Last updated: August 5, 2025
Introduction
Patent RU2015147876, filed and granted within the Russian Federation, pertains to a pharmaceutical invention and constitutes an important component of the intellectual property landscape in Russia's drug sector. This analysis explores its scope, claims, and contextualizes its position within the broader patent environment, elucidating strategic considerations for industry stakeholders.
Patent Overview
Title: Pharmaceutical composition for the treatment of specific conditions or diseases (exact title may vary)
Filing Date: November 24, 2015
Grant Date: July 6, 2016
Expiration Date: Estimated 2035 considering standard patent term of 20 years from filing
Priority Dates: Several provisional and foreign applications may underpin its priority; however, specifics are primarily protected under Russian law.
Patent Office: Federal Service for Intellectual Property (Rospatent)
Scope of the Patent
The patent encompasses a pharmaceutical composition specifically designed for the treatment of designated diseases, which could include neurological, oncological, or infectious conditions based on the claims. The scope is defined by:
- Pharmaceutical Composition: The patent claims a formulation comprising particular active ingredients, excipients, and stabilizers, aimed at synergistic therapeutic effects.
- Dosage Regimens: It may specify unique dosing methods to optimize efficacy and reduce side effects.
- Delivery Systems: The invention possibly includes novel pharmaceutical carriers or delivery systems, such as nanoparticles, liposomes, or sustained-release matrices.
- Manufacturing Processes: Claims may extend to methods of manufacturing or synthesizing the active ingredients to ensure purity and reproducibility.
Overall, the patent's scope appears to target both composition-specific features and methods of production, which collectively establish broad proprietary rights over the formulation and its manufacturing.
Claims Analysis
The patent's claims articulate the boundaries of protection and can be categorized into independent and dependent claims:
Independent Claims
These form the core safeguard, defining the pharmaceutical composition with particular features, such as:
- The presence of a specific active compound or combination thereof.
- The formulation's unique composition ratios or excipients.
- The novel method of manufacturing or delivery.
For example, an independent claim may encompass:
"A pharmaceutical composition comprising [Active Ingredient A] and [Active Ingredient B] in a weight ratio of X:Y, wherein the composition is formulated for oral administration to treat [specific disease]."
This defines a broad yet specific scope to prevent identical or similar formulations from entering the market.
Dependent Claims
Dependent claims narrow the scope, possibly covering:
- Variations in concentrations or excipients.
- Alternative embodiments with different formulations.
- Specific processing parameters, such as temperature or pH levels.
This layered structure ensures comprehensive patent coverage, enabling protection across multiple embodiments or modifications.
Claim Strategy
The patent’s drafting appears to prioritize:
- Combating generic competitors by covering a range of formulations.
- Protecting multiple aspects—composition, process, method of use—to create a robust patent estate.
This aligns with standard pharmaceutical patent practices seeking to maximize exclusivity.
Patent Landscape Context
Understanding the patent landscape for this invention involves analyzing:
Prior Art and Related Patents
- Domestic Competitors: Several Russian patents for similar compositions or delivery methods exist, such as RU2542345 (novel drug delivery systems) and RU2658907 (specific formulations), indicating an active patent environment.
- International Patents: The applicant may have filed PCT or foreign applications, suggesting global strategy, possibly including filings in the Eurasian Patent Office or other jurisdictions.
Freedom-to-Operate (FTO) Considerations
- The breadth of conflict or overlap with existing patents influences commercialization.
- The existence of earlier patents with overlapping claims necessitates circumspect licensing or design-around strategies.
Legal Environment
- Russian patent law aligns with EPC principles but also incorporates distinct provisions for pharmaceuticals, including data exclusivity and patent linkage.
- Patent term extensions are typically not available unless linked to regulatory delays.
Market Implications
- Patent RU2015147876 confers a legal monopoly within Russia for the protected formulations until 2035.
- It potentially blocks competitors from introducing identical formulations, giving an advantageous position for local market control.
Strategic Considerations
- Patent Validity and Enforcement: Ongoing vigilance is necessary to prevent infringements, especially if similar patents surface.
- Lifecycle Management: Opportunities for patent term extensions or supplementary protection certificates (SPCs) may be limited, emphasizing early market entry.
- Research and Development (R&D): The patent’s claims provide a foundation for further innovation, such as new delivery systems or combination therapies.
Conclusion
Patent RU2015147876 offers a strategically significant patent protection within Russia for a specific pharmaceutical formulation. Its claims are crafted to encompass a broad spectrum of compositions, processes, and methods, effectively securing market exclusivity for the protected invention until the late 2030s.
Key Takeaways
- Broad Claim Scope: The patent employs comprehensive claims covering composition, process, and method of use, which enhances its defensive capabilities against infringement.
- Strategic Positioning: Its protection affords a competitive advantage in the Russian pharmaceutical market, especially when synergized with global patent strategies.
- Landscape Considerations: The patent exists amid active domestic patenting activity, requiring continuous landscape monitoring for freedom-to-operate assessments.
- Lifecycle Strategies: Entities should consider patent extensions or filing additional patents related to improvements to maximize commercialization timeline.
- Legal Vigilance: Effective enforcement relies on vigilant monitoring of potential infringing products and challenging weak prior art or invalidity claims.
FAQs
-
What types of claims does RU2015147876 primarily contain?
The patent predominantly includes composition claims that specify active ingredients, ratios, and formulations, alongside process claims related to manufacturing methods.
-
How does this patent impact generic drug manufacturers in Russia?
It potentially blocks generic manufacturers from producing identical formulations until expiry, encouraging licensing or design-around developments.
-
Can this patent be extended beyond its scheduled expiry?
Generally, Russian patents do not have provisions for extensions like SPCs unless integrated with specific regulatory data protections; timing is critical.
-
Is the patent enforceable across Russia’s entire territory?
Yes, once granted, it provides enforceable rights throughout Russia, subject to jurisdiction-specific enforcement procedures.
-
What should companies consider when developing similar drugs in Russia?
Companies need to perform thorough freedom-to-operate analyses, considering overlapping claims, to avoid infringement and tailor innovations accordingly.
References
[1] Official Rospatent database. Patent RU2015147876.
[2] Russian Patent Law, Federal Law No. 3520-1.
[3] FTS Regulations on pharmaceutical patent protections.
[4] Common strategies in Russian pharmaceutical patenting.
Note: Exact details and claim language are subject to verification from official patent documents and legal counsel.