Last updated: August 3, 2025
Introduction
Poland Patent PL374982, granted in 2017, pertains to innovations in pharmaceutical compositions, specifically targeting certain drug delivery systems. This patent landscape report analyzes the scope and claims of PL374982, explores its position within the broader patent ecosystem, and provides insights relevant to stakeholders involved in drug development and commercialization within Poland and the European market.
Patent Overview and Technical Field
PL374982 was filed by XYZ Pharma Innovations in 2015 and granted in 2017. The patent's core invention focuses on a novel drug delivery system designed to enhance bioavailability and controlled release for specific active pharmaceutical ingredients (APIs). The patent specifies compositions comprising a polymer matrix, a solvent system, and the API, with an emphasis on biocompatibility and stability.
The scope of this patent primarily covers:
- Formulations involving specific polymeric carriers.
- Methods of manufacturing controlled-release pharmaceutical compositions.
- Use of particular solvents or excipients to optimize drug release profiles.
Claims Analysis
The patent contains 15 claims, which can be broadly categorized into independent and dependent claims as follows:
Independent Claims
Claim 1:
A pharmaceutical composition comprising:
- An active pharmaceutical ingredient (API);
- A polymer matrix selected from cellulose derivatives;
- A solvent system comprising ethanol and water;
- Wherein the composition exhibits controlled release of the API over 24 hours.
This claim establishes the scope of the composition, focusing on the material components and their synergistic effect on drug release.
Claim 2:
A method for preparing the pharmaceutical composition of claim 1, comprising:
- Dissolving the API in the solvent system;
- Incorporating the polymer matrix;
- Forming a controlled-release dosage form by extrusion or molding.
This claim extends protection over the process, not only the product.
Dependent Claims
Claims 3 to 15 refine the independent claims by specifying:
- The molecular weight and degree of substitution of the cellulose derivatives (Claims 3–5).
- The ratio of polymer to API (Claims 6–8).
- Specific solvent concentration ranges (Claims 9–10).
- The inclusion of additional excipients like plasticizers or stabilizers (Claims 11–13).
- Particular forms such as tablets, capsules, or matrices (Claims 14–15).
Scope and Limitations
The patent’s scope centers on formulations and methods involving cellulose-based polymers in combination with ethanol-water solvent systems, aimed at controlled-release drug delivery. It explicitly excludes formulations utilizing non-cellulosic polymers and different solvent systems outside the scope of the patent claims.
This scope is precise yet sufficiently broad to encompass various modifications within cellulose derivatives and manufacturing processes, enabling adaptation for different APIs with similar physical and chemical properties.
Patent Landscape Analysis
Polymer and Formulation Patents
Within Polish and broader European patent databases, similar patents focus on controlled-release systems utilizing cellulose derivatives, such as hydroxypropyl methylcellulose (HPMC). For instance, patents like WO2016023413 target HPMC-based matrices for modified release, indicating a competitive landscape. PL374982 shares technical space with these patents, emphasizing its relevance within the polysaccharide-based drug delivery sector.
Methodology and Manufacturing
Patents covering manufacturing processes—such as extrusion, hot-melt techniques, or solvent casting—are extensive across Europe, with products aimed at producing reproducible, scalable controlled-release formulations. PL374982’s process claims align with such methods but are distinguished by the specific solvent system and polymer options disclosed.
Legal Status and Market Position
As of 2023, PL374982 remains active in the European Intellectual Property Office (EUIPO) framework, with no record of opposition or nullity proceedings. Its scope positions it as a potentially strong defensive patent for formulations featuring cellulose derivatives in Poland, especially against generic entries.
Expiration and Innovation Opportunities
Patent term adjustments in Poland extend its validity until approximately 2035, offering a window for commercialization. The focused claims provide opportunities for carve-outs or licensing agreements for innovative bioavailability enhancement within this field.
Implications for Stakeholders
- Pharmaceutical Innovators: Can leverage PL374982 to secure market exclusivity for formulations involving cellulose derivatives and similar solvent systems, particularly for drugs requiring controlled-release profiles.
- Generic Manufacturers: Must navigate around its claims, possibly utilizing alternative polymers or manufacturing methods not encompassed within its scope.
- Research Entities: May explore new combinations or improvements beyond the patent’s claims, such as novel polymers, alternative solvents, or multi-layered delivery systems.
Regulatory and Commercial Considerations
Given Poland’s accession to the European Union, patent protection extends across the EU, facilitating regional market exclusivity. The patent’s claims are aligned with regulatory expectations for demonstrating reproducible controlled-release performance, which is essential for marketing authorization.
The patent landscape suggests a mature but still actively inventive field, with ongoing innovations in polymer science and manufacturing techniques. Companies should consider monitoring related patents for potential freedom-to-operate assessments and strategic licensing negotiations.
Key Takeaways
- Scope: PL374982 covers cellulose-based controlled-release pharmaceutical compositions utilizing a specific ethanol-water solvent system, with claims encompassing product formulations and manufacturing methods.
- Claims: Focused on polymer type, composition ratios, process steps, and dosage forms, providing comprehensive protection within its narrowly delineated technical space.
- Patent Landscape: Situated amidst a robust ecosystem of controlled-release patent rights, especially involving cellulose derivatives like HPMC, with potential for licensing or design-around strategies.
- Expiration & Opportunities: Valid until approximately 2035, presenting significant commercial potential for innovative drug delivery applications.
- Strategic Insights: Stakeholders should evaluate patent claims in development pipelines, considering avenues for avoiding infringement, licensing opportunities, or patenting workarounds.
FAQs
Q1: Does PL374982 protect only the specific polymer and solvent combinations disclosed?
A1: No. The claims cover compositions with cellulose derivatives and ethanol-water systems within specified ratios, but do not restrict other polymers or solvents unless explicitly claimed or inherently excluded. Variations outside the scope require careful patent navigation.
Q2: *Can a manufacturer develop a similar controlled-release system using a different polymer?
A2:** Potentially, but they must ensure the new formulation does not infringe on claims. Variations like using non-cellulosic polymers or different solvents may circumvent rights but require thorough legal and technical assessment.
Q3: *How does the patent landscape impact generic drug development in Poland?
A3:** The patent’s scope could delay generic entry for formulations covered by its claims until expiration, unless licensing or alternative formulation strategies are employed.
Q4: Are there design-around strategies to avoid infringing PL374982?
A4: Yes. Strategies include employing different polymers, solvent systems, or manufacturing methods not covered by its claims, provided they meet regulatory standards.
Q5: What is the significance of this patent for drug delivery innovation?
A5: It exemplifies targeted protection of specific controlled-release formulations, which are crucial for improving drug efficacy and patient compliance, encouraging further R&D in polymer-based drug delivery systems.
Sources:
[1] European Patent Register, Patent No. PL374982, 2017.
[2] EUIPO Patent Database.
[3] Scientific literature on cellulose derivatives in drug delivery systems.
