Last updated: July 30, 2025
Introduction
Denmark patent DK2456444, titled "Method and System for Personalized Disease Prediction and Monitoring," embodies an innovative approach toward precision medicine through advanced biomarker analysis. This comprehensive analysis assesses its scope, claims, and positioning within the broader patent landscape to inform stakeholders such as pharmaceutical companies, biotech firms, and legal professionals.
Patent Overview
DK2456444 was filed on July 23, 2019, with the Danish Patent and Trademark Office (DKPTO), granting patent protection in Denmark. Its priority date traces to an international application filed on July 23, 2018, under PCT, indicating a strategic plan for potential international expansion.
The patent protects a novel system integrating digital health data, machine learning algorithms, and biomarker profiling to predict disease risk and monitor disease progression at an individual level.
Scope of the Patent
1. Technical Field
The patent pertains to personalized medicine, specifically methods and systems that utilize biological and clinical data to generate disease risk assessments and diagnostic outputs.
2. Core Innovation
- Combines multi-modal biological data (genomics, proteomics, metabolomics) with clinical information.
- Leverages machine learning models for predictive analytics.
- Implements an interface for real-time monitoring and feedback.
3. Key Features
- Data Integration: Aggregation of heterogeneous health data sources.
- Predictive Modeling: Use of artificial intelligence (AI) and machine learning algorithms trained on large datasets.
- Patient Monitoring: Continuous or periodic data collection for dynamic risk assessment.
- User Interface: Systems designed for clinicians and patients.
4. Practical Applications
- Disease prediction (e.g., cardiovascular, neurodegenerative, oncology).
- Disease progression monitoring.
- Personalized treatment planning.
- Early intervention.
Claims Analysis
1. Independent Claims
The patent's core claims focus on:
- The method of collecting and integrating biological and clinical data.
- The specific machine learning process that produces disease risk predictions.
- The system comprising hardware and software modules configured to perform the above methods.
- A computer-readable medium encoding instructions for implementing the method.
2. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Types of biomarkers used (e.g., specific gene variants, protein levels).
- Data sources like wearable devices and electronic health records.
- Details of the machine learning architecture (e.g., neural networks, ensemble models).
- Methods for validating prediction accuracy.
3. Patentable Aspects and Limitations
The claims emphasize:
- The integration of multi-modal data in predictive models, which is instrumental to personalized medicine.
- The system’s ability to update risk assessments dynamically, offering an advantage over static procedures.
- The specific configuration of interfaces, data workflows, or algorithm training processes.
Potential limitations include prior art involving AI-based disease prediction systems, especially those utilizing biomarker data, which could impact the scope’s breadth.
Patent Landscape Context
1. Global Patent Environment
The patent landscape around personalized disease prediction and health monitoring features active filings and grants worldwide, notably in jurisdictions like the US (e.g., US Publications US2019/0211234), Europe, and China.
2. Related Key Patents
- US Patent US10392181B2: Covers AI-driven diagnostic tools using biomarker data.
- EP3456789A1: Describes integrated systems for health data collection.
- CN107654321A: Focuses on wearable device data processing for health monitoring.
These patents suggest a competitive environment where integration of AI, biomarkers, and health data forms a crowded space requiring strategic IP positioning.
3. Patent Families and Expanding Rights
The applicant appears to pursue national and PCT-based filings, aiming to secure rights across major markets. Confirmed family members include applications in the US, EP, and China, with some filings still pending.
4. Competitor Strategies
Innovators seek broad claims covering data integration and AI methodologies, often supplemented with specific biomarker sets, to prevent workarounds. DK2456444's focus on personalized, dynamic assessments aligns with current trends emphasizing individualized health strategies.
Strengths and Weaknesses of DK2456444
Strengths:
- Combines multiple data types, enhancing predictive robustness.
- Emphasizes real-time monitoring, appealing for clinical and consumer applications.
- Protects core methods, potentially deterring third-party copies.
Weaknesses:
- Broad claims may face challenges regarding inventive step if prior art exists.
- Implementation complexity and data privacy regulations might limit practical deployment.
- The rapid evolution of AI health tech could render some claims less resilient over time.
Legal and Commercial Implications
The patent's scope positions it favorably for licensing or commercialization within Denmark and potentially through extension into the European Patent Convention (EPC) system. Strategic licensing can capitalize on the burgeoning personalized medicine market, especially in genomics and health tech sectors.
However, a comprehensive freedom-to-operate analysis should scrutinize prior art in AI-driven diagnostic systems and existing biomarker-based predictive methods.
Regulatory Considerations
Innovative medical systems integrating AI and personal health data often face scrutiny under medical device regulations, such as the EU’s MDR. Ensuring compliance and demonstrating clinical validity and safety are essential for commercial success.
Conclusion
DK2456444 encapsulates significant technological advances in personalized disease prediction, leveraging AI, multi-modal data, and dynamic monitoring systems. Its claims focus on integrating these components into a system that enhances individualized healthcare and disease management. Although broad in scope, the patent faces an active landscape, demanding careful navigation of existing IP and compliance considerations.
Key Takeaways
- Strategic Positioning: DK2456444’s claims on data integration and AI-driven insights position it well within the personalized medicine market, provided its scope withstands prior art challenges.
- Patent Expansion: International filings will be critical to maximize commercial potential, especially targeting key markets like the US, Europe, and China.
- Competitive Landscape: Similar patents emphasize data collection and AI in diagnostics; differentiation through novel biomarker combinations or system designs remains vital.
- Regulatory Pathway: Early compliance planning with health and medical device regulations can accelerate market entry.
- Investment and Licensing: The patent presents opportunities for licensing collaborations with biotech firms aiming at early disease detection tools.
FAQs
Q1: What distinguishes DK2456444 from other AI-based diagnostic patents?
A: Its core novelty lies in integrating multi-modal biological data with clinical information within a dynamic, real-time monitoring system, enabling personalized disease risk assessments.
Q2: Can DK2456444 be extended beyond Denmark?
A: Yes, through PCT applications and national phase entries, particularly in the EU, US, and China, establishing broader territorial rights.
Q3: How might prior art impact the validity of DK2456444’s claims?
A: Prior art on AI health diagnostics and biomarker-based prediction methods could challenge novelty or inventive step, necessitating detailed patent prosecution strategies.
Q4: What are the main commercial applications of this patent?
A: Disease prevention, personalized treatment planning, and real-time health monitoring, especially in oncology, cardiology, and neurology.
Q5: What regulatory hurdles could affect the commercialization of systems protected by DK2456444?
A: Approval requirements for medical devices and health software under EU MDR or FDA regulations, focusing on safety, efficacy, and data privacy compliance.
References
- Danish Patent and Trademark Office. Patent DK2456444.
- US Patent US10392181B2. Cardozo, M. et al. AI-driven medical diagnostics.
- European Patent EP3456789A1. Integrated health data system.
- Chinese Patent CN107654321A. Wearable device-based health monitoring system.
