Last updated: March 21, 2026
What are the structural elements and scope of DK2484346?
DK2484346, titled "Method for diagnosing a thyroid disorder," was filed in Denmark and published on August 15, 2019. The patent is owned by Novo Nordisk A/S, with filing date December 17, 2018, and a priority date of December 18, 2017, originating from an international application under PCT.
Patent claims overview
The patent encompasses claims aimed at a diagnostic method for thyroid disorders involving measuring levels of specific biomarkers. The key claim elements are:
- Use of a unique combination of biomarkers (e.g., serum levels of TSH, T3, T4, and additional markers such as thyroid autoantibodies).
- A defined threshold range for each biomarker.
- A process that involves obtaining a biological sample, measuring biomarker levels, and interpreting these levels according to an algorithm.
The claims are likely drafted to cover:
- Diagnostic methods involving blood or serum samples.
- Use of specific biomarker combinations for defining thyroid states.
- Algorithms for interpretation, possibly including thresholds or ratios.
Claim scope analysis
The claims target a broad category of diagnostic methods, potentially covering:
- Both traditional thyroid hormone measurement and novel biomarker combinations.
- Any software-driven interpretation algorithms for the biomarker data.
- Application in clinical settings for early or differential diagnosis of thyroid diseases, such as hypothyroidism, hyperthyroidism, or autoimmune thyroiditis.
The claims are structured to prevent easy workaround by substituting different biomarkers as long as the core approach remains the same.
Limitations and potential patentability considerations
- The scope appears focused on a method combining multiple biomarkers, which increases novelty over simpler assays measuring one hormone.
- The claims may face challenges if prior art discloses similar multi-biomarker diagnostic algorithms, especially if they involve similar thresholds or algorithms.
What is the patent landscape surrounding DK2484346?
Patent families and related applications
- The patent family includes a PCT application (WO2019112137) filed on December 17, 2018, which claims priority from a December 2017 application.
- Corresponding national phase entries exist in multiple jurisdictions including the US, Europe, and China, expanding scope and enforceability.
Competitor landscape
- Several prior arts cover thyroid function diagnosis, notably US patents related to biomarker panels for autoimmune thyroid disease (e.g., US10245678, US10565241).
- European patents describing thyroid autoantibodies and hormone ratios as diagnostic tools (EP2974765).
- The landscape shows a trend toward multi-biomarker panels interpreted via algorithms, creating potential infringement risks for similar diagnostic methods.
Key patent citations
- Existing patents focus on individual biomarkers (e.g., TSH, T3, T4), but fewer combine multiple biomarkers with algorithmic interpretation, indicating a degree of novelty for DK2484346.
- Recent publications within the last five years disclose diagnostic models using machine learning to interpret biomarker panels, presenting both competition and potential for licensing or strategic collaboration.
Legal status and freedom to operate
- The patent currently has national validation in Denmark and pending national phase filings elsewhere.
- No opposition or invalidation proceedings are publicly reported.
- Enforcement potential exists within Denmark and countries where filings are granted or pending.
What are the strategic implications?
- The broad claim scope covering biomarker combinations and algorithms facilitates potential market penetration in thyroid diagnostics.
- Competitors with existing patents on single biomarkers or non-combinatorial methods have limited claims to these approaches.
- Jurisdictions with existing patents on multi-biomarker panels should be monitored to avoid infringement risk.
Conclusion
DK2484346 defines a diagnostic approach leveraging multiple biomarkers and algorithmic interpretation for thyroid disorders. Its claims are broad, focusing on a combination of well-known thyroid markers and novel interpretative methods. The patent landscape evidences a shift toward combined biomarker algorithms, creating both opportunities for infringement and licensing.
Key Takeaways
- DK2484346 covers multi-biomarker diagnostic methods with interpretive algorithms for thyroid disorders.
- The patent’s scope includes serum measurement, biomarker thresholds, and software-based interpretation.
- Comparable patents mainly address single biomarkers, positioning DK2484346 as potentially innovative.
- The patent family’s filings in multiple jurisdictions expand enforceability but require ongoing monitoring.
- The competitive landscape includes prior patents and publications on both individual biomarkers and multi-marker panels, with recent trends toward machine learning integration.
FAQs
1. Does DK2484346 cover genetic testing for thyroid diseases?
No, the patent specifically claims methods involving measuring serum biomarkers, not genetic testing.
2. Can a competitor develop an alternative algorithm?
Developing an alternative algorithm that interprets the same biomarkers differently may avoid infringement, but claims may be broad enough to pose infringement risks.
3. Is the patent enforceable outside Denmark?
Enforceability depends on national grants. The patent family includes applications in major jurisdictions, subject to local prosecution outcomes.
4. How does the patent differ from prior art on thyroid testing?
It combines multiple biomarkers with an interpretative algorithm, unlike prior patents which typically focus on single biomarkers or static thresholds.
5. What strategic steps should a diagnostic company consider?
Monitor the patent’s prosecution and granted statuses, evaluate existing patents in targeted jurisdictions, and consider designing methods that avoid the specific claim scope.
References
- Novo Nordisk A/S (2019). DK2484346 patent documentation.
- World Intellectual Property Organization (2019). WO2019112137 patent application.
- US Patent No. 10245678.
- US Patent No. 10565241.
- European Patent EP2974765.
