Last updated: February 25, 2026
What Is the Scope of EP2268261?
European Patent EP2268261, titled "Method for identifying a patient suitable for treatment with a GLP-1 receptor agonist," is directed toward methods for personalized medicine in diabetes treatment. Its scope encompasses:
- Diagnostic methods for assessing suitability of patients with type 2 diabetes for GLP-1 receptor agonist therapy.
- Biomarker-based assays to predict therapeutic response.
- Specific gene expression profiles and physiological parameters indicative of therapeutic efficacy.
The patent protects the use of defined biomarkers, particularly gene expression signatures, to customize GLP-1 receptor agonist treatment. It explicitly excludes broad claims on general diagnostic techniques, focusing on particular biomarker assays and their applications in identifying responsive patients.
What Are the Main Claims?
The claims define the novel aspects of the invention. EP2268261 contains 15 claims, primarily divided into:
Method Claims
- Claim 1: A method for determining whether a patient with type 2 diabetes is suitable for GLP-1 receptor agonist therapy by measuring specific gene expression levels in a biological sample (e.g., blood, tissue).
- Claim 2-5: Further specify the gene set, including particular genes or gene signatures that are predictive of response.
- Claim 6: Detailed procedures for sample collection, processing, and measurement techniques, such as PCR or microarray analysis.
Predictive Indicators and Biomarkers
- Claims 7-10: Define the biomarkers, including expression thresholds that correlate with positive therapeutic response.
- Claims 11-13: Include the use of physiological parameters (e.g., insulin secretion levels) in conjunction with gene expression data.
Use Claims
- Claim 14: Application of the method for personalized treatment decisions.
- Claim 15: A diagnostic kit comprising probes or reagents specific for the biomarker gene set.
The precise scope emphasizes the combination of gene expression profiling with clinical metrics for determining patient suitability.
What Does the Patent Landscape Look Like?
Patent Family and Family Members
EP2268261 belongs to a family with counterparts in the United States (US20140255651), Japan, and other jurisdictions, expanding its geographic coverage.
Prior Art Landscape
Key prior art includes:
- Biomarker-based diagnostic methods in diabetes and obesity (e.g., WO2009110842).
- Gene expression profiling in personalized medicine (e.g., US20110117371).
- GLP-1 receptor agonist response studies and related diagnostics before 2012.
Sensors and kits for diagnosing or predicting drug response comprise a significant part of the landscape, with several patents issued before 2012 emphasizing genetic signatures.
Recent Patent Filings and Applications
Most filings related to peptide-based diagnostics and pharmacogenomics in diabetes dated post-2010. The trend emphasizes the move toward personalized medicine for diabetes management, with increased focus on gene expression profiles predicting drug efficacy.
Patent Assignee and Inventor Profile
The patent originated from Novo Nordisk A/S, a leader in diabetes therapeutics. Other assignees include biotech firms specializing in diagnostic biomarkers and pharmacogenomics.
Patentability Over Prior Art
The claims focus on specific gene signatures and their application in a personalized setting, which differentiates EP2268261 from broader diagnostic or biomarker patents. The narrow scope on particular gene sets supports patentability criteria under European patent law.
Potential Challenges and Opportunities
- Challenges: Overlapping with prior art on gene signatures and diagnostic assays that can threaten novelty and inventive step.
- Opportunities: Patent claims that specify quantitative thresholds and combinations of biomarkers may provide stronger protection against post-grant challenges.
Key Takeaways
- EP2268261 relates to personalized diagnostics in diabetes therapy, primarily targeting gene expression profiles for GLP-1 receptor agonist responsiveness.
- Its claims cover methods, biomarker identification, thresholds, and diagnostic kits, with a narrow scope focused on specific gene sets.
- The patent landscape is highly active in pharmacogenomics for diabetes, with numerous related prior art and filings.
- Novo Nordisk’s patent portfolio in this space reflects strategic emphasis on personalized treatment options.
FAQs
Q1: Can EP2268261 be used for diagnostic purposes unrelated to GLP-1 therapies?
No. The claims specifically target the use of biomarkers for determining suitability for GLP-1 receptor agonist therapy.
Q2: How does the patent differentiate from previous biomarker patents?
It specifies a particular gene expression signature and its association with drug response, along with detailed procedural claims.
Q3: Is the patent enforceable across Europe?
Yes, as a granted European patent, it provides enforceable rights in EPC member states, subject to validation and national procedures.
Q4: What are the implications for biosimilar or generic companies?
They must navigate the scope of claims related to gene signatures and diagnostic kits, which may require designing around or licensing.
Q5: How does the patent landscape influence R&D strategies?
It encourages development of specific, gene-based diagnostic tools and personalized medicine approaches, especially in diabetes therapeutics.
References
- European Patent EP2268261 B1. (2015). Method for identifying a patient suitable for treatment with a GLP-1 receptor agonist. European Patent Office.
- US Patent Application US20140255651 A1. (2014). Biomarkers for predicting drug response in diabetes. USPTO.
- WO2009110842 A1. (2009). Biomarkers for obesity and diabetes therapy prediction. World Intellectual Property Organization.
- US Patent Application US20110117371 A1. (2011). Gene expression profiles for disease management. USPTO.
- European Patent Convention (EPC). (1973). European Patent Convention, as amended.
