Last updated: February 20, 2026
What is the scope of patent TWI421232?
Taiwan Patent TWI421232 protects a novel pharmaceutical composition specifically designed for improving drug stability and bioavailability. The patent covers the formulation of a therapeutic agent comprising active pharmaceutical ingredients (APIs) with an optimized excipient matrix that enhances solubility and reduces degradation. The patent’s scope extends to methods of manufacturing this formulation and its intended use in treatment protocols.
The patent claims are directed toward formulations that include:
- An active pharmaceutical ingredient with low solubility
- An specific combination of excipients, including surfactants and stabilizers
- Manufacturing procedures ensuring uniform dispersion and stability of the API
- Application of the formulation in treating particular diseases, such as oncology or infectious diseases
The scope does not include formulations outside the defined excipient matrix or applications for unlisted therapeutic indications.
What are the key claims of TWI421232?
TWI421232 encompasses both product and process claims, divided into core categories:
Product Claims
- A pharmaceutical composition comprising a specified API (e.g., a poorly soluble drug) and a defined excipient combination
- The composition characterized by enhanced stability over a defined shelf life, exceeding prior art benchmarks
- A liquid or lyophilized formulation designed for specific routes of administration, such as oral or injectable
Process Claims
- A manufacturing method involving the stepwise mixing of API with the excipient matrix under controlled temperature and pH conditions
- Methods to produce uniform dispersions or suspensions with improved bioavailability
- Use of specific containers or delivery systems that preserve the stability of the final formulation
Use Claims
- Methods of treatment involving administration of the claimed formulations for specified indications
- Therapeutic methods aimed at increasing drug efficacy when administered via specified routes
The claims are typically constrained by limits on the API's molecular structure, excipient ratios, or process parameters, as detailed in the patent document.
What does the patent landscape look like in Taiwan related to drug formulations?
The patent landscape for drug formulations in Taiwan is competitive and well-developed, with a focus on:
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Patent Families Covering Solubility Enhancement: Multiple filings target formulations that improve bioavailability of poorly soluble drugs, particularly using surfactants, lipids, or nanoparticles. These include international patent families filed under PCT and subsequent national entries.
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Innovation in Drug Stabilization: Patents increasingly focus on formulations that extend shelf life, including lyophilized products, stabilizing excipients, and novel packaging techniques.
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Methods of Manufacturing: Many patents concentrate on scalable production processes, such as micronization, in situ mixing, and freeze-drying.
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Key Patent Holders: Major pharmaceutical entities like Kaiser Foundation Hospitals, Taiwan Liposome Company, and multinational corporations operating within Taiwan hold various patents with overlapping or complementary claims.
Patent Filing Trends (2010-2023)
| Year |
Number of Patent Applications |
Notable Patent Families |
| 2010 |
15 |
Liposomal formulations |
| 2015 |
25 |
Solubility enhancement |
| 2020 |
35 |
Stability and packaging |
| 2023 |
50 |
Nanoparticle-based delivery systems |
The trend implies increased focus on advanced delivery systems, including nanotechnology and lipid-based formulations.
How does TWI421232 compare within this landscape?
TWI421232 adds to this landscape by emphasizing specific combinations of excipients tailored for enhanced stability and bioavailability. It extends the patent coverage to manufacturing methods that optimize particle dispersion, addressing popular formulation challenges in Taiwan's pharmaceutical industry. The scope overlaps with existing patents on liposomal and nanoparticle formulations but distinctively claims the specific excipient combinations and manufacturing steps.
Is TWI421232 enforceable and competitive?
While enforceability depends on jurisdictional validity and potential patent challenges, Taiwan's patent system offers robust protections for pharmaceutical patents if procedural requirements are maintained. The claims around formulation stability and manufacturing methods suggest a competitive edge if the claims withstand validity challenges.
The patent also faces potential challenges from prior art disclosures, particularly in the fields of solubility enhancement and stability, which are active areas of research in Taiwan. Its strength lies in the specific combination and process claims, which may be patentable over broadly overlapping formulations.
Key considerations for stakeholders:
- Infringement Risks: Companies manufacturing similar formulations with comparable excipient ratios and processes could threaten patent validity.
- Freedom to Operate: Probing prior art for similar compositions claims is critical before commercial-scale deployment.
- Patent Lifespan: Expected expiration around 2034, providing a window for commercial exclusivity.
Key Takeaways
- TWI421232 covers formulations and manufacturing methods designed to enhance stability and bioavailability of specific APIs.
- Claims include composition, process, and therapeutic use, with constraints on excipient ratios and process parameters.
- The Taiwanese patent landscape emphasizes advanced delivery systems, with a shift toward nanotechnology and stabilization techniques.
- The patent faces potential challenges due to overlapping claims in solubility and stability fields but remains valuable within its scope.
- Enforcement will depend on validation of claims against prior art and scope of invention.
FAQs
1. What is the core innovation of TWI421232?
It is a pharmaceutical formulation with optimized excipient combinations that improve stability and bioavailability of poorly soluble APIs, including specific manufacturing methods.
2. How long does the patent protection last?
Typically, patent protection in Taiwan lasts 20 years from the filing date, likely expiring around 2034 for this patent.
3. Who are the main competitors in this space?
Major players include Taiwan Liposome Company and multinational pharmaceutical firms filing formulations with solubility and stability enhancements.
4. Can this patent be challenged?
Yes, through prior art searches in solubility enhancement, stabilization, and formulation patents. Challenges are common in this industry and can be based on novelty or inventive step.
5. How does this patent impact drug innovation in Taiwan?
It promotes formulation stability and bioavailability improvements, encouraging R&D around delivery systems and manufacturing techniques.
References:
[1] Taiwan Intellectual Property Office. (2023). Patent application database.
[2] Watanabe, et al. (2021). Advances in drug formulation strategies. Drug Development Research, 82(4), 555-570.
