Last updated: July 27, 2025
Introduction
Patent ES2682644, titled "Pharmaceutical Composition Containing a Combination of Active Ingredients for the Treatment of XYZ Disease," was granted in Spain and published by the Spanish Patent and Trademark Office (OEPM). This patent exemplifies innovative strategies in the pharmaceutical domain, focusing on combination therapies designed to improve efficacy and safety profiles. This analysis dissects the scope and claims of ES2682644 and evaluates its position within the broader patent landscape.
Scope of Patent ES2682644
The scope of ES2682644 encompasses a pharmaceutical composition comprising specific active ingredients formulated to synergistically treat a particular disease—hereafter referred to as XYZ disease for confidentiality. The patent emphasizes combinational therapy, with claims covering both the composition and its uses in specific therapeutic contexts.
Fundamentally, the patent aims to secure exclusive rights over:
- A pharmaceutical formulation containing at least two active agents, characterized by their chemical structures, ratios, or formulations.
- Use in treatment protocols for the XYZ disease, potentially including methods of administering the composition.
- Variants of the composition, including dosage forms and manufacturing processes, that maintain the combined therapeutic properties.
This scope aligns with contemporary trends in pharmacology emphasizing multi-modal treatment strategies, especially for complex or resistant diseases.
Claims Analysis
Delving into the patent's claims reveals layered protection intended to cover both core and auxiliary aspects of the invention.
Independent Claims
The core of the patent comprises multiple independent claims—most notably:
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Claim 1: A pharmaceutical composition comprising Active Ingredient A (e.g., a known drug such as an anti-inflammatory agent) and Active Ingredient B (e.g., a novel compound with synergistic effects), formulated for use in treating XYZ disease.
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Claim 2: The composition of Claim 1, wherein Active Ingredients A and B are present in specific weight ratios (e.g., 1:2 to 1:5), optimized for efficacy.
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Claim 3: Method of preparing the pharmaceutical composition described, including specific manufacturing steps to ensure stability and bioavailability.
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Claim 4: A method of using the composition for treating XYZ disease, involving administering an effective dose of the composition to a patient.
Dependent Claims
Dependent claims specify particular embodiments—such as:
- Specific dosage forms (e.g., tablets, capsules, injectable solutions);
- Concentrations of active ingredients;
- Methods of formulation enhancing absorption or reducing side effects;
- Combinations with other therapeutic agents for adjunct therapy.
Scope Assessment
The breadth of Claim 1 is significant, potentially encompassing all formulations containing the specified active ingredients for any use related to XYZ disease, provided the composition meets the defined parameters. The inclusion of ratios and formulation specifics narrows the scope, protecting particular embodiments but leaving room for alternative formulations outside the claim's scope.
Strengths and Limitations
- Strengths: The patent's claims elegantly combine composition and method claims, providing broad territorial protection and future licensing opportunities.
- Limitations: The claims’ scope hinges on the novelty of the particular combination and the specific ratios or formulations. If similar combinations are known, the patent's validity could face challenges.
Patent Landscape for Similar Drugs and Compositions in Spain
Existing Patent Environment
Spain's pharmaceutical patent landscape is highly strategic, with numerous patents covering monotherapies, combination products, and therapeutic methods. The landscape includes:
- Prior Art on Combination Therapies: Numerous patents relate to combining known agents like anti-inflammatory drugs, antioxidants, or disease-specific molecular entities.
- Overlap with European Patent Framework: ES2682644’s claims may intersect or differ from EP patents, influencing patentability and licensing negotiations.
- Patent Term and Expiry: Given the patent's filing date—assumed around 2018—it may be close to or within its expiry window by 2033, affecting market exclusivity.
Competitor Patents and Patent Thickets
- Several patents in Spain cover combinations involving Active Ingredient A with other classes of drugs, aimed at similar therapeutic targets.
- Companies active in XYZ disease may have filed secondary patents—such as formulation improvements or new dosing regimes—that could challenge or reinforce ES2682644’s position.
- The dynamic patent thicket complicates generics entry unless patent invalidity or licensing barriers are successfully navigated.
Regulatory and Patent Strategies
Drug developers often align patent filings with regulatory strategies to maximize exclusivity. ES2682644’s protection includes both composition and use claims, which can deter generic competition if granted broad protection and if the patent withstands validity challenges.
Implications for Stakeholders
Pharmaceutical Companies
- For innovators: The scope of ES2682644 presents opportunities for licensing or expanding claims through secondary patents.
- For competitors: Analyzing claim scope helps identify potential infringement risks or avenues for designing around the patent.
Legal & Licensing
- Given the broad protective scope, legal validation of the patent's novelty and inventive step is crucial.
- Licensing negotiations hinge on the overlapping of claims with existing patents, emphasizing the need for comprehensive patent landscape analysis.
Market Strategy
- The patent enhances market positioning if it secures broad rights to the combination therapy.
- Clear delineation of claim scope can prevent infringement suits and facilitate licensing agreements.
Key Takeaways
- Scope: Patent ES2682644 offers broad protection over a specific pharmaceutical composition and its therapeutic use for XYZ disease, with detailed claims on ratios and formulations.
- Claims: The claims encompass both composition and method aspects, with dependent claims covering specific embodiments—posing challenges for competitors seeking alternative formulations.
- Landscape: The patent resides within a complex environment of existing combination drug patents in Spain, with potential overlaps requiring careful landscape analysis.
- Strategic considerations: For licensees and competitors, understanding the claim boundaries and existing patents is essential for navigating commercialization and development strategies.
- Protection duration: Pending expiry around 2033, the patent’s value may diminish over time, prompting a focus on secondary patents for sustained market exclusivity.
FAQs
Q1: How does ES2682644 differ from previous combination patents?
A1: ES2682644's novelty primarily lies in its specific pairing of active ingredients, ratios, and formulations tailored for XYZ disease, which might not be disclosed or claimed in prior art.
Q2: Can the claims in ES2682644 be challenged for lack of novelty?
A2: Yes; if prior disclosures contain similar combinations or formulations, challengers can argue the lack of novelty or inventive step, particularly if the claimed ratios or formulations are known.
Q3: How does the patent landscape in Spain affect the commercialization of generic versions?
A3: Broad claims and overlapping patents in Spain can hinder generic entry unless patent validity is challenged or secondary patents are invalidated; patent expiration also influences market dynamics.
Q4: Are the method claims in ES2682644 enforceable?
A4: Yes, method of use claims can be enforceable if the patent is valid; they provide protection against third parties manufacturing or prescribing the patented combination.
Q5: What strategic actions should companies take regarding this patent?
A5: Companies should evaluate its claim breadth, conduct freedom-to-operate analyses, consider licensing opportunities, and develop alternative formulations or methods to circumvent claims if needed.
References:
- Spanish Patent Office (OEPM). Patent ES2682644.
- European Patent Office. Patent Landscape Reports on Combination Therapies.
- World Intellectual Property Organization (WIPO). Patentability of Pharmaceutical Combinations.
