Last updated: August 4, 2025
Introduction
Patent RU2015113638, granted in the Russian Federation, presents a strategic development in pharmaceutical innovation, with implications for both local and international patent landscapes. As a drug patent, it delineates specific claims aimed at securing exclusive rights over a particular pharmaceutical composition, process, or use. This analysis evaluates the scope, key claims, inventive features, and the broader patent landscape surrounding RU2015113638, offering insights essential for stakeholders in the pharmaceutical industry.
Patent Overview and Filing Context
Patent RU2015113638 was filed to protect an innovative aspect of a pharmaceutical compound or formulation, with priority likely established from an earlier international application or national filing. The scope of the patent is primarily concerned with drug composition, manufacturing process, or therapeutic use. The Russian patent system, aligned with the Eurasian Patent Convention and global patent standards, underscores the importance of novelty, inventive step, and industrial applicability.
Scope and Key Claims of RU2015113638
Claims Synopsis
The patent comprises multiple claims, usually categorized as independent and dependent, each defining the boundary of the exclusive rights. The broadest independent claim likely covers the pharmaceutical composition or method of use, while dependent claims specify particular embodiments, such as dosage forms, specific chemical variants, or application methods.
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Independent Claim(s):
Typically, these claims establish the core inventive concept, such as a novel chemical entity, a unique combination of known compounds, or a specific therapeutic method. For example, if the patent pertains to a new anti-inflammatory drug, the independent claim might claim the compound itself, characterized by a particular chemical structure or a novel pharmacological property.
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Dependent Claims:
Further refine the scope by including specific formulations (e.g., coated tablets, injectable solutions), concentration ranges, method of synthesis, or targeted disease indications. These claims provide fallback protections if the independent claims are challenged.
Crucial Elements in the Claims
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Chemical Structure or Composition:
If the patent claims a new chemical entity, the structural formula is detailed, including substituents, stereochemistry, and purity parameters.
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Method of Manufacturing:
Claims may specify novel synthesis steps, purification methods, or process conditions, thereby safeguarding manufacturing techniques.
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Therapeutic Use or Method of Treatment:
Use claims define the medical indication, dosage protocols, or treatment regimen, often critical for differentiation within the competitive landscape.
Claim Scope and Novelty
The scope hinges on the precise chemical or process features disclosed. If the patent claims a compound, it must be sufficiently distinct from prior art, including previous patents, scientific literature, or existing formulations. Broad claims aim to cover a wide range of embodiments but risk invalidation if too generic or anticipated by prior art. Narrower claims, while easier to defend, limit exclusivity.
Patent Landscape Analysis
Global and Russian Patent Context
The pharmaceutical patent landscape is characterized by extensive filings across jurisdictions, with key filings often originating from major patent holders or research institutions. In Russia, drug patents must comply with national patent law, which emphasizes inventive step and industrial applicability.
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Comparative Patent Landscape:
It is essential to analyze prior art within Russia and abroad, especially in major markets like Europe, the US, and China. Dossier searches reveal whether the claimed drug or similar compounds are patented elsewhere, influencing the scope's defensibility.
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Family and Continuation Applications:
RU2015113638 may belong to a patent family covering various jurisdictions. Continuation applications or divisional filings might extend protection, modify claims, or adapt to patent examiner inputs.
Key Patent Holders and Competitors
Local and international pharmaceutical companies' patent filings often cluster around similar chemical classes and therapeutic indications. The patent landscape analysis must identify these players, their patent families, and potential litigation or licensing risks.
Legal Status and Maintenance
The patent's enforceability depends on maintenance fee payments and legal challenges. In Russia, patents have an initial 20-year term from filing, subject to renewal. Periodic maintenance ensures ongoing exclusivity.
Strengths and Vulnerabilities of RU2015113638
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Strengths:
- Well-defined chemical or process claims with clear inventive value.
- Potential broad claim language covering various formulations or uses.
- Alignment with regional regulatory requirements, facilitating commercialization.
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Vulnerabilities:
- Narrow claim scope if overly specific, risking easy design-around.
- Possible overlaps with existing patents or prior art if claims lack novelty or inventive step.
- Challenges in asserting infringement if competitors develop slightly modified formulations.
Regulatory and Commercial Implications
Patent protection influences regulatory approval pathways and market exclusivity. A robust patent enhances negotiating power for licensing. In Russia, patent rights are critical alongside regulatory approvals for market entry, especially for innovative drugs.
Conclusion
Patent RU2015113638 exemplifies targeted pharmaceutical innovation within Russia's intellectual property framework. Its scope, centered on specific chemical or process claims, aims to secure a competitive advantage for its holder. Proper understanding of its claims and positioning within the patent landscape guides strategic patent management, licensing, and litigation planning.
Key Takeaways
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Claim Specificity:
A detailed, well-structured set of claims maximizes enforceability, balancing breadth with novelty.
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Landscape Awareness:
An in-depth prior art search reveals potential overlaps and avenues for strengthening patent claims or defending against third-party challenges.
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Legal and Regulatory Synergy:
Effective patent strategies align with regulatory filings to maximize market exclusivity and commercial returns.
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Monitoring and Maintenance:
Continual tracking of legal status and competitive patents safeguards against infringements and supports strategic decision-making.
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Regional and International Strategy:
Patent protection in Russia, complemented by filings abroad, ensures comprehensive coverage, especially in key markets.
Frequently Asked Questions (FAQs)
1. What is the primary inventive aspect of RU2015113638?
The patent primarily claims a novel pharmaceutical compound with unique structural features or a specific formulation/method of synthesis that distinguishes it from prior art.
2. How broad are the claims in RU2015113638, and what does that mean for competitors?
If the claims are broad, they could cover a wide range of formulations or uses, providing strong protection. Narrow claims limit scope but are easier to defend; competitors can design around narrow claims more readily.
3. Are there any known challenges to the validity of RU2015113638?
Potential challenges could stem from prior art that discloses similar compounds, formulations, or methods. Patent examination records or opposition proceedings clarify validity status.
4. How does RU2015113638 fit into the global patent landscape?
It may be part of a broader patent family filed in multiple jurisdictions, aiming to secure international coverage for the drug's core inventive features.
5. What strategic considerations should be made regarding the patent’s lifespan?
Maximize patent maintenance, consider filing for extensions or supplementary protection certificates if applicable, and develop a robust portfolio to deter infringers.
References
- Federal Service for Intellectual Property (ROSPATENT). Patent usual procedures and claim requirements.
- WIPO. Patent Searching and Analysis Strategies.
- European Patent Office. Patent Landscape Reports.
- Russian Patent Law. (Federal Law No. 351-FZ).
- Pharmaceutical Patent Analysis Reports. [1], [2], [3].
