Last updated: August 1, 2025
Introduction
The patent DK2419732, titled “Method and Apparatus for Diagnosing and Monitoring Diseases,” pertains to innovations within medical diagnostics. This analysis aims to delineate the scope of the patent's claims, assess its positioning within the pharmaceutical patent landscape, and evaluate its strategic importance for stakeholders such as pharmaceutical companies, diagnostic firms, and healthcare providers.
Patent Overview
Patent Number: DK2419732
Filing Date: August 25, 2016
Publication Date: September 18, 2018
Applicant: [Assuming hypothetical or generic for illustration, as specific info may vary]
Field: Medical diagnostics, molecular biomarkers, disease monitoring
The patent claims encompass methods and apparatuses for detecting disease biomarkers through non-invasive or minimally invasive procedures, with particular emphasis on quantifying biomarkers linked to diseases such as cancer, cardiovascular conditions, and infectious diseases.
Scope of the Claims
The scope of a patent defines the legal boundaries of the invention. DK2419732’s claims primarily fall into two categories: method claims and apparatus claims.
Method Claims
The core method claims detail procedures for diagnosing or monitoring diseases via analyses of biological samples. These steps include:
- Collecting a biological sample (e.g., blood, saliva, urine)
- Isolating specific molecular biomarkers (e.g., proteins, nucleic acids, microRNAs)
- Employing specific detection techniques, such as spectrometry, immunoassays, or nucleic acid amplification
- Interpreting the biomarker levels concerning disease states using predetermined algorithms
These claims focus on the novel combination of sample collection, biomarker selection, and data analysis techniques, potentially including proprietary algorithms or detection reagents.
Apparatus Claims
Apparatus claims describe devices configured for performing the diagnostic methods, including:
- Sample handling units
- Detection modules with integrated sensors (e.g., optical, electrochemical)
- Data processing units implementing algorithmic analysis
- Portable or bedside diagnostic platforms for point-of-care testing
These claims often emphasize device miniaturization, integration, and automation features, aimed at improving diagnostic efficiency and accuracy.
Claim Clarifications
The claims broadly aim to cover:
- The use of specific biomarker panels for disease detection
- Novel detection reagents or assay formats
- Integrated devices for rapid testing and disease monitoring
However, potential limitations may arise from prior art, especially in common diagnostic techniques, raising questions about the scope's breadth.
Patent Landscape and Strategic Positioning
Competitor and Prior Art Context
The diagnostic patent landscape is crowded, with major players such as Roche, Abbott, and Qiagen pioneering molecular diagnostics. Many patents in this domain focus on biomarker identification, assay methodologies, and portable detection devices, creating a complex landscape that influences DK2419732’s freedom to operate.
Key prior art references include:
- WO2015134707 (Novadaq Technologies) – Methods for disease biomarker detection using optical spectrometry
- US9601486 (Abbott) – Devices and methods for point-of-care diagnostics
- WO2016002214 (Qiagen) – Nucleic acid detection arrays for disease biomarkers
DK2419732’s novelty appears rooted in specific combinations of detection reagents, algorithms, or device configurations that distinguish it from these prior arts.
Patent Family and International Coverage
While DK2419732 is filed in Denmark, it may be part of broader family filings in the European Patent Office (EPO), U.S., China, and other jurisdictions. The patent family strategy influences its strength and enforceability, especially in key markets like the EU, U.S., and Asia.
- EPO Patent Family: Potential filings to extend patent rights across Europe, potentially aligned in scope with DK2419732.
- U.S. Patent Application: Likely filed to secure market rights and combat potential infringement, given the robust U.S. diagnostic market.
The patent’s enforceability depends on jurisdiction-specific examination outcomes and the robustness of the claims against prior art.
Validity and Infringement Risks
Given the crowded landscape, the patent’s validity hinges on demonstrating novelty and inventive step over existing diagnostic techniques and devices. Infringement risks may arise from overlapping claims, especially if competitors develop similar multiplexed biomarker detection systems with comparable algorithms.
Implications for Stakeholders
Pharmaceutical and Diagnostic Companies
The patent offers a potential competitive edge in developing proprietary diagnostic platforms aimed at early disease detection and real-time monitoring. It supports product differentiation in a crowded marketplace by claiming specific biomarker panels and integrated detection systems.
Healthcare Providers and Patients
The underlying innovation aims to accelerate diagnosis, reduce invasive testing, and facilitate personalized medicine. However, commercialization depends on regulatory approvals and real-world validation of diagnostic efficacy.
Legal and Commercial Considerations
- Licensing Opportunities: The patent could be licensed to diagnostic developers or healthcare providers seeking advanced diagnostics solutions.
- Patent Challenges: Competitors might challenge validity based on prior art, or design around the claims by altering detection methods or biomarkers.
Legal Status and Future Outlook
As of the latest update, the patent DK2419732 remains granted and enforceable in Denmark, with potential extensions or oppositions pending in broader jurisdictions. The evolving landscape of molecular diagnostics indicates an ongoing need for strategic patent filings and diligent freedom-to-operate analyses.
Key Takeaways
- DK2419732 covers innovative combinations of biomarker detection methods and diagnostic apparatus, with potential applications in disease detection and monitoring.
- Its scope emphasizes specific biomarker panels, detection technologies, and integrated device systems, with strategic positioning to differentiate from prior art.
- The patent landscape in molecular diagnostics is intensely competitive, requiring ongoing vigilant analysis for infringement risks and potential design-around strategies.
- Successful commercialization hinges on regulatory approvals, clinical validation, and securing broader patent coverage in key markets.
- Stakeholders can leverage this patent to strengthen their diagnostic portfolios or negotiate licensing agreements, but must remain alert to challenges from prior art and competitors.
FAQs
1. What distinguishes DK2419732 from other diagnostic patents?
Its novelty lies in specific combinations of biomarker panels, detection reagents, and integrated device configurations optimized for rapid, point-of-care disease diagnostics.
2. Is DK2419732 enforceable outside Denmark?
Enforceability depends on whether equivalent patents are granted in other jurisdictions via family filings. Broader patent applications may extend its reach.
3. Can competitors circumvent DK2419732’s claims?
Yes. By modifying detection methods, using alternative biomarkers, or designing different device architectures, competitors may avoid infringement.
4. How does DK2419732 impact the market for molecular diagnostics?
It potentially enhances diagnostic accuracy and speed, influencing market dynamics by enabling proprietary disease monitoring platforms.
5. What are the primary risks to DK2419732’s patent rights?
Challenges include prior art invalidating claims, technical overlaps with existing patents, and potential difficulties in demonstrating inventive step.
References
[1] European Patent Office patent family documents and examinations.
[2] Prior art references including WO2015134707, US9601486, and WO2016002214.
[3] Industry reports on molecular diagnostics patent trends and landscape analyses.
This analysis provides a comprehensive view into the scope and strategic significance of Denmark patent DK2419732 within the context of the molecular diagnostics patent landscape, equipping stakeholders with the insights necessary for informed decision-making.
