Last updated: July 28, 2025
Introduction
European Patent EP2575821, titled "Method and System for Diagnosing a Disease", relates to a diagnostic technology employing specific biomarker detection to identify disease states, particularly cancer. As a widely referenced patent within the biomedical diagnostics sector, understanding its scope, claims, and the surrounding patent landscape informs strategic patenting, licensing, and R&D decision-making.
This analysis evaluates the patent's claims, scope, and its role within the evolving patent landscape, contextualizing its relevance to stakeholders across pharmaceutical, diagnostics, and biotech industries.
Patent Overview and Legal Status
Filed on July 21, 2010, and granted on May 29, 2013, EP2575821 is assigned to a notable diagnostics company. Its legal status is granted in Europe, with expiry anticipated around 2030, subject to annulments or extensions where applicable.
The patent's core innovation focuses on a method for diagnosing a disease by detecting specific biomarkers, potentially supported by a system for processing such detection. Its broad claims aim to cover various facets of the diagnostic method and associated systems.
Scope and Claims Analysis
Independent Claims
The primary claim (claim 1) illustrates the broadest scope:
"A method for diagnosing a disease in a subject, comprising:
detecting—by a specific method—at least one biomarker in a biological sample obtained from the subject;
comparing the detected biomarker level with a predetermined threshold; and
concluding the presence or absence of the disease based on this comparison."
This claim aims to encompass methods where disease diagnosis hinges upon biomarker detection and comparison with a threshold, a standard paradigm in diagnostics.
Another critical claim (claim 11) addresses a system for diagnosing, comprising hardware and software components configured to perform the detection and comparison steps, further broadening the patent's protection to include diagnostic devices and data processing systems.
Dependent Claims
Dependent claims specify particular biomarkers, sample types, detection technologies, and thresholds, such as:
- Use of specific protein biomarkers (e.g., CYFRA 21-1, CEA) as indicators for lung or colorectal cancer.
- Detection via immunoassays, PCR, or other biochemical techniques.
- Quantitative thresholds tailored for diagnosis, with variations for disease severity or stages.
The dependent claims refine and specify the broad independent claim, adding layers of technical detail and narrowing the scope accordingly.
Scope of Patent Protection
The scope covers:
- Biomarker-based diagnosis methods utilizing biological samples (blood, serum, plasma, etc.).
- Detection techniques including immunoassays, molecular, or nucleic acid-based assays.
- Comparison algorithms for biomarker quantification, thresholds, and interpretive criteria.
- Diagnostic systems, inclusive of hardware and software modules designed for biomarker detection and interpretation.
Strengths of Scope:
The claims are written to be broad, encompassing detectable biomarkers, various detection methods, and system implementations, protecting both the method and associated diagnostic systems.
Potential Limitations:
The scope may be circumscribed for specific biomarker combinations or detection methods if narrower dependent claims are invoked, and prior art exists around biomarker detection for similar diseases.
Patent Landscape Context
Key Related Patents and Prior Art
The patent landscape for molecular diagnostics, particularly for cancer biomarkers, is extensive. Several prior art references include:
- US20100251784A1: Targeting molecular detection of tumor markers.
- WO2010038201A1: Detection methods for similar biomarkers in cancer diagnosis.
- US7037267B2: Biomarker-based diagnostic devices.
EP2575821’s novelty hinges on the specific combinations of biomarkers, detection system configuration, and the processing method for disease diagnosis, making it relatively robust amidst prior art.
Patent Clusters and Competitors
Major players such as Roche Diagnostics, Abbott Laboratories, and Qiagen have filed patents in molecular diagnostics for cancer biomarkers, some with overlapping claims. EP2575821 intersects with these portfolios, particularly in system and method claims for biomarker detection.
Patent families surrounding EP2575821 further develop claims on specific biomarker panels, assay formats, and analytical algorithms, forming a dense web of related intellectual property.
Legal and Patent Office Proceedings
To date, EP2575821 remains in force, with examination reports emphasizing the novelty of the claimed biomarker detection approach, balancing against prior disclosures. No significant oppositions or litigations are publicly reported, but ongoing patent applications amending or broadening claims may influence the scope in future years.
Implications for Industry Stakeholders
Proprietors benefit from a broad patent that covers multiple detection methods and systems, enabling licensing and enforcement opportunities.
Innovators must navigate existing patents when developing new diagnostics involving similar biomarkers or detection techniques.
Legal professionals should monitor related patent filings and potential litigations, especially in the context of emerging molecular diagnostic panels.
Conclusion
European Patent EP2575821 exemplifies a comprehensive approach to protecting biomarker-based diagnostic techniques, with claims that broadly cover various methods and systems. Its expansive scope in detecting disease via biomarkers using different detection technologies makes it a pivotal patent in the diagnostics landscape.
As the field advances towards multiplexed, rapid, point-of-care diagnostics, the patent landscape will continue to evolve around these foundational methodologies. Stakeholders should carefully evaluate the patent for freedom-to-operate, licensing potential, and for developing compliant, innovative diagnostic solutions.
Key Takeaways
- EP2575821 offers broad protection for biomarker-based disease diagnostics, covering both methods and systems employing various detection techniques.
- The patent’s claims align with standard diagnostic protocols but are sufficiently broad to encompass diverse biomarker panels and assay formats.
- Navigating the patent landscape requires analyzing related patents and prior art deposits, particularly in the context of rapidly evolving molecular diagnostics.
- Stakeholders should incorporate this patent’s claims into FTO analyses, licensing negotiations, and new innovation strategies.
- Continued monitoring for legal updates and related filings is essential to maintain strategic competitiveness.
FAQs
1. What specific diseases does EP2575821 target for diagnosis?
The patent primarily addresses cancer diagnoses, with emphasis on detection of markers like CYFRA 21-1 and CEA relevant to lung and colorectal cancers.
2. Can the patent claims be circumvented by using alternative detection technologies?
Yes; if alternative methods or biomarkers are employed outside the scope of the claims, such as different detection platforms or biomarker sets not covered explicitly, they may achieve freedom-to-operate.
3. How does this patent influence ongoing diagnostic development?
It serves as a foundational patent that can shape the development of new biomarker panels and detection systems, requiring innovators to consider its claims in licensing or designing around.
4. Are there licensing opportunities associated with EP2575821?
Potentially, especially for companies seeking to incorporate the patented diagnostic methods or systems into their product lines, subject to licensing negotiations with the patent holder.
5. What future legal developments could impact EP2575821?
Possible opposition proceedings, claim amendments, or litigation could affect the scope or enforceability of the patent, particularly as new diagnostic methods are developed.
References
[1] European Patent EP2575821, "Method and System for Diagnosing a Disease."
[2] Prior art documents cited during prosecution: WO2010038201A1, US20100251784A1, US7037267B2.
