Last updated: July 27, 2025
Introduction
China patent CN101579344, titled "Method for screening and/or predicting temperature-sensitive mutant viruses and kits therefor", pertains to biotechnological innovations targeting temperature-sensitive viral mutants. Such patents hold significant commercial and scientific value, particularly in vaccine development and viral research. A thorough understanding of its scope, claims, and landscape context offers strategic insights for stakeholders involved in pharmaceutical innovation in China and globally.
Patent Overview
CN101579344 was filed by Beijing Institute of Microbiology and Epidemiology, with a filing date of July 21, 2008, and granted in December 2010. It encompasses methods for identifying and predicting temperature-sensitive mutations in viruses, along with corresponding detection kits. Its scope spans methods, genetic markers, and kits designed for screening viral mutants with temperature sensitivity, an essential trait for attenuated vaccine strains.
Claims Analysis
Scope of Claims
The patent includes a total of 19 claims, categorized into independent and dependent claims:
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Independent claims:
- Claim 1: Describes a method for screening a virus for temperature-sensitive mutants, comprising steps such as isolating viral strains, cultivating under specific conditions, and detecting mutations associated with temperature sensitivity.
- Claim 16: Presents a kit comprising specific detection components (e.g., primers, probes) for identifying temperature-sensitive mutations.
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Dependent claims:
Cover specific embodiments, such as the type of viruses applicable (e.g., influenza virus), particular genetic loci relevant for mutation detection, and specific detection techniques (e.g., PCR, hybridization).
Key Claim Highlights
- Claim 1 emphasizes a comprehensive method for screening viral mutants directly relevant for vaccine development: isolating viral strains, subjecting them to temperature variation, and detecting relevant mutations at genetic loci known or suspected to confer temperature sensitivity.
- Claims 2-15 specify parameters such as assay types (PCR-based, hybridization), mutation detection sites (e.g., PB2 gene in influenza), and temperature conditions, refining the scope.
- Claim 16 extends the scope to kits, including primers, probes, or reagents tailored for the detection steps.
Implication:
The claims broadly protect methods for screening and predicting temperature-sensitive mutants, as well as comprehensive kit products for such purposes.
Scope of the Patent
Strengths in Claims
- Broad Methodology: Covers not only the detection of known mutations but also methods for discovering new temperature-sensitive mutants.
- Versatility: Applicable across various viruses where temperature-sensitive mutants are relevant, including influenza, poliovirus, and others.
- Commercial Coverage: Encompasses diagnostic kits, enabling downstream commercial applications and partnerships.
Limitations
- Genetic Focus: Claims primarily concern the detection of mutations at specific loci; novel mutations could potentially be outside the scope unless explicitly included.
- Detection Technologies: Focus on PCR and hybridization, potentially limiting coverage of newer methods like next-generation sequencing unless explicitly claimed.
Patent Landscape Context
Domestic Landscape
In China, the patent landscape for viral mutation detection is relatively dense, driven by strategic efforts in pandemic preparedness and vaccine research. Key players include:
- Beijing Institute of Microbiology and Epidemiology: As the assignee, leading in innovation, especially for influenza and other respiratory viruses.
- Other Chinese biotech firms: Engaged in diagnostic tool innovations, often citing or building upon CN101579344’s framework.
International Landscape
Although primarily Chinese, the patent parallels global inventions, such as:
- US Patent US7786528B2: Covering methods for detecting influenza virus mutations.
- European Patent EP2 148 588B1: Methods for identifying temperature-sensitive viral mutants.
CN101579344’s scope overlaps with these, yet it maintains novelty through specific mutation loci and kit compositions unique to the Chinese patent system.
Patent Influence and Citation
The patent has been cited by subsequent filings focused on:
- Rapid detection of viral mutants.
- Vaccine strain screening.
- Diagnostic kit development.
This indicates a foundation for ongoing innovation within the Chinese biotech sector.
Strategic Implications
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For Innovators:
The broad claims on screening methods and kits offer opportunities for licensing or developing complementary technologies, provided innovations do not infringe on the specific claims.
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For Competitors:
Detailed knowledge of claim scope clarifies potential patent barriers, especially in RT-PCR detection methods for influenza and other viruses.
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For Patent Holders:
The patent’s scope can be extended or combined with newer technologies (e.g., sequencing) to broaden protection or circumvent overlaps.
Summary of Patent Landscape
| Aspect |
Details |
| Patent Type |
Method and kit patent |
| Filing Date |
July 21, 2008 |
| Grant Date |
December 2010 |
| Assignee |
Beijing Institute of Microbiology and Epidemiology |
| Target Viruses |
Influenza, others |
| Key Claims |
Virus screening methods, detection kits |
| Overlap |
Similar patents in US/EU, but specific Chinese claims remain distinct |
Conclusion
China patent CN101579344 establishes a comprehensive legal scope covering methods and kits for detecting temperature-sensitive viral mutants. Its broad claims provide a strong foundation for vaccine development, diagnostics, and viral research. Stakeholders must navigate its claims carefully, especially in the context of the evolving patent landscape and technological advances such as sequencing-based diagnostics.
Key Takeaways
- The patent’s core innovation lies in methods for screening and predicting temperature-sensitive mutants applicable across various viruses.
- Its claims cover both the conceptual methodology and practical detection kits, offering broad commercial protection.
- The patent landscape features similar innovations globally, but CN101579344 maintains unique features, especially relevant within the Chinese biotech environment.
- Future innovation should consider the scope of these claims, particularly when integrating advanced detection technologies.
- Strategic deployment, licensing, or patent clearance should involve careful analysis of these claims to mitigate infringement risk.
FAQs
Q1: How does CN101579344 differ from global patents on viral mutant detection?
A1: It emphasizes Chinese-specific mutation loci and kits, with claims covering methods and reagents tailored to Chinese viral strains, particularly influenza, providing a localized patent protection scope.
Q2: Can this patent be enforced against international companies?
A2: Yes, within China’s jurisdiction, provided the infringement occurs within Chinese territory. Enforcement internationally depends on corresponding filings or patent treaties.
Q3: Are the detection methods limited to PCR and hybridization?
A3: The primary claims focus on PCR-based and hybridization techniques; however, future claims could expand to include next-generation sequencing or other molecular diagnostics as the patent landscape evolves.
Q4: Does the patent provide protection for discovering new mutations?
A4: Yes, the broad method claims encompass identifying novel temperature-sensitive mutations, provided detection steps are used as described.
Q5: What strategic moves can competitors make regarding this patent?
A5: Competitors may develop alternative detection methodologies not covered by these claims or focus on different viral loci, while considering licensing opportunities or designing around the specific kit components.
References:
- Chinese Patent CN101579344, "Method for screening and/or predicting temperature-sensitive mutant viruses and kits therefor." (2010).
