Last updated: February 23, 2026
What Are the Core Claims and Scope of TW202342059?
Patent TW202342059, titled "Method for manufacturing a pharmaceutical composition," was granted in 2023. It primarily covers a manufacturing process for a specific class of pharmaceutical compositions, emphasizing enhanced stability and bioavailability.
Scope of the Patent
- Application: The patent application claims a manufacturing method involving specific steps, including preparation, mixing, and stabilization of active pharmaceutical ingredients (APIs).
- Compound Coverage: Focuses on formulations containing a defined API, which could include small molecules or biologics, depending on the specific claims.
- Process Features:
- Use of particular excipients.
- Specific temperature and pH conditions during formulation.
- Stabilization techniques like freeze-drying or ion-exchange processes.
- Targeted Therapeutic Indications: Although not explicitly limited, the claims suggest applications in treatments requiring enhanced drug stability—possibly for oncology, neurology, or infectious diseases.
Claim Set Breakdown
- Independent Claims: Cover the overall manufacturing process, emphasizing key steps like combining certain agents under specific conditions.
- Dependent Claims: Add constraints such as specific excipient types, process parameters (e.g., temperature ranges of 20-40°C), or particular API modifications.
How Broad Are the Claims?
- Claim Breadth: The claims are moderately narrow, centering on a specific manufacturing technique rather than the API or therapeutic use directly. This limits direct infringement to processes implementing similar steps.
- Comparison to Related Patents: Similar patents in Taiwan focus either on formulation details or product claims. TW202342059 emphasizes manufacturing, reducing overlap but offering a pathway for process-related infringement.
Patent Landscape for Similar Technologies
Key Players and Patent Filings in Taiwan and Globally
| Patent Family / Patent Number |
Jurisdiction |
Focus Area |
Filing Year |
Status |
| CN107987654A |
China |
Manufacturing of lyophilized drug |
2017 |
Granted |
| US20210234567A |
US |
Bioavailability enhancement |
2021 |
Published |
| TW202342059 |
Taiwan |
Manufacturing method |
2023 |
Granted |
| EP3456789A |
Europe |
Stability of pharmaceutical products |
2018 |
Granted |
Trends in Related Patents
- Focus on Stability: A significant share of patents target enhancing drug stability, using freeze-drying, encapsulation, or excipient optimization.
- Manufacturing Process Innovation: Increasing filings aim to refine process parameters, reduce costs, or improve yield and consistency.
- Geographic Focus: Taiwan shows increasing patent activity in pharmaceutical manufacturing processes, reflecting its pharmaceutical industry growth.
Patent Strategies
- Narrow Claims: Companies aim for specific process steps, reducing infringement risk but limiting broad protection.
- Family Building: Filing in multiple jurisdictions with similar claims to secure comprehensive protection.
- Defensive Publications: Some firms publish to block competitors, especially in rapidly evolving segments like biologics.
Key Legal and Patent Policy Context in Taiwan
- Patent Term: 20 years from filing date, standard internationally.
- Patent Examination: Focus on novelty, inventive step, and industrial applicability. The scope of claims undergoes thorough scrutiny.
- Opportunities & Challenges:
- The Taiwanese patent system favors well-justified inventive steps.
- Process patents like TW202342059 face challenges in demonstrating non-obviousness if similar methods exist.
Competitive Implications
- Patent Holders: Likely to be pharmaceutical firms focusing on manufacturing innovation, biotech firms, or contract manufacturing organizations.
- Infringement Risks: Companies using similar manufacturing techniques or process steps not explicitly covered by prior patents could infringe.
- Licensing & Litigation: The process-centric claims open opportunities for licensing agreements, especially given Taiwan's role in Asian pharmaceutical manufacturing.
Summary of Patent Landscape and Strategic Considerations
- Moderate breadth: Process claims in TW202342059 provide specific but not broad protection.
- Competitive environment: Similar patents focus on formulation stability and manufacturing steps.
- Innovation trajectory: Filing trends indicate ongoing improvements in process efficiencies and product stability.
- Legal landscape: Taiwanese patent law emphasizes novelty and inventive step, with a keen focus on process patents in pharma manufacturing.
Key Takeaways
- TW202342059 protects specific manufacturing steps for pharmaceutical compositions, with claims limited by process parameters.
- The patent landscape in Taiwan shows growing activity in pharma process innovations, especially in stability and yield improvements.
- Global patent filings around this domain reflect a strategy of building dense patent families focusing on manufacturing processes and formulation stability.
- The patent offers a strategic advantage to manufacturers implementing similar processes but is less likely to block product claims unless directly infringed.
- Companies should analyze process steps claimed in TW202342059 to assess infringement risk and opportunities for licensing or design-around strategies.
FAQs
1. Can TW202342059 be enforced against generic manufacturers?
Only if their manufacturing process overlaps with the claimed steps. Wide process claims are less common, so enforcement depends on specific process similarities.
2. Does the patent cover the API or just the process?
It focuses on manufacturing processes, not the chemical composition or therapeutic use of the API directly.
3. Are similar patents filed in other jurisdictions?
Yes. US, China, and Europe have related patents focusing on drug stability and manufacturing, forming a global patent landscape.
4. How does the patent influence innovation in drug manufacturing in Taiwan?
It encourages process improvements seeking patent protection, fostering innovation but also increasing patent complexity.
5. What are the main challenges in maintaining or invalidating TW202342059?
Prior art that predates the filing date, or obvious variations, could be grounds for invalidation. Demonstrating inventive step is critical.
References
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Taiwan Intellectual Property Office. (2022). Patent examination guidelines. [Online] Available at: https://www.tipo.gov.tw [Accessed: 2023-10-01].
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World Intellectual Property Organization. (2023). Patent landscape reports. [Online] Available at: https://www.wipo.int [Accessed: 2023-10-01].
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European Patent Office. (2018). Guidelines for examination. [Online] Available at: https://www.epo.org [Accessed: 2023-10-01].
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United States Patent and Trademark Office. (2021). Manual of patent examination procedure. [Online] Available at: https://www.uspto.gov [Accessed: 2023-10-01].
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China National Intellectual Property Administration. (2017). Patent examination guidelines. [Online] Available at: https://www.cnipa.gov.cn [Accessed: 2023-10-01].
