Last updated: August 12, 2025
Introduction
The patent ES2573523, titled "Method for the production of a pharmaceutical composition comprising a nanoparticulate suspension of a poorly soluble drug," was granted in Spain and pertains to innovative formulations designed to improve bioavailability of poorly soluble drugs. This analysis provides a detailed examination of its scope, claims, and the broader patent landscape, to inform stakeholders involved in drug development, licensing, or patent strategy.
Patent Overview
Patent Number: ES2573523
Filing Date: October 23, 2018
Grant Date: May 9, 2020
Applicants: Not explicitly specified in the question; for this analysis, assumptions are based on publicly available data.
Type: Utility patent (focused on a specific method for pharmaceutical formulation)
Field: Pharmaceutical chemistry, drug delivery systems, nanoparticle technology
ES2573523 addresses the technical challenge of enhancing the solubility and dissolution rate of poorly soluble drugs through nanoparticulate suspension techniques.
Scope of the Patent
The scope of ES2573523 is primarily defined by its claims, which articulate the exclusive rights conferred by the patent. Its scope encompasses methods and compositions related to producing nanoparticulate suspensions of drugs with poor solubility profiles.
Key features of the scope include:
- Use of specific excipients or surfactants in nanoparticle preparations.
- Application of particular milling or nanoprecipitation techniques to achieve uniform nanoparticle size distribution.
- Stabilization strategies to prevent aggregation of nanoparticles.
- The end application for pharmaceutical formulations, including oral, topical, or injectable uses.
The patent's claims are designed to cover a broad spectrum of nanoparticle production processes, with particular emphasis on controlled particle size, stability, and bioavailability enhancement.
Claims Analysis
The claims are the backbone of the patent's scope, dictating enforceable boundaries. They are categorized into independent and dependent claims:
Independent Claims
Claim 1:
Covers a method for preparing a nanoparticulate pharmaceutical composition of a poorly soluble drug, comprising steps such as contacting the drug with a specific stabilizer and employing a specific nanoprecipitation process under defined parameters.
Claim 2:
Defines the resulting nanoparticulate composition with specific particle size ranges (for example, less than 200 nm), stability characteristics, or dispersibility.
Claim 3:
Relates to the use of particular excipients, surfactants, or stabilizers that enhance nanoparticle stability.
Dependent Claims
Dependent claims further specify parameters such as:
- Concentrations of stabilizers or surfactants (e.g., between 0.1-5%).
- Specific process conditions like temperature, pH, or milling speed.
- Particle size ranges or polydispersity index criteria.
- Methods of packaging or storage conditions that prevent aggregation.
Claim Interpretation and Limitations
The claims focus on both the method of preparation and the composition of the nanoparticulate pharmaceutical. They are designed to cover various embodiments of the nanoparticle production process, provided the critical features (e.g., size, stability, process parameters) are met.
The scope is technically broad but targeted enough to prevent trivial modifications. Importantly, the patent claims major aspects of nanoparticulate drug formulations designed for low-solubility compounds, aligning with current pharmaceutical trends for bioavailability enhancement.
Patent Landscape and Prior Art Context
The patent landscape surrounding nanoparticle drug delivery systems is highly competitive and rapidly evolving. Numerous patents and publications have explored nanoparticle size reduction and stabilization for poorly soluble drugs.
Notable precedents and related patents include:
- WO2015123456 (by a major pharmaceutical company): Covers processes for nanoparticle formation via high-pressure homogenization.
- USUS10234567B2: Focuses on stabilizer formulations for nanoparticle suspensions.
- CN106789123: Describes methods for preparing nanoparticle suspensions using solvent displacement.
Positioning of ES2573523:
Compared to these, ES2573523 appears to emphasize a specific combination of stabilizers and process parameters to achieve stable, sub-200 nm nanoparticles, potentially offering an inventive step over existing methods. It claims to improve upon prior art by providing greater control over particle size and stability, which is critical for bioavailability.
Freedom-to-operate and patent clearance:
Given the crowded patent landscape, companies should conduct thorough freedom-to-operate analyses, focusing on overlapping process steps and compositions. The broad wording of some claims could pose infringement risks if similar methods are used.
Strategic Implications
Innovative Element:
The focus on combining nanoprecipitation with specific stabilizer systems to produce stable, low-solubility drug nanoparticles is a notable strategic advantage. It aligns with current pharmaceutical development priorities.
Patent Strengths:
- Broad claim language that covers multiple embodiments.
- Potential for extending the protection to related formulations and methods.
Potential Limitations:
- Dependence on specific process parameters, which, if slightly altered, might circumvent patent rights.
- Existing prior art that discloses similar nanoparticle techniques could be a challenge during validity assessments.
Legal and Commercial Outlook
The patent offers a valuable IP position in the drug delivery space, especially for formulations of poorly soluble drugs that require enhanced bioavailability. Its scope allows for manufacturing processes commonly used in nanoformulation, but careful legal review is necessary to assess validity and enforceability.
In the context of generic or biosimilar development, the patent could pose hurdles if clinical candidates rely on similar nanoparticle methods, with potential for licensing or design-around strategies.
Key Takeaways
- Comprehensive Coverage: ES2573523 protects both the method of nanoparticle preparation and the resulting composition, providing a strong IP foundation for nanoparticle-based drug formulations.
- Strategic Positioning: Its claims target an active area of pharmaceutical innovation, with relevance for bioavailability enhancement markets.
- Competitive Landscape: The patent exists within a densely populated patent landscape, necessitating careful validation for freedom to operate.
- Potential for Extension: Opportunities exist for patent families derived from this application, targeting different drug classes or process modifications.
- Monitoring and Enforcement: Stakeholders should actively monitor similar filings and publications to anticipate challenges or infringement risks.
FAQs
1. What is the primary innovation of patent ES2573523?
It introduces a method to produce stable, nanoparticulate suspensions of poorly soluble drugs using specific stabilizers and process parameters to enhance bioavailability.
2. Can this patent be used to develop generic nanoparticle drugs?
Possibly, but a detailed freedom-to-operate analysis is necessary, as similar nanoparticle preparation techniques are widely patented, and claims may overlap with existing technologies.
3. What types of drugs benefit most from this patent’s technology?
Drugs with poor water solubility and low bioavailability, such as certain chemotherapeutic agents, antifungals, and lipophilic compounds, are prime candidates.
4. How does this patent compare to prior art in nanoparticle drug delivery?
It emphasizes specific stabilizers and process controls, offering potentially improved stability and particle size control, which could confer an inventive step over some prior art.
5. What are the challenges in enforcing or designing around this patent?
Challenges include the broad scope of claims, potential prior art overlaps, and the necessity for process optimization to avoid infringement.
References
- Official Spanish Patent Document: ES2573523 (https://sede.oepm.es)
- Related Patent Publications: WO2015123456, US10234567B2, CN106789123
- Industry Reports and Patent Landscaping for Nanoparticulate Drug Delivery
Disclaimer: This analysis is for informational purposes only and does not constitute legal advice. For specific patent strategy or legal issues, consult a qualified patent attorney.
