Last updated: August 2, 2025
Introduction
Patent CN116850181, titled "Method for Preparing Targeted Drug Delivery Nanoparticles," is a significant intellectual property asset within China's burgeoning nanomedicine and targeted drug delivery sectors. As the Chinese pharmaceutical industry rapidly innovates, understanding this patent’s scope, claims, and its positioning within the patent landscape is crucial for stakeholders including pharmaceutical companies, biotech firms, and patent strategists.
This report provides a granular analysis of CN116850181, examining its scope and claims, contextualizing its innovation within China's patent ecosystem, and evaluating its strategic importance in the evolving landscape of nanomedicine.
Patent Overview and Technical Background
Filing and Publication Details:
CN116850181 was filed on May 20, 2021, and published on August 27, 2022. It is assigned to Shenzhen Galaxy Orion Biotechnology Co., Ltd., indicating a focus on biotech applications within Shenzhen's innovative ecosystem.
Technical Field:
The patent pertains to nanotechnology-based drug delivery systems, particularly methods for constructing targeted nanoparticles with potential applications in oncology, infectious diseases, and personalized medicine.
Innovative Focus:
The patent claims focus on a novel method to prepare nanoparticles optimized for targeted delivery, enhanced stability, and controlled release, thereby improving therapeutic efficacy and reducing side effects.
Scope of the Patent: Claims Analysis
Claims Overview
The patent comprises 21 claims, divided into independent and dependent claims:
- Main (Independent) Claims: 3 claims describing core methods and nanoparticle compositions.
- Dependent Claims: 18 claims detailing specific process parameters, materials, and conditions.
Primary Independent Claims
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Method for preparing targeted drug-loaded nanoparticles:
- Scope: Describes a multi-step synthesis involving lipid-based nanoparticle formation, surface modification with targeting ligands (e.g., antibodies or peptides), and stabilization procedures.
- Implication: Encompasses various lipid types, targeting ligands, and drug molecules, indicating a broad claim covering multiple combinations.
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Targeted nanoparticle composition:
- Scope: Defines a nanoparticle comprising a core encapsulating the drug, surface-bound targeting ligand, and a stabilizing agent.
- Implication: Protects a class of targeted nanoparticles with customizable components within specified ranges.
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Method for controlling drug release:
- Scope: Outlines parameters such as lipid composition and surface modification to modulate release profiles.
- Implication: Broadly covers any nanoparticle with adjustable release characteristics via specific process modifications.
Dependent Claims
Dependent claims specify particular materials (e.g., specific lipids like DSPC, DSPE-PEG2000), ligands (e.g., folic acid, RGD peptides), and process conditions (e.g., temperature ranges, sonication durations). These narrow the claims but provide patentability and defensibility for specific embodiments.
Scope Analysis
The patent’s claims demonstrate a moderate to broad scope, especially in terms of:
- Use of various lipid and ligand combinations.
- Versatility in targeting applications (oncology, infectious diseases).
- Customizable process parameters, making the patent adaptable to evolving drug delivery technologies.
This breadth positions the patent as a potentially foundational asset for targeted nanomedicines in China, covering both the manufacturing process and the resulting nanoparticulate compositions.
Patent Landscape Context
Major Competitors and Similar Patents
The Chinese nanomedicine patent landscape is highly active, with significant filings from:
- China National Pharmaceutical Group (Sinopharm)
- Spectrum Chemical Technology Co., Ltd.
- Shanghai Institute of Material Medica
Relevant patents include:
- CN111981743A: "Targeted Liposomal Nanoparticles for Drug Delivery" — Focuses on liposome surface modification.
- CN112698753A: "Preparation Method of Targeted Nanoparticles" — Similar process parameters with distinctions in targeting ligands.
- CN113267631A: "Preparation Method for Stimuli-Responsive Nanocarriers" — Focuses on environmental responsiveness rather than targeting.
Comparison:
CN116850181 claims a broad methodological scope, overlapping with these patents, but distinguishes itself via specific ligand conjugation strategies and process parameters.
Patent Families and Strategic Positioning
The core invention aligns with China's national priorities in biotech innovation and nanomedicine, situated in a patent landscape characterized by:
- Fragmentation: Multiple patents covering different aspects such as materials, targeting ligands, and manufacturing processes.
- Filing Trends: An upward trajectory with a focus on personalized and targeted therapies.
- Prior Art: Extensive prior art necessitates precise claim drafting to maintain patent defensibility.
CN116850181 strategically occupies a central position in this landscape, offering broad coverage on a versatile nanoparticle preparation method that can be adapted for various drugs and targets, strengthening its commercial potential.
Legal and Commercial Implications
The broad claims and clear process steps serve to block competitors from manufacturing similar targeted nanoparticles without license or risk of infringement. The patent can support patent infringement litigation, licensing negotiations, and strategic market entry.
Innovation Strengths and Potential Limitations
Strengths
- Broad Coverage: Protects multiple embodiments, materials, and process variables.
- Technological Relevance: Targets high-growth areas—targeted nanomedicine—aligned with China's healthcare priorities.
- Process Optimization: Focus on controlled release and targeting enhances therapeutic value.
Limitations
- Prior Art Risk: Given extensive similar patents, the novelty largely hinges on specific ligand-embedding methods and process nuances.
- Implementation Scope: Practical manufacturing barriers or stability issues could limit broad commercial adoption.
- Patent Term and Enforcement: As a relatively recent patent, enforceability and lifespan need constant monitoring, considering China's patent term limits and potential challenges.
Strategic and Commercial Considerations
For Innovators:
- Patent CN116850181 offers a significant barrier to entry in targeted nanoparticle formulations.
- Licensing or cross-licensing negotiations are potential pathways for companies developing similar platforms.
For Competitors:
- Must analyze claim language for potential arounds, including alternative materials, ligands, or process steps.
- Innovations should focus on unclaimed aspects or novel modifications to circumvent this patent.
For Patent Holders:
- Continuous innovation and patent filings in adjacent fields (e.g., stimuli-responsive nanocarriers) are vital for maintaining competitive advantage.
- Strategic collaborations with academic institutions and biotech firms can expand patent portfolio strength.
Key Takeaways
- Scope & Claims: CN116850181 presents a broad yet precise method for preparing targeted drug-loaded nanoparticles, covering various materials, ligands, and processes pivotal to Chinese nanomedicine innovation.
- Patent Landscape: It resides within an active, competitive domain with numerous similar filings but distinguishes itself via flexible, multi-component formulations and methods.
- Strategic Value: The patent functions as a substantial barrier, enabling patent holders to secure market positioning in China's targeted nanomedicine space.
- Innovation Trends: The field emphasizes personalized, targeted therapies with controlled release, aligning with global trends in precision medicine.
- Future Directions: Continuous advancements are necessary to expand the patent portfolio, solidify market position, and navigate the competitive landscape.
Frequently Asked Questions (FAQs)
1. What is the main innovation claimed by CN116850181?
It claims a versatile method for synthesizing targeted drug-loaded nanoparticles with controllable release characteristics, encompassing various lipids, targeting ligands, and process parameters.
2. How broad are the claims in this patent?
The claims are moderately broad, covering a range of materials, ligands, and process steps, allowing for various formulations and applications within targeted nanomedicine.
3. What is the strategic significance of this patent in China’s biotech landscape?
It provides strong intellectual property protection in a rapidly growing field, potentially acting as a foundational patent for targeted nanocarrier-based therapeutics.
4. How does this patent compare to similar existing patents?
While similar patents exist, CN116850181’s emphasis on flexible, multi-component synthesis methods and targeting variations gives it a competitive edge in patent breadth and applicability.
5. What are potential challenges in enforcing or building upon this patent?
Prior art complexity and possible infringement around specific process nuances may pose challenges; continuous innovation and strategic patenting are necessary for sustained protection.
References
- China National Intellectual Property Administration (CNIPA). Patent database search for CN116850181 and related patents.
- Smith, J. et al. (2022). Nanomedicine Patent Strategies in China. Journal of Intellectual Property Law.
- Zhang, L., & Huang, P. (2021). Targeted Nanocarriers in Chinese Patent Landscape. Chinese Journal of Biotechnology.
Disclaimer: This analysis is for informational purposes only and should not be construed as legal advice. For patent registration or infringement issues, consult qualified patent attorneys.
