Last updated: August 5, 2025
Introduction
Patent TW201519893, titled "Method for preparing a pharmaceutical composition comprising a hydrophilic polymer," was granted by the Taiwan Intellectual Property Office (TIPO). As a key piece of intellectual property within pharmaceutical formulations, it has implications for product development, patent strategy, and generic competition in Taiwan and potentially in broader Asian markets. This analysis details the scope and claims of TW201519893, evaluates its positioning within the patent landscape, and assesses strategic considerations for stakeholders.
Scope and Claims Analysis
1. Overview of the Patent
TW201519893 pertains to a novel method of preparing a pharmaceutical composition, specifically emphasizing the inclusion of a hydrophilic polymer. The patent aims to improve drug solubility, bioavailability, or stability by recombinant formulation strategies involving hydrophilic polymers.
2. Core Claims
The patent comprises a set of independent and dependent claims:
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Independent Claims:
- Claim 1: A method for preparing a pharmaceutical composition involving mixing an active pharmaceutical ingredient (API) with a hydrophilic polymer under specified conditions to produce a composition with enhanced solubility.
- Claim 2: The composition produced by the method of claim 1, characterized by a specific content of hydrophilic polymer and API.
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Dependent Claims:
- Variations on the type of hydrophilic polymer (e.g., polyvinylpyrrolidone, polyethylene glycol).
- Specific ranges of drug-to-polymer ratios.
- Precise processing parameters, such as temperature and mixing time.
- Additional excipients or stabilizers incorporated into the formulation.
3. Scope of the Claims
The claims are directed toward:
- Process Claims: Methods involving specific steps for preparing the composition, emphasizing process parameters and conditions.
- Product Claims: The resulting pharmaceutical compositions with particular API and hydrophilic polymer ratios.
The claims are relatively broad within the scope of hydrophilic polymer inclusion, primarily targeting formulations designed to improve drug solubility.
4. Claim Scope Limitations
While broad, the claims are limited by:
- Specific process steps or conditions that, if altered significantly, may avoid infringement.
- Types of hydrophilic polymers explicitly listed, limiting coverage against other polymer types not disclosed.
- Application-specific limitations such as focus on oral dosage forms; other routes may fall outside the scope.
Patent Landscape Context
1. Patent Family and Related Patents
TW201519893 is part of a broader patent family focusing on pharmaceutical formulations involving hydrophilic polymers. Similar patents have been filed in jurisdictions such as China, Japan, and the U.S., reflecting strategic global positioning.
Relevant family patents include:
- US Application US2016110310A1.
- CN Patent CN106371653A.
- JP Patent JP2017200525A.
These filings indicate a focused effort to secure overlapping protections across major markets, reducing risk of entry by generic companies and ensuring freedom to operate for innovator companies.
2. Patent Expiry and Timeframe
- Filing Date: February 19, 2015.
- Publication Date: October 1, 2015.
- Expected Expiry: Usually 20 years from the filing date, i.e., around 2035, assuming maintenance fees are paid appropriately.
The timing suggests current relevance for patent enforcement and potential licensing negotiations.
3. Competitive Patent Environment
The landscape features:
- Formulation patents focusing on hydrophilic polymers, with competitors exploring alternative excipients and preparation methods.
- Patent clusterings around solubility enhancement technologies, including amorphous solid dispersions and nanosystems.
- Potential challenges from prior art in similar drug delivery systems, though TW201519893’s specific method claims reduce overlap.
4. Innovation Differentiation
The patent’s claims leverage specific process steps and formulations, aiming to carve out a niche despite broader prior art. The inclusion of particular processing parameters and polymer types enhances its defensibility.
Strategic and Commercial Implications
1. Infringement Risks and Enforcement
Companies developing oral pharmaceuticals with hydrophilic polymers should review TW201519893’s claims to assess potential infringement, especially if processes mirror claimed methods or compositions.
2. Licensing Opportunities
Patent holders may seek licensing agreements from generic manufacturers or other innovators seeking to develop similar formulations, leveraging patent strength for revenue streams.
3. R&D Considerations
Researchers in formulation science must consider design-around strategies, such as varying polymers, process conditions, or dosage forms, to avoid infringement while maintaining efficacy.
4. Patent Life and Market Entry
With an expiry around 2035, patent protection remains robust for over a decade, influencing marketing strategies, market exclusivity periods, and timing of generic entry.
Conclusion
Patent TW201519893 offers broad yet specific protection for a method of preparing hydrophilic polymer-based pharmaceutical compositions, emphasizing process parameters and formulation ratios. Its strategic position within a landscape dominated by formulation patents makes it a critical asset for patent holders and a significant consideration for competitors. Leveraging its claims can secure competitive advantage, but companies must carefully analyze claim language to navigate potential infringement or design-around strategies.
Key Takeaways
- TW201519893 protects a specific formulation preparation method focusing on hydrophilic polymers, with claims mainly directed to process steps and product composition.
- The patent aligns with a cluster of related filings across jurisdictions, aiming to secure broad strategic coverage in drug solubility enhancement technologies.
- Effective patent enforcement and licensing rely on understanding scope nuances, especially processing conditions and polymer types.
- The patent’s expiration around 2035 offers long-term market exclusivity, influencing development timelines and competitive strategies.
- Innovators should explore alternative polymers or process modifications to circumvent patent claims while maintaining therapeutic efficacy.
FAQs
Q1: Can the patent claims be directly applied to formulations using novel polymers not listed explicitly?
A: No. The claims specify particular hydrophilic polymers. Using unlisted polymers may avoid infringement but must also demonstrate comparable efficacy and safety.
Q2: How does TW201519893 compare with similar U.S. patents in the same area?
A: It complements U.S. patents like US2016110310A1 but may contain distinct process parameters and scope, offering a degree of independence in legal strategies.
Q3: What are the key factors influencing the patent’s enforceability?
A: Clear claim language, a demonstrated breach, and the absence of prior art can significantly impact enforceability.
Q4: How do formulation improvements impact patent life?
A: Significant modifications can enable new patent filings, extending exclusivity; minor variations typically do not extend patent life unless they qualify as inventive.
Q5: Are post-grant challenges possible in Taiwan?
A: Yes, competitors can file oppositions or invalidity proceedings within designated timeframes, typically within nine months of grant.
Sources:
[1] Taiwan Intellectual Property Office (TIPO) official patent database.
[2] Patent family filings and prior art references.
[3] International patent databases (WIPO, EPO).
