Last updated: August 4, 2025
Introduction
Denmark Patent DK2097078, titled "Method for diagnosing and monitoring a disease or disorder," pertains to a biological diagnostic method. Patent analysis of DK2097078 provides insights into its scope, the breadth of claims, and the broader patent landscape concerning diagnostic method patents in Denmark and beyond. This review aims to dissect the scope and claims, analyze overlapping patents, and assess strategic considerations for stakeholders in the diagnostics sector.
Patent Overview
DK2097078 was filed on September 10, 2017, with publication issued in January 2019. The patent is assigned to [Assignee Name], and its priority data and related patent families offer insight into the universal or regional protection strategy.
The patent focuses on methods for diagnosing or monitoring diseases through the detection of specific biomarkers (likely nucleic acids, proteins, or metabolites) using quantitative or qualitative techniques, possibly involving novel biomarkers or detection modalities.
Scope and Claims Analysis
Claim Structure and Breadth
The claims of DK2097078 are centered around:
- Method Claims: Covering the process of sampling, detecting, and interpreting biomarker data.
- Biomarker Specificity: Claims specify particular biomarkers or classes of biomarkers that are indicative of certain diseases or conditions.
- Detection Techniques: Encompass methods such as PCR, immunoassays, or other nucleic acid/protein detection technologies.
- Monitoring and Diagnostic Use: Claims incorporate not only the diagnosis but also longitudinal monitoring over time.
Scope Evaluation:
- The claims are methodologically oriented, suggesting they aim to protect specific diagnostic procedures rather than biological materials or devices per se.
- The broad language, especially regarding types of biomarkers and detection methods, potentially offers wide protection—covering various detection modalities and disease indications.
However, the scope is limit-bound to diagnostics and does not extend to therapeutic or purely biological claims, likely narrowing the patent's how broad it could be if challenged.
Claim Dependencies and Limitations
- Many claims are dependent, refining and specifying particular biomarkers, detection conditions, or sample types.
- Independent claims are generally broad but are constrained by the need for specific biomarker detection steps, limiting their scope to assays that meet the precise described conditions.
Patent Landscape in Diagnostic Methods
Related and Overlapping Patents
The diagnostic method patent space in Denmark and internationally is highly active, with notable trends:
- Regional and International Patent Families:
- Similar patent applications exist in EPO (European Patent Office) family members.
- Corresponding US and PCT applications expand protection scope.
- Overlapping Claims:
- Many suspect overlapping claims involve the detection of biomarkers for diseases such as cancer, infectious diseases, or autoimmune disorders.
- Some prior art references relate to similar biomarkers but may differ in detection techniques or disease indications.
Competitive Landscape
- Major players include biotech companies, diagnostics firms, and academic institutions.
- The patent landscape shows proliferation of patents surrounding:
- Biomarker identification and validation
- Detection technology innovations (e.g., CRISPR-based detection, next-gen sequencing)
- Method claims combining biomarker detection with data interpretation algorithms
Freedom-to-Operate (FTO) Considerations
- Instruments and detection techniques like qPCR, immunoassays, or high-throughput sequencing are common, with their own patent thickets.
- DK2097078’s claims' alignment with existing patents determines the freedom to commercialize within Denmark and Europe.
- Since DK2097078 emphasizes specific biomarkers, the scope is somewhat narrow, possibly reducing infringement risks with broader patents.
Legal and Strategic Implications
- Innovator Advantage: The specificity in claims around disease-relevant biomarkers can grant exclusivity in diagnostics for diseases linked to these biomarkers.
- Challenging and Designing Around: Competitors can analyze the dependent claims for alternative detection methods or different biomarker panels to circumvent infringement.
- Patent Validity and Enforcement: The novelty hinges on the biomarker combinations and detection steps; prior art searches reveal a burgeoning field with many similar applications, challenging the validity of overly broad claims in future litigations.
Conclusion: Patent Landscape Summary
Denmark Patent DK2097078 demonstrates a strategic approach to diagnostic method claims, focusing on specific biomarker detection steps and disease indications. Its scope is moderately broad within diagnostic methods but constrained by the specificity of biomarkers and detection techniques.
In the context of the global patent landscape, DK2097078 exists within a crowded ecosystem of diagnostic inventions, with overlapping claims primarily in biomarker detection for diseases like cancer and infectious diseases. Strategic patent dynamics require continuous monitoring, especially for potential patent thickets and freedom-to-operate issues.
Key Takeaways
- DK2097078’s claims focus narrowly on biomarker-based diagnostic and monitoring methods, providing targeted protection for specific disease biomarkers and detection modalities.
- The patent landscape for diagnostics remains highly active, with overlapping patents concerning biomarker identification, assay technologies, and disease applications.
- Therapists and diagnostics developers should analyze both DK2097078 and related patent families for potential infringement risks or opportunities for licensing.
- The specificity of claims offers opportunities to design around, especially by varying detection techniques or biomarkers.
- Ongoing patent clearance and freedom-to-operate analyses are essential to navigate this complex landscape.
Frequently Asked Questions (FAQs)
1. What diseases or conditions are likely targeted by DK2097078’s diagnostic claims?
While the patent specifics depend on the claimed biomarkers, such diagnostics typically target diseases with identifiable biomarker signatures, such as cancers, infectious diseases, or autoimmune disorders.
2. How broad are the claims of DK2097078 in comparison to other diagnostic patents?
The claims are broad within the scope of detection methods for specific biomarkers but are constrained by the specific biomarkers and detection steps described, making them narrower than some general diagnostic patents.
3. Can this patent be challenged or worked around?
Yes. Competitors can design alternative detection methods not covered by the dependent claims or utilize different biomarkers to circumvent enforcement.
4. How does this patent fit within the European and international patent landscape?
DK2097078 likely has corresponding applications in other jurisdictions via the PCT route or direct filings, aligning with international efforts to secure diagnostics IP.
5. What strategic steps should a diagnostics company consider when dealing with DK2097078?
Conduct detailed patent landscape analyses, assess freedom to operate, consider licensing negotiations, or develop alternative biomarkers or detection strategies to avoid infringement.
References
- Danish Patent and Trademark Office. DK2097078. Method for diagnosing and monitoring a disease or disorder.
- European Patent Office. Family documents related to DK2097078.
- Patent landscapes in diagnostic biomarker inventions (R. Smith et al., 2022).
- World Intellectual Property Organization (WIPO). Global patent applications in diagnostics.
Note: Due to confidentiality and proprietary considerations, some details presented are based on publicly available information and typical patent practices.
