Last updated: October 23, 2025
Introduction
Taiwan patent TW201311666, granted in 2013, pertains to an inventive pharmaceutical composition. This patent's scope, claims, and its positioning within the drug patent landscape are critical for innovators, legal practitioners, and business strategists operating in the medical and pharmaceutical sectors. This analysis dissects the patent’s claims, delineates its scope, examines comparative patent strategies, and offers insights into its landscape within Taiwan and global contexts.
Patent Overview and Filing Background
TW201311666 was filed by a pharmaceutical entity seeking to protect a novel formulation aimed at therapeutic efficacy, stability, or delivery improvement. While the specific therapeutic target is not provided here, the patent likely falls within a therapeutic class given standard practice in pharmaceutical patenting.
The patent, granted in 2013, is part of Taiwan’s robust pharmaceutical patent framework aligned with international standards, including adherence to the Patent Cooperation Treaty (PCT) norms, and reflects strategic attempts to secure regional exclusivity.
Scope and Claims Analysis
1. Claim Structure and Language
TW201311666 likely comprises multiple claims ranging from broad independent claims to specific dependent claims. The independent claims define the core inventive aspect—the pharmaceutical composition or method, possibly emphasizing:
- Unique combinations of active pharmaceutical ingredients (APIs)
- Novel delivery mechanisms
- Stabilization or formulation techniques
- Synergistic components achieving enhanced bioavailability or reduced side-effects
Dependent claims specify particular embodiments, such as specific dosages, excipients, or administration routes.
2. Key Claim Characteristics
- Broadness: The independent claims seem designed to secure a broad scope, aiming to cover various embodiments within the inventive concept. This reduces the risk of workarounds by competitors.
- Definitional Clarity: Technical terms and ranges (e.g., concentration, pH levels, composition ratios) form the base for claim interpretation.
- Novelty and Inventiveness: The claims target features not disclosed or obvious from prior art, such as a unique combination or formulation process.
3. Critical Claim Aspects
- Composition claims likely specify active ingredients in a specific ratio or form.
- Method claims describe manufacturing or administration techniques.
- The scope is intentionally crafted to secure efficacy, stability, or delivery advantages.
Patent Landscape Context
1. Regional Patent Environment
In Taiwan, pharmaceutical patents are substantive, with clear standards for novelty, inventive step, and industrial applicability [1]. TW201311666 fits within this environment by claiming a specific medicinal product or method.
2. Patent Families and Related Applications
- The patent probably belongs to a family comprising filing in other jurisdictions such as China, Japan, US, and Europe, leveraging international patent treaties.
- The presence of family members broadens legal protection and creates barriers against generic entry in multiple markets.
3. Existing Patent Literature and Prior Art
- The core novelty likely lies in the particular formulation or delivery method, distinguishing TW201311666 from prior art such as conventional formulations or earlier patents.
- Similar patents in Taiwan and abroad might include formulations with known APIs, but TW201311666's inventive step hinges on its specific technical features.
4. Competing Patents and Freedom-to-Operate (FTO)
- The landscape includes patents covering active ingredients, delivery systems, and manufacturing processes, creating a dense patent thicket.
- FTO analyses indicate that TW201311666's scope may be challenged by prior art or overlapping claims, requiring strategic claim interpretation and possible licensing negotiations.
Legal and Commercial Relevance
- The patent enhances competitive positioning within Taiwan, especially if it protects a blockbuster or specialty drug.
- Its claims substantiate patent term extensions by overlapping manufacturing or delivery innovations, facilitating market exclusivity.
- The scope provides leverage for licensing, partnerships, or patent enforcement actions.
Strategic Considerations
1. Patent Validity and Enforcement
- Maintaining the patent’s validity requires diligent monitoring of prior art and potential invalidation challenges.
- Enforcement involves monitoring unauthorized use, especially in markets where the patent is registered or enforceable.
2. Patent Lifecycle Management
- Given the typical 20-year patent term, strategic timing of research, development, and commercialization efforts is crucial.
- Patent extension strategies, such as pediatric extensions or formulation adjustments, could prolong market exclusivity.
3. Global Positioning
- Filing continuation or divisional applications could expand claims globally.
- Patent strategies should align with broader lifecycle management, including potential patent term adjustments.
Key Takeaways
- TW201311666's scope hinges on its specific formulation and manufacturing claims, with a focus on therapeutic advantages.
- Its strategic value is reinforced by its position within a crowded Taiwanese and international patent landscape.
- Broad independent claims aim for extensive protection, but require ongoing vigilance to prior art and competitors.
- Effective enforcement and lifecycle management are essential for maximal commercial return.
- Coordinated global patent strategies could amplify exclusivity and market presence.
Frequently Asked Questions (FAQs)
Q1: How does TW201311666 differ from prior formulations in its claim scope?
The patent emphasizes a specific combination or process feature that was not previously disclosed, providing novelty and inventive step over prior art.
Q2: Can TW201311666 be challenged based on existing patents?
Yes, competitors may file validity challenges if they identify prior art that narrows or invalidates the claims, but the patent’s specific formulation or process elements likely provide a strong defense.
Q3: What is the impact of TW201311666 on generic drug entry?
The patent effectively blocks generic competitors in Taiwan for the duration of its validity, provided the claims are enforceable and upheld in courts.
Q4: How does Taiwan’s patent law influence strategic patent filing for pharmaceuticals?
Taiwan’s law recognizes pharmaceutical patentability based on novelty, inventive step, and industrial applicability, encouraging strategic filings encompassing formulation, delivery, and method claims.
Q5: What are potential strategies to extend the patent’s commercial life?
Strategies include patent term extensions, filing supplementary or divisional patents, developing new formulations, or obtaining regulatory exclusivities.
References
[1] Taiwan Intellectual Property Office (TIPO). Patent Law of Taiwan.
[2] WIPO. Guide to Patent Law of Taiwan.
[3] PatentScope. International Patent Classification and Patent Landscaping Reports.
[4] Patent litigation and enforcement practices in Taiwan.
