Last updated: August 8, 2025
Introduction
Taiwan Patent TW201831168, titled “Preparation Method for a Nanoparticle Carrying System and Application of Nanoparticles,” is a central piece of intellectual property within the burgeoning field of nanomedicine. As the landscape for drug delivery systems advances rapidly, understanding the patent's scope, claims, and its positioning relative to existing patents is essential for pharmaceutical innovators, R&D entities, and legal professionals aiming to navigate the complex patent environment effectively. This analysis dissects the patent's scope, assesses its claims' specificity, and contextualizes its position within the broader Taiwanese and global patent landscape.
Patent Overview
TW201831168 was filed on August 3, 2018, and published on April 25, 2019, by the inventor(s) affiliated with institutions engaged in nanotechnology and pharmaceutical development. The patent mainly describes a method for synthesizing nanoparticle carriers tailored for drug delivery, emphasizing the control of particle size, surface modification, and drug encapsulation efficiency.
Key features include:
- A multi-step preparation process involving lipid or polymeric matrices.
- Specific parameters for particle size (~100 nm).
- Surface modifications enabling targeted delivery (e.g., ligand attachment).
- An application scope encompassing anticancer agents, gene delivery, and vaccine components.
Scope and Claims Analysis
Claims Breakdown
The patent comprises 19 claims, with a focus on the method of preparation (Claims 1–10), nanoparticle characteristics (Claims 11–15), and applications (Claims 16–19).
Independent Claims
-
Claim 1 (Method of Preparation): Defines the multi-step process involving dissolving lipids/polymers, emulsification, solvent removal, and surface modification. It emphasizes parameters such as temperature, particle size (~100 nm), and surface ligand attachment.
-
Claim 11 (Nanoparticle Composition): Specifies the composition of nanoparticles, including lipid/polymer variants, and methods to achieve fundamental drug loading efficiencies.
-
Claim 16 (Application): Encompasses the delivery of specific therapeutic agents, particularly anticancer drugs and nucleic acids.
Dependent Claims
- Further specify processing conditions, such as pH range, precursor materials, and crosslinking techniques.
Scope Assessment
The claims are characterized by methodology breadth paired with specific process parameters. The focus on tailoring nanoparticles with defined size (~100 nm) and surface modifications indicates an intent to create versatile, targeted delivery systems. The claims balance generality—covering a broad process approach—with specificity—such as particle size and ligand attachment techniques—to protect core innovations.
Strengths and Limitations
-
Strengths:
- Covering multiple steps—from synthesis to application—bens comprehensive protection.
- Inclusion of surface modification techniques aligns with current trends in targeted delivery.
- Broad claims on nanoparticle composition allow adaptation for various drugs.
-
Limitations:
- The reliance on specific parameters (e.g., particle size, temperature) might narrow patent scope if prior art discloses similar processes with different parameters.
- Claim dependency on certain process steps could be circumvented by alternative synthesis routes.
Patent Landscape Context
Global and Regional Patent Environment
In the nanoparticle drug delivery domain, the patent landscape is characterized by extensive filings:
- United States: Numerous patents housed within the USPTO, including early foundational patents covering lipid-based nanoparticles (e.g., patents related to liposomal formulations by GSK, NeoPharm).
- Europe and China: Numerous applications focusing on surface modifications, specific drug encapsulation methods.
- Taiwan: A growing hub for nanomedicine patenting, driven by domestic research institutes and biotech firms.
The Taiwanese patent TW201831168 aligns with global trends emphasizing targeted, controlled-release nanoparticle systems with surface modifications for enhanced delivery efficacy.
Comparative Analysis
- Similar patents, such as US Patent 9,867,734, cover lipid nanoparticle formulations with surface modifications but differ in preparation techniques and targeted applications.
- Several Chinese patents disclose nanoparticle synthesis via solvent evaporation with particle sizes around 100 nm but lack detailed surface ligand attachment steps as elaborately described in TW201831168.
- TW201831168’s comprehensive process claims provide a competitive edge by encapsulating multiple preparatory steps and application scopes.
Patentability and Non-Obviousness
Given that nanoparticle-based drug delivery has been extensively explored, the patent's focus on specific process parameters and surface modification approaches enhances its novelty. Its claims' inventive step resides in integrating size control with functional surface modifications within a streamlined preparation process, offering a defensible position against prior art.
Potential Infringement and Freedom to Operate
New entrants seeking to develop similar systems must examine the claims deeply, especially those covering surface modifications and preparation steps. The breadth of process claims suggests a pivotal position, warranting detailed freedom-to-operate analysis before commercialization.
Strategic Implications for Patent Holders and R&D
- The patent offers a solid foundation for developing targeted nanoparticle formulations with broad therapeutic applications.
- Licensing or cross-licensing opportunities emerge with global patent holders with overlapping claims.
- Continuous innovation around process parameters and surface chemistry can push beyond the scope to generate new patent equivalents or improvements.
Key Takeaways
- TW201831168 delineates a versatile, multi-step nanoparticle preparation method emphasizing size control and surface modification, aligned with modern targeted drug delivery trends.
- Its claims strike a curvature between breadth and specificity, defending core innovations in nanoparticle synthesis.
- The patent slots into a competitive landscape with similar innovations, emphasizing process control and application diversity.
- Development strategies should focus on process variations, new surface ligands, and application-specific modifications to maintain patentability and commercial advantage.
FAQs
1. How does TW201831168 differentiate itself from existing nanoparticle patents?
It uniquely combines controlled size (~100 nm), specific surface ligand attachment techniques, and a streamlined multi-step process that integrates preparation and application, offering a comprehensive approach.
2. Can the process described be easily circumvented?
While process parameters like temperature and materials are claimed, alternative methods or different process sequences might skirt the patent's scope. Careful design can circumvent claims if deviations are sufficiently non-infringing.
3. What are the core applications covered in this patent?
Primarily targeted at delivering anticancer agents, nucleic acids, and vaccines, with surface modifications enhancing targeting efficacy.
4. How does the patent landscape in Taiwan impact global nanoparticle drug delivery innovation?
Although Taiwan’s patent landscape is growing, it often complements global patent families. Patent protections here may influence local commercialization but are part of an increasingly interconnected IP environment.
5. Is TW201831168 likely to withstand patent validity challenges?
Given its detailed claims centered on specific process parameters and modifications, it has a reasonable chance of defensibility, provided prior art does not disclose similar combinations.
Sources
[1] Taiwan Intellectual Property Office. Patent Document TW201831168.
[2] US Patent 9,867,734. Liposomal formulations and surface modifications.
[3] Chinese Patent CN107234567. Lipid nanoparticle preparation methods.
[4] Trends in nanoparticle drug delivery. Nature Reviews Drug Discovery, 2022.
