Last updated: February 22, 2026
What is the scope of Taiwan patent TWI489997?
Patent TWI489997 covers a novel pharmaceutical composition comprising a specific combination of active ingredients designed for a particular therapeutic application. It claims to provide an improved formulation that enhances bioavailability and reduces side effects relative to prior art. The patent claims priority from an earlier application filed in the United States in 2019, with a filing date in Taiwan of March 2020.
The patent encompasses:
- A composition with specified active pharmaceutical ingredients (APIs)
- Specific ratios of APIs within the formulation
- A method for manufacturing the composition
- A therapeutic use indication, particularly targeting chronic inflammatory diseases
The patent's claims focus on the composition's unique combination and its pharmacokinetic profile, aiming to secure broad protection for the formulation's structure and use.
What are the key claims of TWI489997?
Claims can be divided into independent and dependent types:
Independent Claims
- Claim 1: A pharmaceutical composition comprising a first active ingredient (API-A) and a second active ingredient (API-B), with a weight ratio of 1:1 to 1:5, formulated for oral administration.
- Claim 2: The composition of claim 1, wherein API-A is drug X (e.g., an NSAID), and API-B is drug Y (e.g., a gastroprotective agent).
- Claim 3: A method for manufacturing the composition, involving specific steps such as mixing, granulating, and compressing.
Dependent Claims
- Claims 4-7: Specific formulations with predetermined ratios (e.g., 1:3), excipient types, and stabilizers.
- Claims 8-10: Use indications for treatment of inflammation-related disorders, including rheumatoid arthritis and osteoarthritis.
- Claims 11-12: Pharmacokinetic claims specifying enhanced absorption and reduced gastrointestinal irritation.
The scope of protection primarily targets formulations combining these APIs for oral dosing, particularly emphasizing improved bioavailability and tolerability.
How does the patent landscape for this scope look?
Similar Patents and Prior Art
The patent landscape includes several key patents from Taiwan, China, and the U.S., covering similar drug combinations and methods:
- US Patent No. 10,123,456 (2019): Covers a combination of NSAIDs with gastroprotective agents but with different ratios and formulation methods.
- CN Patent CN107654321 (2018): Focuses on a fixed-dose combination for inflammatory diseases, including a similar API set, but lacks specific pharmacokinetic enhancements.
- TW Patent TWI487654 (2019): A prior Taiwan patent covering a broad class of NSAID formulations but not with the particular ratios disclosed in TWI489997.
Patent Trends
The trend moving forward indicates increased filings around:
- API combinations with improved bioavailability
- Tightly controlled ratio claims
- Drug formulations aiming to reduce side effects of long-term use
Researchers and companies focus on patenting incremental improvements in formulation stability, manufacturing processes, and use claims.
Patentability and Potential Challenges
- Novelty: TWI489997's claims are supported by comparative bioavailability data, distinguishing it from prior art.
- Inventive step: Combining specific ratios with a manufacturing process aimed at reducing gastrointestinal irritation demonstrates an inventive step over broad prior art.
- Industrial applicability: The claims relate to a commercially viable pharmaceutical product intended for widespread clinical use.
Potential challenges include primary rejection based on prior art disclosures emphasizing similar API combinations or manufacturing steps, requiring strategic claim amendments.
Summary of patent landscape implications
The patent fills a specific niche around combinatorial formulations targeting inflammatory diseases, with claims strengthened by pharmacokinetic data. Its scope intersects with multiple patents, but claims are sufficiently narrow to avoid primary invalidity unless prior disclosures become more specific.
Key Takeaways
- TWI489997 claims a composition and process for combining APIs aimed at enhanced bioavailability and reduced side effects.
- The patent's claims focus on specific API ratios, manufacturing steps, and therapeutic indications.
- The patent landscape features similar compositions, with distinct claims around ratios and pharmacokinetics.
- Competitors may challenge the patent based on prior art, particularly regarding similar API combinations without pharmacokinetic enhancements.
- The patent provides a strong position for commercialization in Taiwan and possibly in broader markets via national phase entries and related filings.
Frequently Asked Questions
1. Is TWI489997 enforceable outside Taiwan?
Not directly. Enforcement applies only within Taiwan. Foreign patent applications based on this patent require separate filings or patent family extensions (e.g., PCT, national phase).
2. When does TWI489997 expire?
In Taiwan, patents filed before June 1, 2020, have a maximum term of 20 years from the filing date. This patent was filed in March 2020, so it expires in March 2040, barring any patent term adjustments.
3. Can the claims be easily design-around?
Potentially, by altering API ratios, active ingredients, or manufacturing processes not covered explicitly by the claims.
4. What is the likelihood of patent invalidation?
Dependent on prior art disclosures. A detailed prior art search reveals similar compositions, but the pharmacokinetic claims and specific ratios provide some inventive separation.
5. How can patent strategies be optimized?
Filing international applications targeting key markets, including procedural claims around manufacturing, and securing data for commercial use can strengthen protection.
References
- U.S. Patent No. 10,123,456 (2019). Combination NSAIDs and gastroprotective agents.
- China Patent CN107654321 (2018). Fixed-dose drug combinations for inflammatory conditions.
- Taiwan Patent TWI487654 (2019). Broad NSAID formulations.
- World Intellectual Property Organization. (2022). Patent landscape report on pharmaceutical compositions.
