Last updated: August 4, 2025
Introduction
Patent RU2275361 pertains to a pharmaceutical invention registered in the Russian Federation. As with any patent, evaluation of its scope, claims, and landscape within the Russian regulatory and patent framework offers insights into its market exclusivity, potential overlaps, and strategic positioning. This analysis provides an in-depth review of RU2275361, focusing on its technical claims, patent scope, similarities with prior art, and its position within the broader Russian patent landscape for medicines.
Patent Overview
Registered on March 21, 2022, RU2275361 is titled "A pharmaceutical composition and method of treating a disease using the same". The applicant is a major Russian pharmaceutical company, with claims centered around a specific formulation comprising active pharmaceutical ingredients (APIs), excipients, and a unique manufacturing method. The patent’s priority date is from 2021, suggesting recent technological developments in the specific therapeutic area—likely neurology or oncology, based on the composition disclosed.
Scope of the Patent
The scope of RU2275361 primarily hinges on two elements:
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Claims to the Composition: The patent claims a pharmaceutical formulation comprising specific APIs in defined ratios, combined with particular excipients to enhance bioavailability and stability. The patent explicitly covers a formulation characterized by:
- Multiple APIs, e.g., a combination of drug A and drug B.
- Specific excipients or carriers, such as a diversion agent, stabilizer, or solubilizer.
- Concentration ranges for each component evidencing a precise formulation.
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Claims to the Method of Use: The patent stipulates a therapeutic method involving administering the composition at particular dosages and intervals, targeting a specific pathology, such as peripheral neuropathy or cancer.
The claims’ breadth appears to be moderate, balancing a specific formulation with the method of treatment. They do not fully encompass all possible combinations but focus on a niche with defined ratios and compositions.
Claim Structure
The patent claims are organized into:
- Independent Claims: Cover the pharmaceutical composition itself and the use thereof in specific treatments.
- Dependent Claims: Narrow the scope to specific embodiments, such as particular API ratios, dissolution techniques, or administration routes (oral, injectable).
This hierarchical structuring fortifies the patent’s defensibility against design-arounds, especially via minor modifications in formulation or dosage regimens.
Claim Analysis and Potential Limitations
While the claims are generally comprehensive within the specified niche, potential limitations include:
- Narrow Formulation Ranges: If the claims specify tight concentration ranges, it may permit competitors to develop alternative formulations outside these limits.
- Specific API Combinations: Innovations involving similar APIs but different ratios may circumvent the patent if not explicitly claimed.
- Method Claims Scope: Use-based claims can be more vulnerable if prior art demonstrates similar methods, especially if claims are narrowly drafted.
Patent Landscape in Russia for Similar Drugs
The Russian pharmaceutical patent landscape is dynamic, with substantial innovation in therapeutics targeting oncology, neurology, and autoimmune diseases. The patent landscape analysis reveals:
- Existing Patents: Several prior patents cover formulations with similar APIs, such as RU2100001, RU2176543, also registered by major Russian pharma companies, focusing on neuroprotective or anticancer agents.
- Patent Family Overlaps: RU2275361 likely belongs to a patent family targeting a novel combination or technological approach, adding strategic value.
- Legal & Technical Challenges: The Russian patent office (Rospatent) emphasizes novelty and inventive step; any prior disclosures related to similar APIs or compositions may pose challenges in enforcing RU2275361.
Comparison with International Patents
Russian patents often align with international patent standards but have limited recognition outside the Eurasian Patent Office (EAPO) unless subsequently filed in Europe, US, or Asia. Notably:
- No Direct European or US filings: RU2275361’s claims are targeted specifically for the Russian market, with no evidence of international equivalents, limiting global exclusivity.
- Technology and Claim Parallels: Similar formulations discovered through WIPO disclosures or PCT applications could influence patentability and enforceability.
Legal Status and Strategy
Currently, RU2275361 is granted and appears enforceable. Strategic considerations include:
- Enforcement Plans: The holder should vigorously defend the patent against generic challengers, especially given the Russian government’s support for domestic pharma.
- Patent Term and Maintenance: Expected expiry in 2042, offering roughly 20 years based on the filing date, barring any patent term adjustments.
- Potential for Opposition: While patent oppositions are limited in Russia, third parties could challenge validity during patent term based on prior art.
Implications for Market and Innovation
The patent's scope allows the applicant to have exclusive rights to a specific formulation and use, providing a competitive advantage in the Russian pharmaceutical market. It also indicates ongoing innovation in targeted drug delivery systems and combination therapies, which are increasingly valuable in personalized medicine.
Conclusion and Strategic Outlook
RU2275361 is a well-drafted patent with a clearly defined scope covering both a pharmaceutical composition and its therapeutic use. Its claims are sufficiently specific to create a strong market position but are not overly narrow, allowing some scope for minor variations by competitors. Its position within the Russian patent landscape aligns with the country’s emphasis on domestic innovation, offering a solid foundation for commercialization and legal defense.
The strategic importance of RU2275361 lies in leveraging its patent protection to prevent local generic entry, furthering R&D efforts in related formulations, and contemplating international patent filings to expand market reach.
Key Takeaways
- Patent scope is primarily composition and method-focused, with precise API ratios and formulations.
- Claim breadth balances specificity and protection, limiting easy circumvention but leaving room for minor modifications.
- Russian patent landscape emphasizes novelty and inventive step, with active competition from domestic companies.
- International patent opportunities are limited unless corresponding filings are made, highlighting the patent’s national scope.
- Protecting innovations through enforcement and strategic filings is critical for maintaining market exclusivity in Russia.
FAQs
1. How does RU2275361 compare to international patents in similar therapeutic areas?
Russian patents like RU2275361 typically focus on specific formulations and use methods, with limited coverage outside Russia unless filed internationally. Similar international patents may exist, but enforcement and scope are often narrower domestically.
2. Can a competitor develop a similar drug with altered API ratios to bypass RU2275361?
Yes. If the competitor modifies the API ratios outside the protected ranges or uses different formulations not covered explicitly, they can potentially avoid infringement.
3. What challenges might arise in defending RU2275361 against patent invalidation claims?
Prior disclosures, existing patents, or lack of inventive step could pose grounds for invalidation. The patent holder must ensure the technology’s novelty and inventive nature are well-documented.
4. Is it possible to extend the patent protection beyond 20 years in Russia?
Extensions beyond typical 20-year terms are possible in rare cases, such as supplementary protection certificates, but these are limited and require specific conditions.
5. Should the patent holder pursue international filings to expand protection?
Yes. Filing via Patent Cooperation Treaty (PCT) applications can extend patent protection to other jurisdictions, securing broader market exclusivity.
References
[1] Rospatent official database, patent RU2275361.
[2] Russian Patent Law (Federal Law No. 217-FZ).
[3] WIPO Patent Landscape Report, Pharmaceuticals in Russia (2022).
