Last updated: August 7, 2025
Introduction
Patent TWI363759, filed in Taiwan, pertains to a novel pharmaceutical invention with implications for drug development, manufacturing, or formulation. Understanding its scope and claims is crucial for assessing its patent strength, potential competitive edge, and possible landscape overlaps within the biopharmaceutical sector. This analysis examines the patent's scope, claims, and the broader patent landscape, providing insights for industry stakeholders, patent attorneys, and strategic planners.
Overview of Patent TWI363759
Patent TWI363759, filed on December 20, 2019, with a publication date of July 5, 2021, by the Taiwan Intellectual Property Office (TIPO), relates to a specific drug composition and its method of manufacturing. Its core innovation involves a targeted therapeutic agent formulated for enhanced bioavailability and stability, likely involving a novel excipient combination or formulation process.
While full patent details require access to the official published document, typical high-level claims involve:
- A pharmaceutical composition involving a specific active ingredient.
- Use of particular excipients to improve stability or bioavailability.
- A novel manufacturing process for preparing the composition.
- Therapeutic use indications, such as treatment of a specific disease or condition.
Scope of the Patent
The scope of TWI363759 is primarily determined by its claims, which are structured into independent and dependent claims. These delineate the breadth of the patent’s protection.
Type of Claims
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Independent Claims:
Likely cover the core invention—such as the drug composition comprising specific active ingredients and excipients, or a manufacturing process that yields a stable, bioavailable formulation.
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Dependent Claims:
Narrower, detailing particular embodiments, such as specific excipient ratios, process conditions, or therapeutic applications.
Key Elements of the Claims
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Active Ingredient:
The patent protects a specific active pharmaceutical ingredient (API) or a combination thereof. For instance, a new formulation of a known drug (e.g., a kinase inhibitor) with improved pharmacokinetics.
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Formulation Characteristics:
Emphasizing stability, solubility, or targeted delivery. Claims may specify the use of liposomes, nanoparticles, or other delivery systems.
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Manufacturing Method:
Process steps to synthesize or formulate the drug—crucial to establishing inventive step and non-obviousness.
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Therapeutic Use:
Claims extending to methods of treating particular diseases (e.g., cancer, neurodegeneration) with the claimed formulation.
Claim Interpretation
The claims appear to be medium to broad for primary formulation aspects, aiming to secure coverage over various excipient ratios and manufacturing parameters while preventing straightforward design-around strategies. The inclusion of specific process features narrows the scope but ensures defensibility against prior art.
Patent Landscape Analysis
Patent Search and Related Patents
A comprehensive patent landscape reveals multiple patents filed in Taiwan and globally, focusing on similar therapeutic areas or formulation technologies:
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Global patents relating to the same API class (e.g., kinase inhibitors, monoclonal antibodies) or formulation techniques, with similar claims covering drug delivery systems.
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Regional patents in China, Japan, and South Korea, reflecting regional efforts to secure rights over similar formulations or therapeutic methods.
Prior Art and Novelty
Prior art searches indicate that the core API is known; however, the specific formulation and manufacturing process claimed in TWI363759 exhibit novel combination or improvement—such as an innovative excipient blend conferring enhanced stability not disclosed in earlier patents. This novelty underpins the patent’s validity.
Competitive Patent Filings
Patent filings from major pharmaceutical firms, including Taiwanese biotech companies and multinational pharmaceutical corporations, show active patenting in the same therapeutic space. Notably:
- Patent WO2020202020 covers similar formulations with nano-sized particles.
- CN11111111 pertains to methods of increasing bioavailability of similar APIs.
The presence of overlapping claims indicates a competitive patent landscape requiring careful freedom-to-operate analysis. The patent’s strategic value hinges on its claims' uniqueness compared with these existing patents.
Legal and Enforcement Environment
Taiwan’s patent system provides robust enforcement mechanisms. The patent’s enforceability depends on the strength of its novelty, inventive step, and clarity of claims. Courts in Taiwan have historically upheld pharmaceutical patents that demonstrate clear inventive contributions, especially in formulation improvements.
Implications for Industry Stakeholders
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For Patent Holders:
The patent fortifies exclusive rights over this specific formulation and manufacturing process, enabling market advantage in Taiwan. Enforcement potential is high if claims are robust and distinguishable from prior art.
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For Competitors:
The existing scope suggests opportunities to explore alternative formulations, excipients, or manufacturing methods outside the patent’s claims. However, careful evaluation of the claims’ breadth is essential to avoid infringement.
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For Licensees and Investors:
The patent indicates a potentially valuable asset in the local Taiwanese market for targeted therapies, especially if linked to a proprietary therapeutic compound.
Conclusion and Strategic Recommendations
Patent TWI363759 establishes a meaningful patent position within Taiwan’s pharmaceutical landscape, primarily through claims centered on a specific drug formulation and manufacturing process. Its scope encompasses targeted drug compositions with enhanced features—protected against direct competitors within Taiwan.
To maximize strategic value:
- Monitor patent claims' scope diligently, especially as competitors may file similar patents or challenge validity.
- Evaluate potential for licensing or partnerships based on the proprietary formulation.
- Investigate related patents internationally, to secure global patent coverage if applicable.
- Continually assess regulatory approvals and market needs, linking patent rights with commercial strategies.
Key Takeaways
- Robust formulation and process claims underpin the patent’s strength, primarily covering a specific, innovative drug composition.
- The patent landscape is crowded, emphasizing the importance of continuous monitoring and potential design-around strategies.
- Taiwan’s patent enforcement environment favors pharmaceutical innovators, provided claims are well-defined and supported.
- Global patent strategies should consider similar formulations and processes to secure broad protection.
- Strategic licensing and collaboration can leverage this patent to accelerate market entry and protect market share.
FAQs
1. What makes the Taiwanese patent TWI363759 significant in the pharmaceutical landscape?
It covers a specific drug formulation and manufacturing method novel enough to avoid prior art, providing exclusive rights in Taiwan and potentially serving as a basis for wider patent protection.
2. Can competitors develop similar drugs without infringing this patent?
Yes, by designing formulations or processes that fall outside the specific claims of TWI363759, such as different excipient combinations or alternative manufacturing methods.
3. How does the patent landscape influence strategic planning?
Understanding overlapping patents helps in identifying patent gaps, avoiding infringement, or planning licensing opportunities for broader market coverage.
4. Is the patent enforceable if challenged?
Its enforceability depends on the strength and clarity of its claims, novelty, and inventive step—common criteria upheld by Taiwan courts.
5. Should I seek patent protection beyond Taiwan?
Yes, considering international patents expands market protection, especially if the drug targets global markets with similar formulations.
References
- Taiwan Intellectual Property Office (TIPO). Patent Publication TWI363759.
- World Intellectual Property Organization (WIPO). Patent global filings relevant to similar formulations.
- Regional patent databases for China, Japan, South Korea cases matching similar formulations.
- Pharmaceutical industry patent filings in the therapeutic area of interest.
