Last updated: August 27, 2025
Introduction
Russian patent RU2682658, titled "Method of diagnosing and monitoring Parkinson's disease," was granted in the Russian Federation with an effective filing date of April 10, 2019, and publication date of May 26, 2022. Its core contribution lies in a diagnostic method utilizing a specific biomarker panel to identify Parkinson's disease (PD) and track disease progression. This patent addresses a vital niche within neurology diagnostics, offering potential for integration into clinical workflows and personalized medicine approaches.
This analysis provides a detailed review of the patent’s scope, claims, and its positioning within the broader pharmaceutical and diagnostics patent landscape in Russia and internationally. It aims to aid stakeholders—pharmaceutical companies, diagnostic developers, patent attorneys, and regulatory agencies—in understanding the patent’s strength, breadth, and strategic implications.
Scope and Core Claims of RU2682658
Claim Structure & Core Elements
The patent comprises multiple claims, with the independent claim (Claim 1) defining the scope for the diagnostic method:
Claim 1 (paraphrased):
A method for diagnosing and monitoring Parkinson's disease, comprising the detection of specific biomarkers in biological samples (e.g., blood plasma), including elevated levels of neurofilament light chain (NfL), alpha-synuclein, and DJ-1 protein, followed by an analysis of the biomarker profile to confirm diagnosis and assess disease progression.
Subsequent dependent claims specify details such as:
- Types of biological samples (e.g., blood, cerebrospinal fluid).
- Detection techniques (e.g., ELISA, mass spectrometry).
- Threshold values for biomarker levels that distinguish PD from controls.
- Combining biomarker data with clinical symptom scoring for increased accuracy.
Key aspects of scope:
- Focus on biomarkers associated with neurodegeneration in PD.
- Utilization of standard biochemical detection methods.
- Emphasis on diagnostic and disease monitoring applications.
Implication: The claims cover both the identification of PD based on these biomarkers and the longitudinal monitoring of disease progression, positioning the patent as a versatile tool for clinical and research use.
Claims Analysis
The claims balance specificity and breadth, aiming to cover both:
- Diagnostic detection: Using biomarker levels as diagnostic criteria.
- Monitoring: Tracking biomarker changes over time to reflect progression.
The invention's novelty relies on combining multiple biomarkers (NfL, alpha-synuclein, DJ-1) as a panel, which enhances diagnostic accuracy. Prior art predominantly addressed individual biomarkers, but this patent emphasizes a multi-biomarker approach, elevating it in diagnostically challenging conditions like PD.
Strengths:
- Clear criteria for biomarker thresholds.
- Applicability to various sample types.
- Compatibility with routine laboratory methods.
Limitations:
- The claims do not specify novel detection techniques—they rely on existing biochemical assays—limiting coverage to the biomarker detection method rather than the biomarkers themselves.
Patent Landscape in Russia and International Context
Russian Patent Environment
Russia’s biotechnology and diagnostics patent landscape is marked by a strategic focus on neurodegenerative diseases, driven by demographic trends and healthcare demands. RU2682658 sits within a cluster of patents targeting PD biomarkers, albeit with a gap for multi-biomarker panels, indicating potential novelty and non-obviousness.
Prevailing prior art:
- Several Russian patents and publications detail individual biomarkers, such as alpha-synuclein and NfL, primarily in contexts unrelated to a combined diagnostic approach.
- For example, RU2653723 describes alpha-synuclein detection in cerebrospinal fluid, limiting its scope to a singular biomarker.
- No existing patents explicitly cover a multi-biomarker panel for PD diagnosis in Russia, suggesting RU2682658’s potential novelty.
International Landscape and Patentability
Globally, the patent landscape features similar approaches:
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The US, EU, and China have patents on PD biomarkers, including NfL and alpha-synuclein, but fewer cover combinations or panels explicitly.
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Notable patent applications, such as US2020177324 (by biotech entities), disclose biomarker combinations but often focus on antibody-based detection kits rather than diagnostic algorithms.
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The novelty of RU2682658 may hinge on its specific combination and threshold parameters applied in a diagnostic context, which might not be fully anticipated in existing patents.
Potential patentability challenges:
- Overlap with prior art detecting individual biomarkers.
- Obviousness of combining biomarkers, especially if biomarkers have separately been validated for PD diagnosis.
To mitigate this, the patent emphasizes specific thresholds and combined interpretation strategies, grasping a niche not fully explored by prior art.
Strategic Implications
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IP Strength: The patent’s breadth is moderate; it effectively covers a multi-biomarker diagnostic method with defined thresholds. Its enforceability depends on the novelty of combining these specific biomarkers and their parameters.
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Potential for Licensing and Collaborations: Given the global research interest, rights holders could negotiate licensing deals for diagnostic kits or collaborative research.
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Regulatory Considerations: For clinical implementation, validation and potential regulatory approval in Russia and abroad would be necessary, where patent claims may support patent-backed differentiation.
Summary and Recommendations
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Innovative Niche: RU2682658 addresses a clinically significant need by integrating multiple neurodegenerative biomarkers into a diagnostic strategy. Its claim structure leverages combinations and threshold-based interpretation, enhancing its patentability within Russia.
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Patent Strategy: Developers should monitor similar multi-biomarker diagnostics to prevent infringement. For patent applicants, emphasizing the unique combination, thresholds, and analytics methods can strengthen patent protection.
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Commercial Outlook: With neurodegenerative diseases forecasted to rise globally, such diagnostic patents could become foundational for blood-based PD diagnostics, provided they navigate prior art challenges.
Key Takeaways
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RU2682658 claims a multi-biomarker diagnostic method for Parkinson’s disease, focusing on NfL, alpha-synuclein, and DJ-1 proteins detected via routine assays.
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Its scope is tailored around threshold-based interpretation of biomarker levels, supporting both diagnosis and disease monitoring.
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The patent sits within a competitive landscape with existing patents on individual biomarkers; its novelty largely derives from the combined approach and specific parameters.
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International patent landscape shows a trend toward multi-biomarker panels, but coverage remains fragmented; RU2682658’s focus on a specific set and thresholds offers potential patent defensibility in Russia.
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Practitioners should anticipate future legal challenges based on prior art, and innovators should pursue supplementary patent claims emphasizing the unique combination, thresholds, and analytical methods.
FAQs
1. Does RU2682658 cover any specific detection technology?
No. The patent encompasses standard detection techniques such as ELISA and mass spectrometry, focusing on the biomarker panel and interpretation thresholds, not on novel detection technologies.
2. Is the patent limited to Russian territory?
Yes. RU2682658 is valid within Russia. For international protection, applicants must seek patents in other jurisdictions via PCT or regional filings.
3. Can this patent be challenged based on prior art?
Potentially. Prior art exists on individual biomarkers, but the specific combination and threshold parameters may provide defensible novelty. While obviousness could be contested, the claimed multi-biomarker approach offers some inventive step.
4. Are there ongoing patent applications that might affect this patent’s enforceability?
Yes. International entities are researching multi-biomarker diagnostics for PD, which could lead to filings that challenge or overlap with the claimed invention.
5. How is this patent positioned for future commercialization?
Given the rising focus on blood-based PD diagnostics, this patent can serve as a strategic reference point for developing licensed diagnostic kits, subject to regulatory approval and validation.
References
[1] Russian patent RU2682658, Method of diagnosing and monitoring Parkinson’s disease, filed April 10, 2019, granted May 26, 2022.
[2] Prior arts investigating individual biomarkers such as alpha-synuclein (RU2653723) and NfL, as well as global patents on biomarker panels, for contextual landscape analysis.
