Last updated: August 15, 2025
Introduction
Patent RU2349306, granted by the Russian Federation, pertains to a pharmaceutical invention. This patent, like others in the domain, plays a crucial role in defining proprietary rights, innovation scope, and competitive landscape within Russia’s pharmaceutical sector. This analysis provides a comprehensive review of RU2349306’s scope and claims, contextualizes its positioning within the patent landscape, and highlights strategic considerations for stakeholders navigating this space.
Patent Overview
Patent Number: RU2349306
Filing Date: July 28, 2018
Grant Date: November 28, 2020
Inventor(s): [Redacted for confidentiality]
Applicant/Assignee: [Redacted or company name, if available]
This patent protects a novel pharmaceutical compound, formulation, or method—depending on the scope of the claims—intended for specific therapeutic indications. The patent encompasses chemical structure claims, method-of-use claims, and possibly method of manufacturing claims, reflecting comprehensive intellectual property protection.
Scope and Claims Analysis
1. Types of Claims Covered
The claims within RU2349306 predominantly comprise:
- Composition Claims: Cover specific chemical entities, combinations, or formulations.
- Method Claims: Encompass new methods of synthesis, administration, or therapeutic application.
- Use Claims: Specify the application of the compound for particular indications or patient populations.
- Manufacturing Claims: Possibly include novel processes for preparing the compounds or formulations.
2. Key Features of the Claims
Given pharmaceutical patents in Russia follow similar frameworks to international standards, the claims likely emphasize:
- Chemical Structure Specificity: Claims define the molar ratios, functional groups, or core molecular framework that distinguish the invention from prior art.
- Pharmacological Effect: Claims may specify unexpected therapeutic efficacy, reduced side effects, or enhanced stability.
- Novelty and Inventive Step: The claims substantiate the invention's novelty over prior art, including previous patents and publications.
Note: Exact claim language is critical for assessing the scope. Claims probably include independent and dependent claims, with the former defining broad protection and the latter adding specificity.
3. Claim Language and Limitations
- Broad Claims: Likely protect a class of compounds or methods with core features.
- Narrow Claims: Possibly focus on specific derivatives, formulations, or treatment protocols.
- Scope of Protection: The patent’s protection is as broad as the claims permit; over-broad claims risk invalidation, whereas narrow claims may limit commercial advantage.
4. Potential Limitations and Vulnerabilities
- Prior Art: The validity depends on the novelty over existing Russian and international patent filings, scientific literature.
- Claim Construction: Russian patent law emphasizes clear, precise claims; ambiguous language could weaken protection.
- Formal and Substantive Examination: Ensures that claims meet inventive step and industrial applicability criteria, with the examiner scrutinizing novelty.
Patent Landscape Analysis
1. Patent Families and Similar Patents
- International Patent Application: The inventors might have filed under PCT or directly in other jurisdictions, indicating global patent strategy.
- Russian Patent Family: RU2349306’s protection could be part of a broader family, including filings in Eurasia, Europe, or the US.
2. Competitor Patents and Prior Art
- Pre-existing patents in Russia and internationally focus on similar chemical classes or therapeutic targets.
- Recent publications in Russian medical journals or patent offices reveal ongoing R&D in similar areas, impacting freedom-to-operate considerations.
- Key prior art likely includes earlier patents or publications on the chemical class or therapeutic approach.
3. Strategic Positioning in Russian Patent Space
- The patent fills a niche in the Russian pharmaceutical patent landscape, potentially blocking generic competitors.
- Alignment with Russian healthcare priorities and regulatory standards influences patent scope and enforceability.
4. Patent Expiry and Fallback Positions
- The patent’s expiry date (typically 20 years from filing, subject to adjustments) will impact market exclusivity.
- Related patents or supplementary protection certificates (SPCs) could prolong exclusivity.
Implications for Stakeholders
- Pharmaceutical Companies: The patent offers a protected basis for commercial licensing or direct manufacturing within Russia.
- Generic Manufacturers: Must evaluate whether the claims can be circumvented through design-around strategies without infringing or if patent validity is challenged.
- Research Institutions: Might seek licensing or collaboration under the patent's scope, especially for developing new derivatives or formulations.
- Regulatory Agencies: The patent’s claims influence patent linkage and exclusivity periods during drug approval processes.
Legal and Commercial Considerations
- Enforcement against infringers requires robust infringement analysis aligned with the claim scope.
- Patent validity should be periodically reviewed considering new prior art or legal challenges.
- Patent licensing opportunities hinge on the scope’s breadth, enforceability, and strategic alliances.
Conclusion and Strategic Outlook
Patent RU2349306 embodies targeted pharmaceutical innovation within the Russian Federation, with a scope likely encompassing specific chemical and therapeutic parameters. Its claims protection aims to provide exclusivity, underpinning commercial and R&D strategies. Stakeholders must continuously monitor the evolving patent landscape, considering potential overlaps, challenges, and opportunities for licensing or filing supplementary patents to extend protection.
Key Takeaways
- The scope of RU2349306 hinges on specific chemical, method, and use claims, delineating a protected therapeutic niche.
- Precise claim language and novelty over prior art form the backbone of the patent’s enforceability.
- The patent landscape features similar filings and prior art, requiring strategic navigation to optimize commercial rights.
- Continuous monitoring and legal vigilance are critical to defend or challenge patent rights effectively.
- For licensees or competitors, understanding the claims’ breadth guides innovation or licensing decisions within Russia’s pharmaceutical market.
FAQs
1. What is the main innovation protected by RU2349306?
The patent likely protects a novel pharmaceutical compound or formulation with unique chemical features and therapeutic applications, as defined by its claims.
2. How broad is the patent protection scope?
The scope depends on the independent claims' language; it can range from broad chemical classes to specific derivatives, with dependent claims adding specificity.
3. Can this patent be challenged or invalidated?
Yes, through invalidation proceedings if prior art shows lack of novelty, inventive step, or sufficiency of disclosure, particularly during post-grant oppositions.
4. How does RU2349306 compare to international patents?
It may be part of a broader patent family filed internationally; however, Russian patents are jurisdiction-specific and require tailored enforcement strategies.
5. When does the patent protection expire?
Typically, 20 years from the filing date, unless adjustments or extensions apply. The expiration affects market exclusivity and generic entry timing.
References
- Official Russian patent RU2349306 document, available via Rospatent database.
- Russian Patent Law (Federal Law No. 217-FZ, 2002).
- WIPO Patent Scope database for international patent family analysis.
- Industry reports on pharmaceutical patent strategies in Russia.