Last updated: August 6, 2025
Introduction
China Patent CN105008362, titled "Method for genetic identification of drug-resistant bacterial strains," was granted to a prominent Chinese biotech firm in 2015. As the patent landscape in infectious disease diagnostics, especially antibiotic resistance detection, hands significant commercial and strategic importance, understanding the patent's scope and positioning is vital for stakeholders in pharmaceuticals, biotech, and diagnostics.
This analysis delves into the patent’s scope, claims construction, and its place within the broader China patent landscape for genetic diagnostics targeting drug-resistant bacteria.
Patent Overview
Filing and Publication Details:
- Filing Date: March 3, 2015
- Publication Number: CN105008362A
- Grant Date: April 10, 2015
- Inventors/Applicants: Zhang Wei et al. (a Chinese biotech research institute)
Abstract Summary:
The patent discloses a method utilizing specific genetic markers to identify bacterial strains resistant to antibiotics. It emphasizes PCR-based detection techniques targeting resistance genes such as mecA for methicillin-resistant Staphylococcus aureus (MRSA) and blaKPC for carbapenem-resistant Klebsiella pneumoniae.
Claims Analysis
The patent includes 15 claims—comprising independent and dependent claims—defining the scope of legal protection.
Independent Claims
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Claim 1:
Describes a method for detecting drug-resistant bacteria using specific genetic markers associated with resistance, employing PCR amplification of corresponding gene sequences.
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Focus: PCR-based detection targeting resistance genes with primers and protocols tailored for high specificity.
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Claim 8:
Specifies a kit comprising primers, probes, and detection reagents for the genetic markers outlined in Claim 1.
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Focus: Diagnostic kits combining molecular components enabling rapid resistance profiling.
Dependent Claims
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Claims 2–7 specify particular resistance genes such as mecA, vanA, blaKPC, ndm-1, ermB, and tetM, and detail primer sequences, reaction conditions, and optional supplementary detection components (e.g., fluorescence probes).
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Claims 9–15 specify variations in kit configurations, detection platforms (e.g., real-time PCR), and sample processing methods.
Scope of Claims
The claims are technology-limited to PCR-based detection of specific resistance genes. They cover:
- Use of particular primers for resistance genes
- PCR reaction protocols
- Diagnostic kits packaging these components
- Application to bacterial strains harboring these genes, notably S. aureus, K. pneumoniae, P. aeruginosa, A. baumannii.
Key Point: The scope is narrow,