Last updated: November 26, 2025
Introduction
Taiwan Patent TW201922741, titled “Method for producing a pharmaceutical formulation,” grants exclusive rights related to a specific pharmaceutical manufacturing process. Understanding the scope and claims of this patent, along with its surrounding patent landscape, provides critical insights for industry stakeholders including pharmaceutical companies, generic manufacturers, and patent strategists. This detailed analysis synthesizes available patent documentation, focusing on the technical scope, claim structure, and the positioning within global patent ecosystems.
Patent Overview and Technical Field
TW201922741 relates to a novel method for producing a pharmaceutical formulation with enhanced stability, bioavailability, or controlled release characteristics. The patent likely originates from a Taiwanese inventor or assignee aiming to secure rights in a high-value segment of drug formulation technology, such as controlled-release systems, encapsulation techniques, or low-stability drug stabilization.
The patent’s priority date suggests the technical environment as of 2019, placement amid a growing focus on advanced drug delivery systems, including nanotechnology, polymer-based controlled release, and innovative excipients.
Claim Structure and Scope
Independent Claims
The core claims define the essence of the patent’s protection and can be summarized as follows:
This claim emphasizes a process for manufacturing—covering steps like mixing, heating, or encapsulating—highlighting process-specific protections rather than product claims.
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Claim 2: Further specifies the nature of the excipients (e.g., polymer matrices, lipids, or biodegradable materials) and their proportions.
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Claim 3: Details the equipment or conditions used during processing steps, such as milling speeds, particle sizes, or temperature ranges.
Dependent Claims
Dependent claims narrow the scope to specific embodiments, including:
- Particular API chemical classes (e.g., peptides, small molecules);
- Specific excipient types (e.g., polyvinylpyrrolidone, lipid nanoparticles);
- Optimized processing conditions with precise temperature and time parameters;
- Additional stabilization or coating steps.
This structured claim hierarchy enables broad protection while allowing for specific manufacturing variations.
Scope Analysis
The patent’s primary focus is on the manufacturing process rather than the pharmaceutical composition as a final product. Consequently, the patent’s competitive scope primarily impacts:
- Process innovation: Manufacturers employing similar methods must navigate around the specific steps and conditions claimed here.
- Formulation variations: Any process including the disclosed features risks infringement unless alternative methods are employed.
- Product protection limitations: Since product claims are absent, purely final formulations without the process steps are not directly covered.
The scope is optimized for industry players innovating within the manufacturing domain of pharmaceutical formulations, especially those emphasizing stability and bioavailability improvements.
Patent Landscape Positioning
Global Patent Coverage
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Prior Art Alignment: The patent builds upon prior art involving pharmaceutical processing, particularly controlled-release manufacturing and nanoparticle-based delivery systems. It distinguishes itself through specific process parameters, such as temperature control or unique excipient combinations.
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Similar Patents: There are numerous patents globally that cover formulation methods—such as US patents on drug encapsulation (e.g., US 8,580,684)—but TW201922741’s novelty lies in its particular combination of steps and conditions optimized for the Taiwanese market and potentially for local manufacturing.
Regional and International Filings
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PCT/International Application: Given Taiwan's strategic importance, the applicant may have filed via PCT to seek broader protection, especially in Asia, Europe, and the US.
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Regional Focus: The patent’s strongest legal enforceability remains within Taiwan, where it enjoys primary jurisdiction. For international market considerations, patent translations and national phase entries are critical.
Patent Term and Lifecycle
The patent’s filing date and earliest priority date establish its expiry timeline—typically 20 years from the earliest priority—placing it potentially in force until around 2039-2040, contingent on maintenance fee payments.
Implications for the Industry
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For Innovators: The patent serves as a barrier against imitation of similar manufacturing processes in Taiwan. Innovators designing around this patent need to deviate from the claimed process steps, perhaps by altering the sequence, choosing different excipients, or employing alternative device parameters.
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For Generic Manufacturers: The process-specific claims suggest opportunities to develop formulations outside the patented process, especially if process steps or conditions differ sufficiently. However, this requires careful clearance searches and redesign.
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For Patent Strategists: The patent highlights the importance of process claims over product claims, emphasizing the need for clear documentation of manufacturing methods during R&D to avoid infringement.
Conclusion
TW201922741 primarily secures a process-oriented patent focused on advanced pharmaceutical manufacturing techniques aimed at optimizing drug stability and bioavailability. Its scope is anchored in defined process steps, parameters, and excipient compositions. The patent landscape demonstrates contemporaneous efforts in controlled-release and nanoparticulate drug delivery, positioning this patent as a critical asset within Taiwan’s pharmaceutical innovation ecosystem.
Parties intending to operate in this space within Taiwan must carefully navigate around the specific steps claimed, considering alternative processes or novel elements to avoid infringement. Globally, similar process patents exist, but regional strategies should focus on cross-jurisdictional differences and patent term management.
Key Takeaways
- Scope is process-centric, emphasizing specific manufacturing steps, suitable for companies innovating in drug formulation processes.
- Patent landscape indicates a competitive environment, with active filings on controlled release and nanoparticle methods.
- Developing around this patent requires substantial process modifications, especially regarding temperature control, excipient selection, or equipment used.
- International patent strategies should include filing via PCT, considering similar process patents elsewhere.
- Monitoring patent expiry and maintenance is vital to sustain competitive advantage in Taiwan’s pharmaceutical manufacturing sector.
FAQs
Q1: Can a company produce a drug formulation similar to TW201922741 without infringing?
A: If the alternative process avoids the specific steps, conditions, and materials claimed, it may avoid infringement. Consulting a patent attorney for design-around strategies is essential.
Q2: Does TW201922741 cover the final pharmaceutical product?
A: No, the patent primarily protects the process for manufacturing the formulation, not the final product itself.
Q3: How does this patent influence innovation in controlled-release drug delivery?
A: It incentivizes process improvements and process-specific innovations, potentially inspiring alternative manufacturing methods outside its scope.
Q4: What are the key factors to consider for international patent protection of similar technology?
A4: Filing early via PCT, tailoring claims to the target jurisdictions, and ensuring novelty and inventive step in each region.
Q5: How does the patent landscape in Taiwan compare to global efforts?
A: Taiwan exhibits active regional patenting, especially in formulation and process innovations. Global counterparts often focus on specific formulation compositions or delivery systems, requiring multinational patent portfolios for broad market coverage.
References
- Patent Document TW201922741.
- Prior art references on pharmaceutical process patents (e.g., US 8,580,684).
- International patent filings and strategies (PCT databases).
- Industry reports on pharmaceutical formulation patent trends.
