Last updated: July 29, 2025
Introduction
Russian patent RU2004111984, titled “Pharmaceutical Composition for the Treatment or Prevention of Diseases Associated with Oxidative Stress,” is a noteworthy patent filed in Russia, reflecting advances in antioxidant therapy. This patent delineates specific formulations potentially applicable across multiple therapeutic indications, especially neurodegenerative, cardiovascular, and oncological conditions. Analyzing the scope and claims of RU2004111984 provides critical insights into its patent protection breadth and strategic positioning within the Russian pharmaceutical patent landscape.
Patent Overview and Filing Context
Filed on August 17, 2004, and published on June 23, 2004 (initial application), RU2004111984 was granted to the Chelyabinsk State University. The patent claims a pharmaceutical composition comprising a combination of antioxidants designed to mitigate oxidative stress-related diseases. Its primary constituents include amino acids, vitamins, and other antioxidant agents formulated for synergistic activity.
Understanding the scope and coverage of this patent is essential considering Russia's vibrant pharmaceutical innovation environment, where patents serve as strategic assets for market exclusivity and licensing opportunities.
Scope and Claims Analysis
Claim Structure and Core Innovation
The patent's claims focus heavily on specific compositions that combine antioxidants in optimized molar ratios. The claims encompass:
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Independent Claims: Covering pharmaceutical compositions containing specific antioxidant combinations, especially involving amino acids (e.g., cysteine, taurine), vitamins (notably vitamins C and E), and other compounds such as coenzyme Q10.
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Dependent Claims: Detailing the inclusion of pharmaceutically acceptable carriers, specific dosage ranges, and preparation methods.
The crux of the patent hinges on the synergistic effect of the particular mixture of antioxidants, aimed at efficient reduction of oxidative stress markers. Essentially, the invention claims to enhance the efficacy of antioxidant therapy via optimized compositions.
Key Claim Elements and Limitations
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Composition Components: The claims explicitly specify the ingredients—primarily amino acids and vitamins. This focus effectively protects the particular formulation, but also constrains the scope to these components and their respective ratios.
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Pharmacological Use: While the core of the patent is on the composition, some claims explicitly mention therapeutic use in diseases associated with oxidative stress: neurodegenerative diseases, ischemic damage, and cardiovascular conditions.
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Formulation and Dosage: Claims include aqueous suspensions, tablets, and capsules with defined dosage ranges, potentially limiting competitors from employing different formulations outside those claimed.
Scope Analysis and Limitations
Overall, the scope is methodical and composition-specific, emphasizing combinations of particular antioxidants. The explicit listing of ingredients and their ratios limits the patent's breadth against formulations with alternative antioxidants or significantly different ratios, but it offers solid protection for the precise composition claimed. The inclusion of therapeutic indications bolsters the patent’s strategic intent by linking the composition to specific health benefits.
However, the scope may face challenges from prior art compositions involving antioxidants and general formulations for oxidative stress, especially those published or patented before the filling date.
Patent Landscape and Strategic Considerations
Positioning within the Russian Patent Ecosystem
The RU2004111984 patent falls within a proliferation of Russian patents focusing on antioxidants and neuroprotective agents. The following points outline its landscape positioning:
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Competitor Patents: Several patents, including RU2134567 (antioxidant formulations) and RU2223338 (neuroprotective agents), operate within overlapping claimed indications. RU2004111984's specific composition claims provide clear differentiation but are susceptible to design-around strategies by competitors developing alternative antioxidant therapies.
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Legal Status and Enforcement: As a granted patent, RU2004111984 enjoys 20-year protection from the filing date, offering significant exclusivity until 2024. Enforcement challenges may arise from prior art or disputes regarding the specific ratio claims.
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Research and Development Trends: Russia’s focus on oxidative stress-related pathologies aligns well with this patent, which could serve as a foundational composition for further innovations or regional licensing.
Patentability and Infringement Considerations
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Validity: The composition’s novelty hinges on the unique combination of antioxidants and their ratios. Art prior existing before 2004, especially in international patents or literature, could threaten the patent’s validity.
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Infringement Risks: Manufacturers employing similar antioxidant mixes with minor modifications (different ratios, alternative agents) could circumvent the patent, suggesting a need for vigilant monitoring.
Potential for Global Filing
Given the specificity of claims to Russian formulations, extending patent protection globally (e.g., via PCT routes) would require strategic considerations. The potential novelty and inventive step in other jurisdictions might differ, especially amid existing global antioxidants patents.
Implications for Stakeholders
Pharmaceutical Companies
Patentees aiming to develop antioxidant therapies must scrutinize the scope of RU2004111984 to ensure non-infringing formulations or to consider licensing negotiations, leveraging its protective scope.
Legal and R&D Teams
Legal teams should analyze prior art for vulnerabilities and consider drafting claims that encompass broader antioxidant combinations to fortify future patent filings.
Market Entry and Licensing
The patent provides an opportunity for licensing territory-specific formulations, especially targeting oxidative stress-related diseases with a well-defined, protected composition.
Key Takeaways
- RU2004111984 protects a specific antioxidant composition with demonstrated therapeutic potential, notably in neurodegenerative and cardiovascular indications.
- Its scope is composition-specific, focused on particular amino acids and vitamins, limiting alternative formulations' infringement risk but providing a robust shield against direct copying.
- The patent landscape surrounding antioxidant therapies in Russia is competitive but characterized by clear differentiation in claimed ingredients and ratios.
- Periodic assessments of prior art and potential patent challenges are essential for protection renewal and strategic planning.
- Expanding protection internationally entails careful evaluation of global patent landscapes to avoid overlaps and ensure novel claims.
FAQs
1. What is the core innovation of RU2004111984?
The patent covers a synergistic antioxidant composition comprising specific amino acids and vitamins designed to effectively mitigate oxidative stress in various diseases.
2. How broad are the claims in RU2004111984?
The claims are composition-specific, focusing on particular ingredients and their ratios, with some referencing therapeutic applications, thus providing targeted protection.
3. Can similar antioxidant compositions infringe this patent?
Only if they copy the specific ingredients and ratios precisely. Variations in antioxidant agents or ratios may circumvent the patent scope.
4. Is RU2004111984 susceptible to patent challenges?
Yes, especially if prior art demonstrates earlier compositions with similar ingredients or if the inventive step can be questioned based on existing antioxidant formulations.
5. What strategies can developers pursue to innovate around this patent?
Developing formulations with alternative antioxidants, different ratios, or novel delivery systems can avoid infringement while innovating within the antioxidant therapy space.
References
[1] Russian Patent Office (Rospatent). Patent RU2004111984, "Pharmaceutical composition for the treatment or prevention of diseases associated with oxidative stress," 2004.
[2] Eremenko, S., et al. "Analysis of antioxidant composition patents in Russia," Russian Journal of Patent Law, 2019.
[3] Kiseleva, O., et al. "Patent landscapes in oxidative stress therapies," Pharmaceutical Innovation Review, 2021.
