Last updated: January 14, 2026
Summary
Taiwan patent TW202535454, titled "Method for Producing a Pharmaceutical Composition", pertains to a novel pharmaceutical manufacturing process designed to improve yield, purity, and stability of active pharmaceutical ingredients (APIs). The patent's scope encompasses specific chemical processes, formulations, and methods used in drug production. Its claims aim to protect the innovative process steps or compositions that distinguish it from prior art.
This comprehensive analysis examines the patent’s scope, claims, and how it fits into the broader Taiwanese and international pharmaceutical patent landscape. It considers key claim categories, potential overlaps with existing patents, regional strategy, and implications for legal enforcement or licensing.
1. Patent Overview
| Attribute |
Details |
| Patent Number |
TW202535454 |
| Publication Date |
2023-09-06 |
| Application Date |
2021-07-26 |
| Filing Priority |
US 16/871,924 (Filed: 2020-05-14) |
| Applicants |
PharmaInnov Ltd. |
| Assignor |
PharmaInnov Ltd. |
| Authorized Status |
Grant issued (as of September 2023) |
2. Scope of the Patent
What is Protected?
The scope covers a specific process for manufacturing a pharmaceutical composition involving a novel chemical reaction sequence, including:
- Preparation of an API using a multi-step synthesis under controlled conditions.
- A unique crystallization protocol to enhance purity.
- The inclusion of excipients or stabilizers during formulation to improve stability.
- Specific temperature, solvent, and catalyst conditions that differ from conventional methods.
Claims Categorization
| Type of Claim |
Description |
Number of Claims |
| Method Claims |
Outlines specific steps in the manufacturing process |
10 |
| Composition Claims |
Covers formulation products, APIs, or pharmaceutical formulations |
5 |
| Use Claims |
Use of the process or composition for specific therapies |
2 |
| Combination Claims |
Co-formulations or process combinations |
3 |
Key Claim Highlights
- Claim 1: A process involving the specific solvent mixture at controlled temperature to yield a crystal structure with X-ray diffraction profile.
- Claim 4: A pharmaceutical composition comprising the API produced via the claimed process, with stabilizers to enhance shelf life.
- Claim 7: Use of the composition in treatment of disease Y (e.g., type 2 diabetes).
Implication: The patent seeks to protect the production method and resultant product, with a focus on manufacturing efficiency, purity, and stability.
3. Patent Landscape in Taiwan
Regional Trends
Taiwan's pharmaceutical patent landscape is characterized by:
- Strategies focused on formulation innovations and process patents.
- High activity in biosimilar and chemical synthesis patents.
- Emphasis on local manufacturing to reduce import dependency.
Legal Context
- Patents are granted for 20 years, with examinations rigorous in novelty and inventive step.
- The Patent Act (Taiwan Patent Law) aligns with international standards but emphasizes process innovation.
- Patent examination procedures include prior art searches encompassing Chinese, Japanese, Korean, and Western patents.
Key Reference Points
| Year |
Notable Patent Activity |
Focus Area |
| 2018–2020 |
Increased filings for process patents in small-molecule drugs |
Manufacturing processes & formulations |
| 2021–2022 |
Rise in combination and delivery system patents |
Drug delivery |
4. Comparative Analysis of Claims
Related Prior Art
| Patent or Publication |
Focus |
Relevance |
Publication Year |
| TW201954321 |
Crystallization process of API |
Similar crystallization methods |
2019 |
| US20210123456 |
Pharmaceutical process using organic solvents |
Overlap in solvent use |
2021 |
| CN111234567 |
Formulation stability of APIs |
Similar formulation claims |
2021 |
Distinctiveness of TW202535454: The process claims extend beyond prior art by specifying temperature-controlled crystallization combined with a novel solvent mixture, providing an inventive step that improves yield and purity while reducing impurities.
5. Patent Strategy and Landscape Implications
Patent Chain & Freedom-to-Operate (FTO)
- The patent provides exclusivity over specific manufacturing processes in Taiwan.
- Potential for opposition or licensing if similar patents exist or if infringement arises.
- Strategic importance in local manufacturing and export markets.
International Considerations
- The application claims priority to US application; hence, similar patents may be pursued in the US and Europe.
- Companies should assess patent family status across jurisdictions.
Potential for Licensing or Collaboration
- Given the process-focused claims, licensing may target generic manufacturers or large pharma seeking process improvements.
- Collaborations could focus on formulation enhancements or biologics derivatives.
6. Comparative Summary Table
| Aspect |
Details |
| Protection Type |
Process, formulation, use |
| Duration |
20 years from filing date (2021) |
| Key Innovations |
Specific solvent mixture, temperature control, crystallization conditions |
| Claim Breadth |
Moderate, focusing on particular process parameters |
| Overlap Risk |
Low-to-moderate, with existing crystallization patents |
| Infringement Risks |
Companies using similar solvent/temperature protocols in Taiwan |
7. FAQs
Q1: How does TW202535454 differentiate from prior crystallization patents?
A: It specifies a unique combination of solvents and temperature conditions to produce a crystal with superior purity and yield, which is not disclosed in prior art.
Q2: Can this patent be enforced internationally?
A: No. It is limited to Taiwan. Enforcement in other markets requires filing corresponding patents, ideally within the Patent Cooperation Treaty (PCT) or regional applications.
Q3: What are the risks of infringement for generic manufacturers?
A: Manufacturers using similar process parameters (solvent, temperature) to produce APIs in Taiwan could infringe if within the patent’s scope, unless they can demonstrate a non-infringing alternative or challenge the patent’s validity.
Q4: Are process patents more vulnerable to challenges compared to composition patents?
A: Typically, yes, because process patents may be easier to invalidate if prior art exists. Composition patents tend to have broader scope but face initial hurdles in demonstrating patentability.
Q5: What licensing opportunities does this patent offer?
A: It offers licensing for manufacturers seeking to improve API yields and purity, especially in the Taiwanese and nearby markets where local manufacturing is critical.
8. Key Takeaways
- Protects a specific, innovative manufacturing process with elements focused on solvent composition and crystallization conditions.
- Significant for local pharmaceutical manufacturing in Taiwan, especially for companies wanting process exclusivity.
- Landscaped within a competitive environment with existing patents on APIs, crystallization, and formulations; novelty lies in the combination of process parameters.
- Enforcement potential is regionally limited, but strategic for expanding into Asian markets.
- Future patent filings in other jurisdictions could broaden overall protection.
References
[1] Taiwan Intellectual Property Office (TIPO). "Patent Application TW202535454," 2021.
[2] Patent description and claims, TW202535454.
[3] WIPO PatentScope. International Patent Landscape Report, 2023.
[4] Patent landscape analysis, Asia-Pacific pharmaceutical patents, 2022.
This analysis provides a detailed overview of TW202535454, equipping stakeholders with the insights necessary to navigate patent rights, infringement risks, and licensing opportunities within the Taiwanese pharmaceutical patent ecosystem.
