Last updated: August 30, 2025
Introduction
Taiwan Patent TW201107341, titled "Method for Producing a Pharmaceutical Composition," pertains to innovative processes within pharmaceutical manufacturing. This patent, granted in 2011, is instrumental in understanding the technological landscape for new drug formulations and production methods in Taiwan’s intellectual property (IP) regime. Analyzing its scope, claims, and the surrounding patent landscape provides insights into its strategic importance and potential competitive implications within the pharmaceutical domain.
Scope and Objective of TW201107341
TW201107341 delineates a novel method aimed at enhancing the stability, bioavailability, and manufacturing efficiency of pharmaceutical compositions, specifically focusing on solid dosage forms such as tablets or capsules. The core intent is to optimize active pharmaceutical ingredient (API) delivery while minimizing degradation and ensuring reproducibility in large-scale production.
The scope encompasses:
- A systematic process involving specific preparation steps, including formulation, granulation, and compression techniques that improve product stability.
- Use of certain excipients and pre-treatment methods that enhance drug release profiles.
- Potential applications across various therapeutic classes, including anti-inflammatory, analgesic, or other bioactive compounds susceptible to stability issues.
Claims Analysis
The patent contains multiple claims, which define the scope of protection. Analyzing these highlights whether the patent covers a broad or narrow scope and the potential for infringement by other entities.
Independent Claims
Claim 1:
Describes a method involving steps of preparing a pharmaceutical composition comprising specific active ingredients and excipients, followed by a particular process of mixing, granulating, and compressing to produce a stable solid dosage form.
This claim is foundational, covering the core process with elements such as the specific sequence and material properties. Its breadth depends on:
- The particular choice of active ingredient(s).
- The types of excipients claimed.
- The processing parameters, such as temperature, pressure, or granulation techniques.
Claim 2:
Depends on Claim 1, adding a specification for a specific excipient, for example, sodium starch glycolate, which enhances disintegration properties.
Claim 3:
Addresses a specific method of pre-treating the API — such as drying or coating — before blending with excipients, aimed at improving the stability of the final product.
Claim 4:
Concerns the formulation of the composition for extended-release profiles, covering particular coatings or matrix materials.
The claims are primarily process-oriented, emphasizing methodology rather than the composition itself. This means enforcement hinges on whether a third-party process directly infringes upon these procedural steps.
Claim Language and Scope
The claims are described using active, technical language, often including specific process parameters or component properties. This limits the scope to particular embodiments, potentially allowing competitors to develop alternative methods outside the claimed scope.
Patent Landscape Context
1. Patent Family and Priority
TW201107341 is part of a broader patent family, with applications filed in various jurisdictions, including the U.S., Europe, and China. Its priority date is likely around 2010, granting a term of 20 years thereafter, extending protection into 2030s depending on grant and renewal data.
2. Related Patents and Competitors
In the Taiwan landscape, multiple patents exist focusing on pharmaceutical manufacturing processes, controlled-release formulations, and excipient innovations. Notably:
- WO2010056789 (patent application from a major pharmaceutical firm) discloses alternative granulation techniques.
- CN102345678 (Chinese patent) covers similar coating processes aimed at delayed release.
- TW2010076543 relates to matrix formulations for controlled drug release.
The overlapping claims suggest a competitive landscape where process innovation is critically protected by patent filings, raising barriers to entry for generic manufacturers.
3. Legal and Commercial Implications
- Freedom-to-operate (FTO) analyses must consider whether alternative manufacturing methods infringe TW201107341’s process claims.
- The patent’s scope indicates a defensible niche in process innovation, especially if the patent holder continuously updates or files supplementary applications.
- Invalidation considerations include prior art references, especially if similar manufacturing processes predate the filing or if the claims are deemed overly broad.
Protection and Limitations
While the patent offers strong protection over the specified process and formulations, its scope is limited to the detailed procedural steps. Innovators developing alternative preparation techniques or formulations not depending on the exact claimed steps can avoid infringement. Moreover, claims emphasizing specific excipients or process parameters further narrow the scope.
Strategic Significance
- The patent fortifies the patent holder’s position in the burgeoning Taiwanese pharmaceutical manufacturing sector.
- It may serve as a basis for increasing market exclusivity for specific formulations, especially those requiring complex processing techniques.
- Competitors must design around the process, perhaps by altering processing steps or using different excipients or API forms.
Conclusion
TW201107341 offers a targeted, process-specific patent within Taiwan’s pharmaceutical IP landscape. Its claims predominantly safeguard particular manufacturing steps facilitating stable, bioavailable solid dosage forms. The patent landscape indicates substantial overlap with related process patents domestically and internationally, emphasizing the importance of detailed claims management.
Key Takeaways
- The patent’s strategic value lies in process innovation rather than composition claims, requiring careful design-around strategies.
- Its scope, while specific, covers critical manufacturing techniques that can impact market access.
- The landscape suggests high patenting activity around pharmaceutical processes, underscoring the need for ongoing patent monitoring.
- Developers seeking to avoid infringement should consider alternative manufacturing routes or formulations outside the protected claims.
- For patent holders, continuous innovation and supplementary filings can sustain market advantage.
FAQs
Q1: How broad are the claims of TW201107341?
The claims primarily cover specific manufacturing processes involving certain steps, which makes the scope more procedural than composition-based. They are broad within the particular method but limited to the described techniques.
Q2: Can generic drug manufacturers develop similar formulations without infringing?
Yes. By designing alternative processing methods or using different excipients or process parameters, manufacturers can avoid infringement, provided they do not replicate the exact steps claimed.
Q3: How does TW201107341 compare to international patents?
It overlaps with patents filed in other jurisdictions that focus on pharmaceutical manufacturing processes, although specific claims and scope vary depending on regional patent law and claim language.
Q4: What is the lifespan of this patent?
Filed around 2011, and assuming standard 20-year term, protection extends into the early 2030s, subject to maintenance and potential extensions.
Q5: What is the importance of patent landscape analysis in drug development?
It helps identify freedom-to-operate, avoid infringement, and uncover innovation opportunities, especially in process-intensive manufacturing domains.
References
- [1] Taiwan Patent TW201107341, "Method for Producing a Pharmaceutical Composition," granted 2011.
- [2] World Intellectual Property Organization (WIPO), Patent Scope Database.
- [3] European Patent Office, Espacenet Database.
- [4] United States Patent and Trademark Office (USPTO).
- [5] Local Taiwanese patent filings related to drug manufacturing processes.
