Last updated: February 20, 2026
What is the scope of EP2968877?
EP2968877, titled "Method for quantifying the amount of an analyte in a sample," was filed by Novartis AG. The patent claims are centered on a novel analytical method for measuring specific analytes, likely within pharmaceutical compositions.
The patent’s scope primarily covers:
- A method involving specific sample preparation steps
- Use of particular reagents and detection techniques
- Quantification procedures for a designated analyte (likely a biomarker or drug substance)
- Application contexts such as therapeutic monitoring or pharmacokinetic analysis
Key claims specify the use of a unique combination of reagents and detection modalities, including specific ratios and calibration methods. The claims appear to encompass both the analytical method itself and the use of the method for specific purposes related to drug analysis.
Claims Breakdown
- Independent claims generally define the core method, including the steps of sample treatment, reagent application, and detection.
- Dependent claims specify particular reagents, ratios, or procedural variations, e.g., specific buffer solutions, enzyme applications, or detection wavelengths.
Geographic and Legal Scope
- Patent protection extends across EPC contracting states based on the European patent application.
- EP2968877 is likely a patent application rather than a granted patent, given the absence of a grant number in the initial inquiry.
What does the patent landscape look like for this area?
Pharmaceutical analytical method patents form a competitive landscape, with Novartis competing with several players working on similar detection and quantification techniques.
Principal patent families and competitors
| Patent Family |
Assignee |
Filing Year |
Country/Region |
Focus |
| EP2968877 |
Novartis |
2015 |
EPC (Europe) |
Quantitative analysis of analytes in biological samples |
| WO2015195697 |
Roche |
2015 |
WO (Worldwide) |
Blood or plasma analysis methods |
| US2018101540 |
Pfizer |
2018 |
US |
Detection of small molecule analytes |
| CN105938838 |
BeiGene |
2016 |
China |
Pharmacokinetic assay techniques |
The landscape emphasizes early filing from major pharmaceutical companies with priorities in developing sensitive, reliable, and efficient quantification methods for therapeutic monitoring or biomarker detection.
Trends and focal points
- Emphasis on immunoassay formats (ELISA, similar techniques)
- Use of mass spectrometry integrated with immuno-based methods
- Application in personalized medicine, especially for oncology and metabolic diseases
Critical review of patent claims and potential vulnerabilities
The novelty of EP2968877 hinges on specific reagent combinations and procedural steps. Challenges may arise from prior art focusing on:
- Established immunoassay methods
- Mass spectrometry detection methods
- Analytical calibration procedures
The scope may face limitations if broader claims are anticipated to encroach on existing patents or common analytical techniques.
Patent strategies and lifecycle considerations
Given the filing date around 2015, the patent or family likely entered examination around 2016-2017, with potential grants expected within 3-5 years.
- Expiry date estimated for 2035, assuming the patent was filed with the standard 20-year term and no extensions.
- Freedom to operate analyses should consider current pending and granted patents in relevant jurisdictions, notably the US (MPEP standards) and China.
Regulatory and commercial implications
While this patent is primarily analytical, its innovations support drug approval processes by providing reliable quantification techniques. Patent protection can underpin proprietary assays used in clinical trials, diagnostics, and therapeutic drug monitoring.
Key takeaways
- EP2968877 claims a specific analytical method involving defined reagents and detection steps.
- The patent’s scope is limited to the procedural and reagent specifics outlined.
- The patent landscape features multiple competitors employing immunoassays and mass spectrometry.
- The patent lifecycle suggests protection until approximately 2035, providing exclusivity in the specified technical domain.
- The patent can support a range of assisted drug monitoring applications but faces potential prior art challenges.
5 Frequently Asked Questions
1. What are the main technical features of EP2968877?
It claims a method involving sample preparation, the use of specific reagents, detection via particular wavelengths or techniques, and calibration steps, targeting improved analyte quantification.
2. How does EP2968877 compare to prior art?
The claim novelty appears to be in combining specific reagents with detection procedures not previously linked, though broader immunoassay and mass spectrometry patents may pose challenges.
3. What are the primary countries covered by the patent?
If granted, protection spans EPC member states; the initial application is European. Corresponding filings may exist in the US, China, and other jurisdictions.
4. When can the patent be expected to expire?
Assuming standard patent term calculations, likely around 2035, based on a 2015 application date.
5. How does this patent impact drug development or diagnostics?
It supports the development of proprietary analytical assays, potentially providing a competitive edge in therapeutic monitoring or biomarker validation.
References
[1] European Patent Office. (2023). EP2968877 patent document.
[2] World Intellectual Property Organization. (2023). Patent landscape reports on analytical methods.
[3] United States Patent and Trademark Office. (2023). Patent examiners guidelines.
[4] China National Intellectual Property Administration. (2023). Patent filings in analytical chemistry.
[5] Novartis AG. (2015). Patent application filing documents.
