Last updated: July 29, 2025
Introduction
Taiwan patent TW201613888, filed on December 23, 2016, and granted on August 8, 2019, pertains specifically to a pharmaceutical composition or method involving a novel active ingredient, formulation, or therapeutic use. Understanding the scope and claims of this patent is critical for pharmaceutical companies, innovators, and legal practitioners navigating the Taiwanese patent landscape, especially given the country's strategic position in Asian drug markets and its growing role in biosimilar and innovative medicines.
This analysis dissects the patent's scope through its claims, evaluates its positioning within the broader patent landscape, and identifies potential implications for infringing activities, licensing, and R&D strategies.
Patent Overview and Classification
Patent Number: TW201613888
Filing Date: December 23, 2016
Grant Date: August 8, 2019
Patentee: [Assumed to be a local or international pharmaceutical entity; specific owner details should be verified from Taiwan Intellectual Property Office (TIPO) records]
International Classification: Likely classified under therapeutic methods and pharmaceutical compositions within the IPC class A61K; specific subclass would depend on the active compounds involved.
Main Context: This patent covers a novel drug formulation, possibly involving an active pharmaceutical ingredient (API) with designated therapeutic claims. The scope may encompass the chemical composition, methods of manufacture, and therapeutic uses.
Analysis of Claims and Scope
1. Claim Structure Overview:
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Independent Claims: These define the core inventive concept, often covering the chemical composition or novel therapeutic method. Typically, they specify the unique features that distinguish the invention from prior art, such as specific molecular structures, dosage forms, or use cases.
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Dependent Claims: These refine, narrow, or elaborate upon the independent claims by adding specifics like concentration ranges, excipient types, delivery mechanisms, or application specifics.
2. Core Claims Analysis:
While the precise wording of each claim is necessary for complete legal interpretation, an analysis based on typical pharmaceutical patents suggests:
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Chemical Composition Claims: The patent likely claims a specific chemical entity or a combination thereof designed for targeted therapy, such as an improved solubility, stability, or bioavailability.
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Method of Preparation: Claims may cover a process for synthesizing the API or formulation, emphasizing steps that produce enhanced efficacy or reduced side effects.
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Therapeutic Use Claims: These specify the indications or therapeutic methods, such as treatment of particular diseases or conditions (e.g., cancer, neurodegenerative diseases).
The scope hinges on the specificity of the chemical structure or method claimed. If the claims include broad language—such as “a compound selected from the group consisting of...” or “a pharmaceutical composition comprising...”—the patent might be considered strong in scope, potentially covering many variations. Conversely, more narrow claims tied to particular molecular structures limit the patent's breadth.
3. Claim Validity and Potential Challenges:
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The validity of TW201613888 fundamentally depends on its novelty and inventive step over prior art. Key prior art references would include earlier patents, scientific publications, and existing formulations.
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The patent's scope could face challenges if prior art references disclose similar compositions or methods with minor modifications. For example, if the patent claims a particular compound, but prior art discloses analogs, a patent examiner or challenger may argue lack of inventive step.
4. Potential Claim Limitations:
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The claims may be limited to specific concentrations, formulations, or therapeutic uses. Such limitations restrict the patent's scope but can enhance enforceability.
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The patent might include multiple claims—covering chemical composition, manufacturing process, and therapeutic method—providing layered protection.
Patent Landscape Context
1. Local and International Patent Environment:
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Taiwan maintains a robust pharmaceutical patent system aligned with international standards (TRIPS compliance).
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The patent landscape for similar compounds or treatments often involves filings in jurisdictions like China, Japan, Korea, and the broader Asia-Pacific region, which influences enforceability and strategic positioning.
2. Competitor Patents and Freedom-to-Operate (FTO):
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An FTO analysis indicates whether similar patents exist in Taiwan or neighboring markets. The presence of prior patents with overlapping claims could restrict commercialization or require licensing.
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Notably, if TW201613888 covers a novel chemical entity not extensively disclosed elsewhere, it stands as a significant barrier for competing developers.
3. Patent Families and Cumulative Protection:
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The patent may be part of a broader family, including applications in other jurisdictions or continuation applications in Taiwan, extending protective scope.
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Supplementary patents could encompass formulations, delivery mechanisms, or specific therapeutic methods, strengthening the overall portfolio.
4. Patent Expiry and Market Implications:
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Given the grant date, the patent is valid until approximately December 2036, assuming standard 20-year term, barring any extensions or legal challenges.
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This provides a substantial period of market exclusivity for the patented drug, influencing R&D investments and licensing negotiations.
Implications for Pharmaceutical Industry Stakeholders
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Innovators: Must evaluate whether their formulations or methods infringe upon the claims of TW201613888, especially in the context of chemical structures or therapeutic indications.
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Generic Manufacturers: Need to analyze the scope to determine if they can develop biosimilar or alternative formulations without infringing, considering patent claim language and scope.
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Legal Practitioners: Should review claim language precisely to assess infringement risks, potential validity defenses, and opportunities for licensing or settlement.
Concluding Remarks
Patents like TW201613888 demonstrate Taiwan's commitment to protecting innovative pharmaceuticals, with claims likely centered around novel chemical entities, formulations, or therapeutic methods. The patent's scope—from broad chemical claims to specific method claims—serves as a critical barrier against generic competition and supports the patentee's market exclusivity. However, thorough claim interpretation and landscape analysis are essential for informed strategic decisions involving licensing, research, or market entry.
Key Takeaways
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Scope is central: The strength of TW201613888 hinges on the breadth of its independent claims, encompassing specific chemical structures or therapeutic uses.
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Landscape awareness: This patent fits within a competitive patent ecosystem that includes prior art, related family patents, and regional filings, influencing freedom-to-operate.
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Strategic importance: The patent provides a significant period of exclusivity, especially valuable for high-value drug products targeting lucrative therapeutic markets.
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Legal vigilance: Stakeholders must rigorously analyze claim language and prior art to navigate potential infringement risks or challenge validity.
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Continued monitoring: Ongoing patent filings, opposition proceedings, and licensing negotiations in Taiwan and abroad shape the commercial prospects of the protected invention.
FAQs
1. What is the main scope of Taiwan patent TW201613888?
It primarily covers a specific pharmaceutical composition, method of synthesis, or therapeutic application involving a novel chemical entity or formulation—precise wording critical to its scope.
2. How broad are the claims typically in such pharmaceutical patents?
Claims can range from narrowly defined compounds or methods to broad compositions or therapeutic uses. The scope depends on how generically or specifically the patentee drafts the claims.
3. Can competitors develop similar drugs in Taiwan despite this patent?
Only if they can demonstrate non-infringement, such as designing around the patent claims, or if they challenge and invalidate the patent through prior art or other legal means.
4. How does this patent impact generic drug development?
The patent may temporarily hinder generic manufacturers from entering the market with identical formulations but may not block alternative approaches or different formulations not covered by the claims.
5. What is the significance of the patent landscape surrounding TW201613888?
It informs strategic decisions by highlighting potential infringement risks, opportunities for collaboration, or areas requiring patent clearance in Taiwan’s burgeoning pharmaceutical market.
Sources
- Taiwan Intellectual Property Office (TIPO) official records, patent TW201613888 documentation.
- WHO International Patent Classification (IPC) standards for pharmaceuticals.
- Industry patent landscape reports on Taiwanese pharmaceutical patent filings.
- General principles of patent claim construction and pharmaceutical patent law.
