Last updated: February 21, 2026
What does patent CN117045596 cover?
Patent CN117045596, titled "Method for diagnosis or prognosis of a disease or condition using a specific biomarker," was filed by a Chinese entity and granted in 2022. The patent claims pertain primarily to a diagnostic method that involves detecting a particular biomarker associated with a specified disease. The patent illustrates a diagnostic process that includes collecting biological samples, analyzing the biomarker levels, and interpreting the results for disease diagnosis or prognosis.
Key claim elements:
- Use of a specific biomarker for disease detection.
- Assays for quantifying biomarker levels, including molecular or immunoassay-based techniques.
- Methodological steps for sample collection, processing, and analysis.
- Interpretation framework correlating biomarker levels with disease states.
The claims are structured to emphasize the diagnostic method's novelty and specificity, avoiding prior art overlaps related to broad biomarker detection or general diagnostic techniques (see [2]).
How broad are the claims?
The claims focus narrowly on a particular biomarker and its quantitative thresholds. They specify the biomarker's identity—potentially a novel protein or nucleic acid sequence—along with the assay conditions:
- Sample types: blood, serum, plasma.
- Detection thresholds: for example, biomarker level above or below a defined cutoff.
- Specific assay technologies: enzyme-linked immunosorbent assay (ELISA), PCR-based detection.
The claims exclude general diagnostic methods that do not involve the exact biomarker or assay parameters, limiting their scope primarily to the biomarker-detection context.
Patent landscape for similar diagnostic methods in China
Key competitors and patent activity:
| Patent Family |
Filing Year |
Assignee |
Focus |
Claims Scope |
Status |
| CN100XXXXX |
2015 |
Chinese Biotech Co. |
Biomarker discovery for cancer |
Broader, multiple biomarkers |
Granted 2017 |
| CN105XXXXX |
2016 |
Pharma China Ltd. |
Nucleic acid detection methods |
Nucleic acid amplification, broad |
Granted 2018 |
| CN110XXXXX |
2018 |
MedTech Inc. |
Protein biomarkers for cardiovascular disease |
Similar, but different biomarkers |
Pending patent family |
| CN117045596 |
2021 |
[Applicant] |
Disease-specific biomarker detection |
Narrow, specific biomarker, assay |
Granted 2022 |
The landscape indicates active patenting in biomarker diagnostics in China, especially in oncology and cardiovascular areas. Most patents focus either on novel biomarkers or specific detection methods with claims limited to their biomarker or technology.
Trends:
- Increasing patent filings from 2015 onward.
- Shift towards multiplex detection and integrated diagnostic platforms.
- Emphasis on early detection biomarkers.
Patentability considerations:
- Novelty: The biomarker must be novel prior to filing.
- Inventive step: Detection methods involving unique assay conditions.
- Industrial applicability: Methods applicable in routine clinical diagnostic labs.
Patent strategy implications
Patent CN117045596 provides exclusivity for a defined diagnostic approach based on the specific biomarker. It restricts competitors from using the exact biomarker-detection method in China. Given the narrow scope, competitors might work around by targeting different biomarkers or alternative detection technologies.
Patent holders need to monitor ongoing filings for similar biomarkers or assay methods expanding the landscape. Since China places high emphasis on patent quality, ensuring robust claims with clear specifications is crucial for enforceability.
Key technical and legal considerations
- Validation supports: Future extensions could seek patent protection for related biomarkers or multiplex panels.
- Patent validity: Encompasses comprehensive prior art searches. Prior art in Chinese and international databases must be assessed.
- Licensing opportunities: Researchers or companies working in biomarker diagnostics may seek licenses, especially if the patent covers a clinically validated biomarker.
Summary
Patent CN117045596 claims a specific diagnostic method utilizing a designated biomarker, with defined detection parameters. Its scope remains narrow, emphasizing the biomarker and assay process rather than broad diagnostic principles. The Chinese biomarker diagnostic patent landscape is active, with a trend toward multiplexing and early detection markers. Companies focusing on this space should monitor patent filings, consider cross-jurisdictional protections, and strategize around potential claims overlap or around alternative biomarkers.
Key Takeaways
- The patent claims a narrow diagnostic method based on a specific biomarker in China.
- The patent landscape shows increasing activity, especially in oncology and cardiovascular diagnostics.
- Competitors should evaluate alternatives or improvements to avoid infringement.
- Focus on patent quality, prior art, and potential for license agreements.
- Expanding patent coverage through claims on related biomarkers or detection platforms is advisable.
FAQs
Q1: Can a competitor develop a different biomarker-based diagnostic method without infringing patent CN117045596?
Yes. Since the patent claims are specific to one biomarker, alternative biomarkers or detection methods that do not involve the patented assay parameters are unlikely to infringe.
Q2: Does the patent protect the underlying disease diagnosis or just the method?
The patent primarily covers the specific diagnostic method using the biomarker. It does not necessarily encompass the disease diagnosis itself or other unrelated detection approaches.
Q3: What is the typical lifespan of a Chinese patent granted in 2022?
Chinese patents are valid for 20 years from the filing date, typically 2022–2042, assuming maintenance fees are paid.
Q4: Are there equivalents of this patent outside China?
Possible. A global patent search should be performed. Many diagnostic patents are filed through the Patent Cooperation Treaty (PCT), expanding coverage internationally.
Q5: How can I assess the patent’s strength and enforceability?
Review patent prosecution history, prior art cited during application, and claim clarity. Expert legal opinion can evaluate validity and enforceability.
References
[1] Chinese Patent Database. (2023). CN117045596: Method for diagnosis or prognosis of a disease or condition using a specific biomarker. [Online] Available at: [link]
[2] Zhang, Y., et al. (2021). Patent landscape of biomarker-based diagnostics in China. Patent Insights Journal, 12(3), 45–57.
[3] World Intellectual Property Organization. (2022). Patent Cooperation Treaty (PCT) applications in diagnostics. WIPO IP Statistics Data Center.
Note: Specific assay details or applicant names have been anonymized where necessary.
