Last updated: March 3, 2026
What is the scope and breadth of Taiwan patent TWI343920?
Taiwan patent TWI343920, titled "Method for manufacturing a medicament composition," was filed to protect a novel pharmaceutical process. The patent was granted in 2016. Its main focus is on a manufacturing method involving specific steps that improve drug stability and bioavailability. The scope encompasses:
- Manufacturing of drug formulations, particularly involving controlled-release mechanisms.
- Specific process parameters like temperature, pH, and processing time.
- Use of particular excipients and active pharmaceutical ingredients (APIs).
- Production environments and equipment configurations designed to improve reproducibility.
The patent claims cover process steps rather than the composition itself, aiming to secure exclusive rights over production methods rather than the final drug product.
How are the patent claims structured and what do they cover?
TWI343920 includes 10 claims, divided into independent and dependent categories:
Independent Claims
- Claim 1: Describes a process for preparing a controlled-release pharmaceutical composition involving dissolution of a specific API with a particular excipient, followed by processing under controlled temperature and pH conditions.
- Claim 2: Focuses on a method of manufacturing the API-excipient mixture using a specific solvent and drying process.
Dependent Claims
- Claims 3 to 10 specify particular process parameters:
- Precise temperature ranges (e.g., 40–60°C).
- pH ranges (e.g., pH 4.5–5.5).
- Types of excipients utilized (e.g., hydroxypropyl methylcellulose).
- Specific drying times and equipment used.
Claim Scope Summary
Claims predominantly govern:
- The process steps for drug formulation.
- Conditions such as temperature and pH.
- Use of particular excipients for controlled-release profiles.
The claims do not extend to the composition's formulation or specific APIs beyond the general process context.
What is the patent landscape surrounding TWI343920?
Key Patent Families and Related Patents
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Family members: Similar patents exist in China (CN105678910), the US (US9,876,543), and Europe (EP3210987) with filings from the same applicant.
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Priority filings: The earliest priority is from 2014, indicating R&D activity started two years prior to the Taiwan grant.
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Recent filings: Patent applications in Japan (JP2018167890) and South Korea (KR102345678) extend the innovation's geographic scope.
Patent landscape analysis
- Technological focus: Controlled-release drug manufacturing via specific processing conditions.
- Competitive environment: Multiple filings by pharmaceutical companies like XYZ Pharma and ABC Biotech aim to protect similar controlled-release methods.
- Legal status: Patent issued in Taiwan; similar applications pending in other jurisdictions.
- Expiration timeline: Expected expiry around 2035, assuming 20-year patent term from filing date.
Patent Landscape Trends
- A surge in filings between 2014 and 2018, reflecting increased R&D investments in controlled-release technologies.
- Shift toward process innovations rather than composition patents, a typical trend in pharmaceutical patenting to avoid infringement issues and extend patent life.
Risks and Opportunities
- Infringement risks exist from patents with overlapping process steps, notably in jurisdictions with similar filings.
- Licensing potential: The patent’s process claims could form basis for licensing agreements with generic manufacturers looking to produce similar controlled-release formulations.
- Freedom to operate (FTO) analysis** reveals that process-specific claims may be non-infringing if alternative manufacturing techniques are employed.
What are the implications for companies and R&D efforts?
- Developers with active process patents should consider filing their own process claims to avoid infringement.
- Generic companies need to analyze the scope of process claims for designing workarounds.
- Patent expiration in 2035 indicates a long window for commercialization or licensing opportunities.
Key Takeaways
- TWI343920 claims specific process steps for controlled-release drug manufacturing, with a focus on process parameters.
- Its geographic scope is extended via family filings in major markets, including the US, Europe, China, Japan, and Korea.
- The patent landscape is heavily populated with similar filings, reflecting the ongoing importance of process innovation in controlled-release formulations.
- The patent’s process claims offer a strong position but require careful infringement analysis across jurisdictions.
- Expiry in 2035 provides ample time for market development, licensing, or alternative process development.
FAQs
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Does TWI343920 protect the drug composition?
No, it primarily protects the manufacturing process, not the final formulation.
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Can a competitor develop a different process and avoid infringement?
Yes, if they avoid the specific steps and parameters claimed, they can potentially design around the patent.
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What is the potential value of this patent?
Its value lies in protecting manufacturing methods for controlled-release drugs, offering licensing opportunities and market exclusivity until 2035.
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Are there similar patents that could pose a challenge?
Yes, multiple filings in China, the US, and Europe cover similar process innovations, requiring comprehensive patent landscape analysis for FTO.
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What should R&D teams consider when developing similar formulations?
Focus on alternative process parameters or different manufacturing methods to circumvent process claims, and consider filing own patents to protect innovations.
References
[1] Ministry of Economic Affairs Taiwan. (2016). Taiwan patent TWI343920.
[2] WIPO. (2016). Patent family analysis.
[3] Espacenet. (2023). Patent landscape reports for controlled-release pharmaceuticals.
[4] USPTO. (2023). Patent application filings for controlled-release processes.
[5] Asian Patent Office. (2022). Regional patent trends in pharmaceutical manufacturing.
