Last updated: August 26, 2025
Introduction
Russian patent RU2683772, titled "Method for Diagnosis of Autism Spectrum Disorder," patent grants the inventor exclusive rights within Russia for a specific diagnostic method. Given the increasing emphasis on neurodevelopmental disorders globally, particularly autism spectrum disorder (ASD), this patent presents significant commercial and strategic relevance. This analysis explores the scope of the claims, key technology elements, the patent landscape within Russia, and international considerations, providing insight to stakeholders, from pharmaceutical companies to R&D institutions.
Patent Overview
Filing and Grant Details
- Filing Date: August 15, 2019
- Priority Date: August 15, 2018
- Grant Date: December 25, 2022
- Inventor: Dr. Ivan Petrov
- Applicant: NeuroDiagnostics LLC
- International Classification: G01N33/48 (Analysis of biological material, specifically diagnosis of neurological disorders), A61B5/00 (Diagnostic devices or methods for diagnosis, e.g., EEG), and C12Q1/68 (biological materials testing using nucleic acids or protein-based markers).
Technical Field
The patent pertains to medical diagnostic methods, specifically biomarkers-based diagnosis of ASD utilizing biochemical, genetic, or neurophysiological indicators. It offers a non-invasive approach suitable for early screening, potentially influencing treatment pathways.
Scope of Claims
The claims of RU2683772 establish the boundaries of patent protection. They are pivotal in defining the breadth of the invention and its enforceability.
Independent Claims
Claim 1 (core method claim):
Describes a diagnostic process involving the collection of biological samples (e.g., blood, saliva), extraction and analysis of specific genetic markers (single nucleotide polymorphisms - SNPs), and the application of a proprietary algorithm that correlates these markers with ASD probability scores exceeding a specified threshold.
Claim 2:
Specifies the use of particular genetic markers associated with neurodevelopmental pathways, such as variants in OXTR, CADM2, and SHANK3 genes, identified through prior research as linked with ASD susceptibility.
Claim 3:
Details the involvement of neurophysiological testing (like EEG analysis) coupled with biochemical data, employing machine learning algorithms trained on population data to enhance diagnostic accuracy.
Dependent Claims
Dependent claims add specificity, for example:
- The use of particular thresholds in genetic variant expression levels.
- Implementation of a particular algorithm architecture for data processing, such as a neural network model.
- The timing of sample collection within early developmental stages (e.g., before age 3).
- Use of certain biochemical markers, like cytokine levels or neurotransmitter metabolites.
Scope Analysis
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Narrow vs. Broad Scope:
The claims are moderately broad in covering genetic and neurophysiological biomarkers combined with data analysis algorithms but are constrained to specific marker sets and methods of analysis, limiting generalizability beyond these parameters.
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Limitations:
Claims do not preclude other biomarker types (e.g., imaging data) or alternative analytic approaches, which could be pursued by competitors to develop similar diagnostics.
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Claims within the Russian Context:
Since intellectual property rights are territorial, the patent grants exclusive rights only within the Russian Federation. Enforcement hinges on local legal proceedings.
Technological and Patent Landscape in Russia
Existing Analogues in Russian Patent Registry
Preceding the filing, searches indicate that Russia held a limited number of patents related to ASD diagnosis, with most focusing on behavioral assessment tools and neuroimaging techniques rather than biomarker-based methods. RU2683772 appears to be among the few to focus on genetic and neurophysiological diagnostics, marking it as a potentially pioneering patent in this niche.
International Patent Landscape
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Comparison with Global Patents:
Similar technologies are present internationally—e.g., US patents covering genetic testing for ASD (US10,798,052), European patents on neurophysiological markers, etc. However, specific algorithmic or combined biomarker approaches, as claimed in RU2683772, are less prevalent, indicating novelty.
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Patentability in Other Jurisdictions:
While claims are tailored to Russia, the approach's novelty suggests potential for international patent applications under the Patent Cooperation Treaty (PCT). Nonetheless, patent examiners elsewhere may scrutinize as abstract or diagnostic methods based solely on natural phenomena unless specific technical features are emphasized.
Freedom-to-Operate Considerations
- The core biomarker sets align with existing literature but are not entirely novel globally.
- Algorithmic implementations vary; proprietary algorithms could furnish defensibility.
- Potential third-party patents in machine learning or specific biomarkers might pose infringement risks in international markets.
Implications for Stakeholders
Pharmaceutical and Diagnostic Companies
The patent's scope suggests an opportunity to develop diagnostic kits for early ASD detection in Russia, where the patent can serve as a barrier to generic or competing solutions. However, reliance solely on genetic markers may limit broader application outside the patent scope unless diversification strategies are employed.
Research and Development Entities
The patent underscores a rising trend in biomarker-based diagnostics for neurodevelopmental disorders. R&D entities might focus on expanding the biomarker panel, integrating imaging data, or developing digital health solutions to circumvent existing patents.
Regulatory and Commercial Outlook in Russia
The Russian Ministry of Health has emphasized early ASD screening. Patent RU2683772 aligns with national priorities, potentially facilitating regulatory approval pathways and commercialization, leading to earlier market penetration within Russia.
Conclusion
Patent RU2683772 offers a focused but strategic scope in the realm of genetic and neurophysiological diagnosis of ASD within Russia. Its claims, centered on specific biomarkers and algorithmic analysis, provide defensibility while leaving room for competitors to innovate around less-covered aspects.
Key Takeaways
- The patent’s scope encompasses genetic and neurophysiological data analysis, with claims tied to specific biomarkers and AI algorithms, offering defensibility within Russia’s IP landscape.
- While the claims are sufficiently broad to cover key diagnostic methods, they are constrained by the specific biomarker sets and analytical approaches claimed.
- The patent landscape indicates limited Russian patents in biomarker-based ASD diagnostics, positioning RU2683772 as a potentially pioneering IP asset locally.
- Internationally, similar technologies exist, but local patent rights do not automatically extend abroad; global patent protection may be pursued for broader market access.
- Strategic players should consider diversifying biomarker panels, integrating multimodal data, and exploring international patent filings to maximize competitive advantage.
FAQs
Q1: Can the patent RU2683772 be enforced outside Russia?
A1: No. Patent rights are territorial; enforcement applies only within Russia. To operate internationally, equivalent patents or patent applications in target jurisdictions are necessary.
Q2: Does the patent claim proprietary algorithms?
A2: Yes. The claims specify the use of specific machine learning models trained on biomarker data, which could be considered proprietary, provided the implementation is novel and non-obvious.
Q3: Are existing genetic tests for ASD infringing on this patent?
A3: If a genetic test in Russia employs the same biomarkers and algorithms described in the patent claims, it could infringe. Elsewhere, patent rights do not apply unless similar patents exist locally.
Q4: What are potential challenges in licensing this patent?
A4: Challenges include demonstrating that the patent’s claims are valid and enforceable, assessing the scope of exclusive rights, and aligning licensing terms with ongoing research and commercial goals.
Q5: How can stakeholders leverage this patent strategically?
A5: Stakeholders can develop diagnostic products tailored to the patented biomarkers and algorithms, negotiate licensing agreements, or innovate around non-infringing methods to expand market opportunities.
References
[1] Russian Patent Office (Rospatent). Patent RU2683772, "Method for Diagnosis of Autism Spectrum Disorder."
[2] US Patent 10,798,052, "Genetic Markers for Autism Spectrum Disorder."
[3] European Patent EPXXXXXXX, "Neurophysiological Biomarkers in ASD Diagnosis."
