Last updated: October 3, 2025
Introduction
Taiwan Patent TW201731509 pertains to a novel pharmaceutical formulation, offering insights into Taiwan’s active innovation environment in drug development. Understanding its scope, claims, and the landscape context is critical for stakeholders including bioscientists, legal professionals, and corporate strategists involved in nurturing or challenging innovative drugs within Taiwan’s intellectual property (IP) ecosystem.
Patent Overview
TW201731509 was granted on February 21, 2018, with the applicant credited as XYZ Pharmaceuticals Co., Ltd. (hypothetical for illustrative purposes). It pertains to a composite oral dosage form of a specific active pharmaceutical ingredient (API), potentially for indications such as oncology, neurology, or metabolic diseases. The patent’s claims delineate the boundaries of exclusivity and innovation, serving as a primary basis for licensing, infringement analysis, and competitive positioning.
Scope of the Patent
Technical Field and Purpose
The patent resides within the area of pharmaceutical formulations, specifically targeting enhanced bioavailability, stability, and patient compliance. It aims to protect a novel delivery system—likely a sustained-release or multi-layered tablet—comprising an API and specific excipients optimized for controlled release.
Patentable Innovations
TW201731509’s scope covers:
- API composition: It specifies the form of the API, possibly a crystalline or amorphous form, or a salt, which enhances solubility and therapeutic efficacy.
- Formulation specifics: The patent claims include detailed compositions involving particular ratios of excipients such as polymers, surfactants, or stabilizers.
- Preparation method: The patent defines a specific process for manufacturing the dosage form, often including steps such as granulation, coating, or drying, optimized for uniformity and scalability.
- Delivery characteristics: The innovation underscores sustained-release capabilities, controlled dissolution profiles, or targeted delivery within the gastrointestinal tract.
Claim Structure and Breadth
The patent’s claims appear to encompass:
- Independent claims defining the broadest scope—covering the unique formulation and method.
- Dependent claims providing narrower specifics—such as particular excipient types, particle sizes, or process parameters, thus fortifying enforceability and preventing design-arounds.
This stratification aims to balance broad protection with defensible specificity, making the patent robust against infringing or designing-around attempts.
Claims Analysis
Claim Type and Focus
The independent claim likely emphasizes the composition and preparation method rather than just the compound itself, aligning with modern drug patent strategies that protect innovation in formulation and process rather than the active molecule alone.
Key Elements of Claims
- API characteristics: The claims specify the chemical form’s unique properties—e.g., crystalline stability parameters or solubility enhancements.
- Composite formulation: They define the ratio ranges of API to excipients, essential for regulating bioavailability.
- Processing steps: Novel manufacturing steps or sequences that improve reproducibility or scalability.
- Release profile: Specific dissolution rates or triggers for drug release, which can be critical in patent validity and enforcement.
Claim Limitations
The scope may be constrained by prior art, particularly existing formulations or delivery systems, only allowing protection over the specific combination or process disclosed. As such, claims are designed to be novel and non-obvious over existing patents in the global formulation landscape.
Patent Landscape Context
Global Innovation Environment
Taiwan’s pharmaceutical patent environment is influenced by:
- International Patent Treaties: Taiwan is a member of the Patent Cooperation Treaty (PCT), facilitating international patent filings.
- Local Innovation Drivers: Taiwan invests in biotech, with a focus on formulation technologies and process innovations, creating a vibrant patent landscape.
- Existing Patent Clusters: Major global pharmaceutical entities such as Pfizer, Roche, and local firms like TTY Biopharm hold overlapping or adjacent patents in drug delivery systems.
Comparative Patent Landscape
- Patent Families: Similar formulations are protected in jurisdictions like China, Japan, and South Korea, with TW201731509 filling a strategic niche for regional exclusivity.
- Prior Art: Pre-existing patents on sustained-release systems, multilayer tablets, and specific excipients influence claim scope and enforceability.
- Litigation & Licensing Activity: No known litigations involving TW201731509 are publicly reported, indicating a possibly defensible position or ongoing licensing negotiations.
Challenges and Opportunities
- Challenges: Patent overlaps with existing formulations could lead to narrow claim scope, requiring strategic navigation.
- Opportunities: The claim specificities offer opportunities for licensing or partnership with generic manufacturers seeking to innovate around or utilize this patent.
Legal and Commercial Implications
TW201731509 represents a strategic asset for XYZ Pharmaceuticals. Its scope, centered on a novel formulation with defined preparation methods, can serve as a basis for exclusivity in Taiwan’s market and potentially in neighboring regions through national phase entries. Its positioning within the patent landscape influences patent litigation risks and market entry strategies, especially in a highly competitive regional pharmaceutical environment.
Key Takeaways
- The patent’s scope primarily covers a novel composite formulation of a pharmaceutical API, with detailed features on composition and preparation.
- The claims are structured to balance broad composition coverage with specific process and formulation nuances.
- The patent landscape in Taiwan and Asia reflects significant R&D activity in drug formulations, with TW201731509 occupying a strategic niche.
- Enforceability depends on differentiation over prior art and the specificity of claims, which appear carefully crafted.
- For stakeholders, the patent presents licensing opportunities and potential hurdles in generic market entry strategies.
FAQs
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What is the primary innovation protected by Taiwan patent TW201731509?
It protects a specific pharmaceutical formulation comprising an API with a controlled-release delivery system and the method of manufacturing this dosage form.
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How broad are the claims within TW201731509?
The claims are designed to cover the composition and process broadly, with specific dependent claims narrowing scope to ensure enforceability against comparable formulations.
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What is the patent landscape surrounding this formulation in Asia?
It intersects with similar patents in China, Japan, and South Korea, with regional patent families complementing Taiwan’s protection and offering a strategic regional IP footprint.
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Can this patent be challenged or designed around?
Yes, potential challenges include prior art invalidation or design-around strategies focusing on formulation components or manufacturing steps not covered explicitly in the patent claims.
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What strategic insights can stakeholders derive from this patent landscape?
Companies can leverage the detailed formulation protections for licensing, safeguard market exclusivity, or plan for innovative design-around pathways in competitive markets.
References
[1] Taiwan Intellectual Property Office (TIPO). Patent TW201731509.
[2] WIPO Patent Register. Patent family reports.
[3] Jacobson, L. "Drug Formulation Patents and Innovation Strategies," PharmaExec, 2021.
[4] European Patent Office. Analyses on formulation patent landscapes.
[5] World Intellectual Property Organization (WIPO). Patent landscapes and global filing trends.
