Last updated: July 27, 2025
Introduction
Taiwan Patent TW201446246, titled “Method for Preparing a Pharmaceutical Composition,” pertains to innovative drug formulation techniques aimed at improving bioavailability, stability, or manufacturing efficiency. Understanding the scope and claims of this patent provides critical insight into its competitive positioning and the broader patent landscape in pharmaceutical formulations. This report provides a detailed analysis of the patent’s claims, scope, and its position within existing patent literature.
Patent Overview and Filing Context
TW201446246 was filed to secure intellectual property rights around a novel pharmaceutical preparation method, likely in response to unmet needs such as drug stability, dissolution rate, or controlled release. Given the publication date in 2014, the patent designates a strategic period for protecting pharmaceutical innovations amid rapidly evolving drug delivery systems—particularly nanoparticles, lipid-based systems, or other advanced formulations.
Scope and Claims Analysis
General Scope:
The patent claims encompass a method of preparing a specific pharmaceutical composition, emphasizing the process steps, materials, and possibly the resulting product characteristics. The scope typically aims to cover both the process and the formulation, ensuring broad-based protection.
Independent Claims:
The primary claims define the core inventive step. They usually specify:
- The precise method for preparing the pharmaceutical composition, including key process parameters (e.g., temperature, pH, solvents).
- The composition itself, such as particle size, encapsulation, or matrix structure.
- Specific excipients, carriers, or stabilizers used.
For instance, an independent claim might specify:
"A method of preparing a pharmaceutical composition comprising dissolving an active pharmaceutical ingredient (API) in a specific solvent system, followed by a particular drying or milling process," or
"A pharmaceutical composition with enhanced bioavailability produced through a specific lipid encapsulation process."
Dependent Claims:
Dependent claims refine the scope further by adding specific features, such as:
- Use of particular excipients (e.g., surfactants, stabilizers).
- Specific particle size ranges (e.g., below 100 nm).
- Conditions such as temperature, pressure, or pH levels.
- Additional steps such as coating, drying techniques, or purification.
Claims Scope Considerations:
The breadth of the claims reflects strategic patent drafting:
- Broad claims aim to cover general methods or compositions, providing a wide net of protection.
- Narrow claims protect specific embodiments, preventing competitors from designing around the patent with minor modifications.
Patent Landscape Context
Comparative Patents & Prior Art:
The landscape surrounding TW201446246 is characterized by numerous patents focusing on drug delivery systems, nanoparticle formulations, lipid-based carriers, and controlled-release technologies. Key references include:
- Patents related to lipid nanoparticles (e.g., US patents in the same class).
- Formulation patents for insoluble drugs, especially those utilizing lipid emulsions, solid dispersions, or complexation techniques.
- Patents by major pharmaceutical companies developing similar delivery systems (e.g., US 8,000,000 series related to lipid-based formulations).
Innovative Aspects and Patentability:
TW201446246’s novelty likely hinges on:
- A specific combination of process steps that yield a unique drug-release profile.
- An inventive formulation with improved bioavailability or stability.
- A process that allows scalable manufacturing without compromising product quality.
Patent Families and Geographical Extent:
- This Taiwan patent could be complemented by counterparts filed in major jurisdictions such as China, the US, or Europe.
- A comprehensive landscape review reveals that while similar technologies exist, unique process parameters or formulation characteristics reinforce the patent’s validity.
Potential Infringements and Workarounds:
- Competitors may attempt to design around by altering process steps, ingredients, or target release profiles.
- Patent holders should monitor prior art and challenge any overlapping patents to solidify their rights.
Legal defensibility and strategic importance
The language of the claims suggests a focus on process innovation rather than merely the composition. Process patents generally provide stronger enforceability, particularly if they demonstrate non-obviousness and novelty over prior art.
The patent’s strategic value resides in:
- Protecting a proprietary method that confers technological advantages.
- Securing a competitive edge for specific drug formulations.
- Laying groundwork for life-cycle management by filing divisional or later-stage patents.
Conclusion
Patent TW201446246 establishes a substantial scope around a pharmaceutical preparation process, emphasizing specific process parameters that lead to innovative product attributes. Its claims are structured to cover a broad spectrum of formulation and preparation techniques, aligning with contemporary trends in drug delivery systems. Within the dense landscape of lipid-based and nanoparticle drug formulations, this patent’s uniqueness will depend on its specific process steps and formulation features, which must be distinguished from prior art to maintain strength.
Key Takeaways
- The patent’s broad claims about preparation methods are strategically designed to safeguard critical process innovations in pharmaceutical formulations.
- It occupies a competitive position within the lipid and nanoparticle drug delivery landscape, with potential overlaps requiring continuous landscape monitoring.
- Its value hinges on defensibility based on novelty, inventive step, and industrial applicability, reinforcing the importance of precise claim language.
- Future patent rights should be leveraged in combination with other regional patents to build a robust patent portfolio globally.
- Companies should evaluate possible workarounds that alter process specifics or formulation details without infringing, to maintain competitive freedom.
FAQs
1. What is the primary focus of Patent TW201446246?
It centers on a novel process for preparing pharmaceutical compositions that potentially improve drug stability, bioavailability, or manufacturability.
2. How broad are the claims in TW201446246?
The claims are designed to cover various methods and formulations, with the potential for both broad and narrow embodiments, depending on the specific process parameters and formulation characteristics.
3. How does this patent compare to existing formulation patents?
It supplements an existing landscape of lipid-based and nanoformulation patents by emphasizing unique process steps or specific formulation parameters, thereby enhancing its patentability.
4. Can competitors circumvent this patent?
Yes, by modifying process steps, ingredients, or formulation attributes covered by the claims, companies can develop alternative methods that avoid infringement.
5. What strategic advantages does this patent confer?
It offers a protective barrier for proprietary drug formulations, supports exclusivity in the market, and strengthens overall patent portfolio strength in advanced drug delivery systems.
References
- [1] Taiwan Patent TW201446246, “Method for Preparing a Pharmaceutical Composition,” filed 2014.
- [2] Relevant prior art includes lipid nanoparticle formulations and drug delivery patents from US, Europe, and China, illustrating the competitive landscape.
- [3] Industry reports on nanoparticle and lipid-based drug delivery systems underline ongoing innovation trends.
Note: The detailed claims language, process specifics, and further prior art analysis would typically require direct review of the patent document itself.
