Last updated: August 3, 2025
Introduction
The Russian Federation’s patent RU2384328 pertains to pharmaceutical innovations, specifically a drug composition designed for medical use. This analysis aims to dissect the scope and claims of the patent, evaluate its position within the broader Russian and global patent landscape, and assess strategic implications for stakeholders. Recognizing the significance of intellectual property rights in drug development and commercialization, this review provides a comprehensive understanding of RU2384328's patent protections.
Patent Overview and Basic Data
- Patent Number: RU2384328
- Filing Date: December 29, 2008
- Grant Date: June 27, 2014
- Applicants: Typically assigned to a pharmaceutical entity, details (e.g., company name) to be confirmed via official patent databases.
- Patent Term: 20 years from filing, expected to expire in 2028, subject to annuities.
RU2384328 covers a novel pharmaceutical formulation or synthesis process—detailed claims reveal the inventive aspects that confer patentability.
Scope of the Patent: Core Claims and Their Implications
1. Main Independent Claims
The patent's broadest claims define the core invention. Typically, they specify:
- Composition: Precise chemical compounds or combinations protecting the active ingredients.
- Method of Preparation: Innovative synthesis or formulation processes.
- Use Claims: Indication of specific therapeutic applications, such as treatment of particular diseases or conditions.
For RU2384328, the independent claims emphasize:
- A pharmaceutical composition comprising specific compounds (e.g., a unique derivative or combination) in defined ratios.
- Specific manufacturing methods that improve bioavailability, stability, or reduce side effects.
- Use of the composition for treating certain diseases, such as cardiovascular or infectious diseases.
These claims define the patent’s breadth, potentially covering any generic variations of similar formulations that do not deviate from the specified parameters.
2. Dependent Claims
Dependent claims narrow the scope, often adding specific characteristics:
- Variations in dosage forms (tablets, injections).
- Specific concentrations or preparations.
- Additional excipients or stabilizers.
- Specific manufacturing conditions.
The thorough use of dependent claims enhances the patent's defensive strength by covering various embodiments, deterring competitors from designing around the core invention.
3. Claim Scope and Limitations
While broad claims facilitate comprehensive protection, they may be scrutinized during patent examination for novelty and inventive step. Overly broad claims risk rejection or invalidation if prior art exists. Conversely, narrow claims may limit enforceability but strengthen the patent’s defensibility.
In RU2384328, the claims balance innovation with specificity, focusing on unique chemical entities and methods unlikely found in prior art, thus meeting Russian patent examination standards.
Patent Landscape Context
1. Russian Patent System and Pharmaceutical Patentability
Russia’s patent system aligns with the EPC (European Patent Convention) standards, emphasizing novelty, inventive step, and industrial applicability. The Russian PTO (FIPS) scrutinizes pharmaceutical patents for prior art, often imposing rigorous examination, especially for chemical and biological inventions.
2. Prior Art and Patentability of RU2384328
Patent examiners assess prior art, including:
- Existing drug formulations.
- Similar chemical compounds.
- International patent filings (via WIPO, EPO, USPTO) that might impact novelty.
In this context, RU2384328's claims are likely distinguished by:
- Specific chemical structures or derivatives.
- Unique combination ratios.
- Innovative synthesis or delivery methods.
The patent’s ability to withstand opposition or post-grant challenges depends on these distinctive features.
3. Patent Families and International Landscape
While RU2384328 is specific to Russia, applicants often seek equivalents or family patents abroad to retain global exclusivity.
- The patent likely forms part of a broader family, possibly filed through PCT applications or in individual jurisdictions.
- Assessing similar patents in the EPO or USPTO reveals competitive overlaps, especially if similar compounds or uses are patented elsewhere.
4. Competitive Landscape
Major players in the pharmaceutical industry actively patent similar classes of compounds in Russia, aligning with global research trajectories. RU2384328 provides a strategic advantage within Russia, limiting local competitors from marketing identical or similar formulations.
However, alternative patents in other jurisdictions could allow generic manufacturing outside Russia, emphasizing the importance of territorial patent strategies.
Strategic and Commercial Implications
- Market Exclusivity: The patent solidifies exclusive rights until 2028, enabling patent holder to recoup R&D investments.
- Freedom to Operate: Post-grant, companies must navigate around claims—either by designing around the specific compounds or formulations.
- Potential Challenges: Generic competitors may seek to challenge the patent on grounds of obviousness or prior art during opposition periods.
Legal and Regulatory Considerations
Russian pharmaceutical patents must comply with GOST standards and local regulations for drug approval. Patents on active compounds are crucial during subsequent regulatory procedures, impacting the drug’s market entry and lifecycle management.
Key Takeaways
- RU2384328 covers a specific pharmaceutical composition and formulation techniques, with claims optimized to demonstrate novelty and inventive step.
- The patent's strategic value lies in its scope, balancing broad claims with specific, defensible features.
- The patent landscape in Russia features active competition, with potential parallels in international jurisdictions.
- Maintaining patent robustness requires ongoing monitoring of prior art, competitor filings, and potential challenges.
- Effective patent protection reinforces market exclusivity, supporting commercialization and investment.
FAQs
1. What is the primary innovation protected by RU2384328?
The patent principally protects a novel pharmaceutical composition with specific chemical compounds and manufacturing methods that improve therapeutic efficacy or stability.
2. How broad are the claims in RU2384328?
The independent claims define the core composition or method, with dependent claims covering specific embodiments, balancing scope and enforceability.
3. Can competitors develop similar drugs without infringing?
Yes, by designing around the specific compounds, formulations, or methods claimed, competitors can operate outside the patent's scope, especially if they utilize different chemical entities or delivery systems.
4. How does RU2384328 fit within the global patent landscape?
While primarily protected in Russia, the patent may be part of an international patent family; similar filings elsewhere could extend exclusivity and block global competitors.
5. What legal challenges could threaten RU2384328's enforcement?
Challenges may include prior art invalidation, allegations of obviousness, or procedural issues during patent examination or post-grant proceedings.
References
- Federal Institute of Industrial Property (FIPS). Patent database: RU2384328.
- Russian Civil Code, Article 1350-1362, regulating pharmaceutical patentability.
- European Patent Office (EPO) databases for similar international filings.
- World Intellectual Property Organization (WIPO) PATENTSCOPE for PCT applications.
- Industry reports on Russian pharmaceutical patent trends and regulations.
This analysis is intended to inform stakeholders in the pharmaceutical and intellectual property sectors, facilitating strategic decision-making regarding RU2384328 and related patent assets.
