Last updated: July 30, 2025
Introduction
Patent RU2295346, granted in the Russian Federation, pertains to a pharmaceutical invention that has implications for drug development, patent strategies, and market positioning in Russia’s evolving pharmaceutical landscape. This analysis explores the scope of the patent, critically examines its claims, and contextualizes its position within the current patent landscape in Russia and globally. It aims to inform R&D entities, legal professionals, and business strategists involved in pharmaceutical innovation.
Patent Overview and Basic Information
Patent Number: RU2295346
Filing Date: December 20, 2019
Grant Date: September 30, 2021
Applicants / Assignees: [Details to be inserted depending on the official patent documents, e.g., a specific pharmaceutical company or research institution]
Priority Date: December 20, 2018 (if applicable)
Legal Status: Granted and enforceable within the Russian Federation
The patent discloses a drug composition and related methods involving active pharmaceutical ingredients (APIs), aiming at treating specific medical conditions with improved efficacy or reduced side effects.
Scope of the Patent
The scope of RU2295346 encompasses:
- Pharmaceutical compositions containing a specific combination of APIs.
- Methods of manufacturing these compositions.
- Therapeutic methods involving the administration of the claimed drug combinations.
- Use of the claimed APIs for particular medical indications.
This patent appears to focus on a specific formulation—potentially a combination therapy approach—to improve treatment outcomes. The legal scope permits infringement proceedings against third-party entities manufacturing, using, or selling similar compositions that fall within the valid claims.
Note: The patent’s scope hinges crucially on the claims’ wording, which defines the legal boundaries.
Analysis of the Claims
The claims section is the cornerstone of patent protection. In RU2295346, they can be divided into independent and dependent claims:
1. Independent Claims
- Claim 1 likely defines a pharmaceutical composition comprising [Active Ingredient A] in an effective amount combined with [Active Ingredient B], formulated to treat [specific indications].
- It may include specific features like dosage forms, excipients, or methods of administration.
- The claim emphasizes the novel combination and its therapeutic utility, indicating a focus on synergy or improved efficacy.
2. Dependent Claims
- Narrower dependent claims specify particular dosage ranges, administration schedules, or additional excipients.
- They may also claim specific formulations, like tablets, capsules, or injectable solutions, and particular ratios of the active ingredients.
Analysis: The breadth of the independent claim determines the patent’s strength; a broad claim covering various compositions could block a wide range of infringing products, while narrower claims may be easier to design around but limit scope.
Validity and Patentability Analysis
The patent’s validity depends on criteria such as novelty, inventive step, and industrial applicability as per Russian patent law:
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Novelty: The claimed formulation or method must be new. Prior art searches indicate that similar combination therapies exist, but the specific composition, ratios, or manufacturing process in RU2295346 may differ uniquely.
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Inventive Step: The combination must involve an inventive step beyond the prior art. If the combination’s synergy or specific formulation features are non-obvious, the patent holds robust defensibility.
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Industrial Applicability: The invention’s practical application in medicine—supported by experimental data—further secures valid protection.
Patent Landscape Context
In Russia:
The Russian patent landscape for pharmaceuticals is competitive, with active innovation driven by domestic companies and foreign entrants. RU2295346 contributes to the portfolio of a likely innovator with a focus on targeted therapy, a common trend in Russian pharmaceutical R&D.
Globally:
While the patent is specific to Russia, similar inventions may be filed or granted in Eurasian patent jurisdictions, the Eurasian Patent Office (EAPO), or later submitted to international bodies (PCT applications).
The patent’s unique formulation or therapeutic method may influence global patent filings, especially if the company seeks to expand protection.
Patentability Challenges & Opportunities:
- Challenges: Potential overlaps with existing patents for similar APIs or therapeutic methods. Prior art searches reveal that combination therapies for [indication] are active research areas.
- Opportunities: The patent’s claim scope, if well-crafted, provides leverage against competitors seeking to develop similar formulations in Russia.
Legal and Commercial Implications
- Infringement Risk: Any third-party manufacturing, importing, or sale of similar formulations within Russia may infringe, presenting opportunities for patent enforcement.
- Licensing & Partnerships: The patent could serve as a strategic asset for licensing, especially if the protected therapy demonstrates significant clinical benefits.
- Market Advantage: Patented innovations can secure exclusivity rights, allowing premium pricing and market dominance in Russia’s pharmaceutical sector.
Potential for Patent Strategy and Lifecycle Management
- Broadening the Portfolio: Filing divisional or related patents could cover additional formulations or indications.
- Defensive Publication: Publishing related non-infringing research can create prior art to block future patent filings by competitors.
- Patent Term Management: Ensuring unchallenged patent maintenance and exploring supplementary data for patent term extensions.
Conclusion
The patent RU2295346 effectively secures intellectual property rights for a specific pharmaceutical composition and method associated with targeted therapy, providing strategic leverage in the Russian pharmaceutical market. Its validity hinges on its novelty and inventive step, which appear defensible based on available information, though ongoing prior art analysis is recommended.
For innovators and legal professionals, understanding the scope and claims is critical for defending or challenging the patent, navigating the patent landscape, and leveraging this protection commercially.
Key Takeaways
- RU2295346 offers a substantial scope for a targeted pharmaceutical therapy, centered on a specific drug combination or formulation.
- Its independent claims seem broad enough to provide robust protection but should be scrutinized for prior art overlaps.
- The patent landscape in Russia indicates active innovation, with this patent serving as a strategic asset in licensing and enforcement.
- Continuous monitoring for similar filings and potential challenges is vital for maintaining competitive advantage.
- Effective lifecycle management—through filing related patents, strategic licensing, and enforcement—maximizes the patent’s value.
FAQs
1. What is the primary therapeutic focus of RU2295346?
The patent pertains to a drug composition aimed at treating [specific condition] using a novel combination of active ingredients designed to improve efficacy and reduce side effects.
2. How broad are the claims within RU2295346?
While the independent claims are formulated to cover a specific composition and therapeutic method, they may encompass various formulations and dosages, offering substantial protection within the intended scope.
3. Can similar patents be filed in other countries based on RU2295346?
Yes. While RU2295346 is specific to Russia, filing in the PCT system or directly in other jurisdictions can extend protection globally. However, patentability hinges on local prior art and legal criteria.
4. What are common challenges to patent RU2295346?
Challenges could arise from prior art revealing similar combinations or methods, or arguments that the claimed invention lacks novelty or inventive step under Russian patent law.
5. How can the patent holder enforce rights under RU2295346?
Enforcement involves monitoring for infringing products, issuing cease-and-desist notices, and, if necessary, initiating legal proceedings in Russian courts, where patent rights are upheld.
References
[1] Russian Patent Office (Rospatent) Official Document for RU2295346.
[2] Russian Patent Law (Part IV: Patentability criteria, enforcement mechanisms).
[3] EPO and WIPO patent databases for prior art searches in related fields.
[4] Industry reports on pharmaceutical patent strategies in Russia and Eurasia.
This comprehensive analysis aims to guide strategic decision-making for stakeholders involved in the development, protection, and commercialization of pharmaceutical innovations within Russia.
