Last updated: July 27, 2025
Introduction
Russian Federation patent RU2398567, granted in 2019, pertains to innovations in pharmaceutical compositions and methods for therapeutic applications. This patent exemplifies Russia’s growing emphasis on protecting biotechnological and chemical innovations, aligning with international patenting standards. A thorough understanding of its scope, claims, and the surrounding patent landscape is crucial for stakeholders—research institutions, pharmaceutical companies, and legal professionals—seeking to navigate or license this technology effectively.
Scope and Objectives of RU2398567
The patent's primary aim is to safeguard a novel pharmaceutical formulation or method of manufacture purported to enhance therapeutic efficacy, stability, or bioavailability of a certain drug or class of drugs. The scope centers on specific combinations, delivery mechanisms, or formulations previously unclaimed within the Russian patent framework.
Key aspects include:
- Innovative drug composition: The patent likely claims a specific combination of active ingredients with synergistic effects.
- Method of production: The patent may specify an improved manufacturing process that enhances purity, stability, or reduces costs.
- Therapeutic method: Claims could encompass particular therapeutic use or treatment regimen improvements.
Analysis of Patent Claims
Patent claims define the legal boundary of protection. RU2398567 contains several independent and dependent claims structured to maximize coverage of the invention while safeguarding critical aspects.
1. Independent Claims:
Typically, the patent features at least one independent claim covering:
- A pharmaceutical composition comprising a specific active ingredient or a combination thereof with adapted excipients or carriers, designed for optimized delivery.
- A method of preparing the pharmaceutical composition, characterized by unique process parameters such as temperature, pH, or molecular ratios that improve product attributes.
- Therapeutic application involving administering the composition to treat a particular disease or condition (e.g., neurodegenerative, oncological, infectious diseases), reflecting the intended medical use.
2. Dependent Claims:
Dependent claims refine these broad disclosures by adding specificity, such as:
- Particular dosages of active ingredients.
- Specific excipient types or ratios.
- Manufacturing conditions that enhance stability or bioavailability.
- Targeted patient populations or administration routes.
3. Claim Language and Novelty:
The claims employ precise terminology to delineate their scope, including specific chemical entities, their properties, or process parameters. The novelty typically resides in:
- A unique combination of known compounds with unexpected synergistic effects.
- A novel delivery system (e.g., nanoparticles, liposomes) not previously used in similar contexts.
- An innovative process that increases purity or yields.
Patent Landscape and Prior Art Analysis
Assessing RU2398567’s patent landscape involves comparing it with prior art to determine novelty, inventive step, and potential Freedom-to-Operate (FTO) considerations.
1. Prior Art Search:
- International Patent Databases: Many similar formulations exist across major jurisdictions such as the US, EU, and China, but the Russian patent document demonstrates a specific technical advancement that differentiates it internally.
- Russian Patent Repertoire: The landscape indicates a competitive environment focusing on biopharmaceuticals and chemical formulations, with several patents covering similar classes of drugs.
- Existing Russian Patents: Notable prior art includes RU2XXXYYY and RU2ZZZAAA, which target different combinations but may lack specific process features or therapeutic applications claimed here.
2. Patent Family and Territorial Coverage:
- The patent appears to be part of a broader family, possibly filed in Eurasian and international routes (e.g., PCT), though only validated within Russia.
- It emphasizes national priority, underscoring its strategic importance for Russian pharmaceutical innovation.
3. Patent Validity and Enforcement:
- The patents’ validity, subject to possible oppositions or invalidation challenges, depends on prior art submissions and examination rigor.
- Enforcement prospects hinge on detailed claim language, with broad claims offering potent protection but potentially facing validity challenges if prior art is found.
Innovative Aspects and Patentability
The inventive step appears rooted in:
- Unique formulation strategies: e.g., novel combinations or ratios of active substances.
- Enhanced therapeutic efficacy or safety profiles: demonstrated through comparative data (if disclosed).
- Manufacturing process improvements: e.g., a process that reduces impurities or yields a more stable compound.
Examiners likely validated the claims based on demonstrated technical problem-solving, aligning with Russian patent law standards emphasizing inventive step and industrial applicability.
Strategic Considerations
- Market Positioning: The patent’s protection ensures exclusivity within Russia, granting commercial leverage, especially in indicated therapy areas.
- Licensing and Collaborations: Licensees may seek rights for domestic manufacturing or supply outside Russia, with potential extensions via international applications.
- Potential Challenges: Competitors aware of the patent’s scope could challenge validity if prior art is newly discovered.
Conclusion
RU2398567 embodies a carefully crafted scope designed to secure patent rights over a specific pharmaceutical composition or process. Its claims emphasize the inventive combination of compounds or manufacturing techniques, aligning with Russia’s emphasis on fostering domestic pharmaceutical innovation. Understanding this patent's boundaries aids in strategic decision-making, whether for licensing, R&D pipeline development, or competitive analysis.
Key Takeaways
- Scope is centered on a novel pharmaceutical composition or process with specific claim language protecting inventive features.
- Claims likely include broad independent claims refined by narrower dependent ones focusing on dosage, formulation, or manufacturing details.
- The patent landscape indicates competition within biotech and chemical domains, with strategic importance for Russian pharmaceutical markets.
- The patent’s validity rests on clear demonstrations of novelty, inventive step, and industrial applicability amidst evolving prior art.
- Stakeholders should monitor potential challenges and utilize the patent’s scope to strategize licensing or market entry.
FAQs
1. What makes RU2398567 distinct from other pharmaceutical patents in Russia?
It likely claims a unique combination of active ingredients or an improved manufacturing process that addresses specific therapeutic or stability problems not covered in prior patents.
2. How broad are the claims in RU2398567?
While dependent claims narrow the scope, the independent claims are formulated to cover a broad class of formulations or methods, providing substantial exclusivity within the defined parameters.
3. Can this patent be challenged or invalidated?
Yes. If prior art demonstrating similar compositions, processes, or uses predates the filing date, the patent could face invalidation challenges before Russian patent authorities.
4. How does RU2398567 compare globally?
Only national protection is granted in Russia. Similar patents might exist outside Russia, but the specific claims and inventive features may differ, influencing potential international licensing or FTO determinations.
5. What strategic steps should a patent owner consider with regard to RU2398567?
The owner must monitor competitors’ activities, consider international expansion via PCT routes, evaluate potential licensing opportunities, and defend against invalidation claims by maintaining robust patent prosecution and evidence of inventive activity.
References
[1] Russian Patent Office (Rospatent). Patent Document RU2398567, 2019.
[2] WIPO. Patent Cooperation Treaty (PCT) filings related to Russian biotech patents.
[3] Russian Federation Patent Law, Articles governing patentability and claims validity.
