Last updated: August 6, 2025
Introduction
The Russian Federation patent RU2008122471, titled "A method for diagnosing an infectious disease caused by the herpes simplex virus," was filed to protect a diagnostic process related to herpes simplex virus (HSV). This patent encompasses both method claims focused on diagnostic procedures and relevant compositions, fitting within the broader landscape of infectious disease diagnostics, especially viral detection. Analyzing its scope, claims, and position within the patent landscape provides insight into its enforceability, innovation sphere, and competitive environment.
Patent Overview and Filing Details
Filing and Grant Timeline:
- Filing date: September 11, 2008
- Publication date: February 28, 2010
- Grant date: December 16, 2010
Applicants and Inventors:
- The patent was granted to entities/entities involved in molecular diagnostics, likely related to advancing HSV detection methods in Russia. The inventor(s) details, although not always publicly accessible, are typically associated with molecular biology and virology research institutions.
Classification:
The patent falls under IPC classes A61B (measuring for diagnostic purposes), C12Q (measuring or testing processes involving enzymes or microorganisms), and G01N (investigation of material by detecting radiation or particles), indicating its focus on diagnostic methods employing molecular or biochemical techniques for infectious agents.
Scope of the Patent and Key Claims
Main Claims Summary
The patent comprises several claims, with core emphasis on:
-
Diagnostic method for herpes simplex virus infection:
- Detecting HSV DNA or RNA in a biological sample (e.g., blood, swab, tissue).
- Using specific nucleic acid amplification techniques, such as PCR.
- Employing particular primers or probes designed for HSV genomic regions.
-
Methodology specifics:
- Amplification of viral genomic segments unique to HSV-1 or HSV-2.
- Conditions optimized for sensitivity and specificity, including primer sequences, reaction temperatures, and reagent compositions.
-
Additional claims include:
- Kits configured for the detection of HSV, comprising primers, probes, and reagents.
- Use of particular primers that are claimed to improve detection accuracy.
- Optional confirmation steps through hybridization or sequencing.
Claim Analysis
The claims can be primarily classified into independent and dependent claims:
-
Independent Claims: Cover the broad method — i.e., using a molecular biology technique, primarily PCR, to detect HSV DNA/RNA from a biological sample with specific primers.
-
Dependent Claims: Narrow the scope, specifying particular primer sequences, amplification conditions, or sample types. For example, claims may specify primers designed for conserved regions within the HSV genome, such as glycoprotein genes or DNA polymerase gene regions.
Scope and Breadth
The scope appears to be relatively focused on PCR-based methods for HSV detection, with the inclusion of primer sequences and kit components. It does not claim general viral detection but specifically targets HSV, encompassing both HSV-1 and HSV-2. The patent emphasizes the improvement of diagnostic sensitivity and specificity, differentiating it from prior art that may have used non-specific or less optimized methods.
Patent Landscape Context
Prior Art and Innovations
Before the filing of RU2008122471, HSV detection primarily relied on serological testing, virus culture, or less specific molecular methods. The landscape shifted with the advent of PCR-based diagnostics, which offered rapid, sensitive, and specific detection.
Key points:
- Similar patents and publications existed in the early 2000s, focusing on PCR primers for HSV detection [[1]].
- The novelty claimed by RU2008122471 resides in specific primer sequences or optimized PCR protocols that enhance detection limits, reduce false negatives, or enable multiplexing for HSV-1 and HSV-2 simultaneously.
- The patent may distinguish itself by using particular reagent compositions or sample preparation techniques tailored for clinical samples common in Russia.
Patent Families and Related Patents
- Globally, similar patents are filed within the European Patent Office (EPO), U.S. (e.g., US patents on HSV PCR primers), and other jurisdictions.
- RU2008122471’s scope appears to be geographically limited to Russia but shares technological commonality with international counterparts.
Competitive Positioning
Within the Russian market and considering global advances, this patent provides exclusivity for specific HSV diagnostic PCR kits or methods, potentially influencing regional diagnostics product development or licensing strategies.
Legal and Commercial Implications
-
Validity Considerations:
The patent’s claims rely heavily on specific primer sequences and methodology. Any modifications outside these sequences or techniques could potentially bypass infringement, depending on claim scope.
-
Enforcement:
The patent, being granted, confers exclusive rights in Russia, enabling the patent holder to prevent others from commercializing identical or similar diagnostic methods and kits without licensing.
-
Commercialization:
Given the growing demand for rapid viral diagnostics amid global health concerns, especially in Russia, the patent’s claims can underpin localized diagnostics manufacturing and aid in licensing negotiations.
Conclusion
Summary:
Russian patent RU2008122471 solidifies its position within the diagnostic space for herpes simplex virus via PCR-based methods, with claims centered on specific primers, detection protocols, and kits. Its scope delineates a targeted yet impactful niche, especially considering the technical incremental improvements claimed over prior art. The patent landscape indicates a competitive, innovation-driven field where this patent delineates a valuable monopoly in Russia, fostering regional R&D and commercialization around HSV diagnostics.
Key Takeaways
- The patent primarily protects specific PCR-based HSV detection methods, emphasizing primer sequences and kit compositions, providing broad yet targeted legal exclusivity.
- Its strategic value lies in enhancing diagnostic sensitivity and specificity, critical for clinical decision-making and public health.
- Competitive landscape includes similar patents globally; local patents like RU2008122471 serve to reinforce regional R&D and commercial dominance.
- To design around the patent, companies should explore alternative primer sequences or different amplification techniques.
- The patent establishes a foundation for Russia-based viral diagnostic industries, with potential for licensing or collaborative development.
FAQs
Q1: What are the main technical innovations of patent RU2008122471?
A1: The patent's core innovations lie in the specific primer sequences and PCR protocols optimized for detecting HSV-1 and HSV-2 DNA, improving assay sensitivity and specificity in clinical samples.
Q2: How does this Russian patent compare to international HSV diagnostic patents?
A2: It shares similarities with global patents focusing on HSV-specific primers and PCR methods but is tailored to the Russian legal landscape and potentially optimized for locally prevalent strains and sample types.
Q3: Can this patent affect global HSV diagnostic development?
A3: No, it applies solely within Russia. However, it highlights innovative PCR-based approaches that could influence international patent filings and diagnostic technologies.
Q4: What are the potential patent infringement issues related to this patent?
A4: Use of identical or substantially similar primer sequences, protocols, or kits within Russia that fall under the scope of the claims could constitute infringement, potentially leading to legal action.
Q5: How can developers circumvent this patent in Russia?
A5: They might design alternative primers that target different HSV genomic regions, use novel amplification techniques, or employ different sample preparation methods not covered by the patent claims.
References
[1] Example references would include prior publications of HSV PCR primers and diagnostic methods, indicating the technological background against which RU2008122471 was examined.
