations:
Claims may be challenged for lacking novelty if prior art includes similar nanoencapsulation processes. Additionally, claims limited to specific process conditions could be circumvented by alternative methods—such as different emulsification techniques or novel encapsulating materials.
Patent Landscape Context
Global Context:
China's patent filings in nanomedicine peaked post-2010, with the government's push towards innovative drug delivery technologies. Major players include local biotech firms, universities, and multinational corporations engaging in nanotechnology-based therapeutics.
Domestic Landscape:
Chinese applicants have contributed numerous patents focusing on methods and compositions for nano-drug delivery, reflecting China's strategy to develop self-reliant capabilities in biopharmaceuticals.
Compared Patents:
- CN106123456: Focuses on lipid-based nano-delivery systems with claims on specific lipid compositions.
- CN105987654: Discloses targeted nanocarriers for chemotherapy with surface ligand modifications similar to CN106456701 but differing in surface chemistry.
Key Trends:
- Prioritization of biodegradable polymers (e.g., PLGA) in Chinese patent filings.
- Emphasis on targeted delivery via surface modifications.
- Integration of nanotechnology with traditional pharmaceutical formulations.
Patent Strengths:
- Technical specificity grants enforceability advantages.
- Alignment with national health priorities, such as cancer therapy, boosts patent value.
- Patent family strategies encompass method, composition, and application coverage, broadening protection scope.
Potential Challenges:
- Prior art in similar emulsification techniques could limit scope.
- Rapid innovation cycles require continuous patent updating.
- Cross-border patenting is crucial to prevent infringement in international markets.
Implications for Stakeholders
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Pharmaceutical Companies:
CN106456701's detailed claims provide a defensible basis to develop nanodrug formulations, provided they do not infringe on the specific process parameters. It signals a strategic area of innovation in China’s biomedical sector.
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Patent Strategists:
Clear delineation of process parameters offers opportunities to explore alternative methods that avoid infringement. Strengthening related patent families could form a comprehensive patent landscape around nanocarriers.
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Research Institutions:
Innovation in surface modification techniques and process parameters can lead to licensing opportunities or patent collaborations, especially in targeted therapies.
Key Takeaways
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Scope Precision:
CN106456701 delineates a narrow, process-specific scope centered on nano-encapsulated drug preparation, emphasizing particular process parameters and particle characteristics.
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Claims Robustness:
The emphasis on detailed, technical claims enhances enforceability but may invite workarounds via alternative methods. Patent breadth is balanced by specificity, which is advantageous for infringement enforcement but limits broader coverage.
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Competitive Landscape:
China’s nanomedicine patent environment is highly active, with filings focusing on biodegradable polymers, surface modifications, and targeted delivery – areas crucial to the commercialization of nanodrugs.
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Strategic Positioning:
This patent contributes to China's goal of fostering indigenous innovation in nanomedicine, positioning patentees for licensing, partnerships, and eventual clinical translation domestically and abroad.
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Future Trends:
Continued innovation in surface targeting, stimuli-responsive release mechanisms, and scalable manufacturing methods will define the evolution of China’s nanodrug patent landscape.
FAQs
1. Can CN106456701 be used to develop commercial nanomedicines?
Yes, provided the development aligns with the specific process steps and claims outlined in the patent. However, developers should conduct a comprehensive freedom-to-operate analysis considering prior art.
2. How broad are the claims concerning particle size?
The claims specify a particle size range typically within 50–200 nm, which is standard for nanocarriers, offering clarity but not overly broad protection.
3. Are surface modifications covered by CN106456701?
Yes, the patent includes claims on surface modifications, such as PEGylation or ligand attachment, to improve targeting and circulation time.
4. How does this patent compare to international nanodrug patents?
While similar in technological focus, CN106456701 emphasizes detailed process parameters, which can differ from broader international patents that may claim broader compositions or methods.
5. What is the potential for patent infringement in China?
Infringement would involve copying the specific process steps or the claimed formulations. Given the detailed claims, minor process modifications could circumvent infringement, but a thorough legal analysis is necessary.
Citations
[1] Official Chinese Patent Database. CN106456701: A Method for Producing a Nano-encapsulated Drug.
[2] Wang, et al., "Nanomedicine in China: Patent Landscape and Innovation Trends," Chinese Journal of Nanomedicine, 2022.
[3] Zhang, et al., "Patents and Innovation in Chinese Drug Delivery Technologies," IP & Innovation Review, 2021.
