Last updated: August 1, 2025
Introduction
China Patent CN102076362, titled "Method for detection of multiple drug resistance gene of tuberculosis", represents a significant development within the domain of infectious disease diagnostics, particularly focusing on tuberculosis (TB). As antimicrobial resistance, especially multidrug-resistant TB (MDR-TB), continues to challenge global public health, innovations like CN102076362 address crucial needs in rapid and accurate detection of resistance genes. This report delivers a comprehensive analysis of the patent’s scope, claims, and its position within the broader Chinese patent landscape for diagnostic methods targeting drug-resistant TB.
Overview of Patent CN102076362
Filing and Publication:
CN102076362 was filed on December 30, 2010, and published on August 15, 2012, by applicant Beijing Institute of Microbiology and Epidemiology (BIME). The patent primarily claims a molecular genetic method for detecting multiple drug resistance genes in Mycobacterium tuberculosis, facilitating early diagnosis and effective treatment regimens.
Technical Field:
The patent belongs to the field of microbiology, molecular diagnostics, and clinical laboratory methods, particularly focusing on nucleic acid amplification techniques for bacterial resistance gene identification.
Scope of the Patent
Core Focus:
The patent covers a comprehensive method for simultaneously detecting multiple resistance-associated mutations in M. tuberculosis using nucleic acid-based technologies. The scope extends to specific primers, probes, and reaction conditions optimized for multiplex detection.
Claims Overview:
The claims broadly encompass:
-
Detection of Multiple Resistance Genes:
Targeting genes such as rpoB (rifampicin resistance), katG and the inhA promoter (isoniazid resistance), gyrA (fluoroquinolone resistance), and others implicated in MDR-TB.
-
Multiplex PCR Assays:
Specific primers and probes designed to amplify several resistance determinants within a single assay, reducing turnaround time.
-
Hybridization and Melting Curve Analyses:
Use of probe-based hybridization analyses to distinguish wild-type from mutant sequences according to melting temperature shifts.
-
Sample Processing:
A method encompassing specimen preparation, DNA extraction, and amplification steps tailored for clinical samples such as sputum.
-
Result Interpretation:
Algorithmic criteria for interpreting multiplexed fluorescence signals to determine resistance profiles.
What Is Not Covered:
The patent does not claim novel chemical entities but rather a specific combination of molecular techniques and assay design optimized for MDR-TB detection.
Claims Analysis
1. Claims Detailing Nucleic Acid Amplification:
The patent claims the design of specific primer sets that amplify resistance mutation regions of rpoB, katG, and inhA, among others. These primer sets are optimized for multiplex PCR reactions, ensuring compatibility and efficiency in detection.
2. Claims on Probe Design and Hybridization:
Probes labeled with different fluorophores are designed to hybridize to WT or mutant sequences. The patent claims the design of these probes to discriminate single nucleotide polymorphisms (SNPs), crucial for identifying resistance-conferring mutations.
3. Claims on Diagnostic Algorithm:
The patent also covers the methodology for interpreting fluorescence signals or melting curves to accurately determine the presence of resistance mutations. This involves specific thresholds for melting temperatures that differentiate wild-type and mutant alleles.
4. Claims on Kit and Protocols:
The claims extend to kits comprising the primers, probes, and reagents necessary for the assay, as well as detailed protocols for specimen processing and analysis.
5. Claims on Application Scope:
The patent emphasizes broad applicability across clinical laboratories and potential adaptation for automated platforms, indicating commercial viability.
Patent Landscape Context
1. International and Chinese Patents on MDR-TB Diagnostics:
- Global Patents: The patent landscape includes filings such as US patents (e.g., US20160034098A1—CDC’s molecular detection methods), and European applications that focus on PCR-based MDR-TB detection methods.
- Chinese Patents: Several patents, such as CN101756969 (method for detecting MDR-TB via molecular assays), address similar avenues, creating a competitive space.
2. Key Competitors and Assignees:
- Chinese institutes like BIME and Shanghai Public Health Clinical Center actively file for molecular diagnostics patents.
- International diagnostic companies, including Hain Lifescience and Cepheid, develop analogous nucleic acid-based platforms, although their patents primarily remain outside China.
3. Innovation Position:
CN102076362 aligns with existing innovations by providing a multiplex, rapid detection method tailored for Chinese clinical needs, including specific mutation panels relevant to prevalent strains in China.
4. Patent Family and Continuations:
- No patent family continuations or divisional applications publicly extend from CN102076362. However, its core technology likely forms the basis for subsequent patents focusing on automated platforms or new probe chemistries.
Implications for Commercialization and IP Strategy
Conclusion
CN102076362 embodies a strategically formulated patent aligned with China’s public health priorities to combat MDR-TB through molecular diagnostics. Its claims extensively cover multiplex PCR and hybridization techniques, reflecting contemporary diagnostic trends. The patent’s broad scope within nucleic acid detection methods positions it as a valuable asset within China’s increasingly active patent landscape for infectious disease diagnostics.
Business and research sectors seeking to develop or commercialize MDR-TB diagnostic tools within China must consider the patent’s scope to ensure non-infringement, while leveraging its foundational claims for further innovation.
Key Takeaways
- CN102076362 claims a multiplexed nucleic acid detection platform for Mycobacterium tuberculosis resistance genes, emphasizing rapid, accurate diagnostics for MDR-TB.
- Its scope extends to primer and probe designs, as well as interpretative algorithms, with broad applicability in clinical laboratory settings.
- The patent fits within a competitive landscape of Chinese and international molecular diagnostic patents, with opportunities for licensing or for positioning new technologies around its claims.
- Continuous evolution in allele-specific detection methods necessitates vigilant monitoring of patent landscape developments to safeguard innovations.
- For stakeholders, understanding this patent’s scope is crucial to navigating Chinese IP rights, fostering both compliance and strategic advantages in MDR-TB diagnostics.
FAQs
Q1: What are the primary resistance genes targeted in CN102076362?
A1: The patent targets key resistance genes in M. tuberculosis, notably rpoB (rifampicin), katG and inhA promoter (isoniazid), and gyrA (fluoroquinolone), which are critical markers for MDR-TB.
Q2: How does the patent facilitate rapid detection of drug resistance?
A2: By employing multiplex PCR combined with fluorescent probe hybridization and melting curve analysis, the method allows simultaneous detection of multiple mutations, significantly reducing diagnostic turnaround time.
Q3: Can this patent be used to develop commercial diagnostic kits?
A3: Yes. The claims explicitly include kits comprising primers, probes, and reagents optimized for the described method, supporting commercialization within Chinese markets.
Q4: How does CN102076362 compare to international patents on MDR-TB diagnostics?
A4: It shares technological similarities with international patents but is tailored to Chinese strain profiles and clinical practices, giving it strategic importance within the Chinese patent landscape.
Q5: What are potential patenting gaps or areas for improvement?
A5: Future innovations could explore alternative amplification techniques, novel probe chemistries, or automation to circumvent current claims and enhance diagnostic sensitivity or throughput.
References
- Chinese Patent CN102076362. Method for detection of multiple drug resistance gene of tuberculosis. Beijing Institute of Microbiology and Epidemiology, 2012.
- World Intellectual Property Organization. Patent Landscape Reports on Tuberculosis Diagnostics.
- US Patent US20160034098A1. Method and system for detecting multidrug-resistant TB. 2016.
[Please note: The above references include patent citations and publicly available patent landscape data.]
