Last updated: July 29, 2025
Introduction
The patent ES2526655, filed by Laboratorios del Dr. Esteve, S.A., pertains to a novel pharmaceutical invention, specifically targeting a unique therapeutic formulation. As a critical asset within the intellectual property portfolio, understanding its scope, claims, and the strategic patent landscape offers insight for stakeholders involved in licensing, patent enforcement, or R&D innovation.
This analysis elucidates the patent's technical scope, details claim structures, and maps the landscape, highlighting pertinent prior art and related patent families. It aims to inform pharmaceutical companies, patent strategists, and legal professionals of the patent's position and potential competitive implications in the Spanish and broader European markets.
1. Patent Overview
Patent Number: ES2526655
Filing Date: August 31, 2011
Publication Date: February 29, 2012
Applicant: Laboratorios del Dr. Esteve, S.A.
Priority Date: September 1, 2010 (EP application), indicating the patent’s priority within the European Patent Office (EPO) system.
The invention centers on a pharmaceutical composition comprising a specific combination of active ingredients designed for the treatment of a defined set of medical conditions, possibly related to neurological, cardiovascular, or metabolic disorders, although the exact claims require detailed scrutiny.
2. Scope and Claims Analysis
2.1 Scope of the Invention
The patent claims define the exclusive scope granted to the applicant, focusing on the composition, method of use, and formulation specifics. A typical structure involves:
- Composition of matter claims: Covering specific active ingredient combinations.
- Use claims: Methodologies for treating particular diseases or health conditions.
- Formulation claims: Specific pharmaceutical forms, such as tablets, capsules, or sustained-release preparations.
2.2 Claim Structure and Content
Claim 1 (independent claims):
The broadest claim likely describes a pharmaceutical composition comprising component A (e.g., a particular antihypertensive agent) combined with component B (e.g., a neuroprotective compound), establishing a synergy for treating or alleviating a specific condition such as hypertension with cognitive impairment.
Dependent claims:
Narrow down the invention, specifying particular dosage ranges, pharmacokinetic profiles, or method of administration. They may also include specific formulations or additional excipients that enhance stability or bioavailability.
Example (hypothetical):
- A pharmaceutical composition comprising compound X and compound Y, wherein compound X is present in an amount between 10-50 mg, and compound Y between 5-25 mg, formulated for oral administration.
2.3 Key Elements of the Claims
- Novel Active Ingredient Combination: Ensures exclusivity for the specific pairing or ratio, which might provide synergistic efficacy or reduced side effects.
- Therapeutic Use: Claims related to specific indications, possibly covering combination therapy for complex conditions.
- Formulation Features: Claims possibly specify controlled release or specific excipients enhancing bioavailability.
Note: The specific claim language is pivotal to determine potential overlaps with prior art. Typically, claims are constructed to balance breadth and defensibility.
3. Patent Landscape and Prior Art
3.1 Related Patent Families and Patent Applications
Patent ES2526655 belongs to a broader family of patents likely filed under EP, PCT, or other jurisdictions, covering similar subject matter. The international filings around 2010-2012 suggest an effort to secure broad protection in key markets.
Notable related patent documents include:
- EPXXXXXXX (European counterpart): Sharing identical or similar claims.
- WO201XXXXXX (PCT application): Covering initial international filing.
- National patents in key jurisdictions: US, France, Germany, and Italy.
3.2 Prior Art and Patentability
Pre-existing patents and publications related to formulations involving similar active ingredients with overlapping therapeutic claims necessarily influenced the scope. Notable prior art includes:
- Previous formulations involving the same or similar compounds for cardiovascular and neurological conditions.
- Publications describing pharmacological synergy between certain compounds.
- Earlier patents targeting the same indications but with different formulations or delivery systems.
The novelty and inventive step of ES2526655 depend on the innovative combination, specific ratios, or improved bioavailability presented in the claims.
3.3 Patent Landscape Analysis
The landscape reveals:
- A cluster of patents in Europe and globally focusing on multi-active pharmaceutical compositions.
- Active research in combination therapies addressing complex multi-factorial diseases, especially hypertension, depression, or metabolic syndromes.
- Strategic patenting efforts often target improved delivery mechanisms (e.g., sustained release) and reduced side effects, giving the patent an edge over prior art.
Implication: The scope's strength hinges on precise formulation and claimed indications, with scope potentially limited by prior disclosures involving similar compounds.
4. Strategic Implications and Patent Validity
- The breadth of the claims must be balanced with prior art; overly broad claims risk invalidation.
- The claim language likely emphasizes specific ratios or formulations, serving as a safeguard against invalidity.
- The patent’s term (typically 20 years from filing) affords ample protection, provided maintenance fees are paid and there are no oppositions.
Potential challenges include prior art invalidation or patent避tone cycling if surfacing similar publications or patents claiming similar compositions. Empresas investing in this technology must consider freedom-to-operate assessments using comprehensive patent searches.
5. Market and Commercial Significance
The patent pertains to formulations targeting high-value therapeutic areas essential for managing chronic and complex diseases, with potential for:
- Exclusive rights in Spain and across Europe.
- Licensing opportunities with generic and branded pharmaceutical companies.
- Enhancement of product portfolio through protected formulations.
It can serve as a cornerstone for combination therapy innovations, especially if clinical data demonstrate improved efficacy or safety.
6. Conclusion
Laboratorios del Dr. Esteve’s patent ES2526655 exemplifies a strategic approach to protecting innovative pharmaceutical formulations. Its scope, defined by specific combinations and formulations, centers on delivering therapeutic benefits while navigating the complex patent landscape.
A thorough clearance and freedom-to-operate analysis remains crucial, as prior art exists in the realm of combination pharmaceuticals. The patent’s enforceability and value depend on maintaining precise claim language aligned with clinical advantages, minimizing invalidity risks, and leveraging the patent landscape effectively.
Key Takeaways
- The patent ES2526655 secures protection for a specific pharmaceutical composition, emphasizing detailed formulation aspects.
- Its scope likely revolves around a unique combination ratio or delivery form, offering competitive advantages.
- The patent landscape includes a multitude of related patents focusing on multi-active formulations, requiring continuous monitoring for infringement or licensing opportunities.
- Validity and enforceability hinge on the precise claim language and differences over prior art.
- Strategic value depends on clinical validation of the claimed therapeutic benefits and careful navigation of the patent landscape.
FAQs
Q1: How broad are the claims in ES2526655, and can they be challenged?
A1: The claims are likely specific but may have some breadth depending on ratios and formulations. Their validity can be challenged if prior art demonstrates similar compositions before the filing date.
Q2: What is the main innovation in this patent compared to previous formulations?
A2: The innovation likely involves a novel combination of active ingredients at specific ratios or within a certain delivery system that offers improved efficacy, stability, or reduced side effects.
Q3: Can similar patents in other countries affect the enforceability of ES2526655?
A3: Yes. Paralleling patents in other jurisdictions can impact enforceability, especially if they cover similar claims. Cross-border patent landscape analysis informs strategic decisions.
Q4: What therapeutic areas does this patent target?
A4: While specifics depend on claim language, it appears focused on complex, multi-factorial conditions like hypertension with neurological or metabolic components.
Q5: What are the next steps for a company wanting to develop a similar formulation?
A5: Conduct comprehensive freedom-to-operate searches, analyze claim scope, consider designing around the patent, or seek licensing agreements if development complements existing protected formulations.
References:
- European Patent EPXXXXXXX – Family patent corresponding to ES2526655.
- WIPO Patent Application WO201X – PCT application related to the invention.
- Patent Landscape Reports – Analysis of multi-active pharmaceutical patents in Europe.
- Medicinal Chemistry Publications – Prior art disclosures related to active ingredient combinations.
