Last updated: November 27, 2025
Executive Summary
Taiwan patent TW201519889, titled "Novel pharmaceutical composition for treating metabolic disorders," was filed on November 25, 2015, by PharmaInnovate Inc., with a publication date of December 9, 2015. The patent aims to secure exclusive rights for a unique combination of active ingredients targeting metabolic syndrome and related disorders. Its scope covers specific formulations, dosage forms, and methods of treatment, with claims emphasizing innovative synergy among components.
This analysis delineates the patent's claims, scope, and its position within the broader Taiwanese drug patent landscape. We explore the technical specifics, compare similar patents, and evaluate potential for infringement, licensing, or freedom-to-operate considerations.
1. Patent Scope and Claims Overview
1.1. Patent Abstract and Technical Field
The patent relates to a pharmaceutical composition comprising a combination of a PPARγ agonist, an anti-inflammatory agent, and a lipid-lowering agent, designed for treating conditions like type 2 diabetes, obesity, and cardiovascular risks linked to metabolic syndrome.
1.2. Main Claims Summary
| Claim Number |
Claim Type |
Summary |
Focus Area |
| 1 |
Independent |
A pharmaceutical composition comprising: (a) a PPARγ agonist, (b) an anti-inflammatory agent, and (c) a lipid-lowering agent. |
Composition, synergy, formulation |
| 2 |
Dependent |
The composition of claim 1, wherein the PPARγ agonist is pioglitazone. |
Specific active ingredient inclusion |
| 3 |
Dependent |
The composition of claim 1, wherein the anti-inflammatory agent is curcumin. |
Specific anti-inflammatory agent |
| 4 |
Dependent |
The composition of claim 1, wherein the lipid-lowering agent is atorvastatin. |
Specific lipid-lowering agent |
| 5 |
Method claim |
A method of treating metabolic syndrome comprising administering an effective amount of the composition of claim 1. |
Therapeutic method |
1.3. Highlights of the Claims
- Broad Composition Claim: Covers any combination of specified classes of active compounds, with flexibility in specific agents.
- Specific Embodiments: Narrow claims focusing on particular active agents (pioglitazone, curcumin, atorvastatin).
- Method Claim: Encompasses treatment protocols using the composition.
1.4. Claims Analysis
The scope of patent TW201519889 is moderately broad, especially given the inclusion of classes of drugs rather than specific molecules alone. The composition claims do not specify dosage or ratios, which could open opportunities for alternative formulations that avoid infringement.
2. Patent Landscape in Taiwan for Similar Pharmaceuticals
2.1. Taiwanese Patent Filing Trends (2010–2022)
| Year |
Total Pharma Patents Filed |
Major Focus Areas |
Notable Trends |
| 2010 |
1,200 |
Diabetes, cardiovascular, metabolic diseases |
Rising focus on combination therapies |
| 2015 |
1,600 |
Increased filings on multi-drug compositions |
Surge in patents for metabolic syndrome drugs |
| 2020 |
2,300 |
Gene-based therapies, biosimilars |
Shift toward biologics and personalized medicine |
Source: Taiwan Intellectual Property Office (TIPO) Annual Reports
2.2. Key Similar Patents in Taiwan
| Patent No. |
Title |
Filing Date |
Focus |
Notable Claims |
Status |
| TW201608887 |
Combination therapy for metabolic disorders |
Aug 2016 |
Metformin + α-glucosidase inhibitors |
Composition and methods |
Granted 2018 |
| TW201702345 |
Lipid-lowering agents in combination |
Feb 2017 |
Statins + PCSK9 inhibitors |
Composition |
Pending |
| TW201803210 |
Anti-inflammatory compositions for metabolic syndrome |
Mar 2018 |
Curcumin derivatives |
Composition & methods |
Granted 2019 |
Implication: TW201519889 overlaps with existing patents that combine anti-diabetic and lipid-lowering agents but retains novelty by specific combinations and formulations.
3. Technical Comparison & Patent Validity Considerations
3.1. Novelty and Inventive Step
The composition's novelty stems from the combination of a PPARγ agonist, anti-inflammatory, and lipid-lowering agent, aimed specifically at synergistically treating metabolic syndrome.
- Prior art existing as individual agents or pairwise combinations.
- TW201519889 distinguishes itself with its triple combination and claimed synergistic effects.
3.2. Claims and Potential Infringement
| Aspect |
Details |
Implications |
| Composition scope |
Covers broad range of active agents within each class |
Risk of infringement with similar combinations |
| Specific agents |
Pioglitazone, curcumin, atorvastatin |
Lower infringement risk if substantially different agents are used |
| Formulation |
No dosage ratio detailed |
Alternative ratios may avoid infringement |
3.3. Patent Validity Challenges
- Obviousness: Similar multi-drug therapies were known, potentially challenging based on prior combination therapies.
- Inventive Step: May rely heavily on demonstrating synergistic effects, which must be sufficiently supported experimentally.
- Prior Art: Articles and patents indicating multi-drug approaches for metabolic syndrome exist, but triple combination with specified agents and methods could be considered inventive.
4. Strategic Evaluation & Business Implications
4.1. Opportunities
- Licensing potential: For companies developing combination therapies, especially those focusing on metabolic syndrome.
- Design-around strategies: Substituting agents within the claims, adjusting ratios, or developing novel formulations.
- Patent enforcement: If granted with claims emphasizing synergy and specific combinations, TW201519889 could serve as a robust patent asset in Asia.
4.2. Risks
- Infringement issues: Due to broad claims covering various agents.
- Patent invalidation: If prior art or lack of inventive step is established.
- Regulatory hurdles: Ensuring that combination therapy claims align with local drug approval policies.
5. Regulatory and Policy Context
- Taiwan's Taiwan Food and Drug Administration (TFDA) emphasizes clinical validation of combination therapies.
- Patent linkage policies influence drug approval and patent enforcement.
6. Summary Tables
Patent Claims & Scope
| Type |
Description |
Examples |
Scope Impact |
| Composition |
Multi-component drug formulations |
PPARγ agonist + anti-inflammatory + lipid-lowering |
Broad, covers multiple agents and formulations |
| Method |
Treatment procedures |
Administering composition for metabolic syndrome |
Method-specific, narrower scope |
| Embodiments |
Specific agents like pioglitazone, curcumin, atorvastatin |
Focused, easier to design-around |
More vulnerable to infringement challenges |
Patent Landscape Summary
| Patent No. |
Focus |
Filing Date |
Status |
Specificity |
Overlap Potential |
| TW201519889 |
Multi-drug combo for metabolic syndrome |
Nov 2015 |
Pending |
Broad |
High with similar agents |
| TW201608887 |
Combined metformin and other agents |
Aug 2016 |
Granted |
Moderate |
Moderate |
| TW201702345 |
Lipid-lowering combo |
Feb 2017 |
Pending |
Specific |
Low-moderate |
| TW201803210 |
Anti-inflammatory compositions |
Mar 2018 |
Granted |
Specific |
Low |
Key Takeaways
- TW201519889 offers a strategic patent position in Taiwan for multi-agent therapies targeting metabolic syndrome, with claims covering broad classes of drugs.
- Scope flexibility allows potential design-arounds but raises infringement considerations for similar compositions.
- Patent validity hinges on demonstrating novelty over prior art and inventive step based on claimed synergy.
- Business strategy should include licensing, development of novel formulations, or alternative agents to mitigate infringement risks.
- Continued patent monitoring is critical due to evolving patent filings in this therapeutic area.
Frequently Asked Questions
Q1: What are the key components of patent TW201519889?
A1: The patent covers a pharmaceutical composition comprising a PPARγ agonist, an anti-inflammatory agent, and a lipid-lowering agent, along with methods for treating metabolic syndrome using this combination.
Q2: How broad are the claims in this patent?
A2: The claims are moderate to broad, including any agents fitting within the defined classes, not limited to specific compounds, which could impact freedom to operate.
Q3: How does this patent compare to other Taiwanese patents in metabolic disorder treatments?
A3: It overlaps with patents focusing on multi-drug combinations but uniquely emphasizes a triple-component formulation for synergy, offering competitive differentiation.
Q4: Could similar formulations infringe this patent?
A4: Yes, unless significantly different agents or formulations are used, given the broad scope of claims.
Q5: What should developers consider to avoid infringement?
A5: Use alternative agents outside the claimed classes, modify ratios and formulations, or develop novel therapeutics with different mechanisms.
References
[1] Taiwan Intellectual Property Office (TIPO). Annual Patent Filing Reports, 2010–2022.
[2] WHO. "Management of metabolic syndrome," 2017.
[3] Wang, Y et al. "Multi-drug therapies for metabolic syndrome," Taiwan Journal of Pharmacology, 2018.
[4] Patent Application TW201519889, filed Nov 25, 2015.
