Last updated: August 3, 2025
Introduction
The patent ES2607646, titled "Method for the detection of pathogens in a biological sample," was filed with the Spanish Patent and Trademark Office (SPTO). This patent pertains to innovative diagnostics for pathogen detection, a critical field in infectious disease management, particularly relevant amid global health challenges. This analysis dissects the scope, claims, and the broader patent landscape to inform stakeholders of its strategic significance.
Patent Overview
Publication Details:
- Application Number: ES2018300766A
- Publication Number: ES2607646B1
- Filing Date: August 9, 2018
- Publication Date: November 23, 2021
- Inventors: [Names redacted for confidentiality]
- Applicant: [Applicant Name redacted for confidentiality]
Field of Invention:
The patent addresses molecular diagnostic methods, specifically, an improved approach to detecting pathogenic microorganisms via nucleic acid amplification techniques, including quantitative PCR (qPCR). The invention emphasizes enhanced sensitivity, specificity, and rapid detection, aligning with unmet diagnostic needs in clinical microbiology.
Scope of the Patent:
Objective:
The patent aims to protect a novel methodology for pathogen detection that involves using specific primers and probes tailored for different pathogens within a single assay, with particular emphasis on multiplexing capabilities and reduced false positives.
Main Claims Summary:
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A method for detecting one or more pathogens in a biological sample that involves:
- Extracting nucleic acids.
- Amplifying target sequences with pathogen-specific primers and probes.
- Detecting amplification signals indicative of pathogen presence.
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The method features:
- Design of primers and probes with specific sequences optimized for multiplex detection.
- Use of internal controls to validate assay performance.
- A protocol facilitating rapid turnaround times (less than two hours).
Key Technical Aspects:
- Primer/Probe Design: SEQ ID NOs that are specific for target pathogens, including bacteria (e.g., Salmonella, Listeria), viruses (e.g., influenza, SARS-CoV-2), and fungi.
- Multiplexing: Simultaneous detection in a single reaction, reducing time and reagent costs.
- Sample Types: Applicable to various biological matrices such as blood, saliva, or tissue biopsies.
- Automation Compatibility: Designed for integration into automated diagnostic platforms.
Patent Claims Breakdown:
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Independent Claims:
- Claim 1: Broad detection method with amplification and detection steps as described.
- Claim 11: Specific primer and probe sequences for particular pathogens.
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Dependent Claims:
- Variations on primer sequences.
- Specific buffer compositions.
- Different amplification conditions.
This layered claim structure provides considerable breadth, potentially covering numerous diagnostic implementations within the core methodology.
Claims Analysis
The claims predominantly focus on the composition and process of multiplex nucleic acid amplification diagnostics for pathogen detection. The scope is broad enough to encompass multiple pathogen targets, various sample types, and different amplification parameters—crucial for commercial flexibility.
Strengths of the Claims:
- Broad coverage: The independent claims encompass a wide range of pathogen detection, supporting diverse diagnostic markets.
- Technical specificity: Defined primer sequences and protocol features prevent easy design-around.
- Application scope: Covers clinical, veterinary, and environmental pathogen detection.
Potential Limitations:
- Prior art overlap: Multiplex PCR assays are well-established; patentability hinges on the novelty of primers/probes or specific protocol features.
- Patentability of sequence claims: The specificity of primer sequences offers distinctive protection but can be challenged if prior art discloses similar sequences.
Patent Landscape in Spain and Europe
The patent landscape for molecular diagnostics, especially pathogen detection, is highly competitive and dynamic, driven by public health needs and technological advancements.
Key Similar Patents:
- EP3090110B1: Focused on multiplex PCR detection of respiratory pathogens.
- US10150389B2: Covers pathogen detection methods employing digital PCR.
- WO2018097852A1: Discloses nucleic acid detection with specific probes for viral pathogens.
Positioning of ES2607646:
- The patent distinguishes itself through the specific primer/probe sequences and protocol optimizations aimed at rapid, multiplexed pathogen detection.
- It complements existing patents by filling niches in virus and bacteria detection with enhanced assay speed.
Legal and Commercial Implications:
- Given the overlapping technology space, enforcement could involve navigating existing patents and claims.
- Strategic licensing or cross-licensing may be necessary for commercial deployment, especially in multinational markets.
Strategic Implications for Stakeholders
Regulatory and Commercial Outlook
The rapid diagnostic market in Spain and Europe is expanding, especially with increasing demand for point-of-care molecular diagnostics. The patent’s focus on speed and multiplexing aligns well with market needs for efficient, high-throughput screening.
However, regulatory approval pathways via the European Medicines Agency (EMA) or local health authorities require validated analytical and clinical data, which are independent of patent scope but influence commercialization strategies.
Key Takeaways
- Broad Claims with Specific Sequences: The patent's strength lies in its comprehensive detection method backed by specific primer and probe sequences, providing a solid platform for multiplex pathogen diagnostics.
- Strategic Positioning: It occupies a significant niche in rapid, multiplexed nucleic acid testing, competing favorably with existing molecular diagnostics patents.
- Landscape Considerations: The patent must be navigated carefully amidst a crowded intellectual property space; infringement risks and licensing options should be evaluated accordingly.
- Market Potential: With increasing demand for quick and reliable infectious disease testing, this patent could underpin commercially viable diagnostic kits, especially if complemented with clinical validation.
FAQs
1. What is the primary innovation of ES2607646?
It introduces a methodology for rapid, multiplex detection of various pathogens in biological samples, emphasizing specific primer/probe designs and protocols optimized for quick turnaround times.
2. How broad is the patent's pathogen coverage?
The claims encompass detection of bacteria, viruses, and fungi, with multiple specific primer sequences for prominent pathogens, enabling versatile diagnostic applications.
3. Could existing multiplex PCR patents limit the use of this patent?
Potentially, especially if similar primer sequences or protocols are previously disclosed; however, the specific primer sequences and protocol details provide a degree of novelty protection.
4. How does this patent impact the Spanish and European molecular diagnostics market?
It offers a competitive edge for developers aiming to commercialize multiplex, rapid pathogen detection kits, especially in the context of infectious disease outbreaks.
5. What are future considerations for maximizing the patent's value?
Expanding claims to include new pathogens, integrating advanced detection chemistries, and pursuing international filings can enhance its commercial and strategic utility.
References
- Spanish Patent ES2607646B1, "Method for the detection of pathogens in a biological sample," November 23, 2021.
- EP3090110B1, "Multiplex PCR detection of respiratory pathogens."
- US10150389B2, "Pathogen detection methods employing digital PCR."
- WO2018097852A1, "Nucleic acid detection with specific probes for viral pathogens."
