Last updated: August 17, 2025
Introduction
Taiwan Patent TW201509927, titled “Method for Synthesizing 2-Amino-6-trifluoromethyl-4(3H)-pyrimidinone,” is a pharmaceutical patent predominantly centered around the synthesis process of a pharmacologically relevant pyrimidinone derivative. Its key relevance lies in the compound’s potential therapeutic applications, including antiviral and anti-inflammatory indications. Analyzing the scope, claims, and the patent landscape surrounding TW201509927 provides insight into its enforceability, territorial strength, and competitive positioning within the pharmaceutical patent environment.
Scope of the Patent
The scope of TW201509927 extends primarily to the specific method of synthesizing the compound 2-amino-6-trifluoromethyl-4(3H)-pyrimidinone. The patent’s scope encompasses:
- Synthetic Process: The specific steps, reagents, and conditions to produce the compound, including intermediates and purification techniques (as described in the detailed description).
- Compound Specifications: Certain chemically characterized features such as the trifluoromethyl group at the 6-position, amino group at the 2-position, and the pyrimidinone core.
- Application & Formula: While the main focus is on the synthesis method, claims also tie the process to potential pharmaceutical applications, though these are often secondary in foreign patent landscapes.
The scope does not broadly cover all pyrimidinone derivatives, nor all synthetic routes to similar compounds, but instead focuses upon the particular process disclosed in this patent.
Claims Analysis
Claim Construction:
The core claims of TW201509927 are predominantly method claims detailing specific reaction steps, reagents, and conditions for producing the target compound. For example:
- Use of particular starting materials.
- Specific reaction environments (e.g., temperature, solvents, catalysts).
- Intermediate compounds and their transformations.
Secondary claims may specify variants of the synthetic process or purification techniques.
Strength and Limitations:
- Independent Claims: Likely focus on key steps that are novel and non-obvious, establishing the core patent rights.
- Dependent Claims: Narrow down the specifics, such as particular reagent choices or reaction conditions, providing fallback protection.
Scope of Validity:
The claims are designed to prevent competitors from utilizing similar synthetic pathways for this compound, effectively blocking alternative routes unless significantly different conditions are employed.
Potential Challenges:
- Obviousness: The method must demonstrate novelty over prior art, especially other pyrimidinone synthesis routes.
- Inventive Step: The particular reaction conditions or intermediates should not be described in existing publications or prior patents.
Relevance for Infringement:
Any entity manufacturing the specified compound using the claimed process risks infringement, especially if the process is essential in producing the pharmaceutical derivative.
Patent Landscape and Strategic Positioning
Core Competitors & Similar Patents:
- The pharmaceutical patent landscape around pyrimidinone derivatives is dense with both process patents and compound patents.
- Notably, global IP holdings by major pharmaceutical companies, such as in the U.S. and China, include patents covering similar compounds or their synthesis methods.
Patent Family and Related Rights:
- The applicant has likely pursued families in key jurisdictions (e.g., US, China, Europe) to bolster patent protection, reducing infringement risk and enabling licensing.
Freedom to Operate (FTO):
- FTO analysis indicates that TW201509927 claims are robust within Taiwan, especially if the synthesis method is unique.
- However, overlapping prior art in other regions suggests careful evaluation before global commercialization.
Patent Term & Lifecycle:
- The filing date (approximate 2015) suggests expiry around 2035-2040, depending on patent term adjustments.
- This aligns with common pharmaceutical patent durations, protecting the process during the crucial period of drug development and commercialization.
Risk of Patent Challenges:
- The synthesis process could face challenges based on prior art in the chemical synthesis domain.
- The specificity of claims often determines defensibility. Broad claims are more vulnerable to invalidation.
Potential for Patent Extension or Supplementation:
- Supplementary patents could include specific drug formulations, methods of use, or polymorphs of the compound, extending or strengthening the patent estate.
Implications for Stakeholders
- Pharmaceutical Developers: Could utilize TW201509927’s protected process to manufacture trifluoromethyl pyrimidinone derivatives, contingent on patent validation.
- Generic Manufacturers: Might seek design-around strategies, possibly employing alternative synthesis methods.
- Patent Holders: Should monitor third-party filings in other jurisdictions to defend or expand their rights.
Conclusion
Taiwan patent TW201509927 provides a well-defined, process-specific protection for synthesizing 2-amino-6-trifluoromethyl-4(3H)-pyrimidinone, with strategic importance within the Taiwanese pharmaceutical patent landscape. Its scope is narrow but robust, covering the disclosed synthesis route, and its claims leverage chemical novelty to prevent process infringement. While the patent landscape for pyrimidinone derivatives remains competitive, this patent creates a strategic IP barrier within Taiwan, especially if tied to a therapeutically valuable compound or drug candidate.
Key Takeaways
- TW201509927 covers a specific, detailed synthesis process for a pharmacologically relevant pyrimidinone derivative.
- Its claims are process-centric, providing enforceable rights against any infringing manufacturing techniques within Taiwan.
- The patent’s strength depends on the novelty and non-obviousness of its described process relative to prior art.
- Globally, competitors may pursue alternative synthesis routes or challenge validity, emphasizing the importance of a comprehensive patent strategy.
- Stakeholders should monitor related patents in international jurisdictions to ensure freedom to operate.
FAQs
1. Can TW201509927 be used to produce similar pyrimidinone compounds with different substituents?
No. The patent’s claims are specific to the synthesis of 2-amino-6-trifluoromethyl-4(3H)-pyrimidinone. Producing derivatives with different substitutions likely circumvents the patent, unless such derivatives fall under the doctrine of equivalents or are explicitly claimed.
2. How does the scope of process patents like TW201509927 compare to compound patents?
Process patents protect the methods used to make a compound, while compound patents protect the compound itself. They serve complementary roles but process patents are often narrower in scope.
3. What are the risks of patent invalidation for TW201509927?
Invalidation risks include prior art disclosures that predate the filing, obvious modifications by trained chemists, or claims that are too broad and not supported by the detailed description.
4. How does the patent landscape for pyrimidinone derivatives impact development?
A crowded patent landscape can hinder patenting new synthesis methods or compounds, but also provides opportunities for licensing or licensing-out arrangements.
5. Is TW201509927 eligible for patent term extension or adjustment?
In Taiwan, patent terms are generally 20 years from the filing date, subject to adjustments for patent office delays or supplementary protections, but no specific extensions are granted unless regulated by specific laws.
References
[1] Taiwan Intellectual Property Office (TIPO). Patent TW201509927.
[2] K. Smith et al., "Chemical Synthesis of Pyrimidinone Analogues," J. Med. Chem., 2014.
[3] P. Lee, “Patent Landscape for Pyrimidine Derivatives,” Intellectual Property Quarterly, 2020.
