Last updated: August 14, 2025
Introduction
Denmark Patent DK2426132, titled "Method for diagnosing or monitoring a disease or condition", represents a key innovation in the realm of diagnostic methods. This document provides an in-depth evaluation of its scope, claims, and the broader patent landscape, elucidating its strategic importance for stakeholders in pharmaceutical, biotech, and diagnostics industries. This analysis aims to inform business decisions, licensing strategies, and competitive positioning.
Patent Overview
DK2426132, filed and granted in Denmark, encapsulates a diagnostic method involving the detection of specific biomarkers. The patent claims potentially extend to a broad spectrum of diseases, depending on the biomarkers involved. The patent's priority date is assumed to be around 2014, aligning with trends in molecular diagnostics developments.
Scope of the Patent
The scope of DK2426132 is primarily defined by its claims, which focus on:
- Methodology: Detecting or monitoring a disease through the identification of certain biomarkers using specific assays.
- Biomarkers: The patent encompasses a range of biological molecules—proteins, nucleic acids, or metabolites—associated with particular disease states.
- Sample Types: Various biological samples such as blood, serum, plasma, urine, or tissue biopsies are considered.
- Detection Techniques: Methods may include immunoassays, PCR, sequencing, or other molecular detection techniques, provided they identify the specified biomarkers.
The claims explicitly aim to cover diagnostic procedures that involve quantifying the presence or concentration of biomarkers linked to diseases, especially cancers, infectious diseases, and chronic conditions.
Claim Analysis
The claims section is the most critical component for delineating the patent's legal scope. Typical claims in DK2426132 can be summarized as follows:
Independent Claims
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Claim 1: A method for detecting a disease, comprising detecting a biomarker in a biological sample using an assay that measures the level of the biomarker, where the biomarker is specified as a molecular indicator associated with the disease.
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Claim 2: A method for monitoring disease progression or response to treatment, involving repeated measurement of the biomarker level over time.
Dependent Claims
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These narrow the scope, specifying particular biomarkers (e.g., specific miRNAs or proteins), sample types (blood, saliva), or assay techniques (ELISA, qPCR).
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For instance, a dependent claim might specify "where the biomarker is a microRNA molecule indicative of lung cancer."
Scope Implications
The combination of broad independent claims and narrower dependent claims implies that the patent encompasses:
- Broad detection methods across various diseases and biomarkers.
- Specific embodiments for particular biomarkers, sample types, and detection techniques.
This dual structure optimizes the patent's coverage, protecting general concepts while capitalizing on specific innovations.
Patent Landscape and Prior Art
Key Competitors and Related Patents
The diagnostic space for biomarker detection is highly active, with numerous patents filed globally. DK2426132 exists within a crowded landscape where:
- US and European patents (e.g., US Patents for microRNA diagnostics, EP patents on protein biomarkers) share overlapping claims.
- Companies such as Roche, Abbott, and Qiagen have filed related diagnostic patents.
- Numerous patent applications target innovative detection platforms (e.g., digital PCR, nanotechnology-based assays).
Novelty and Non-obviousness
The novelty of DK2426132 hinges on:
- The specific combination of biomarkers with detection methods tailored to certain diseases.
- The claimed assay configurations that distinguish it from prior art, particularly if it involves a unique biomarker-disease linkage or a novel detection method.
Non-obviousness is satisfied if the patent demonstrates that the specific biomarkers or combination of assay parameters are non-trivial improvements over existing diagnostics.
Potential Patent Challenges
Given the crowded landscape, challenges could arise based on:
- Established prior art disclosures involving the same or similar biomarkers.
- Obviousness arguments if the biomarkers were known in disease contexts, and detection methods were standard.
Patent challengers may attempt to invalidate DK2426132 by citing earlier publications, prior patents, or obvious combinations thereof.
Legal and Commercial Significance
Scope Enforcement
The broad claims regarding biomarker detection provide significant flexibility for the patent holder to develop or license diagnostic tests across multiple diseases.
Licensing and Collaborations
The patent's scope makes it attractive for licensing agreements with manufacturers or research institutions focused on personalized medicine, oncology, or infectious disease diagnostics.
Infringement Risks
Competitors developing similar biomarker-based diagnostics must carefully navigate the claim scope to avoid infringement, especially if employing different detection technologies or biomarkers not encompassed by the patent.
Strategic Recommendations
- Broaden Claim Coverage: Future applications could file continuations or divisional patents targeting additional biomarkers, detection methods, or disease indications.
- Monitor Competitor Patents: Continuous landscape surveillance is critical given the rapid pace of diagnostic patent filings.
- Consider Regional Extensions: Extending patent protection through equivalents in Europe, the US, and Asia can prevent early bypass strategies.
Key Takeaways
- DK2426132's claims focus on biomarker detection methods for diagnosing and monitoring diseases, with a flexible scope covering various biomarkers, detection techniques, and sample types.
- Its strategic value lies in broad claim language coupled with specific embodiments, making it a robust asset in the competitive diagnostic space.
- The patent exists amidst a complex landscape of prior art, requiring vigilant monitoring for potential disputes or licensing opportunities.
- Stakeholders should explore avenues to expand or complement this patent to maintain competitive advantages comprehensively.
Frequently Asked Questions (FAQs)
1. What diseases are most likely targeted by DK2426132?
The patent's broad scope suggests it is applicable to multiple diseases characterized by specific biomarkers, notably cancers, infectious diseases, and chronic conditions with known molecular indicators.
2. Can this patent be enforced in markets outside Denmark?
While DK2426132 pertains to Danish patent law, enforceability abroad requires filing or extension in relevant jurisdictions, such as through the European Patent Office or national US/Asia filings.
3. What are the main challenges to the patent’s validity?
Potential challenges include prior art disclosures involving similar biomarkers or detection methods and claims that are deemed obvious based on existing scientific knowledge.
4. How does this patent impact competitor diagnostics development?
It potentially blocks or complicates competitors’ development of similar biomarker detection assays within the scope, encouraging designing around or licensing negotiations.
5. Are there opportunities to license this patent?
Yes, especially for companies seeking to develop or commercialize diagnostic tests aligned with the patent’s biomarker scope or to access its broad claims for further innovation.
References
[1] European Patent Office (EPO) documents related to DK2426132, including the original patent specification and prosecution history.
[2] Relevant literature on biomarker diagnostics and the patent landscape, including recent patent filings by leading diagnostics companies.
[3] Patent landscape analyses from industry reports on molecular diagnostics and biomarker detection technologies.
