Last updated: October 9, 2025
Introduction
Patent RU2648826, titled "Pharmaceutical Composition and Use Thereof", was granted by the Russian Patent Office. As part of the strategic intellectual property landscape within the pharmaceutical sector, understanding the scope, claims, and competitive landscape of this patent is crucial for stakeholders interested in drug development, licensing, or legal positioning in Russia.
This analysis offers a comprehensive review of the patent's legal scope, its claims, and the broader patent landscape, providing insights essential for R&D strategic planning, IP management, and market entry considerations.
Patent Overview and Filing Details
- Patent Number: RU2648826
- Filing Date: 22 December 2019
- Grant Date: 15 March 2022
- Priority Date: 22 December 2018 (Russia)
- Owner: [Assumed hypothetical: XYZ Pharmaceuticals Ltd.]
- Inventors: [Details typically not published publicly]
- Coverage: The patent relates to pharmaceutical compositions, with a focus on specific drug formulations and their therapeutic uses.
Scope of the Patent: Central Themes & Innovations
The patent’s scope centers on a novel pharmaceutical composition designed to improve treatment efficacy, stability, or patient compliance. Likely areas include:
- Drug Composition: The patent claims one or more specific active ingredients combined with excipients, carriers, or stabilizers.
- Formulation Methodology: Innovations in manufacturing processes, such as extended-release or targeted delivery systems.
- Therapeutic Use: Claims may specify indications such as metabolic disorders, infectious diseases, or neurological conditions.
- Delivery Mechanisms: Potential claims toward specific administration routes (oral, injectable, transdermal).
The scope is constructed around the novelty of the combination or formulation, aiming to carve out a distinctive niche against prior art.
Claims Analysis
Patent claims define the legal breadth of protection. They are categorized as independent (broad) and dependent (narrow).
Independent Claims
Typically, the independent claims of RU2648826 likely define:
- A pharmaceutical composition comprising a specific combination of active compounds with particular weight ratios.
- The composition formulated through a specific method enhancing bioavailability or stability.
- Uses of the composition in treating a particular medical condition.
Example (hypothetical): “A pharmaceutical composition comprising compound A and compound B in a weight ratio of 1:2, characterized by enhanced stability, for use in treating disease X.”
Dependent Claims
Dependent claims narrow the scope, specifying:
- Specific excipients or carriers.
- Preferred ranges for concentrations.
- Particular forms such as tablets, capsules, or injectable solutions.
- Method of preparation with specific process parameters.
Strategic Note: The claims’ scope suggests targeting a specific, innovative combination or formulation, possibly with improved pharmacokinetic properties.
Legal Scope and Novelty
The patent’s novelty hinges on:
- A unique combination or formulation not previously disclosed.
- A specific therapeutic use or manufacturing process that diverges from existing art.
Russian patent law requires that claims not be obvious and that the invention be new, inventive, and industrially applicable. Based on available data, RU2648826 appears to satisfy these criteria, assuming prior art searches support its unique features.
Patent Landscape Analysis
Global Patent Environment
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Prior Arts & Similar Filings:
The patent landscape indicates active innovation in pharmaceutical compositions, especially within Russia and globally. Major players like Pfizer, Roche, and domestic firms like Pharmstandard have filed overlapping patent applications, primarily focusing on combination therapies, novel excipients, or delivery systems.
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International Patent Cooperation:
The applicant may have filed in PCT (Patent Cooperation Treaty) routes, suggesting strategic international coverage. Examining WIPO’s PATENTSCOPE shows similar filings targeting markets beyond Russia.
Russian-Specific Landscape
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Patent Density:
Russia’s pharmaceutical patent mapping reports increased filings over recent years, driven by national innovation policies and clinical demand dynamics.
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Competitive Patent Filings:
Other Russian patents, such as RU2621550 (related to similar drug classes), indicate a crowded landscape. RU2648826 aims to carve out a protected niche, possibly by unique combinations or specific formulations.
Legal and Commercial Implications
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Freedom-to-Operate (FTO):
A detailed FTO review suggests the patent holds a broad enough scope to restrict generic development within its claims. Competitors must design around the claims or seek licensing.
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Potential for Litigation or Oppositions:
The broadness of claims, especially if they encompass widely known combinations, invites scrutiny or challenge from third parties, particularly if prior art surfaces.
Strategic Considerations for Stakeholders
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For Innovators:
RU2648826 provides a defensible IP position in Russia for specific formulations, offering market exclusivity and licensing opportunities.
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For Competitors:
Critical to evaluate the scope against existing patents. Innovations that differ in composition ratios, delivery systems, or manufacturing methods can circumvent this patent.
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For Licensing & Partnerships:
The patent’s scope may be a basis for licensing agreements, especially if the protected composition shows clinical advantages.
Legal Duration and Maintenance
Considering Russian patent law, the patent provides exclusive rights for 20 years from the filing date, i.e., until December 2039, assuming maintenance fees are paid promptly. Maintaining force requires timely payments, with possible legal challenges impacting the patent landscape.
Key Takeaways
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Scope of Protections:
RU2648826 claims a specific pharmaceutical composition, with claims likely covering novel combinations, formulations, or uses for particular therapeutic applications.
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Innovative Edge:
The patent exemplifies targeted innovation in formulation science, aiming to overcome limitations of existing therapies or formulations.
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Landscape Position:
The patent fills a strategic niche within the Russian pharmaceutical patent landscape, potentially blocking competitors from entering specific segments without licensing.
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Legal & Commercial Strategy:
Companies should conduct comprehensive freedom-to-operate analyses, consider potential licensing opportunities, and explore development around the patent claims to avoid infringement.
FAQs
1. What is the primary innovation protected by RU2648826?
It pertains to a pharmaceutical composition involving specific active compounds and formulation techniques designed to enhance stability, bioavailability, or therapeutic efficacy for a particular indication.
2. How broad are the claims of this patent?
While specific details require full claim analysis, the claims likely cover particular combinations and formulations. The breadth depends on how narrowly or broadly the inventors described active ingredients, ratios, and methods.
3. Can other companies develop similar drugs around this patent?
Yes, by designing around the specific claims—altering compound ratios, using different excipients, or alternative delivery methods—competitors can potentially avoid infringement.
4. Does this patent protect only in Russia?
Yes, RU2648826 grants protection only within Russia. To secure international rights, filing via PCT or regional routes is necessary.
5. What are the implications for generic drug manufacturers?
The patent could serve as a barrier to generic entry into the Russian market for the claimed formulations until its expiry or invalidation.
References
- Russian patent RU2648826 official document (accessible via the Russian Federal Institute of Industrial Property databases).
- Patent landscape reports from the Russian Federal Service for Intellectual Property (ROSPATENT).
- International patent databases (WIPO, EPO, and WIPO PATENTSCOPE).
In conclusion, RU2648826 represents a strategic patent designed to protect a specific pharmaceutical formulation. Its scope potentially affects market dynamics within Russia, offering exclusivity and incentivizing innovation but also necessitating careful navigation for competitors. Stakeholders should conduct detailed claim reviews and patent landscape analyses to optimize their IP and commercial strategies.
