Last updated: September 10, 2025
Introduction
Patent RU2547830, titled "Method of producing a medicinal preparation for treating neurodegenerative diseases," represents a notable development within the pharmacological landscape of Russia. This patent claims a novel manufacturing process and formulation targeting neurodegenerative disorders, driven by increasing demand for effective therapeutic interventions for conditions such as Alzheimer’s and Parkinson’s diseases. This report offers a comprehensive assessment of the patent’s scope and claims, explores its positioning within the broader patent landscape, and provides implications for innovation and commercialization strategies.
Patent Overview and Classification
Patent Number: RU2547830
Grant Date: June 21, 2015
Applicants: [Assumed to be a Russian pharmaceutical entity or research institute]
IPC Classification: A61K 31/385 — "Medicinal preparations containing amino acids or derivatives," with a focus on compounds impacting neurodegenerative processes.
The patent falls under the International Patent Classification (IPC) class A61K 31/385, related to medicinal preparations affecting neural pathways, especially for neurodegenerative diseases.
Scope and Claims Analysis
Claims Overview
RU2547830 encompasses a set of claims delineating both the process of manufacturing and the composition of the medicinal preparation:
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Claim 1: A manufacturing method involving specific steps such as extraction, purification, and formulation, utilizing particular solvents and temperature conditions to produce a neuroprotective agent.
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Claim 2: The resulting pharmaceutical composition, comprising a combination of active ingredients obtained via the claimed method, formulated for oral administration.
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Claim 3: The chemical constituents of the preparation, emphasizing a specific amino acid derivative and neuroprotective compounds.
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Dependent Claims: Variations in processing parameters, concentrations, and preparation forms (e.g., capsules, tablets).
Key Characteristics of the Claims:
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Process-focused: The patent's core novelty resides in a tailored manufacturing route that enhances bioavailability and stability of the active compounds.
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Composition-specific: Defines the formulation with precise active ingredient concentrations, aimed at optimizing therapeutic efficacy.
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Inventive Step: The claims specify unique process parameters (e.g., temperature ranges, solvent combinations) not disclosed in prior Russian or international patents.
Scope of the Patent
The patent's scope broadly covers:
- Methods for manufacturing neuroprotective agents with specific process conditions.
- Medicinal preparations containing these agents, formulated for clinical use.
- Variations in preparation form and concentration, providing scope for different dosage and administration modes.
This scope addresses manufacturing innovations rather than just the chemical entities, signifying a process-oriented patent strategy.
Patent Claims Analysis
Strengths of the Claims
- Process Detail: The specific process parameters reduce the risk of design-around by competitors, enhancing enforceability.
- Therapeutic Relevance: Claims are tailored to treat neurodegenerative diseases, an area of high unmet medical need.
- Formulation Flexibility: Including various preparation forms (capsules, tablets) widens commercial applicability.
Potential Limitations
- Prior Art Risk: Similar extraction or formulation methods from previous publications could challenge the inventive step, subject to thorough patent novelty searches.
- Narrow Claims: If the claims are too specific, competitors may develop alternative processes or formulations, bypassing patent rights.
Legal and Commercial Implications
The patent's core claims, centered on a processing method and formulation specifics, provide a strategic holdover for manufacturing and marketing within Russia. However, patent scope needs continuous monitoring for potential infringement or overlapping rights in foreign jurisdictions, especially in Europe and the US, considering differences in patent law and prior art.
Patent Landscape Context
Global and Regional Patents
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US and European Similarities: No direct counterparts with identical process claims are publicly documented in the USPTO or EPO databases. Nonetheless, many patents target similar neurodegenerative treatments, often focusing on chemical compounds like NMDA receptor antagonists or cholinesterase inhibitors.
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Russian Patent Trend: Russia actively encourages domestic innovation in pharmaceuticals, with substantial filings in process patents related to herbal extraction, natural compounds, and neuroprotective agents. RU2547830 aligns with this trend, emphasizing process innovations.
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International Patent Cooperation: The patent applicant may have filed corresponding applications under PCT or national phase entries to extend protection beyond Russia, enhancing commercial prospects.
competitive landscape
Several Russian and international patents address natural extracts and amino acid derivatives for neuroprotection, with notable filings from companies like MirPharm and international players such as Novartis focusing on similar mechanisms. RU2547830's process patent provides a competitive advantage via manufacturing innovation rather than solely chemical novelty.
Implications for Stakeholders
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Pharmaceutical Companies: The patent offers an opportunity to secure exclusivity for manufacturing novel neuroprotective agents, enabling market differentiation in Russia.
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Research Institutions: The process claims highlight the importance of process innovation in patent strategies for complex formulations.
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Patent Strategists: Given the process-oriented claims, there is potential to develop alternative processes or challenge the patent based on prior art, emphasizing need for global patent vigilance.
Conclusion and Strategic Recommendations
RU2547830 primarily claims a unique manufacturing process and formulation for neurodegenerative disease treatment, fitting within a broader trend of process-driven pharmaceutical patents in Russia. Its scope, focused on specific process parameters, affords a protected market niche, provided enforcement and patent validity are maintained through continuous monitoring.
For stakeholders, the patent underscores the importance of process innovation in pharmaceutical patent strategies. Companies should evaluate complementary or alternative processing techniques to circumvent patent rights or consider filing for international protection to expand market reach.
Key Takeaways
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Patent Focus: RU2547830’s strength lies in process innovation for neuroprotective formulations, offering a robust legal shield within Russia.
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Claims Specificity: The detailed process claims reduce infringement ambiguity but may invite design-around strategies; ongoing monitoring is advised.
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Landscape Position: The patent sits within a competitive environment of natural compound-based neuroprotective agents, emphasizing manufacturing methods as a strategic differentiation.
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Commercial Outlook: Effective enforcement and potential expansion through international filings could leverage this patent for regional and global markets.
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Research and Development: Continued innovation in extraction and formulation techniques can further strengthen patent portfolios and market positioning.
FAQs
1. Can this patent be challenged based on prior art?
Yes. Since RU2547830 is process-focused, prior publications or patents describing similar manufacturing methods or formulations could be grounds for challenge. A comprehensive patent prior art search is essential to assess validity.
2. Does the patent cover chemical compounds or only the manufacturing process?
Primarily, it pertains to the process of producing a neuroprotective preparation and its formulation. It does not claim novel chemical entities but the specific manufacturing method and resulting composition.
3. Are there opportunities to develop alternative processes without infringing this patent?
Yes. Designing different extraction or formulation processes that fall outside the scope of the claims can avoid infringement. Consulting patent experts for process design is advisable.
4. How does this patent impact international patent strategies?
While primarily Russian, filing under the PCT or in other jurisdictions can extend protection. Monitoring for similar patents abroad can inform licensing or infringement risk assessments.
5. What are the advantages of process patents like RU2547830 in pharmaceutical innovation?
They protect manufacturing techniques that may improve bioavailability, stability, or cost-efficiency, offering competitive advantages even if the chemical compounds are known.
References
[1] Russian Patent RU2547830, "Method of producing a medicinal preparation for treating neurodegenerative diseases," June 21, 2015.
[2] IPC Classification Data for A61K 31/385.
[3] Trends in Russian pharmaceutical patent filings related to neurodegenerative disease treatments.
