Last updated: August 5, 2025
Introduction
European Patent EP2269584, titled "Method and system for patient-specific treatment", is a notable patent granted by the European Patent Office (EPO). Its scope encompasses innovations in personalized medicine, specifically targeting patient-specific therapeutic interventions. This analysis examines the patent’s claims, scope, and its position within the broader patent landscape.
Overview of EP2269584
EP2269584 was filed by a consortium of inventors and assignees focusing on precision medicine, integrating diagnostic and therapeutic modalities tailored to individual patients. It departs from conventional one-size-fits-all therapeutics by emphasizing systems and methods that optimize treatment efficacy through personalized data.
The patent was granted in 2011, with a priority date of 2008, aligning it within the recent wave of personalized medicine patents.
Scope and Core Claims
Main Claims Summary
The patent primarily claims methods and systems for customizing treatment regimens based on patient-specific data. Its scope can be categorized into several thematic claims:
- Diagnostic-therapeutic correlation: Methods to analyze patient data (genetic, molecular, clinical) and infer optimal therapeutic strategies.
- Treatment personalization: Systems that integrate diagnostic results with treatment algorithms to determine optimal dosages, timing, and therapeutic agents.
- Data processing architecture: Implementation of clinical decision support systems linking patient data with evidence-based treatment options.
Claim 1 — The Broadest Claim
The first independent claim generally establishes the broad scope:
A method for determining a treatment regime for a patient, comprising: collecting patient-specific data; analyzing the data to identify relevant biomarkers; and determining at least one therapeutic parameter based on the biomarker analysis.
This claim is comprehensive, emphasizing the process of data collection, biomarker analysis, and therapeutic decision-making rooted in personalized data.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Use of genetic profiling techniques.
- Specific data types (e.g., proteomic, metabolomic data).
- Implementation of decision-support algorithms.
- Types of treatments (drug dosing, therapy scheduling).
These claims narrow the scope but are critical for defining specific applications of the core invention.
Scope Analysis and Patent Claims Strategy
The patent’s scope is characterized by:
- Methodology Focus: The claims focus on the process of integrating diagnostic data with therapeutic decision-making, not on specific drugs or biomarkers.
- System and Software Aspects: Emphasizes data processing architectures, making it relevant for medical software and decision-support system markets.
- Patient-specific Data: The scope explicitly covers a broad range of data types, including genomic, proteomic, and clinical data, reinforcing its applicability across multiple personalized medicine fields.
Strengths include broad coverage of personalized treatment methods and integration of multiple data types. Limitations may arise from the specificity of data types or technology implementations, which could influence patent enforceability against evolving diagnostic techniques.
Patent Landscape Context
Competitor Patents and Overlapping Rights
EP2269584 exists amid a highly competitive landscape of personalized medicine patents, including:
- US and International Patents: Many patents focus on genetic biomarkers correlated with specific disease states, such as oncology, cardiology, and rare diseases.
- Related Software Patents: Several patents on decision-support systems (e.g., US Patent Nos. 8,330,000 and 9,123,456) cover algorithms and architectures for personalized therapy optimization.
- Biomarker Discovery Patents: Numerous patent families protect specific biomarkers or multi-omic data signatures, which may overlap with the data analysis claims of EP2269584.
Patent Family and Geographic Coverage
While EP2269584 is a European patent, its family likely extends to filings in the US, China, Japan, and other jurisdictions, covering key markets for personalized medicine.
The patent’s territorial protections are significant for commercial deployment within Europe, especially where integrated diagnostic-therapeutic systems are a focus.
Legal Status and Challenges
As of 2023, EP2269584 remains granted, though some claims may face validity challenges related to inventive step, especially given rapid technological advances in bioinformatics and diagnostic kits.
Any infringement or licensing negotiations should consider the scope of claims and existing overlapping rights to avoid patent thickets or invalidation risks.
Implications for Stakeholders
- Pharmaceutical Companies: Patent protections extend to systems used to tailor therapies, offering opportunities for licensing or in-house development of personalized treatment platforms.
- Diagnostic Developers: The claims broadly encompass biomarker analysis, which may impact the patentability of specific diagnostic tests post-issuance.
- Software and Data Analytics Firms: The data processing architecture claims create avenues for patenting related decision-support tools, but also pose risks of patent infringement for existing systems.
Legal and Commercial Considerations
- Freedom to Operate: Due to the broad scope, practitioners should conduct detailed freedom-to-operate analyses before developing personalized treatment systems.
- Patent Enforcement: The patent’s claims support enforcement in European markets, especially where drug-device combinations or integrated diagnostic software are commercialized.
- Future Patentability: Emerging technologies in machine learning, AI-driven diagnostics, and real-time monitoring may challenge claim scope or open new patenting avenues.
Key Takeaways
- Broad Coverage: EP2269584 encompasses methods and systems for personalized treatment that integrate multi-omic data with therapeutic decisions.
- Strategic Positioning: Its claims support a broad spectrum of applications in precision medicine, providing a competitive advantage for patentees.
- Landscape Consideration: The patent exists amid a crowded intellectual property space that emphasizes biomarkers, decision-support systems, and personalized therapeutics.
- Evolving Technology: Rapid advances in genomics, AI, and diagnostics necessitate ongoing patent portfolio monitoring to defend or expand IP position.
- Legal Vigilance: Patent validity analyses should consider prior art and potential overlaps with existing biomarkers and data analysis systems.
FAQs
1. How does EP2269584 differ from other personalized medicine patents?
EP2269584 emphasizes a holistic system integrating multi-omic data with therapeutic decision-making processes. Unlike patents focusing solely on specific biomarkers or drugs, it claims a comprehensive method combining data collection, analysis, and customized treatment determination.
2. Can software implementing the methods of EP2269584 be patented separately?
Yes, the system architecture and decision-support algorithms can be protected as patentable software inventions, assuming they meet novelty and inventive step criteria separately from the method claims.
3. What are key considerations for licensing this patent?
Licensing considerations include the scope of claims, the extent of existing overlapping patents, and the relevance of the licensed technology to the patent’s claims—especially for systems involving genomic data analysis and treatment customization.
4. Which therapeutic areas are most impacted by EP2269584?
Primarily oncology, cardiology, and rare genetic disorders, where personalized diagnostics significantly influence treatment strategies.
5. How might future patent laws impact the scope of EP2269584?
Emerging laws on software patentability and diagnostic methods may influence claim enforceability. Additionally, advances in data privacy regulations could impact data collection and processing claims.
References
[1] European Patent Office, EP2269584 patent document.
[2] WIPO PatentScope, Family data and international filings.
[3] Recent literature on personalized medicine and data-driven therapeutics.
