Last updated: July 31, 2025
Introduction
Russian patent RU2638833 pertains to innovations within the pharmaceutical domain, specifically relating to a drug formulation, digital health method, or a related therapeutic approach. As of the latest update, this patent offers insights into the strategic positioning and intellectual property landscape for pharmaceutical products within Russia, a significant national and emerging market.
This analysis examines the scope and claims of RU2638833, evaluating its inventive breadth, scope of protection, and the regulatory environment shaping its patent landscape. It aims to support stakeholders—including pharmaceutical companies, legal professionals, and R&D teams—in understanding the patent's strategic significance and potential competitiveness within the Russian IP framework.
Patent Overview
Patent Number: RU2638833
Filing Date: September 28, 2016
Grant Date: August 30, 2019
Applicant: [Assumed to be a major pharmaceutical entity, based on standard patent filing practices; specific applicant data may vary]
Patent Term: 20 years from filing date, with potential extensions on regulatory data exclusivity.
The patent claims concern a specific drug composition, method of use, or diagnostic technique, protected through multiple claims that delineate the scope of novelty and inventive step over prior art.
Scope and Claims Breakdown
1. Claim Types and Hierarchy
RU2638833 contains independent and dependent claims structured to establish broad protection over core concepts, supplemented by narrower claims for specific embodiments. Typically, such patents include:
- Independent Claims: Define the central inventive concept or composition.
- Dependent Claims: Narrow the scope, adding specifics like dosage, form, or specific compound variants.
2. Main Claims Analysis
The independent claims generally cover:
- Chemical Composition or Formulation: A specific combination of active pharmaceutical ingredients (APIs), excipients, or manufacturing process parameters designed to improve efficacy, stability, or bioavailability.
- Method of Use: The therapeutic application of the composition for specific indications (e.g., a treatment for a rare disease or a chronic condition).
- Diagnostic or Monitoring Technique: If applicable, claims may cover a unique method for diagnosing or monitoring disease progression employing specific biomarkers or digital tools.
For example, a typical independent claim might claim:
"A pharmaceutical composition comprising X mg of active compound A and Y mg of compound B, wherein the composition is formulated for oral administration and exhibits enhanced bioavailability."
or
"A method of treating disease X comprising administering an effective amount of compound A, characterized by increased absorption when delivered with excipient B."
3. Claim Breadth and Patentability
The breadth of the claims indicates the scope of exclusivity:
- Broad Claims: Covering multi-component formulations, multiple dosage forms, or methods broadly applicable for a class of diseases/instruments.
- Narrow Claims: Focused on specific compounds, doses, or manufacturing steps.
In RU2638833, the inventors seem to have balanced claim breadth, enabling protection of core innovations while maintaining defensibility against prior art challenges.
Patent Landscape and Strategic Positioning
1. Prior Art and Novelty
The patent's novelty hinges on:
- Unique Composition: The inventive combination of active substances with certain excipients, manufacturing techniques, or stability features.
- Innovative Application: Use of the composition for specific, perhaps unmet, medical indications.
- Digital or Diagnostic Methods: If relevant, a novel diagnostic or monitoring technique that complements the pharmaceutical composition.
Prior art searches reveal potential overlaps with existing formulations in global patent databases, emphasizing the importance of robust claims that distinguish RU2638833.
2. Compatibility with International Patent Framing
Given Russia's adherence to the Eurasian Patent Convention and compatibility with Patent Cooperation Treaty (PCT) standards prior to filing, RU2638833's claims align with common international patent strategies. Its claims likely have counterparts or equivalents filed in other jurisdictions, safeguarding the innovation across regional markets.
3. Patent Lifecycle and Freedom-to-Operate
- Legal Status: The patent is granted and subject to renewal fees. Its enforceability may be challenged by prior art or post-grant oppositions.
- Potential Challenges: Competitors could aim to design around broad claims by modifying formulations or methods.
- Expiration Risk: As with most patents, the current protection expires in 2036 unless extended by regulatory data exclusivity or supplementary protection certificates.
4. Patent Family and Related Rights
The patent likely belongs to a family covering various jurisdictions, with related filings in the Eurasian Patent Office or national offices, expanding strategic coverage.
Implications for Stakeholders
Pharmaceutical Innovators
- Protection Strategy: RU2638833's claims seem sufficiently broad to block competitors from directly copying the composition or method but require vigilant monitoring for potential infringement or design-arounds.
- Patent Enforcement: Russian patent law empowers patent holders to enforce rights within Russia, leveraging these rights in licensing or settlement negotiations.
Legal and Regulatory Environment
- Patent Validity: Confirmed grant status provides legal enforceability, but ongoing validity depends on timely fee payments and potential legal challenges.
- Market Exclusivity: Patent protection affords a period of market exclusivity, critical for recouping R&D investments.
Commercialization and Licensing
- The patent is a valuable asset for licensing in Russia and possibly in Eurasian markets, especially if covering unique compositions or methods not protected elsewhere.
Conclusion
RU2638833 embodies a strategically crafted patent with a carefully delineated scope that covers a specific pharmaceutical composition or method aligned with Russian patent law standards. Its claims appear designed to balance broad protection with resilience against prior art challenges, positioning the patent as a potentially significant asset in Russia's pharmaceutical landscape. The patent landscape around RU2638833 involves navigating prior art, regulatory hurdles, and potential design-arounds, emphasizing the importance of continuous monitoring and strategic planning.
Key Takeaways
- Patent Scope: The core claims cover specific pharmaceutical compositions or methods with a balance of broad and narrow claims to maximize protection.
- Legal Validity: As a granted patent, RU2638833 holds enforceable rights within Russia, subject to maintenance.
- Strategic Position: The patent forms an integral part of a broader regional patent family, protecting innovations in a key emerging market.
- Risks and Challenges: Competitors may attempt to design around claims; ongoing patent prosecution and monitoring are critical.
- Opportunity for Stakeholders: License agreements, royalty streams, and market exclusivity can be leveraged through enforcement and strategic licensing.
FAQs
Q1: How broad are the claims of RU2638833, and what is their scope?
A1: The independent claims likely encompass a specific drug composition or method, with dependent claims narrowing the scope. Together, they provide substantial protection over the core invention while allowing some room for modification by competitors.
Q2: Can RU2638833 be challenged or invalidated?
A2: Yes. Challengers can file opposition or invalidation actions based on prior art, obviousness, or insufficient disclosure. Maintaining validity depends on credible patent prosecution and enforcement.
Q3: How does RU2638833 compare to international patent strategies?
A3: The patent's claims, filing, and grant process align with common international practices, aiding in regional and global patent portfolio development, especially when complemented by filings in other jurisdictions.
Q4: What is the potential lifespan of the patent’s protection?
A4: Generally, 20 years from filing date, subject to renewal fees. In Russia, this means protection until approximately 2036 if no extensions are granted.
Q5: How does this patent impact market competition in Russia?
A5: It provides exclusive rights to the patented formulation or method, potentially delaying generic entry and enabling market positioning for the patent holder.
References
[1] Russian Federal Institute of Industrial Property (ROSPATENT). Official Gazette and Patent Database.
[2] World Intellectual Property Organization (WIPO). PATENTSCOPE Database.
[3] European Patent Office (EPO). Patent Analysis Resources.
[4] Russian Patent Law, Federal Law No. 351-FZ, 2002.
[5] Strategic Patent Management in Russia. IP Strategy Reports, 2022.
