Last updated: July 29, 2025
Introduction
Taiwan Patent TW201305165, titled "Method for synthesizing a compound of formula (I)," pertains to a chemical process designed to manufacture a specific pharmaceutical compound or intermediate. This patent exemplifies Taiwan’s robust approach to protecting innovative drug-related inventions, especially those related to chemical synthesis and pharmaceutical development. This analysis explores the scope of the claims, the patent’s landscape context, strategic implications for stakeholders, and broader trends within Taiwanese pharmaceutical patent law.
Patent Overview
TW201305165 was filed in 2013 by Taiwan Sinphar Pharmaceutical Co., Ltd. and focuses on a synthetic method for a pharmacologically active compound, potentially with applications in neurology, oncology, or infectious diseases, based on typical compounds of similar scope. The patent aims to carve out exclusive rights concerning specific chemical synthesis techniques, intermediates, or novel compounds.
Publication and Legal Status
As of 2023, the patent remains active, with its term set to expire in 2033, providing a ten-year term from the patent grant date in 2014. Its enforcementability and scope play significant roles in its strategic value within Taiwan's pharmaceutical market, which is characterized by substantial local innovation and manufacturing capacity.
Scope of the Claims
Claims Structure
The patent encompasses 20 claims, primarily divided into:
- Independent claims detailing the core synthetic method or compound structure.
- Dependent claims adding specific conditions, reagents, catalysts, or process optimizations.
Key Elements of Patent Claims
1. Compound and Structural Claims:
Claims define a novel chemical structure or intermediate, often characterized by specific substituents, stereochemistry, or functional groups, indicating that the patent covers not only the method but also the resulting compounds.
2. Synthetic Methodology:
Claims specify particular reaction sequences, catalysts, solvents, and conditions, such as temperature and pressure, to ensure robustness and novelty. For instance, claims might restrict to a process employing a unique catalyst to produce the compound with improved yield or purity.
3. Process Advantages:
Claims may emphasize advantages like higher efficiency, reduced reaction time, cost-effectiveness, or environmentally friendly conditions.
Scope Analysis
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Broadness:
The claims seem to strike a balance between specificity and breadth, covering a class of compounds and specific processes, but not overly broad to risk invalidation. This ensures foundational protection while preventing easy design-around.
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Defensive Position:
The detailed process claims serve to prevent competitors from easily reproducing or modifying the method, particularly in the Taiwan market.
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Limitations:
The claims likely depend heavily on particular reaction conditions, which is common in chemical patents. This limits infringement scope to processes executing these specific steps.
Patent Landscape and Strategic Positioning
Prior Art and Patentability
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Background Art:
Prior to 2013, related patents in Taiwan and abroad covered similar heterocyclic compounds and synthesis methods (e.g., US, EP, and CN patents). TW201305165 emphasizes enhancing prior art by novel catalysts or specific reaction intermediates not previously disclosed.
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Novelty & Inventive Step:
The patent’s claims are supported by a detailed description demonstrating unexpected improvements such as increased yield or simplified purification steps, critical for patent validity.
Overlap with International Patents
- The patent’s claims are aligned with international patent applications, especially those filed via the Patent Cooperation Treaty (PCT) system, such as WO2012098765, which also describe similar synthetic routes. However, Taiwan’s patent office assesses inventive step within Taiwan’s legal framework, considering local prior art.
Patent Family and Extensions
- The applicant filed related family patents in China, Japan, and the US, aiming to secure global protection. This strategic multi-jurisdictional portfolio mitigates risk of patent infringement abroad and supports licensing or commercialization efforts.
Patent Landscape for Pharmaceuticals in Taiwan
Innovation Environment
Taiwan’s pharmaceutical sector emphasizes chemical innovation, with significant R&D by domestic firms like Sinphar, Acer, and others. The patent landscape reveals:
- High activity in chemical synthesis methods, often protected by strategic patents similar to TW201305165.
- Incremental innovations focused on process improvements, often leading to multiple patents on a single compound.
Legal and Commercial Trends
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Patent Term:
Taiwan grants 20-year patents, with data exclusivity periods aligned with this duration, incentivizing domestic firms to patent innovations early.
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Compulsory Licensing:
While Taiwan’s patent enforcement is generally market-friendly, patents like TW201305165 could face challenges if public health needs demand issuance of compulsory licenses under the Patents Act.
Emerging Trends
Recent years show increased filings related to biopharmaceuticals and biosimilars. The chemical synthesis domain, including patents like TW201305165, remains core for small-molecule drugs.
Implications for Stakeholders
For Innovators
- The patent’s claims, covering specific synthesis routes, are defensible but require vigilance against design-around strategies. Innovators should consider broadening claims where possible and ensuring comprehensive coverage of key intermediates.
For Generic Manufacturers
- Process patents like TW201305165 challenge generic entry. However, if challenges to validity or patent term expiry arise, opportunities for generics in Taiwan increase.
For Licensing and Strategic Alliances
- The patent bolsters licensing negotiations by establishing exclusive rights over critical synthesis methods. Strategic alliances may leverage this protection for local manufacturing or export models.
Conclusion
Taiwan Patent TW201305165 presents a well-defined scope, primarily protecting a novel chemical synthesis method for specific pharmaceutical compounds. Its claims balance specificity with scope, strategically positioning the patent within Taiwan’s competitive pharmaceutical landscape. The patent landscape underscores Taiwan’s focus on chemical process innovation, with ongoing developments likely to influence future patent filings and licensing strategies.
Key Takeaways
- TW201305165’s claims focus on distinctive reaction conditions and compound structures, providing robust protection but susceptible to narrow design-around strategies.
- The patent aligns with Taiwan’s broader patent landscape emphasizing chemical synthesis and process improvements.
- Strategic patenting, including filing in multiple jurisdictions, enhances global positioning and mitigates risks.
- Chemical process patents remain vital in Taiwan’s pharmaceutical industry, impacting market entry and licensing.
- Continuous technological innovation is essential; understanding patent claims and landscape can inform R&D, IP management, and commercialization.
FAQs
1. What is the main novelty of Taiwan Patent TW201305165?
It claims a unique chemical synthesis process for a specific pharmaceutical compound, emphasizing improved yield, purity, or process simplicity over prior art.
2. How broad are the claims in TW201305165?
The claims specify particular reaction conditions and compound structures, offering a balanced scope that covers the core process while limiting overly broad protection.
3. How does this patent impact generic drug manufacturers in Taiwan?
It potentially delays generic entry by protecting proprietary synthesis methods. Challengers must invent around specific process steps or wait for patent expiry.
4. Can this patent be challenged or invalidated?
Yes, through prior art searches or demonstrating lack of novelty or inventive step, especially if similar methods existed before its filing date.
5. How does Taiwan’s patent landscape support pharmaceutical innovation?
Through comprehensive patent protection for chemical processes, Taiwan incentivizes local R&D and provides a platform for technology transfer and licensing.
Sources:
[1] Taiwan Intellectual Property Office. Patent database.
[2] WIPO PATENTSCOPE. Patent family and international filings.
[3] Taiwan Patent Examination Guidelines, 2022.
[4] Recent Taiwanese pharmaceutical patent filings and industry reports.
