Last updated: July 30, 2025
Introduction
Denmark Patent DK1746976, titled "Method for identifying, characterizing, and treating disease states", relates to a proprietary biotechnological invention focused on diagnostic and therapeutic approaches rooted in molecular profiling. This patent plays a strategic role in the evolving landscape of personalized medicine, leveraging genetic and molecular data to improve disease management. This report provides an in-depth analysis of the scope, claims, and patent landscape surrounding DK1746976, offering insights into its enforceable breadth, regional protections, and potential implications for competitors and innovators.
Patent Overview
DK1746976 was filed as a Danish national patent application, with priority claims likely originating from international filings, given its focus on innovative molecular diagnostics. Its primary focus is on methods that involve:
- Identifying disease-associated molecular markers.
- Characterizing disease states based on biomolecular signatures.
- Tailoring treatment strategies aligned with molecular profiles.
The patent encompasses both diagnostic methodologies and potential therapeutic interventions, reflecting the integrated nature of modern personalized medicine.
Scope of the Patent
Core Technical Focus
The patent covers methods of diagnosing, characterizing, and treating diseases through the detection and analysis of specific molecular markers. Such markers include nucleic acids, proteins, or other biomolecular entities associated with particular disease states—most notably, complex or multifactorial diseases like cancer, autoimmune disorders, or neurodegenerative conditions.
Methodology Claims
The claims are centered on:
- Sample preparation protocols.
- Detection techniques (e.g., hybridization, PCR, immunoassays).
- Molecular signature analysis algorithms.
- Interpretation of molecular profiles to identify disease subtypes or progression.
- Customization of therapeutic strategies based on molecular data.
This broad approach aims to encompass various diagnostic platforms, including plasma, tissue, or cell-based assays, with an emphasis on high-throughput and multiplexed detection technologies.
Therapeutic Claims
While primarily diagnostic, the patent also extends to:
- Use of biomolecular signatures to guide treatment decisions.
- Specific therapeutic agents or interventions tailored to molecular subtypes.
- Combination diagnostics and therapeutics designed to optimize personalized treatment regimens.
This dual claim strategy aligns with the trend toward integrated diagnostics and therapeutics—sometimes termed 'theranostics'.
Claims Analysis
Claim 1: Broad Diagnostic Method
The broadest independent claim likely pertains to a method of diagnosing a disease characterized by detecting specific biomolecular signatures. It may be expressed as:
"A method for diagnosing a disease in a subject, comprising detecting at least one biomolecular marker specific to the disease in a biological sample, thereby indicating the presence or severity of the disease."
This can encompass a supply chain of detection techniques, from molecular hybridization to advanced sequencing.
Dependent Claims
Dependent claims narrow the scope, referencing specific biomolecular markers, detection modalities, or particular disease states. For example:
- Use of specific gene expression panels in cancer diagnosis.
- Detection of particular mutations or epigenetic modifications.
- Assay conditions optimized for sensitivity and specificity.
Claim Scope and Limitations
The claims' scope appears broad enough to cover multiple detection platforms and disease types, yet specific enough in dependent claims to prevent undue broadness. Patent claims likely specify the use of particular biomolecular markers, sample types, and detection methods, which shape enforcement boundaries.
Potential Patent Thickets
Given the active field of molecular diagnostics, patent landscapes may include overlapping patents on specific markers, methods, and platforms (e.g., PCR, microarrays). DK1746976's claims encompass broad diagnostic principles, but its enforceability and commercial value will depend on the creativity of competitors' claims and licensing.
Patent Landscape in the Molecular Diagnostics and Personalized Medicine Sector
Key Competitors and Patents
The landscape features key players such as Roche, Abbott, Foundation Medicine, and emerging biotech firms, all holding patents covering diagnostic biomarkers, detection platforms, and associated methods. Similar patents focus on:
- Tumor profiling (e.g., FoundationOne, US patents on gene panels).
- Blood-based diagnostics ("liquid biopsy" patents).
- Epigenetic markers for disease stratification.
The patent landscape is highly fragmented, often characterized by:
- Blocking patents on core detection platforms (e.g., PCR, next-generation sequencing).
- Biomarker-specific patents (e.g., specific gene mutations or methylation patterns).
- Method-of-use patents that encompass specific applications in clinical or research settings.
Regional Patent Strategies
In Denmark, and Europe generally, patenting strategies emphasize broad claims with regional protection. DK1746976's territorial rights are limited to Denmark unless complemented by European Patent (EP) or international applications, which could extend its enforceability.
European patents are often challenged or licensed across jurisdictions, influencing the commercial viability of DK1746976.
Legal and Patent Landscape Considerations
- Freedom-to-operate (FTO): Given the dense patent environment, companies must navigate overlapping claims, especially concerning biomarker detection and data interpretation.
- Patent term and scope: The patent's expected expiry, typically 20 years from filing, influences its strategic value.
- Potential for patent expiry or non-maintenance: A risk that patent rights could lapse if maintenance fees are unpaid or the patent is challenged.
Implications and Strategic Considerations
For Innovators
- DK1746976 offers a robust foundation for building proprietary diagnostic or therapeutic platforms, especially if aligned with current molecular marker discoveries.
- It’s critical to assess whether specific claims cover the intended biomarkers or methods, influencing product development and licensing strategies.
For Competitors
- Recognition of the patent's scope helps avoid infringement, especially on core detection technologies.
- Opportunities exist to develop alternative methods or biomarkers outside the patent's scope.
For Patent Holders
- The patent should be continuously monitored for potential legal challenges or opportunities to expand scope via divisional or continuation applications.
- Licensing negotiations should consider existing overlapping patents to avoid infringement or to strengthen collaborative ventures.
Conclusion
DK1746976 exemplifies a strategic patent in the personalized medicine arena, claiming broad yet precise diagnostic and therapeutic methods based on molecular signatures. Its scope spans detection technologies, disease characterization, and tailored treatment approaches, positioning it as a potentially influential patent within Denmark’s biotech ecosystem and potentially in Europe if filed for broader protection.
Its enforceability hinges on specific claim limitations and the evolving patent landscape. Strategic IP management, coupled with ongoing biomarker research, will determine its future commercial impact.
Key Takeaways
- Broad Diagnostic Scope: DK1746976 covers molecular profiling methods pivotal for personalized medicine, with claims potentially including detection techniques, sample types, and disease applications.
- Targeted Claims: The patent’s independence likely centers on disease diagnosis using biomolecular signatures, with dependent claims defining specific biomarkers and assay methods.
- Strategic Positioning: Its scope makes it a valuable asset for entities developing molecular diagnostics in Denmark, potentially impacting licensing and collaboration prospects.
- Competitive Landscape: The patent sits amid a complex ecosystem of overlapping patents on biomarkers, detection platforms, and methods—necessitating careful FTO analyses.
- Regional and Global Extension: While limited to Denmark, a strategic extension through European or international filings could broaden protections and mitigate infringement risks.
Frequently Asked Questions (FAQs)
1. What types of diseases does DK1746976 mainly target?
The patent broadly encompasses diseases characterized by specific molecular signatures, with likely emphasis on cancer, autoimmune, and neurodegenerative diseases due to the nature of molecular diagnostics.
2. Can this patent be used for developing commercial diagnostic tests?
Yes, provided the development aligns with the scope of the claims and does not infringe on other overlapping patents. Licensing or partnership arrangements may also be necessary.
3. How does the patent landscape impact innovation in personalized medicine?
A complex patent environment can both foster innovation through licensing opportunities and pose barriers due to overlapping "patent thickets" that complicate product development.
4. Does DK1746976 cover all molecular diagnostic methods?
No, the patent claims specific methods involving certain biomarkers and detection techniques. It does not patent all molecular diagnostics but defers to its particular claims and embodiments.
5. How can a company determine if it infringes DK1746976?
This requires a detailed comparison of the company's diagnostic methods with the patent’s claims, ideally performed by patent counsel specializing in regulatory and intellectual property law.
References
- Danish Patent Office. DK1746976: Method for identifying, characterizing, and treating disease states.
- European Patent Office. Guidelines for Examination of Patent Applications in the Field of Biotechnology.
- World Intellectual Property Organization. Patent Landscape Reports on Molecular Diagnostics.
- Industry analysis reports on personalized medicine and molecular diagnostics patent trends.
