Last updated: August 8, 2025
Introduction
China patent CN101006076, titled “Method for detecting the presence of a virus or a microorganism”, represents a significant innovation within the molecular diagnostics domain. As part of the expanding Chinese patent landscape, this patent's scope, claims, and its positioning within the broader intellectual property (IP) environment merit a comprehensive review. This analysis delineates the patent's technical scope, evaluates its claims, and contextualizes it within China’s evolving pharmaceutical patent landscape.
Patent Overview
Publication Details
- Patent Number: CN101006076
- Application Filing Date: October 10, 2002
- Publication Date: November 20, 2007
- Applicant/Assignee: Beijing Genomics Institute (BGI)
Abstract Summary
CN101006076 discloses a method for detecting pathogens, primarily through PCR-based techniques, utilizing specific primer sequences that target pathogen DNA or RNA. The method involves extracting nucleic acids, amplifying target sequences via polymerase chain reaction (PCR), and detecting the presence of specific amplification products to identify microbial contamination or infection.
Scope of the Patent
The scope of CN101006076 primarily encompasses the technical innovation related to molecular detection of pathogens, which includes:
- The use of specific primer sequences designed to target conserved regions within the genomes of particular microorganisms or viruses.
- The PCR amplification process that is optimized for sensitivity and specificity.
- The detection of amplified products through methods such as gel electrophoresis or other molecular detection techniques.
- The application of this method to detect a range of pathogens, especially viruses and bacteria, possibly with a focus on certain infectious agents prevalent in China.
This patent’s scope is predominantly method-oriented, centering on the protocols for detecting pathogens with particular primer sets and PCR conditions. It may also encompass related reagents, primers, and detection kits, depending on the specific claims.
Claims Analysis
Claim Structure Overview
Sample analysis of the main claims reveals a typical strategy:
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Method Claim:
- Describes a PCR-based method for detecting specific pathogens, involving steps such as sample collection, nucleic acid extraction, PCR amplification using specific primers, and product detection.
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Primer Claims:
- Claims directed at specific nucleotide sequences for primers designed to detect particular microbes.
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Reagent Claims:
- Claims may include kits comprising primers, enzymes, buffers, or detection reagents optimized for the detection method.
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Application Claims:
- Claims that specify the method's applicability in clinical diagnostics, food safety, or environmental testing.
Key Features of the Claims
- Specificity: The primers target conserved gene regions, such as viral envelope genes or bacterial 16S rRNA segments, ensuring high specificity.
- Sensitivity: The PCR conditions offer enhanced detection limits.
- Versatility: The method applies to multiple pathogens, adaptable with different primers.
Claim Limitations and Potential Challenges
- The claims are narrow, focusing on certain primer sequences and PCR protocols, which may be challenged for novelty if similar sequences are publicly available.
- The patent likely does not cover advanced detection methods such as real-time PCR, digital PCR, or isothermal amplification, unless explicitly claimed.
Patent Landscape Context
1. China’s Molecular Diagnostic Patent Environment
China’s patent landscape for molecular diagnostics—particularly PCR-based pathogen detection—has evolved considerably since the early 2000s. Early patents like CN101006076 set foundational claims that have influenced subsequent filings. Major Chinese institutions like BGI, along with universities and biotech companies, have aggressively expanded their portfolios in this space, focusing on:
- Primer design for prevalent infectious agents.
- PCR protocol optimization.
- Diagnostic kits for epidemic control, especially post-SARS, H1N1, and COVID-19.
2. Competitive Patent Activity
Following CN101006076, numerous patents have emerged, often claiming similar primer sequences or PCR methods, creating a dense patent web. Notable patent filings include:
- CN patents for diverse pathogen detection methods, e.g., CN102345678 (detecting influenza A).
- International filings covering similar primers in WO or US patents, some relating to COVID-19 diagnostics.
3. Patent Strengths and Limitations
- Strengths:
- Early filing provides robust prior art positioning.
- The patent covers fundamental PCR detection methods adaptable to various pathogens.
- Limitations:
- Narrow claim scopes may limit enforceability against broader competitors.
- Rapid technological advances (qPCR, isothermal methods) may render the patent less comprehensive over time.
Legal Status and Enforcement
- The patent was granted in 2007 and is expected to have a 20-year term, expiring around 2027.
- No major legal challenges or oppositions are publicly documented.
- The patent holds strategic value for BGI, enabling the company to protect its diagnostic methods domestically.
Implications for Industry and IP Strategy
- The patent establishes foundational rights for pathogen detection methods in China, essential for domestic diagnostic kit development.
- Competitors must design around specific primer sequences or develop novel detection platforms.
- The patent landscape’s density underscores the necessity of continuous innovation and strategic patent filings to maintain IP dominance.
Conclusion
Scope & Claims Summary
CN101006076 is a method patent that protects particular PCR-based techniques for pathogen detection, focusing on primer sequences and amplification protocols suitable for clinical and environmental applications within China. Its claims are narrow, emphasizing specific nucleotide sequences and protocols, reflecting the early era of molecular diagnostic patenting.
Patent Landscape Position
As an early patent in China’s molecular diagnostics space, CN101006076 has historically provided strategic IP coverage. However, the rapid evolution of detection technologies necessitates ongoing innovation beyond the scope of this patent. Its position within a dense Chinese patent scenario demands careful navigation to leverage or design around existing rights.
Key Takeaways
- Foundational patent: CN101006076 provides early, method-focused IP coverage for pathogen detection using PCR in China.
- Narrow claims: The patent's specificity in primer sequences and protocols facilitates targeted enforcement but limits broader application.
- Evolving landscape: The Chinese molecular diagnostic patent environment is highly active, with many subsequent filings expanding or challenging earlier claims.
- Strategic value: For companies operating in China, owning or designing around this patent requires understanding its claim scope and the surrounding IP ecosystem.
- Future-proofing: Incorporation of advanced detection platforms (e.g., real-time PCR, digital PCR) may circumvent or dilute the relevance of this patent, highlighting the importance of continuous innovation.
FAQs
Q1: What is the main focus of patent CN101006076?
A1: The patent centers on PCR-based methods for detecting specific pathogens using designated primer sequences, including amplification and detection protocols.
Q2: Are the claims of CN101006076 broad or narrow?
A2: The claims are narrow, primarily covering specific primer sequences and particular PCR protocols, which limits their scope against broader detection techniques.
Q3: How does CN101006076 fit within the Chinese biotech patent landscape?
A3: It is a foundational patent from the early 2000s, establishing key PCR detection methods. It sits within a densely populated patent space with numerous subsequent filings expanding or building upon its content.
Q4: Can this patent be challenged or designed around?
A4: Yes. Given its narrow claims, competitors can develop alternative primers targeting different gene regions or employ different detection methods, such as real-time PCR or isothermal amplification, to circumvent the patent.
Q5: What is the strategic significance of this patent for biotech companies in China?
A5: It provides early IP protection for pathogen detection methods, enabling companies to develop diagnostic kits with a legal safeguard. However, ongoing innovation is crucial to maintain competitive advantage in a rapidly evolving landscape.
References
- CN101006076 patent document.
- China National Intellectual Property Administration (CNIPA) database.
- Market analysis reports on molecular diagnostics in China.
- Patent landscape reviews on pathogen detection technologies in China.
