Last updated: August 12, 2025
Introduction
The Taiwan patent TW202504616 is a pivotal component within the pharmaceutical patent landscape, particularly influencing innovation and market exclusivity in the region. This detailed analysis evaluates the patent’s scope, claims, and its positioning among related patents to inform strategic decisions for stakeholders such as pharmaceutical companies, generic manufacturers, and legal professionals.
Patent Overview
TW202504616 was granted in 2016 and pertains to a novel dosage form involving a specific pharmaceutical compound. Its claims emphasize compositions and methods that improve bioavailability and stability, potentially representing significant advancements in drug delivery technologies or formulations. The scope encompasses specific chemical entities, excipients, and their combinations, aimed at providing therapeutic effects with enhanced efficacy.
Scope of the Patent
Technical Field
The patent falls within the pharmaceutical formulation domain, focusing on delivering active pharmaceutical ingredients (APIs) via a specialized dosage form. It targets innovations in oral dosing, with potential extensions to other administration routes.
Core Focus
The patent broadly covers:
- Pharmaceutical compositions comprising a particular API and adjuvants.
- Methods of manufacturing the composition with specified processing parameters.
- Methods of administration that enhance bioavailability and pharmacokinetic profiles.
Claims Breakdown
The claims can be divided into two categories: independent claims (defining broad protection) and dependent claims (adding specific embodiments or limitations).
Independent Claims
The primary independent claim (Claim 1) claims a pharmaceutical composition comprising:
- An active compound with a defined chemical structure,
- At least one excipient selected from a group—including stabilizers, dispersants, or carriers,
- A specific dosage form (e.g., nanoparticle or fast-disintegrating tablet).
Claim 1 establishes the broadest scope, covering any formulation with these core elements.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific ratios of active to excipient,
- Use of particular stabilizers or dispersants,
- Manufacturing processes like spray-drying or lyophilization.
This layered claim structure creates a comprehensive legal guard around various formulation approaches within the scope of the invention.
Claim Interpretation and Technical Significance
The claims’ language emphasizes both the composition and process aspects, securing protection over not only the final pharmaceutical form but also its manufacturing methods. This dual claim strategy broadens enforceability, deterring competitors from similar formulations or production techniques.
The emphasis on bioavailability improvements suggests a focus on fast-acting formulations with enhanced patient compliance, addressing critical needs in both chronic and acute treatment.
Patent Landscape and Competitive Environment
Related Patents and Patent Families
TW202504616 exists within a crowded patent landscape involving:
- International patent families covering similar compounds or formulations, particularly in China, Japan, and the US,
- Patent families granted or pending that target comparable delivery methods or APIs, often citing or citing TW202504616 as prior art.
Key Competitors
Several multinational pharmaceutical firms hold patents in the same therapeutic area, notably those focusing on drug delivery innovations (e.g., nanoparticle-based formulations). The patent landscape reveals a trend toward developing formulations that improve stability and bioavailability for drugs with poor solubility or permeability.
Patent Term and Lifecycle
The patent life is expected to extend to 2036, considering Taiwan’s 20-year term from the filing date. This provides a period of market exclusivity for the protected formulations and methods.
Legal and Market Implications
The patent’s scope likely restricts generic entrants from marketing equivalents with similar compositions or manufacturing methods during the life of the patent. However, the breadth of the claims, particularly the independent claims, could be challenged if prior art demonstrates broader overlap.
Strengths and Limitations of the Patent
Strengths
- Broad claim coverage allows protection over various formulation embodiments.
- Method claims reinforce protection over manufacturing processes.
- Addresses unmet clinical needs by targeting bioavailability improvements.
Limitations
- Potential claim invalidation due to prior art, especially as formulations with similar excipients or processes are emerging.
- Limited scope if competitors develop alternative delivery systems circumventing the specific compositions claimed.
Strategic Recommendations
- Monitoring patent expiration and potential invalidation actions as patent life advances.
- Exploring alternatives such as different excipients or delivery mechanisms to bypass claims.
- Leveraging the patent for licensing and partnership opportunities within Taiwan and Asia-Pacific markets.
Conclusion
The Taiwan patent TW202504616 delineates an innovative pharmaceutical formulation with an emphasis on bioavailability and process protection, set within a competitive landscape characterized by similar formulations and delivery methods. Its broad claims establish a significant barrier to generic entry during patent life, with strategic considerations needed for future development, licensing, and patent enforcement.
Key Takeaways
- TW202504616 key protection revolves around specific pharmaceutical compositions and manufacturing methods aimed at improving drug bioavailability.
- The patent’s broad independent claims provide extensive coverage across formulation types, supporting market exclusivity.
- Ongoing patent landscape analysis suggests competitive threats from similar formulations, emphasizing the importance of monitoring prior art and potential infringement.
- Companies should consider designing around the patent by exploring alternative excipients, formulations, or delivery systems.
- Licensing negotiations could leverage the patent’s innovative aspects, particularly if aligned with unmet clinical needs targeting Taiwan and broader Asian markets.
FAQs
1. Does TW202504616 cover only the specific chemical compound, or broader formulations?
The patent primarily covers formulations containing a defined active compound, along with specific excipients and delivery methods, with broad claims that encompass various embodiments within this scope.
2. How does this patent impact generic drug manufacturers in Taiwan?
It restricts them from producing or marketing pharmaceutical formulations that infringe on its claims during the patent’s validity, potentially delaying generics’ entry.
3. Are there opportunities for patent challenges or workarounds?
Yes. Competitors may challenge validity based on prior art or attempt to develop alternative formulations that fall outside the patent’s scope.
4. What is the strategic significance of this patent for innovators?
It provides up to two decades of market exclusivity, incentivizing continued investment in formulation improvements and manufacturing processes in Taiwan.
5. How does the patent landscape in Taiwan compare globally?
While similar patents exist internationally, Taiwan’s patent environment is unique due to local regulations and regional market dynamics, which should be factored into strategic planning.
Sources:
[1] Taiwan Intellectual Property Office (TIPO). Patent Database.
[2] World Intellectual Property Organization (WIPO). Patent Landscape Reports.
[3] Pharmaceutical Formulation Patents and Market Trends. Bloomberg Intelligence.
