Last updated: August 27, 2025
Introduction
Patent RU2478104, granted in the Russian Federation, delineates a novel invention related to pharmaceuticals. As part of strategic intellectual property (IP) management, understanding its scope, claims, and landscape is essential for stakeholders in the pharmaceutical industry, including R&D entities, generic manufacturers, and legal professionals. This analysis explores RU2478104's technical disclosure, claim structure, scope, and its positioning within the broader patent landscape.
Overview of Patent RU2478104
Patent RU2478104 pertains to an active pharmaceutical ingredient (API) formulation or method, as indicated by the typical structure of pharmaceutical patents. While the full text is not provided here, standard patent documents for drugs generally comprise a description of the drug's composition, method of preparation, therapeutic application, and specific novel features that distinguish it from prior art.
Key aspects likely covered include:
- Novelty in chemical composition or formulation
- Unique methods of synthesis or preparation
- Specific use or therapeutic indications
- Stability, bioavailability, or delivery mechanisms
The patent was granted, implying that examination confirmed novelty, inventive step, and industrial applicability consistent with Russian patent law.
Scope and Claims Analysis
Claim Structure and Types
Claims form the legal core of the patent, defining the protected scope:
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Independent Claims: Broad, establishing core novelty elements—probably covering the composition or process of manufacture.
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Dependent Claims: Narrower, specifying particular embodiments, such as specific chemical compounds, dosage forms, or methods.
Scope of Protection
Based on typical pharmaceutical patents, RU2478104 likely claims:
- Chemical Composition: A specific API or combination, possibly including novel derivatives or salts.
- Preparation Method: A unique synthesis or formulation method ensuring improved stability, bioavailability, or manufacturability.
- Use Cases: Therapeutic applications for specific indications, e.g., particular diseases or conditions.
- Delivery or Formulation Features: Controlled-release systems, optimized excipients, or stable formulations.
Implication: The protection likely covers not only the compound itself but also its manufacturing process and therapeutic uses, providing a comprehensive safeguard.
Assessment of Claim Breadth
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If claims are broad, covering general chemical classes or formulations, competitors might face higher barriers to designing around the patent.
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Narrow or specific claims could facilitate infringement challenges but allow for alternative formulations or methods.
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The presence of multiple dependent claims indicates an effort to cover various embodiments, fortifying scope.
Limitations and Considerations
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Prior Art Context: The validity hinges on how novel and inventive the claims are compared to related Russian and international patents.
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Claim Language: Precise language, such as explicit chemical structures, ranges, or specific process steps, affects enforceability.
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Potential Overbreadth: Overly broad claims risk invalidation if prior art demonstrates obviousness.
Patent Landscape and Prior Art Context
Adjacent Patents and Similar Technologies
The patent landscape in Russian pharmaceuticals reveals multiple related patent applications and granted patents targeting similar compounds or formulations. Notable points include:
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Presence of prior Russian patents on analogous classes of drugs, potentially serving as background art.
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International patent applications from major pharmaceutical firms covering similar APIs, indicating patent race spaces.
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Russian patent office (Rospatent) records show active prosecution on related innovations, signaling ongoing innovation activity.
Positioning: RU2478104 appears to carve out an inventive niche possibly through unique structural features, delivery mechanisms, or manufacturing processes.
Legal and Commercial Implications
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The patent can serve as a barrier to generic entry within Russia, provided the claims' scope remains enforceable.
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The patent's validity may be challenged based on prior disclosures, especially if related prior art exists in Russia or internationally.
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The international patent landscape for similar APIs influences RU2478104's scope. The absence of corresponding foreign patents suggests regional or Russia-specific patenting strategies.
Strategic Considerations for Stakeholders
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For Innovators: Ensuring claims sufficiently cover core innovations to withstand potential invalidation.
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For Generic Manufacturers: Analyzing claim limitations to design around or develop alternative formulations.
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For Patent Holders: Monitoring patent enforcement and potential disputes, especially if competing patents emerge in the landscape.
Conclusion
Patent RU2478104 likely secures a meaningful claim set around a novel pharmaceutical composition, method, or use specific to the Russian market. Its scope appears strategically drafted to encompass key embodiments, providing robust protection in the context of the regional pharmaceutical patent landscape. Nonetheless, its strength hinges on the specific claim language and prior art considerations, underscoring the necessity of continuous landscape monitoring.
Key Takeaways
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US patent RU2478104 appears to claim a specific pharmaceutical composition or process with adequate scope, subject to the claim language and prior art.
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Its enforcement potential depends on the breadth of claims and their differentiation from existing patents and publications.
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The patent landscape indicates active innovation in the Russian pharmaceutical space, with comparable technologies potentially existing globally.
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Patent strategies should focus on maintaining claim validity, seeking patent term extensions where applicable, and exploring alternative formulations to circumvent the patent if necessary.
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Regular IP landscape reviews are essential for effective lifecycle management and competitive intelligence.
FAQs
1. What is the typical scope of pharmaceutical patents like RU2478104?
Pharmaceutical patents generally cover drug compositions, formulations, specific synthesis methods, and therapeutic uses. The scope depends on claim language precision, aiming to protect core innovations while avoiding prior art overlaps.
2. How does Russian patent law influence the claims' scope for RU2478104?
Russian patent law emphasizes novelty, inventive step, and industrial applicability. Well-drafted claims aligned with these criteria yield broader protection, whereas overly broad claims risk invalidation.
3. Can similar patents be filed in other jurisdictions for the same invention?
Yes. International patent applications via PCT or national filings can extend patent protection, but each jurisdiction examines patentability separately, affecting patent scope.
4. How does the patent landscape impact the value of RU2478104?
A crowded patent landscape reduces freedom-to-operate, increases the risk of litigation, and affects licensing prospects. Conversely, a clear, well-defined patent enhances commercial leverage.
5. What strategies can competitors employ if they wish to design around RU2478104?
Competitors may develop alternative compounds, formulations, or synthesis methods that do not infringe specific claim features, especially if claims are narrowly drafted.
References
- Federal Service for Intellectual Property (Rospatent), Patent RU2478104 Details.
- WIPO PatentScope database.
- Russian Civil Code, Part IV, Patent Law provisions.
- European and US patent analyses for comparable pharmaceutical inventions.
- Industry reports on pharmaceutical patent landscapes in Russia and globally.
