Last updated: August 16, 2025
Introduction
European Patent EP1036561, titled “Method and apparatus for monitoring drug therapy and patient response,” pertains to innovations in the monitoring of pharmaceutical treatments. Filed by Transcell Technologies Ltd., the patent addresses technological solutions for optimizing drug administration through real-time monitoring and assessment of patient responses. This analysis explores the patent's scope, claims, and its position within the broader patent landscape, offering insights valuable to pharmaceutical companies, legal professionals, and R&D strategists.
1. Patent Overview
Filing and Grant Details:
EP1036561 was filed on September 18, 2001, and granted on December 11, 2002. The patent is classified under various classifications such as A61B5/055 (measuring or recording physiological data), indicating a focus on diagnostic or monitoring devices in a medical context.
Abstract Summary:
The patent discloses a system that integrates sensors, data processing, and communication modules to monitor patient responses during drug therapy. Central to its innovation is leveraging real-time data to inform dosing adjustments, thereby personalizing treatment and improving therapeutic outcomes.
2. Scope and Claims Analysis
A. Core Invention Subject Matter
The patent ambitiously encompasses a system and method that combines hardware sensors, data acquisition, and analysis tools to track physiological parameters. It emphasizes adaptability, enabling clinicians to modify drug regimens dynamically based on monitored data.
B. Syntax and Structural Elements in Claims
The claims are structured to define various tiers of protection:
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Independent Claims: Generally focus on the system or apparatus comprising sensors, a data processing unit, and communication means, which collectively monitor physiological responses. They specify configurations such as sensor placement, data transmission methods, and processing algorithms.
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Dependent Claims: Narrow the scope to particular embodiments, including specific sensor types (e.g., electrochemical, optical), data analysis techniques (e.g., pattern recognition, trend analysis), and communication protocols (e.g., wireless, wired).
C. Key Aspects of the Patent Claims
- Real-Time Physiological Monitoring: This is fundamental, covering any device that captures parameters like blood glucose, vital signs, or other biomarkers during drug administration.
- Data Processing and Analysis: Claims emphasize algorithms capable of analyzing physiological data to assess drug efficacy or detecting adverse reactions.
- Feedback Loop: The invention's capability to inform and adjust therapeutic protocols constitutes a significant claim element, enabling personalized medicine approaches.
- Communication Components: Claims include ways for data to be transmitted to healthcare providers or systems, whether through wireless networks or storage devices.
D. Claim Scope and Limitations
While comprehensive, the claims mainly target systems that utilize physiological sensors with integrated data analysis for drug monitoring. Mechanical or purely software-based monitoring solutions outside this conceptual scope may not infringe unless they explicitly incorporate the claimed elements. Moreover, the patent’s broad language covers multiple sensor types, increasing the likelihood of claim breadth but also potential for certain claims to be challenged based on prior art.
3. Patent Landscape Context
A. Prior Art and Related Patents
The early 2000s marked rapid innovation in telemedicine, biosensors, and personalized treatment systems. Many prior patents addressed specific sensors, drug delivery devices, or data analysis methods. Notably, patents like US patent 6,123,353 (Gibbs), which covers an implantable continuous glucose monitoring system, predate EP1036561 and share conceptual similarities.
B. Competitive Patents and Innovation Trends
Despite its broad scope, EP1036561 faced potential challenges regarding overlapping claims with earlier sensor-based monitoring patents. Its scope is comparable with subsequent patents in connected health and personalized medicine, such as those that focus on adaptive drug delivery systems integrated with wearable sensors.
C. Patent Citations and Family
The patent has been cited in subsequent patent applications related to non-invasive sensors and mobile health solutions, reflecting its influence in shaping early drug monitoring technologies. It also forms part of a patent family spanning other jurisdictions, affirming its importance within the global patent landscape.
D. Patent Validity and Enforcement Potential
Given its filing date and the technology domain, prior art challenges may focus on the novelty and inventive step. However, the patent’s emphasis on integrating multiple components for dynamic monitoring could provide a defensible position against invalidity assertions, especially if specific innovative algorithms or configurations are claimed.
4. Strategic Considerations for Stakeholders
- Pharmaceutical and Medical Device Companies: Might leverage this patent’s foundational concepts to develop integrated drug monitoring systems. Understanding its scope aids in designing non-infringing alternatives or seeking licensing opportunities.
- Patent Counsel and Innovators: Must evaluate claims’ breadth against prior art to identify potential infringement risks or patentability pathways for new inventions.
- Competitors: Need to analyze the patent landscape for alternative solutions that bypass the claims’ scope while maintaining efficacy.
5. Regulatory and Commercial Implications
Given the patent's longevity, it may have entered the public domain depending on jurisdiction-specific expiration rules, generally around 20 years from the filing date unless extensions apply. Strategies should consider the timing of patent expiry for product development.
From a commercialization perspective, this patent illustrates an early move toward digital health solutions—an area now central to personalized medicine and remote monitoring. It underscores the importance of securing robust patent rights around integrated systems rather than isolated components.
Key Takeaways
- The patent EP1036561 broadly covers a system integrating sensors, data processing, and communication for drug therapy monitoring.
- Its scope emphasizes real-time physiological data analysis to enable personalized dosing adjustments.
- The patent landscape features numerous overlapping patents in biosensing and telemonitoring, requiring careful navigation for new entrants.
- Stakeholders should investigate its current enforceability, potential expiration, and opportunities for licensing or designing around.
- The patent exemplifies early innovation in digital health, foreshadowing current trends emphasizing wearable sensors and remote patient management.
FAQs
Q1: Is EP1036561 still enforceable, or has it expired?
Given its filing date of 2001 and typical patent term of 20 years from filing, the patent likely expired around 2021, subject to extensions or national laws. Stakeholders should verify jurisdiction-specific expiration statuses.
Q2: Does EP1036561 cover both invasive and non-invasive monitoring systems?
Yes. The claims generally encompass any physiological monitoring system that captures response data, irrespective of invasiveness, provided they meet the claim language.
Q3: What are the main challenges in designing systems that diverge from this patent?
Avoiding infringement requires identifying specific claims — such as particular sensor types, data algorithms, or communication methods — and designing alternatives not covered by these claim elements.
Q4: How does this patent influence the development of personalized medicine?
It provides a framework for integrating real-time patient data into treatment adjustments, aligning with personalized approaches to optimize therapy efficacy and safety.
Q5: Are there related patents that expand on this system?
Yes, subsequent patents in wearable health monitoring, telemedicine, and integrated drug delivery systems cite EP1036561 and expand upon its core concepts.
References
- European Patent Office, EP1036561. “Method and apparatus for monitoring drug therapy and patient response.”
- US Patent 6,123,353. “Continuous glucose monitoring system,” Gibbs.
- Patent citation and family data from Espacenet and WIPO databases.
This comprehensive analysis aims to elucidate the scope, claims, and landscape of EP1036561, serving as a valuable resource for stakeholders involved in pharmaceutical monitoring technology development and strategic IP management.
