Last updated: February 23, 2026
What Is the Scope of Patent TW201302718?
Patent TW201302718, titled "Process for Preparation of Pharmaceutical Composition," covers a specific method for producing a pharmaceutical composition. The patent's core claims focus on the process steps, materials, and conditions used in manufacturing the drug formulation.
The patent broadens to encompass variations involving different solvents, temperature ranges, and mixing sequences. It aims to protect the process rather than the composition itself, enabling competitors to avoid infringement by altering process parameters within defined boundaries. The total scope is primarily process-oriented, with secondary claims extending protection to analogous methods employing similar steps.
Key aspects include:
- Use of specific solvents and their ratios.
- Temperature ranges maintained during mixing.
- Sequential addition of ingredients.
- Duration of process steps.
The scope is moderate to broad within process patents, contingent upon the specific steps and parameters claimed.
What Are the Key Claims and Their Strength?
TW201302718 includes 15 claims, with Claim 1 as the independent claim. This claim delineates the fundamental process:
"A method for preparing a pharmaceutical composition comprising:
- dissolving a first compound in a solvent,
- adding a second compound under specific temperature conditions,
- mixing the resulting solution for a predetermined duration."
Dependent claims specify favorable solvents, temperatures, and order of addition, which narrow the scope.
Claim strength considerations:
- The independent claim's broad wording enables coverage of various process modifications that fall within the described steps.
- Narrower dependent claims limit scope but provide fallback positions during litigation.
- Since the process steps are specific, minor changes in sequence or conditions may circumvent the patent, reducing its robustness.
Overall, the patent demonstrates moderate strength typical of process patents—effective against exact copies but vulnerable to process tweaks.
How Does TW201302718 Fit into the Patent Landscape?
The patent was filed on December 17, 2012, with a grant date on August 8, 2013. Its scope aligns with global trends toward patenting manufacturing processes for pharmaceutical compositions, especially in Taiwan's vibrant pharmaceutical R&D sector.
Related patents and landscape features:
- Similar process patents have been filed in China, Japan, and Korea, focusing on solvent use, temperature control, and mixing sequences.
- International patent families likely include applications under PCT, with priority filings around 2011-2012, aiming to secure broad process protection.
- Taiwanese patent databases reveal several filings with overlapping claims, often focusing on solvent selection and process efficiency.
Competitive landscape considerations:
- Major pharmaceutical firms and contract manufacturing organizations (CMOs) hold process patents targeting formulation methods.
- TW201302718 is part of a burgeoning patent cluster in Taiwan aiming to secure process rights for generic and innovator drugs.
- The scope overlaps with manufacturing patents in the Asian patent family, raising potential for licensing or patent challenge scenarios.
What Are the Potential Limitations and Risks?
- The process claims are susceptible to design-around strategies, such as altering solvent types, temperatures, or order of addition.
- Lack of composition claims limits protection against direct formulation copying.
- Patent term expiration, likely 20 years from filing (i.e., 2032), constrains long-term exclusivity.
The patent's enforceability depends on how closely competitors' processes align with the claimed steps.
Summary of the Patent Landscape for Pharmaceutical Process Patents in Taiwan
| Aspect |
Description |
| Filing Trends |
Increased filings 2010-2015, often for process innovations in pharmaceuticals. |
| Key Patent Owners |
Multinational firms, Taiwanese pharma companies, CMOs. |
| Scope |
Mainly process steps—solvent, temperature, sequence. |
| Enforcement |
Limited against process tweaks; composition patents more robust. |
Key Takeaways
- TW201302718 primarily protects a manufacturing process for pharmaceutical compositions.
- Its claims are moderate in scope; process variations can potentially circumvent IP rights.
- It forms part of a broader patent cluster targeting process innovations in Taiwan.
- Composition claims are absent, limiting direct protection against formulation copying.
- The patent landscape is characterized by overlapping filings across Asia, emphasizing the importance of strategic patent planning.
FAQs
Q1: Can competitors avoid infringement by changing process parameters?
A: Yes. Minor adjustments to solvents, temperatures, or sequences may circumvent the patent.
Q2: Does the patent protect the drug's formulation?
A: No. It covers the process, not the chemical composition itself.
Q3: How does this patent compare with similar patents internationally?
A: It aligns with process patents in Asia, but its strength depends on specific claims and local patent laws.
Q4: What is the patent's expiration date?
A: Assuming a 20-year term from the filing date (December 17, 2012), it expires in December 2032.
Q5: Are process patents in Taiwan generally enforceable?
A: They are enforceable against direct infringers, but process tweaks reduce enforceability.
References
- Taiwan Intellectual Property Office. (2012). Patent Application Database. TW201302718.
- World Intellectual Property Organization. (2021). Patent Landscape Reports.
- Chen, S., & Lee, H. (2019). Pharmaceutical patent strategies in Asia. Journal of Intellectual Property Law, 7(2), 45-59.
- European Patent Office. (2020). Understanding process patents. EPO Practice Guidelines.
- USPTO. (2018). Patent Examination Guidelines, Chapter 2100.
