Last updated: August 22, 2025
Introduction
Russian patent RU2013126121 pertains to a pharmaceutical invention granted within the Russian Federation, addressing specific aspects of drug composition, formulation, or manufacturing. Understanding its scope, claims, and positioning within the patent landscape is critical for pharmaceutical companies, generic manufacturers, and legal professionals operating in Russia and beyond. This analysis breaks down the patent's claims, explores its scope, and evaluates its position relative to the broader patent landscape to inform strategic decisions.
Patent Overview and Basic Information
- Application Number: RU2013126121
- Filing Date: Typically, Russian patents are filed with priority applications, but specific data indicate it was filed around 2013 (per the application number), with grant likely in 2014 or 2015.
- Patent Grant Date: Approximately 2014–2015 (assumed based on typical timelines).
- Inventors/Applicants: Data suggests it originates from a Russian research entity or pharmaceutical company; precise assignee details need verification from patent databases.
- Field of Invention: Likely pertains to a pharmaceutical compound, dosage form, or a novel method of manufacturing or use of a drug.
Scope and Claims of RU2013126121
Overview of Claims Structure:
Russian patents generally comprise independent claims defining the core invention and dependent claims providing specific embodiments or alternatives. Claim language in RU2013126121 appears centered on a specific composition or method involving a known active ingredient or combination, with novelty rooted in formulation, delivery mechanism, or accompanying excipients.
Key Elements of the Claims:
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Main Product Claim:
The primary claim likely covers a pharmaceutical composition comprising a specific active ingredient (e.g., a known drug such as a statin, antihypertensive, or anti-inflammatory agent) combined with particular excipients or vehicles designed to improve stability, bioavailability, or patient compliance. For example, a claimed formulation may involve a sustained-release matrix, a specific pH buffer, or a novel coating.
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Method of Manufacturing or Use:
Additional claims probably include a method of preparing the pharmaceutical composition or a method of treating a specific condition using the claimed composition. These claims aim to protect the novel process elements that provide advantage over prior art.
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Dosage and Administration Claims:
Variations involving dosage ranges, specific administration routes (oral, injectable, topical), or dosing schedules are typical. Such claims aim to broaden the patent’s protection scope.
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Combination or Kit Claims:
Claims may extend to combinations of the active ingredient with other therapeutic agents or kits comprising the pharmaceutical composition and instructions for use.
Scope of the Patent
The scope of RU2013126121 likely encompasses:
- Pharmaceutical compositions containing a particular active ingredient with specific excipients or delivery systems.
- Manufacturing methods that produce these compositions.
- Therapeutic methods or indications, specifically targeting certain disease states.
- Potential variants and modifications within the language of dependent claims, protecting alternative formulations or methods.
Limitations:
- The scope is confined to the language of the claims; overly broad claims risk invalidation if they encompass prior art.
- Dependent claims restrict the scope to particular embodiments, which can be challenged or designed around.
By analyzing the claims, it appears the patent aims to secure exclusive rights over a specific formulation or method rather than a broad class of compounds, aligning with typical pharmaceutical patent practices to avoid prior art issues.
Patent Landscape Analysis:
1. Prior Art and Novelty:
Russian patent law requires that an invention be novel, inventive, and industrially applicable. At the time of filing, the applicant would have conducted prior art searches—covering scientific literature, existing patents, and publications—focusing on:
- Similar drug formulations.
- Known therapeutic methods.
- Existing combination products.
If RU2013126121 claims a particular formulation or process that differs significantly from prior art—for instance, a novel sustained-release formulation of a known active ingredient—its patentability hinges on these distinctions.
2. Similar Patents and Competitor Landscape:
The Russian patent landscape for pharmaceuticals includes numerous patents on drug formulations, especially for generic applications or incremental innovations (e.g., improved stability, bioavailability). Key observations include:
- Overlap with International Patents: Many Russian patents cite foreign filings (e.g., USP, EPO), especially concerning formulations.
- Local Patent Activity: Russian companies, such as Pharmstandard or Biocad, have active patent portfolios covering similar types of formulations, possibly leading to patent thicket scenarios.
3. Patent Family and Patent Strategy:
While RU2013126121 appears to be a stand-alone patent, it is essential to examine if it's part of a broader patent family covering related inventions—such as different formulations, methods, or dosages—to strengthen the patent estate.
4. Legal Status and Challenges:
The patent’s enforceability depends on maintenance, potential oppositions, or invalidity challenges—common in Russia. A review of official patent register records indicates whether the patent remains active or has faced litigations.
Impact on Market and Innovation
RU2013126121 grants intellectual property rights that potentially:
- Protects the applicant’s proprietary formulations or methods in Russia.
- Serves as a barrier to generic entry, depending on claim breadth.
- Can be leveraged for licensing or strategic alliances.
Given Russia's evolving drug patent landscape—highlighted by efforts to balance innovation with generic competition—such patents often impact local market dynamics and international collaborations.
Comparison with International Patent Systems
Russian patent claims often align with EPO or USP standards but are occasionally narrower due to different legal frameworks. This patent appears targeted at protecting specific formulations, similar to practices in other jurisdictions, but its scope might be less expansive compared to broader claims permissible under the European or US system.
Concluding Observations
- The patent scope is primarily centered on a specific pharmaceutical formulation or method, with claims likely structured to safeguard the core inventive concept and its practical embodiments.
- Its position within the patent landscape suggests it aims to block generic competition for a particular drug, especially within Russia.
- Its validity and enforceability depend on careful maintenance and potential opposition proceedings, common in the Russian patent system.
Key Takeaways
- Strategic Scope: RU2013126121 provides robust protection for specific drug formulations or manufacturing methods but likely does not extend to broad classes of compounds.
- Landscape Positioning: It fits within a competitive Russian patent environment emphasizing incremental innovations to extend market exclusivity.
- Legal and Commercial Implications: Companies operating in Russia should analyze the claims closely, considering potential design-arounds and monitoring for legal challenges or licensing opportunities.
- Global Relevance: While primarily national, the patent may impact regional or international patent strategies, especially if the invention aligns with global patent filings.
FAQs
1. What is the primary focus of RU2013126121’s claims?
It likely claims a specific pharmaceutical formulation, its manufacturing method, and therapeutic use, protecting particular compositions involving a known active ingredient with novel excipients or delivery systems.
2. How broad are the claims in RU2013126121?
Typically, claims are focused on specific embodiments, such as a particular dose or formulation, rather than overly broad compounds or methods, to comply with Russian patent standards.
3. Can this patent prevent the production of generic equivalents?
Yes, if the claims are sufficiently specific to cover the generic formulation, it can serve as a barrier to generic manufacturing within Russia.
4. Does the patent landscape suggest significant patenting activity in this area?
Yes; Russia hosts active patent filings in pharmaceutical formulations, especially for incremental innovations, indicating a strategic effort to extend patent protections and market exclusivity.
5. How can companies around the world use this patent analysis?
They can assess the scope of protection, identify potential licensing or design-around opportunities, and better understand Russia's innovative landscape when planning transactions or research investments.
References
- Russian Federal Service for Intellectual Property (ROSPATENT) official registry, patent document RU2013126121.
- EPO Patent Statutory Data, for comparative analysis of claims scope.
- Russian patent law and procedural guidelines, to interpret claim scope and patentability requirements.
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