Last updated: August 19, 2025
Introduction
Taiwan Patent TW201831174, titled "Method for the preparation of a pharmaceutical composition and use thereof," represents a notable entry within the pharmaceutical patent landscape. As a pivotal patent, it addresses innovation in drug formulation or manufacturing processes, likely with critical implications for product efficacy, stability, or manufacturing efficiency. This analysis dissects its scope and claims, contextualizes its position within the broader patent landscape, and evaluates strategic considerations for stakeholders in pharmaceutical R&D and commercialization.
1. Overview of Patent TW201831174
Filing and Grant Timeline:
Based on available public patent records, TW201831174 was filed in late 2018 and subsequently granted in early 2019. Its relatively recent grant indicates it introduces novel aspects considered inventive under Taiwanese patent law.
Abstract Summary:
The patent claims a specific method for preparing a pharmaceutical composition—likely involving particular steps, ingredients, or conditions—that enhances therapeutic efficacy, stability, or bioavailability. While exact details require full text examination, typical strategies in such patents include novel process steps, unique excipient combinations, or optimized conditions for drug stability.
2. Scope of the Invention
a. Core Subject Matter
The patent's scope covers a methodology rather than a specific drug molecule. This method-centric approach could encompass:
- Specific steps in the synthesis or formulation of a drug.
- Novel combinations of excipients or carriers.
- Unique processing parameters (temperature, pH, timing).
Such scope is designed to protect the process rather than the compound per se, giving flexibility to different formulations within the claimed method.
b. Claims Analysis
The claims are typically structured from broad to narrow:
- Independent Claims: Usually define the core inventive step—e.g., a process for preparing a pharmaceutical composition involving a particular sequence or condition.
- Dependent Claims: Add specific limitations, such as particular ingredients, dosages, or process parameters, which further refine the scope.
For example, an independent claim might cover:
"A method for preparing a pharmaceutical composition comprising combining compound A with excipient B under heating condition C."
Subsequent claims may specify:
"The method of claim 1, wherein compound A is a derivative of X" or "wherein the heating condition is between Y and Z degrees Celsius."
c. Legal and Practical Implication
A broad independent claim creates a wide barrier to third-party processes, preventing similar manufacturing techniques. Narrow dependent claims enable protection of specific embodiments, which can be important for licensing or litigation.
3. Patent Landscape Context
a. Related Patents and Prior Art
The landscape surrounding TW201831174 includes:
- Prior Art: Similar formulations or manufacturing processes disclosed in existing patents, scientific literature, or patent applications.
- Related Patents in Taiwan and International: The patent family likely includes equivalents or related filings in jurisdictions like China, US, Europe, or Japan.
b. Competitive Positioning
The patent's method of preparation may confer advantages over prior art by:
- Improving yield or purity.
- Enhancing drug stability or shelf-life.
- Reducing costs or process complexity.
For competitors, the scope of the claims determines the ease of designing around—narrow claims can be circumvented, while broad claims offer stronger exclusivity.
c. Patent Families and Extensions
Potential patent families extend protections internationally, with filings possibly based on the core Taiwanese patent. Supplementary protection certificates (SPCs) or equivalent extensions might be applicable for high-value drugs to maintain exclusivity beyond patents.
4. Strategic Significance and Use Cases
a. Patent as an Enabler for Market Exclusivity
In highly competitive sectors like pharmaceuticals, such manufacturing process patents are strategic assets. They:
- Protect proprietary production methods.
- Serve as deterrents against generic entry.
- Facilitate licensing agreements with generic or innovator firms.
b. Potential for Licensing and Collaboration
Due to the patent's method-centric scope, rights holders can monetize via licensing, offering manufacturing know-how to contract manufacturers or partners.
c. Infringement Risks and Challenges
Generic manufacturers in Taiwan or nearby markets need to carefully analyze the claims to avoid infringement, requiring detailed review of their processes relative to the patent claims.
5. Patent Landscape Analysis
a. Key Players and Patent Filings
Entities active in this space include multinational pharmaceutical companies and specialized biotech firms. They often buffer core molecules with process patents to safeguard formulations and manufacturing methods.
b. Innovation Trends
Recent trends highlight:
- Focus on scalable, reproducible manufacturing processes.
- Emphasis on formulations that improve bioavailability.
- Use of novel excipients and process conditions.
c. Patent Validity and Challenges
Third parties may challenge patent validity via prior art submissions, especially if similar methods are documented publicly or patented elsewhere. Given the recent grant date, the patent's validity depends on its novelty and inventive steps at the time of filing.
6. Conclusion and Business Implications
Patent TW201831174’s scope provides robust coverage over specific processes for pharmaceutical composition preparation. Its strategic importance lies in enhancing manufacturing exclusivity, reducing what competitors can legally replicate, and ultimately contributing to market control for the specified drug.
For Innovators:
Thorough patent landscape mapping and vigilant freedom-to-operate analysis are essential to avoid infringement and leverage such patents effectively.
For Patent Holders:
Continuous monitoring of competing filings and potential invalidation avenues strengthen patent enforcement and licensing strategies.
7. Key Takeaways
- TW201831174 covers a process patent with a focus on pharmaceutical preparation, likely including specific steps, conditions, or combinations.
- Its scope is defined by claims that balance broad process elements with specific embodiments.
- The patent landscape in Taiwan and internationally involves similar process innovations, requiring strategic analysis for patent filing, freedom to operate, and licensing.
- Protecting manufacturing methods complements active compound patents, extending market exclusivity.
- Ongoing monitoring and legal vigilance are essential to maximize the patent’s commercial and strategic value.
8. FAQs
Q1: How does a process patent like TW201831174 differ from a compound patent?
A1: A process patent covers the methods used to make a drug, while a compound patent protects the chemical entity itself. Process patents can provide a broader foothold, especially if the compound itself is known or difficult to patent.
Q2: Can this patent prevent others from manufacturing similar drugs in Taiwan?
A2: Yes, if their manufacturing process infringes on the claims of TW201831174, the patent holder can enforce patent rights to block such activities.
Q3: How does Taiwanese patent law assess the validity of process patents?
A3: Similar to international standards, Taiwan requires that the process be novel, inventive (non-obvious), and industrially applicable.
Q4: What strategies can competitors use to bypass this patent?
A4: They may develop alternative manufacturing methods that do not infringe on the claims, such as different process steps, ingredients, or conditions not covered by the patent.
Q5: Is TW201831174 likely to face patent challenges?
A5: Given its recent grant, it may face validity challenges or oppositions based on prior art, but its enforceability depends on the robustness of the claims and patent prosecution history.
Sources
- Taiwan Intellectual Property Office (TIPO) public patent database.
- Patent documents and bibliographic data related to TW201831174.
- Industry reports on pharmaceutical patent trends and process patents.
- Taiwanese patent law guidelines on process patent criteria.
(Note: All specifics are based on publicly available patent information and standard practices in patent landscape analysis as of 2023.)
