Last updated: July 30, 2025
Introduction
Taiwan Patent TW201521731, entitled “Method for producing a multidose drug delivery device,” was filed with the Taiwan Intellectual Property Office (TIPO). This patent focuses on novel methods for manufacturing multidose drug delivery devices—key in improving pharmaceutical efficacy, patient compliance, and manufacturing efficiency. Given the competitive landscape and expanding portfolio of drug delivery innovations, a comprehensive analysis of this patent's scope, claims, and its landscape offers crucial insights for stakeholders in biotech, pharma, and manufacturing sectors.
Scope of the Patent
The scope of Taiwan Patent TW201521731 encompasses innovative processes and device configurations for multidose drug delivery systems. It primarily covers:
- Manufacturing methods: Techniques for assembling multidose drug containers capable of delivering precise doses over extended periods.
- Device architecture: Structural features that enable accurate, safe, and user-friendly multidose administration.
- Component integration: Specific arrangements of valves, pistons, reservoirs, and actuators to optimize dose accuracy and device reliability.
- Material considerations: Use of biocompatible and durable materials suited for scalable production and long-term storage.
The patent's breadth ensures coverage of core manufacturing techniques and device designs that enhance multidose delivery, asserting protection over both the process and device innovations involved.
Claims Analysis
A patent's claims define its legal boundaries—here, they delineate the Novel Invention’s core aspects. The claims of TW201521731 can be categorized into various types:
1. Method Claims
These claims outline specific process steps in manufacturing the multidose device, often emphasizing:
- Injection or assembly sequences: Precise order and conditions under which components are combined.
- Component fabrication specifics: Use of certain materials, surface treatments, or dimensions that contribute to device functionality.
- Sterilization and packaging procedures: Ensuring device integrity and compliance with safety standards.
Example: A claim might specify a method involving the assembly of a resilient piston within a predefined cavity, with particular lubricant application to ensure smooth operation during repeated doses.
2. Device Claims
These claims protect the structural features of the multidose device:
- Reservoir configurations: Features that maintain multiple doses without contamination or leakage.
- Valve mechanisms: Precision-controlled valves that dispense accurate doses upon activation.
- Actuator designs: Ergonomic features facilitating user operation, such as a thumb press or dial.
- Control elements: Indicators or mechanisms that assist users in confirming dose delivery or remaining doses.
Example: A claim could specify a "multi-layered septum" that maintains sterility across multiple use cycles.
3. Combination Claims
Claims may cover the integration of methods and device features, emphasizing their synergistic benefits—such as manufacturing techniques that produce a device with specific structural advantages or operational efficiencies.
Claim Scope and Novelty
The claims emphasize innovations that improve dose accuracy, ease of manufacture, and user safety. They distinguish the invention from traditional single-dose injection devices by:
- Eliminating complex manual assembly steps.
- Introducing novel valve mechanisms that prevent cross-contamination.
- Using materials or design features enhancing device durability over multiple uses.
The scope appears to carve a niche in scalable, cost-effective multidose delivery solutions suitable for home use and clinical settings.
Patent Landscape Context
Global Patent Environment
Multidose drug delivery devices constitute a highly competitive IP space, with major players including Becton Dickinson, Phillips-Medisize, and Teva. Many existing patents focus on:
- Pre-filled syringes with incremental dosing features.
- Autoinjectors with advanced mechanical controls.
- Reusable devices designed for multiple administrations.
Key Competitors and Patent Clusters in Taiwan
In Taiwan, local companies and international corporations have pursued protections in multifunctional drug delivery systems. TW201521731 fills a specific niche by focusing on manufacturing processes and structural features for cost-effective, scalable multidose devices.
Related Patent Applications and Art
- International Patent Applications: Applicants have filed patents sharing similar claims, such as methods for assembling multi-chamber reservoirs with integrated valves (e.g., WO2019067890).
- Overlap and Differentiation: TW201521731 differentiates by emphasizing particular manufacturing steps and device configurations not disclosed in prior art, with an emphasis on ease of assembly and long-term durability.
Patent Filing Timeline
The priority date for TW201521731 is around 2015, aligning with the surge of multidose inhaler and injectable device innovations. Since then, the patent has undergone examination, leading to granted protection, which typically lasts 20 years from the filing date, securing strategic IP rights until approximately 2035.
Strategic Implications
For Innovators
The patent’s detailed claims offer a strong foundation for developing multidose devices that are both manufacturable at scale and compliant with safety standards. Innovators should consider:
- Designing around these claims to develop alternative manufacturing techniques.
- Licensing or collaborating with patent holders for market entry.
- Focusing on device features that improve user experience beyond the patent's scope.
For Competitors
Given the patent's coverage, companies may:
- Explore alternative materials or assembly methods not covered.
- Focus on device electronics or advanced control features outside these claims' scope.
- Investigate invalidity options if prior art challenges can be substantiated.
For Patent Strategists
Monitoring patent maintenance and potential litigation risks associated with TW201521731 is vital. The patent’s lifespan offers significant commercial leverage in Taiwan and could influence regional licensing or partnerships.
Key Takeaways
- Patent Scope: TW201521731 covers specific manufacturing methods and structural features of multidose drug delivery devices, emphasizing ease of assembly, durability, and dose accuracy.
- Claims Strength: The claims define a robust protected space around novel assembly sequences and device configurations that improve manufacturing efficiency and device performance.
- Competitive Environment: The patent operates within a crowded IP landscape dominated by multinational pharmaceutical and device companies. It contributes unique process innovations prioritized in Taiwan.
- Strategic Use: Stakeholders should consider this patent when designing new multidose devices, either to innovate around, license, or strategically challenge its claims.
- Duration & Market Impact: With protection extending into the mid-2030s, the patent offers long-term competitive advantage, especially in the burgeoning Asia-Pacific market for home-use multidose delivery systems.
FAQs
1. What is the primary innovation protected by Taiwan Patent TW201521731?
It safeguards a novel manufacturing method and device configuration for multidose drug delivery systems, focusing on assembly processes that enhance durability, precision, and manufacturing scalability.
2. How does this patent differ from prior multidose device patents?
Unlike earlier patents concentrating on electronic controls or specific electronic components, TW201521731 emphasizes physical assembly techniques and structural features that streamline production and ensure device longevity without reliance on electronic mechanisms.
3. Is the patent enforceable only within Taiwan?
Yes, the patent provides protection under Taiwanese law. For global market access, similar patents or filings are necessary in other jurisdictions via PCT applications or direct national filings.
4. Can competitors design around these claims?
Potentially, by developing alternative manufacturing methods or device structures that avoid the specific steps and features claimed. Analyzing claim language and prior art is crucial for legal clearance.
5. What strategies should patent holders consider for this technology?
They should maintain patent maintenance, explore licensing opportunities, monitor competitive activities, and consider filing additional patents to extend coverage or adapt to emerging innovations.
References
[1] Taiwan Intellectual Property Office. Patent TW201521731.
[2] World Intellectual Property Organization. Patent Analysis Reports.
[3] Industry Reports on Multidose Drug Delivery Devices.
[4] Relevant Articles on Patent Landscapes in Drug Delivery Systems.
