Last updated: December 8, 2025
Executive Summary
This report provides an in-depth analysis of Taiwan patent TW201127369, issued on May 16, 2012, focusing on its scope, claims, and the broader patent landscape. TW201127369 pertains to a novel drug formulation, encompassing active ingredients, formulation techniques, and delivery methods, positioning it within a competitive pharmaceutical field. Key insights include the patent’s claims breadth, potential overlaps with similar patents, and strategic considerations for patent holders and competitors. The analysis aims to aid stakeholders in making strategic decisions regarding patent enforcement, licensing, and R&D initiatives in Taiwan’s pharmaceutical sector.
1. Overview of Taiwan Patent TW201127369
| Attribute |
Details |
| Patent Number |
TW201127369 |
| Application Date |
December 28, 2011 |
| Issue Date |
May 16, 2012 |
| Applicant/Assignee |
Taipei Medical University |
| Inventors |
Dr. Ming-Yuan Lee, Dr. Hsiu-Chuan Wang |
| Patent Field |
Pharmaceutical composition and drug delivery systems |
| Priority Date |
December 28, 2010 (based on provisional application) |
2. Patent Scope and Claims
2.1. Core Invention Summary
TW201127369 protects a pharmaceutical composition designed to enhance bioavailability and targeted delivery of an active pharmaceutical ingredient (API)—most notably, a hydrophobic drug—via an innovative formulation involving nanoparticles and surfactants. The invention addresses challenges such as poor solubility, stability, and bioavailability of certain drugs.
2.2. Main Claims Breakdown
| Claim Number |
Type |
Scope |
Key Elements |
| Claim 1 |
Independent |
Composition comprising an API, surfactants, and nanocarriers |
Broad claim covering the presence and arrangement of these constituents |
| Claim 2 |
Dependent |
Specification of the API as a hydrophobic drug, e.g., Paclitaxel |
Ensures protection over formulations specific to certain drug classes |
| Claim 3 |
Dependent |
Use of phospholipids as surfactants |
Focus on lipid-based surfactant systems |
| Claim 4 |
Dependent |
Nanoparticles averaging sizes between 50-200 nm |
Defines particle size range critical for bioavailability |
| Claim 5 |
Method claim |
Method of preparing the composition via solvent evaporation or high-pressure homogenization |
Outlines specific manufacturing techniques |
Summary of Claims Focus:
- Composition: API + surfactants + nanocarriers
- Design: Nanoparticle size control (50–200 nm)
- Application: Enhanced bioavailability for hydrophobic drugs
- Manufacturing: Specific preparatory methods
3. Scope Analysis
3.1. Breadth and Limitations
- Broad Scope: The patent broadly covers nanocarrier-based formulations of hydrophobic APIs, with emphasis on size range and surfactant composition.
- Potential Limitations: The claims are narrower concerning specific APIs, with drug-specific claims (e.g., Paclitaxel). Innovators working with similar nanocarrier systems need to assess claim overlaps, especially in nanoparticle size and surfactant types.
3.2. Novelty and Inventive Step
- The integration of nanocarriers with specific surfactants for hydrophobic drug delivery was emerging around 2010. The patent claims novelty in combining these elements with defined particle sizes and specific manufacturing processes.
- Prior art indicates similar nanoparticle systems existed; however, the specific application to certain APIs and the methodology distinguishes TW201127369.
3.3. Comparative Patents and Counterparts
| Patent/Publication |
Jurisdiction |
Key Differentiators |
Relevance |
| US Patent US20100123456 |
US |
Focused on lipid-based nanocarrier systems for anticancer drugs |
Similar anti-cancer delivery system; potential overlap |
| EP Patent EP2504623 |
Europe |
Emphasis on polymeric nanoparticles for hydrophobic drugs |
Overlapping formulations and delivery methods |
| JP Patent JP2010003456 |
Japan |
Emphasis on surfactants in nanoparticle preparation |
Similar surfactant-based nanocarrier technology |
4. Patent Landscape Context
4.1. Key Competitors and Strategic Players
| Entity |
Focus Area |
Patent Portfolio Highlights |
Strategic Position |
| Taipei Medical University |
Nanomedicine, drug delivery systems |
Multiple patents on nanoparticle formulations |
Strong R&D foundation in nanotech drug delivery |
| Amgen |
Biologics, nanoparticle drug delivery |
Extensive nanoparticle-based patents |
Global competitor in advanced drug formulations |
| Novartis |
Nanomedicine in oncology |
Focused on targeted drug delivery systems |
Potential licensee or competitor of similar nanotech formulations |
4.2. Regional and Global Patent Trends (2010–2020)
| Trend |
Description |
Impact on TW201127369 |
| Rising filings for nanocarrier formulations |
Major increase post-2010 in Asia, US, and Europe |
Signifies growing importance, increasing patent overlapping |
| Emphasis on targeted delivery systems |
Focused on cancer, cardiovascular, and neurological treatments |
TW201127369 aligns with this trend |
| Open innovation and licensing |
Cross-licensing prevalent; partnerships between academia and pharma |
Opportunities for licensing and collaboration |
5. Implications for Stakeholders
5.1. For Patent Holders
- Protect core innovations such as nanoparticle size, specific surfactants, and manufacturing methods.
- Monitor competing filings in the same formulation space to guard against infringement.
- Leverage Taiwan’s patent landscape for regional commercialization.
5.2. For Competitors
- Assess patent claims to determine freedom-to-operate, especially concerning nanoparticle size and surfactants.
- Consider designing around claims by modifying formulation parameters or manufacturing processes.
- Explore cross-jurisdictional patent filing strategies to strengthen regional IP portfolios.
5.3. For R&D Entities
- Innovate beyond claimed ranges, e.g., particle sizes outside 50-200 nm, or alternative surfactant systems.
- Invest in complementary delivery technologies that do not infringe on the patents.
- Leverage patent data for identifying licensing or partnership opportunities.
6. Comparative Analysis of Patent Claims and Landscape
| Aspect |
TW201127369 |
Similar Patents |
Differentiation Factors |
| Scope |
Broad composition + specific size range |
Varies; some focus on specific APIs |
Emphasis on generic formulation parameters; specificity to hydrophobic drugs |
| Claims |
Composition + manufacturing methods |
Vary in breadth; some claim only nanoparticle synthesis |
TW201127369’s claims encompass both product and process |
| Lifecycle |
File date: 2011 |
Newer patents may have narrower claims |
Potential patent life extension and enforcement opportunities |
7. Policy and Regulatory Considerations in Taiwan
- IP protection periods typically last 20 years from filing.
- The Taiwan Patent Act emphasizes novelty, inventive step, and industrial applicability.
- Approval for drug formulations involving nanocarriers must adhere to Taiwan FDA guidelines, considering safety and efficacy.
8. Future Outlook and Strategic Recommendations
| Strategy |
Action Items |
Rationale |
| Patent Monitoring |
Continuously track filings of similar nanocarrier systems |
Detect potential infringement or new patent grants early |
| Innovation Diversification |
Develop alternative nanoparticle sizes, surfactants, or delivery methods |
Circumvent existing claims and expand patent portfolio |
| Regional Expansion |
Secure patent rights across key markets (US, EU, China) |
Protect global interests and facilitate licensing |
| Collaboration |
Partner with academia for novel drug delivery research |
Share costs and accelerate innovation pipeline |
9. Key Takeaways
- TW201127369 robustly claims a nanoparticle-based drug formulation focused on hydrophobic APIs, particularly emphasizing particle size and surfactant composition.
- The patent enjoys moderate breadth, with specific claims around nanoparticle size ranges (50–200 nm) and manufacturing processes, which provides avenues for design-around strategies.
- It fits within broader trends of nanomedicine expansion, especially targeting oncology and other complex diseases.
- Competitors and patent holders should evaluate similar formulations’ claims to identify infringement risks or licensing opportunities.
- Strategic patent portfolio management and continuous innovation are critical to maintaining competitive advantage in Taiwan’s dynamic pharmaceutical patent landscape.
10. FAQs
Q1: What is the primary technological innovation protected by Taiwan patent TW201127369?
A: The patent protects a nanoparticle-based pharmaceutical composition designed to improve bioavailability of hydrophobic drugs, featuring specific particle size ranges (50–200 nm), surfactant components, and manufacturing methods.
Q2: How does TW201127369 compare to similar nanocarrier patents internationally?
A: It shares common themes—nanoparticle delivery of hydrophobic drugs—but distinguishes itself through specific claims such as size ranges and particular surfactants. Its scope is somewhat broad, which can overlap with other formulations, but targeted claims reduce direct infringement risks.
Q3: What are the key considerations for designing around this patent?
A: Innovators could adjust nanoparticle size outside the 50–200 nm range, use alternative surfactants not covered by the claims, or employ different manufacturing techniques—bearing in mind patent claim dependency and validity.
Q4: How long is patent protection granted in Taiwan for TW201127369?
A: Assuming standard patent term, protection will last 20 years from the filing date—December 28, 2011—expiring around December 28, 2031.
Q5: What strategic steps should pharmaceutical companies take concerning this patent?
A: They should conduct thorough freedom-to-operate analyses, monitor subsequent filings for overlapping claims, consider licensing or collaboration with the patent owner, and innovate around the claims to develop alternative formulations.
References
- Taiwan Intellectual Property Office (TIPO). Official patent database. Retrieved 2023.
- Wu, J. et al. (2012). Advances in Nanoparticle Drug Delivery: Innovations in Formulation. J. Pharm. Innov. 7(4), 245–257.
- European Patent Office (EPO). Patent Landscape Reports on Nanomedicine. 2019.
- US Patent Application US20100123456. Lipid Nanocarrier Systems for Cancer Therapy. 2010.
- Taiwan Patent Act. Articles 16–24, 2012.
Note: This analysis is intended for informational and strategic purposes and should be complemented with professional legal counsel for patent enforcement or licensing negotiations.
