Last updated: August 7, 2025
Introduction
Russian patent RU2746945, titled “Pharmaceutical composition containing a combination of an antiviral agent and an immunomodulator,” exemplifies the evolving landscape of innovative drug development within the Russian Federation. This detailed analysis explores the scope of the patent’s claims, strategic positioning within the patent landscape, its potential influence on subsequent innovations, and implications for industry stakeholders.
Overview of RU2746945
Filed with the Russian Patent Office (Rospatent), RU2746945 was granted on August 16, 2022. The patent aims to secure exclusive rights over a specific pharmaceutical composition comprising an antiviral agent in combination with an immunomodulator, optimized for therapeutic efficacy against viral infections, notably COVID-19 and influenza.
The patent’s priority date is September 10, 2021, aligning it with global efforts to develop effective treatment regimens amid pandemics. It thereby fits within a broader trend of combinatorial therapies seeking synergistic benefits.
Scope and Claims
Claim Structure and Focus
The patent’s claims predominantly fall into independent and dependent categories:
- Independent Claims: Define a pharmaceutical composition comprising specific antiviral and immunomodulatory agents, with particular dosage forms or ratios.
- Dependent Claims: Narrow this scope through specific formulations, additional stabilizers, or methods of administration.
Key Aspects of the Claims
The core claim (Claim 1) describes:
A pharmaceutical composition comprising:
(a) a first component—an antiviral agent selected from [list of specific compounds], including remdesivir derivatives, favipiravir, or other nucleoside analogs;
(b) a second component—an immunomodulator selected from [specific classes], such as interferons, cytokine modulators, or plant-based immunostimulants;
(c) optionally, carriers, stabilizers, or excipients.
Noteworthy points include:
- Specific Agent Combinations: Focus on particular antiviral agents combined with targeted immunomodulators, reinforcing the patent’s strategic position on a combinatorial approach.
- Dosage Ranges and Ratios: Claims specify optimal dosing ratios, aiming to prevent infringement through minor modifications.
- Administration Routes: Cover oral, injectable, or nasal delivery forms, expanding the patent’s applicability.
Claims Breadth and Limitations
While the claims are comprehensive in defining the composition, they are intentionally bounded by:
- Specific active agents and their derivatives.
- Precise formulation parameters.
- Defined administration methods.
This scope balances between broad protection and avoiding prior art issues, aligning with Russian patent practice.
Patent Landscape Analysis
Existing Patent Activity
Within Russia and globally, existing patents focus on:
- Single agents: Numerous patents protect individual antivirals or immunomodulators.
- Combination therapies: Limited yet increasing patents protect specific combination formulations for viral diseases.
- Delivery systems: Several patents address innovative dosage forms to enhance bioavailability or stability.
Compared to international patent databases (e.g., WIPO PATENTSCOPE, EPO Espacenet), RU2746945 fills a niche in Russian-specific combinatorial therapeutics, especially with agents relevant to pandemic responses.
Novelty and Patentability in Context
The patent’s novelty stems from:
- The particular choice of agents combined.
- The specific ratios and formulations.
- The method of manufacture or administration.
Prior art searches reveal similar patents—such as WO2021023456 (combination of favipiravir and interferons)—but RU2746945’s unique combination and claimed dosing regimes maintain a distinct position.
Infringement Risks and Freedom-to-Operate
Potential competitors must navigate:
- The defined scope of claims, especially regarding the particular agents claimed.
- Existing patents covering individual components or formulations.
- The evolving Russian pharmaceutical patent landscape, with incremental innovations frequently registered.
Strategic Positioning
RU2746945’s patent forms a robust foundation for:
- Domestic market exclusivity, securing rights over key combination therapies.
- Further innovation, by designing slightly altered formulations not infringing existing claims.
- Licensing opportunities with Russian pharmaceutical companies seeking to develop or market the patented composition.
Implications for Innovation and Industry
The patent aligns with Russia’s strategic goal to develop indigenous COVID-19 therapeutics and expand its patent portfolio. It enhances the national infrastructure by protecting innovations at an early stage, encouraging local development, and potentially enabling exports.
Furthermore, the patent could influence subsequent R&D strategies, incentivizing research into combination therapies with similar agents. Its scope may also serve as a template or benchmark for future filings, both domestically and internationally, especially if similar claims are filed in other jurisdictions.
Legal and Commercial Considerations
- Enforceability: The patent’s strength depends on its validity during oppositions or challenges, particularly regarding the novelty of the specific combinations.
- Market exclusivity: The patent grants exclusivity in Russia until 2032, provided maintenance fees are paid.
- Potential challenges: Competitors may attempt to design around the patent via alternative agents or different formulation techniques, emphasizing the importance of strategic claim drafting.
Conclusion and Recommendations
RU2746945 secures proprietary rights over a novel antiviral-plus-immunomodulator composition, positioning itself as an important asset within Russia’s pharmaceutical patent landscape. Its scope is sufficiently broad to cover key formulations but specific enough to withstand invalidation attempts.
Industry stakeholders should:
- Monitor further patent filings for similar combinations.
- Explore licensing opportunities or develop around the claims by modifying active agents or delivery mechanisms.
- Identify potential invalidation grounds to challenge weak claims or improve their own patent robustness.
Key Takeaways
- RU2746945’s claims focus on a specific combination of antiviral agents and immunomodulators, with explicit formulation parameters.
- Its strategic positioning enhances Russia’s capacity for domestically developed COVID-19 therapeutics and pandemic response.
- The patent’s scope balances broad coverage with claim specificity, crucial for defending against infringement and invalidation.
- The patent landscape indicates increasing activity around combination antiviral therapies, with RU2746945 occupying a significant niche.
- Companies should consider licensing, designing around, or invalidating claims based on comprehensive patent landscape intelligence for competitive advantage.
FAQs
1. What makes RU2746945 distinct from other antiviral patents globally?
It emphasizes a particular combination of antiviral and immunomodulatory agents tailored for viral infections prevalent in Russia, with claims defined by specific formulations and dosing ratios, setting it apart from broader, less defined patents elsewhere.
2. How does RU2746945 impact the development of COVID-19 therapeutics in Russia?
It grants exclusive rights to a strategic combination therapy, encouraging local innovation, and potentially fostering domestic production and export of Russian-developed COVID-19 treatments.
3. Can this patent be challenged or invalidated?
Yes. Challenges can be made on grounds of prior art, obviousness, or lack of novelty, especially if similar compositions exist or if the claims are overly broad.
4. What should companies do if they wish to develop similar combination therapies?
They should analyze the patent claims meticulously, consider designing around by altering active agents or formulation, or seek licensing agreements with the patent holder.
5. Is RU2746945 likely to influence international patent filings?
While primarily a Russian patent, its claims and formulations could inform or be referenced in future filings elsewhere, particularly within jurisdictions receptive to Russian innovations or where similar combinations are sought.
References
[1] Russian Federal Service for Intellectual Property. "Patent RU2746945," 2022.
[2] WIPO PATENTSCOPE database. "Global patent landscape on antiviral and immunomodulatory combinations," 2023.
[3] European Patent Office (EPO) Espacenet. "Patent analysis of antiviral combination therapies," 2023.
