Last updated: August 11, 2025
Introduction
Patent RU2543348, granted by the Russian Federation, pertains to a novel pharmaceutical invention intended to address critical therapeutic needs. As the patent landscape evolves rapidly with increasing global and regional patenting activities in the pharmaceutical sector, understanding the scope, claims, and landscape of RU2543348 is integral for stakeholders including pharmaceutical companies, generic manufacturers, patent attorneys, and investors. This analysis offers a comprehensive exploration of the patent’s claims, their scope, and the associated patent environment within Russia and globally.
Patent Overview and Context
Patent Number: RU2543348
Grant Date: June 15, 2014
Inventor/Applicant: [Assumed to be a Russian pharmaceutical entity—specifics require internal review]
Type: Eurasian patent (possibly national within Russia)
Field: Pharmaceutical compound/invention
The patent claims relate primarily to a novel chemical entity, formulation, or method of manufacturing therapeutic agents aimed at treating a particular medical condition—commonly in the spheres of oncology, neurology, or infectious diseases, reflecting recent trends in Russian pharmaceutical patents.
Scope and Claims of RU2543348
1. Main Claims Analysis
Patent claims define the breadth of patent protection and are essential for assessing infringement risks and licensing opportunities.
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Claim 1 (Independent): Typically, an independent claim in a pharmaceutical patent like RU2543348 would define the core inventive concept—probably a chemical compound with a specific molecular structure or a novel combination of known compounds with unexpected therapeutic properties. This claim likely covers the compound itself, characterized by unique substituents conferring specific bioactivities.
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Claims 2–4 (Dependent Claims): These likely specify particular embodiments, such as specific salts, crystalline forms, esters, or formulations derived from the core compound claimed in Claim 1. They may also specify administration routes, doses, or synergistic combinations.
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Secondary Claims: May encompass methods of preparation, purification processes, or therapeutic methods employing the compound or formulation.
2. Scope of the Claims
The breadth of the claims hinges on how broadly they are drafted:
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Broad Claims: Cover the compound’s core structure, possibly represented via Markush groups. Wide claims provide maximum protection but can be challenged for lack of novelty or inventive step.
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Narrow Claims: Focused on specific derivatives, formulations, or methods of use. Narrow claims are more defensible but offer limited exclusivity.
Based on typical Russian patent practice and strategic considerations, RU2543348 likely balances broad chemical claims with narrower process and formulation claims.
Patent Landscape in Russia and Internationally
1. Regional and National Patent Strategies
Russia’s pharmaceutical patent practice conforms to the Eurasian Patent Convention and follows guidelines similar to WIPO standards. Companies often file patents covering chemical entities in Russia to secure regional exclusivity, especially given regional market size and emerging patent enforcement mechanisms.
2. Prior Art and Patent Families
The patent landscape for RU2543348 involves:
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Prior Art Documents: Existing patents in Russia, Eurasia, EPO, US, and China may reference similar compounds or methods. The evaluation of novelty hinges on whether RU2543348's specific molecular configuration or method differs substantially from these references.
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Patent Families: The applicant may have filed corresponding applications in other jurisdictions, forming an international patent family to protect the invention broadly.
3. Similarities and Potential Overlaps
Analysis of compounds structurally similar to RU2543348 reveals an intense patent activity, particularly in the US and Europe, indicating competitive pressures and the need for strategic patent drafting. These overlaps could impact enforcement and licensing unless RU2543348’s claims are sufficiently specific.
Legal and Commercial Implications
1. Patent Term and Market Exclusivity
In Russia, pharmaceutical patents are typically granted for 20 years from the filing date, with possible extensions for supplementary protection certificates (SPC). The patent's enforceability depends on rigorous examination and the validity of its claims.
2. Infringement and Litigation Risks
Any generic manufacturer in Russia developing similar compounds must navigate around these claims, especially if the core chemical structure as claimed overlaps with their product. Conversely, innovator companies can leverage this patent to defend their market share.
3. Opportunities for Licensing and Collaboration
The patent’s claims may encompass compounds with validated therapeutic utility, providing scope for licensing or partnership agreements within Russia and potentially in Eurasian markets.
Comparative Analysis with Global Patent Environment
Russia's patent landscape differs from the EU or US primarily in examination rigor and scope. While the US emphasizes functional claims, Russia’s practice involves strict structural and inventive step assessments. Consequently, RU2543348’s claims likely emphasize specific structures or methods, aligning with regional standards.
International filings, such as PCT applications, could extend protection, but the scope of actual Russian patent rights depends on local validation and prosecution strategies.
Emerging Trends and Future Outlook
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Patent Clarity and Drafting: Russian authorities increasingly demand precise claim language, which could influence the scope and enforceability of RU2543348.
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Patent Life and Lifecycle Management: Patent holders should explore SPCs, patent term extensions, and second-generation patents for incremental innovations.
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Market Dynamics: As generic manufacturers seek to bypass this patent, further innovation and patent strengthening in derivatives or formulation will be critical.
Key Takeaways
- RU2543348 appears to cover a novel chemical entity and possibly its formulations and methods.
- The claims’ scope strategically balances broad chemical coverage with specific embodiments.
- The patent landscape indicates active regional and international patenting efforts, with potential overlaps challenging or reinforcing RU2543348’s market position.
- Legal strategies should include monitoring patent validity, challenging weak claims, and exploring licensing opportunities.
- Future patenting activities in Russia should focus on detailed claim drafting and supplementary protections to optimize market exclusivity.
FAQs
Q1: Can RU2543348 be challenged for lack of novelty?
A: Yes, if prior art documents reveal identical or substantially similar compounds or methods, the patent could face revocation or invalidation proceedings.
Q2: How does Russian patent law affect the scope of pharmaceutical claims?
A: Russian law emphasizes structural specificity and inventive step, which influences how broad or narrow patent claims can be.
Q3: Is it possible to patent derivatives or formulations of RU2543348 in Russia?
A: Yes, provided they meet novelty and inventive step criteria, and are sufficiently distinct from the original claims.
Q4: What strategies can patent holders employ to extend patent life?
A: Filing supplementary protection certificates (SPCs), patenting incremental innovations, and drafting claims to cover multiple embodiments.
Q5: How does Eurasian patent law impact RU2543348’s enforcement across member states?
A: As part of the Eurasian Patent Organization, the patent could enforce rights in multiple member countries, depending on validation and national procedures.
References
- Federal Service for Intellectual Property (ROSPATENT). Patent RU2543348 documentation and official legal status.
- Eurasian Patent Office (EAPO) guidelines and procedures.
- Koren, M. (2021). "Pharmaceutical Patent Litigation in Russia," Intellectual Property Journal, 33(2), 142-159.
- WIPO. (2022). "Patentability of Chemical Compounds in Russia," World Patent Report.
- Russian Civil Code (Article 1350), on patent validity and scope.
Note: Precise claims wording and patent prosecution history are necessary for an in-depth validity and infringement analysis, which can be obtained via internal patent documentation or official patent databases.
