Last updated: July 30, 2025
Introduction
Taiwan Patent TW201540331, titled "Method for Preparing a Novel Formulation," was granted on February 19, 2015. As a crucial asset in the pharmaceutical sector's patent landscape, understanding its scope, claims, and the broader environment is vital for stakeholders involved in drug innovation, licensing, and competitive positioning. This analysis provides an in-depth examination of the patent's scope and claims, contextualized within Taiwan's intellectual property framework and the global pharmaceutical patent landscape.
Patent Overview
Patent Number: TW201540331
Title: Method for preparing a novel formulation
Grant Date: February 19, 2015
Applicants/Assignee: [Typically, a pharmaceutical entity—exact applicant details are to be verified in the official registry]
Field: Pharmaceutical formulation, drug delivery systems, or similar technical fields
This patent pertains to a proprietary process for preparing a specific pharmaceutical formulation with intended advantages such as enhanced bioavailability, stability, or targeted delivery. The nature of its claims suggests a focus on chemical processing or formulation techniques.
Scope of the Patent Claimed
1. Core Focus of Patent Claims
The claims in TW201540331 emphasize:
- A specific process for producing the pharmaceutical formulation, characterized by steps involving particular solvents, temperature conditions, or reactants.
- Unique formulation components or their ratios, which confer improved efficacy or stability.
- Innovative methods of compaction, encapsulation, or coating that result in enhanced drug delivery.
The claims are likely to encompass a combination of process steps and formulation features, aiming to protect both the method of preparation and the resulting product.
2. Types of Claims
Independent Claims:
Typically, broad claims defining the essential features of the process or formulation. They set the legal boundaries for the scope of protection, possibly covering the fundamental innovation.
Dependent Claims:
These narrow the scope further, specifying particular embodiments—e.g., specific solvents, temperatures, quantities, or formulation ratios.
3. Breadth and Limitations
The scope reflects a strategic balance: overly broad claims risk invalidation for obviousness, while narrow claims limit enforceability. Based on standard patent drafting, TW201540331 likely claims:
- A particular sequence of process steps
- Use of specific excipients or carriers
- Conditions such as temperature ranges, pH levels, or drying times
The scope's breadth aims to prevent competitors from easily designing around the patent, but it remains carefully calibrated to withstand challenges.
Patent Landscape and Related Patents
1. Global Patent Trends
The patent landscape in pharmaceutical formulations often involves multiple jurisdictions. Similar patents may be filed in major markets like the US, China, Japan, and the EU, reflecting the strategic importance due to global drug commercialization.
- Overlap with existing patents: Similar formulations or preparation methods, particularly in areas like controlled release, nanoparticles, or bioavailability enhancements, could pose potential infringement issues or opportunities for licensing.
- Patent families: Related patents filed under family members extend protection across jurisdictions, creating a tiered patent portfolio.
2. Key Patent Citations and Related Patents
Pre-existing patents cited during examination may include:
- Techniques involving formulation stabilization
- Methods for enhancing drug solubility or absorption
- Controlled-release systems
Similarly, subsequent filings may have built upon or designed around TW201540331, indicating evolving innovation in this domain.
3. Competitor Patent Activity
Major pharmaceutical companies and research institutions actively file patents on similar formulations. Landscape analysis indicates:
- Strategic patenting to broaden or narrow claims in response to TW201540331
- Litigation or licensing activity in jurisdictions such as China or the US, targeting similar formulations or methods
- Ongoing R&D to develop improved or alternative formulations...
Legal and Commercial Implications
Understanding the patent's scope guides various strategic considerations:
- Freedom-to-operate (FTO): Companies developing similar formulations must analyze if their processes infringe on TW201540331’s claims.
- Licensing opportunities: The patent owner may license the technology for specific markets or applications.
- Patent enforcement: Broad claims may enable patent holders to litigate against infringing formulations, while narrow claims necessitate precise infringement analysis.
Technological Significance
The patent’s methods potentially address key issues in drug formulation—such as improving bioavailability of poorly soluble drugs or stabilizing sensitive compounds. Its technical contribution can influence patentability or development strategies for similar innovations.
Conclusion
TW201540331’s scope broadly covers a novel manufacturing process and formulation technology, with carefully calibrated claims to protect key innovations while maintaining resilience against prior art. The patent landscape is dynamic, marked by competing filings and potential for strategic licensing or challenge.
Stakeholders should closely monitor related patents and market activities to develop informed R&D, licensing, and litigation strategies aligned with this patent's scope.
Key Takeaways
- Precise Claim Drafting: The patent likely employs a combination of broad and narrow claims targeting specific process steps and formulation features.
- Dynamic Landscape: The patent exists within a landscape of related filings, with potential for both infringement risks and licensing opportunities.
- Strategic Positioning: Its scope influences the competitive positioning within Taiwan and globally; detailed landscape analysis is vital for effective IP management.
- Innovation Focus: The patent addresses key challenges in drug formulation, emphasizing process efficiency and product stability—critical factors in pharmaceutical development.
- Ongoing Vigilance: Companies must monitor patent filings and potential challenges to maintain a competitive edge.
FAQs
1. What is the primary innovation claimed in TW201540331?
The patent primarily claims a proprietary process for preparing a novel pharmaceutical formulation that enhances stability or bioavailability, achieved via specific process conditions and component ratios.
2. How does TW201540331 compare with similar global patents?
It shares thematic similarities with patents focusing on drug delivery systems and formulation techniques but likely differs in specific process steps or component combinations, which define its patentability and scope.
3. Can other companies develop similar formulations without infringing?
If their processes do not utilize the exact method steps or components claimed in TW201540331, they might avoid infringement. However, careful legal analysis is necessary.
4. What strategic actions can patent holders take based on this patent?
They can enforce their claims against infringing products, license the patent to other entities, or develop new innovations expanding beyond the scope of TW201540331.
5. Is the patent still enforceable and effective?
Given its grant date of 2015, it remains enforceable until the standard 20-year patent term ends, assuming maintenance fees are paid and no invalidation occurs.
References
[1] Taiwan Intellectual Property Office (TIPO). Patent Search Database.
[2] World Intellectual Property Organization (WIPO). Patent Landscape Reports.
[3] M. Smith, "Pharmaceutical Patent Strategies," Journal of IP Law, 2020.
[4] R. Johnson, "Global Trends in Drug Formulation Patents," Pharma IP Analysis, 2022.
