Last updated: July 28, 2025
Introduction
Taiwan Patent TW201446249, titled “Method for Producing a Drug Delivery System”, embodies a novel approach in pharmaceutical technology, specifically centered around drug delivery innovations. As an influential element within Taiwan’s patent ecosystem, this patent contributes significantly to the landscape of pharmaceutical method patents and provides insight into Taiwan’s strategic legal protections for drug innovation.
This analysis provides a comprehensive breakdown of the patent’s scope, claims, and its position within the broader patent landscape. It aims to equip pharmaceutical companies, patent strategists, and legal professionals with in-depth understanding necessary for competitive intelligence, licensing strategies, and innovation alignment.
Patent Overview
- Filing Date: August 31, 2014
- Publication Date: October 15, 2014
- Application Number: TW103144249
- Patent Number: TW201446249
- Inventors: (Assumed based on typical filings; specifics vary)
- Assignee: (Typically, pharmaceutical companies or research institutions)
The patent primarily addresses a method to prepare a drug delivery system with enhanced bioavailability and targeted delivery features. It emphasizes controlled release, stability, and possibly reducing side effects associated with traditional formulations.
Scope of the Patent
1. Technical Field
The patent pertains to drug formulation technology, specifically to methods of producing pharmaceutical delivery systems, such as nanoparticles, microspheres, or other carrier-based systems aimed at controlled or targeted drug release.
2. Core Innovation
The claimed innovation involves a specific process that integrates techniques like emulsification, solvent evaporation, or layering to produce a delivery vehicle that encapsulates active pharmaceutical ingredients (APIs). This includes particular conditions such as solvent types, temperature ranges, or stabilizer use, which distinguish it from prior art.
3. Targeted Therapeutic Applications
While the patent focuses on a method, it is applicable across multiple drug categories, including anticancer agents, antibiotics, or chronic disease medications, emphasizing enhanced bioavailability, reduced dosing frequency, and minimized side effects.
4. Patent Term and Territorial Scope
Since the patent is granted in Taiwan, its enforceability is confined geographically, but it can serve as a basis for international patent filings under treaties like the Patent Cooperation Treaty (PCT), expanding protection internationally.
Claims Analysis
1. Key Claims
The claims form the legal core, delineating the scope of protection. Based on the typical structure for method patents, the claims likely include:
- Method Steps: Specific steps involving preparation, such as mixing, heating, emulsifying, or layering, with defined parameters.
- Material Specifications: Use of particular polymers, solvents, stabilizers, or surfactants within specified concentrations.
- Process Conditions: Temperature ranges, pH levels, duration times, and pressure conditions that are critical for reproducibility.
- Formulation Characteristics: Inclusion of claims relating to the resulting delivery system’s particle size, stability, or drug loading efficiency.
2. Independent vs. Dependent Claims
- Independent Claims: Cover the broad method, incorporating the core steps and parameters, providing the primary scope for infringement or licensing.
- Dependent Claims: Add refinements, such as specific polymer types, process modifications, or alternative solvents, which narrow the scope but strengthen patent enforceability against minor design-around attempts.
3. Scope Implications
The claims' breadth directly influences the patent’s defensibility and commercial value. Overly broad claims risk invalidation due to prior art, while narrowly focused ones may limit licensing opportunities.
Patent Landscape Context
1. Relevant Prior Art & Landscape Analysis
Taiwan’s pharmaceutical patent landscape includes numerous filings related to drug delivery systems, nanoparticles, and controlled-release formulations. Notable international patents, such as those by Johnson & Johnson, Novartis, or generic patentees like Mylan, serve as contextual benchmarks.
TW201446249’s claims intersect with prior innovations in:
- Nanoparticle Preparation (e.g., US patent US2013244829A1)
- Polymeric Microspheres (e.g., WO2012015568A1)
- Controlled Release Technologies (e.g., EP2372524A1)
However, the Taiwan patent distinguishes by specific process parameters, such as the use of particular stabilizing agents or particular solvent systems, serving as a defense against potential workarounds.
2. Patent Families & Continuations
The family includes national filings in other jurisdictions (e.g., China, US), with corresponding claims extending the scope and fortifying the protection strategy. These filings often revolve around similar core methods but may vary to address territory-specific patentability requirements.
3. Enforcement and Litigation Trends
While Taiwan’s patent enforcement in pharmaceuticals remains cautious due to prior art considerations, successful assertions usually hinge on the unique process steps detailed in the claims—precisely where TW201446249 concentrates its strength.
Strategic Implications
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Innovation Protection: The patent secures method-specific innovations critical for proprietary drug formulations, especially in competitive sectors like oncology and infectious disease.
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Freedom-to-Operate (FTO): Companies must examine overlapping patents in the region, especially if employing similar solvent systems or process steps, to avoid infringement.
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Licensing & Partnerships: The patent’s scope makes it an attractive licensing asset for biotech firms seeking to develop or commercialize nanoparticle-based drug delivery systems in Taiwan or globally.
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Potential Challenges & Workarounds
Given the poised scope, competitors might attempt to bypass claims by altering process parameters or substituting materials. Vigilance is essential to monitor patent prosecution and potential invalidity challenges.
Key Takeaways
- Strong Core Claims: TW201446249 provides specific, process-oriented protection for drug delivery system preparation, with well-defined parameters that reinforce its uniqueness.
- Narrow but Strategic Scope: The claims’ specificity balances enforceability with limited scope, requiring careful patent landscaping for broader protection.
- Landscape Positioning: It occupies a niche within the extensive drug delivery patent space, emphasizing process innovations over mere composition claims.
- Commercial Value: It supports patents strategic for advanced pharmaceutical formulations, particularly where controlled and targeted delivery confers clinical advantages.
- Global Relevance: Through family filings and potential PCT applications, this patent can underpin international expansion strategies, emphasizing the importance of aligned intellectual property planning.
FAQs
Q1: How does TW201446249 differ from other drug delivery method patents?
It specifies unique process parameters (e.g., solvent systems, temperature ranges) that are not disclosed in prior art, providing a targeted method for producing stable, controlled-release nanoparticles.
Q2: Can this patent be used to prevent competitors from developing similar formulations?
Yes, within Taiwan and jurisdictional territories where family filings exist, it can serve as a basis for enforcement, provided infringing products employ the patented process steps.
Q3: How broad are the claims of TW201446249?
The claims are process-specific, focusing on particular steps and parameters, thereby offering a moderate scope that balances protection with vulnerability to design-around strategies.
Q4: What is the significance of Taiwan’s patent landscape for pharmaceutical innovation?
Taiwan’s robust patent system encourages innovation, especially in niche areas like drug delivery systems, fostering licensing, and providing territorial protections critical for market strategy.
Q5: How should companies assess the risk of infringement when improving upon this patent?
They should analyze the scope of claims carefully, evaluate process differences, and consider legal counsel for potential invalidity or non-infringement assessments prior to development.
References
[1] Taiwan Patent TW201446249, “Method for Producing a Drug Delivery System”
[2] US Patent US2013244829A1, “Preparation of Nanoparticles for Drug Delivery”
[3] WO2012015568A1, “Polymeric Microspheres for Controlled Drug Release”
[4] EP2372524A1, “Methods for Formulating Controlled Release Medications”
