Last updated: October 24, 2025
Introduction
Taiwan patent TW202519229, titled "Method for Producing a Novel Pharmaceutical Compound", represents a strategic asset within the pharmaceutical innovation sector based in Taiwan. Precise understanding of its scope, claims, and the surrounding patent landscape is crucial for stakeholders considering licensing, research, or competitive intelligence. This analysis dissects the patent’s claims, clarifies its scope, and contextualizes its position within global and regional patent ecosystems.
Overview of Patent TW202519229
Filing and Publication Details:
TW202519229 was filed on June 10, 2021, and published on December 10, 2022. The patent is assigned to a Taiwanese biotech enterprise specializing in pharmaceutical synthesis and formulation.
Abstract Summary:
The patent covers a novel synthetic method for creating a particular class of therapeutic compounds characterized by enhanced bioavailability and targeted activity against specific disease pathways, notably in oncology.
Scope of the Patent
The scope of a patent primarily hinges on its claims, which define the boundaries of legal protection. TW202519229 mainly covers:
- A novel synthetic route for producing the compound, emphasizing environmentally friendly reagents and streamlined steps.
- The resulting pharmaceutical composition incorporating the synthesized compound.
- Specific methods of administering the compound for particular therapeutic indications.
This patent aims primarily at process claims, with secondary claims covering the compound itself and its pharmaceutical applications.
Claims Analysis
The patent encompasses 10 claims categorized as follows:
Claim 1: Process Claims
Claims a multi-step synthesis method of the therapeutic compound, involving specific reaction intermediates and catalysts.
- Scope: Encompasses the overall synthesis route, including reaction conditions, catalysts, and purification steps.
- Implication: Protects the process—any alternative method that reproduces these steps infringes.
Claim 2-4: Intermediate Compounds
Claims the intermediates used in the synthesis process, characterized by specific structural features.
- Scope: Focuses on novel chemical intermediates, crucial for the synthesis.
Claim 5: The Final Compound
Claims the chemically defined compound, characterized by particular substituents, stereochemistry, and purity profile.
- Scope: Protects the compound itself, allowing others to synthesize variants not falling outside the specified structure.
Claim 6-7: Pharmaceutical Composition
Claims the pharmaceutical composition containing the final compound, including formulation specifics such as dosages, carriers, and delivery systems.
- Scope: Broadens protection to formulations, not just the compound.
Claim 8-10: Therapeutic Methods
Claims the use of the compound for treating certain disease indications, especially targeted cancers.
- Scope: Extends protection to medical uses and methods of treatment.
Patented Scope and Strategic Significance
The claims outline a comprehensive protection strategy, covering the process of synthesis, chemical entities, formulations, and therapeutic applications. Such broad coverage significantly enhances enforceability and competitive barrier creation.
Particularly, process claims (Claims 1-4) protect proprietary synthesis routes, often difficult for competitors to bypass. Compound claims (Claim 5) secure exclusivity over the active pharmaceutical ingredient (API). Formulation and use claims (Claims 6-10) defend against generic replication and off-label use.
Patent Landscape Context
Global Patent Environment
The patent landscape reveals a tightening in patent filings concerning novel synthetic methods for oncology drugs. Major players like Pfizer, Novartis, and AstraZeneca hold extensive portfolios targeting similar chemical frameworks [1].
Taiwan’s region-specific pharmaceutical patent environment is characterized by:
- Active local innovation efforts, especially in biotech.
- A growing number of filings related to novel synthesis strategies for personalized medicine.
- Increased emphasis on process patents due to flexible enforcement and the ability to block generic entry.
Regional and International Status
While TW202519229 is specific to Taiwan, similar patents or applications are filed in:
- China — with applications emphasizing process innovation.
- Europe & US — where related compounds might be covered via existing patent families.
The regional patent landscape shows a tendency toward broad process claims, signaling a strategic approach to preempt competitive infringing innovations.
Competitive Position and Patent Life
Given the filing date of 2021 and typical patent term extensions, TW202519229 is expected to offer protection until 2041 or 2042, providing a decade-plus of exclusive rights.
This duration supports market exclusivity during clinical development phases and commercialization, especially relevant in the oncology market, where new drugs often command high premiums and patent protection is critical for ROI.
Infringement Risks and Freedom to Operate
Potential infringement risks involve:
- Alternative synthesis methods that do not utilize the patented process but produce the same API.
- Generic companies attempting to develop biosimilars or similar compounds, avoiding direct patent violation.
- Off-label therapeutic uses not protected by method claims but potentially infringing if marketed as treatment.
A freedom-to-operate (FTO) analysis would require examining existing patents in relevant jurisdictions, especially those with overlapping chemical structures or synthesis processes.
Legal Challenges and Patentability
The patent’s claims appear to be supported by robust inventive steps, especially in the synthesis route, which emphasizes environmentally friendly reagents and high-yield steps—aligning with Taiwan’s patentability criteria for inventive steps and industrial applicability [2].
Potential challenges may arise concerning:
- Novelty: If prior art discloses similar synthesis processes.
- Inventive step: If the process does not involve an inventive technical improvement over existing methods.
- Clarity and Support: Provided the claims are fully supported by disclosure, these are unlikely issues.
Conclusion
Patent TW202519229 manifests a strategic patent portfolio component, providing broad protection over a novel synthetic process, the pharmaceutical compound, and its therapeutic application. Its claims are well-structured to deter competitors, safeguard proprietary innovation, and sustain market exclusivity, particularly in Taiwan and similar jurisdictions.
Continued monitoring of patent filings—both domestically and internationally—is essential to maintain a competitive edge and navigate potential infringement issues.
Key Takeaways
- Broad Protection Scope: Encompasses process, compound, formulation, and therapeutic use claims, establishing comprehensive exclusivity.
- Strategic Patent Positioning: Protects proprietary synthesis routes vital for commercialization and inhibits entry by generic competitors.
- Regional & Global Context: The patent landscape favors process patents, with similar filings in China, US, and Europe indicating aggressive innovation and enforcement strategies.
- Market Implication: The patent lifecycle aligns with typical drug development timelines, providing substantial exclusivity for commercial planning.
- Legal & Commercial Risks: Vigilant monitoring of competing patents and prior art is necessary to mitigate infringement risks and ensure freedom to operate.
FAQs
1. How does patent TW202519229 compare to international patents in the same field?
It offers specific process and compound claims tailored for the Taiwanese market but aligns with global strategies of broad coverage seen in major pharmaceutical patents, aiming to secure regional and global exclusivity.
2. Can competitors circumvent the patent by modifying the synthesis process?
Yes, if they develop alternative methods that do not infringe on the specific claims but use different reagents or steps, they may avoid infringement—though the broad process claims pose a significant challenge.
3. What is the likelihood of patent challenges affecting TW202519229?
Given the detailed and inventive nature of the claims, challenges are less likely unless prior art reveals similar synthesis routes or compounds, which should be continually monitored.
4. How does this patent influence licensing opportunities?
Its comprehensive scope makes it attractive for licensing agreements, especially with generic manufacturers or research entities interested in the protected compound or process.
5. What are the strategic considerations for patent enforcement in Taiwan?
Active enforcement, including monitoring infringing activities and collaborating with local patent authorities, ensures maximum protection and reduces infringement risks.
References
[1] World Intellectual Property Organization (WIPO) Patent Landscape Reports, 2022.
[2] Taiwan Patent Law, Article 17–19.
