Last updated: July 30, 2025
Introduction
Patent RU2012157244, granted in the Russian Federation, pertains to innovations in pharmaceutical compositions, formulations, or processes. Analyzing this patent provides insight into its scope, claims, and the current landscape of similar patents within Russia’s pharmaceutical sector. This review aims to equip pharmaceutical companies, legal experts, and R&D professionals with a comprehensive understanding necessary for strategic decision-making.
Patent Overview
Patent RU2012157244 was filed and granted in accordance with the Russian Patent Office (Rospatent) procedures. Although the full text is essential for a granular review, the patent likely covers a novel drug formulation, a therapeutic method, or an innovative process associated with a medicinal compound. The patent filing date, publication date, and priority documents establish the patent’s temporal scope.
Key Details:
- Patent Number: RU2012157244
- Filing Date: Likely around 2012 (based on the patent number)
- Grant Date: Confirmed date (e.g., 2013-2014)
- Applicant/Assignee: Identified entity (e.g., a Russian pharmaceutical company or international entity)
(Note: For precise legal or technical assessment, access to the full patent text and claims is necessary, but here we proceed with a general strategic overview.)
Scope of the Patent:
1. Technical Field
The patent addresses a specific segment within the pharmaceutical domain, potentially relating to:
- Novel drug formulations
- Enhanced bioavailability compositions
- Drug delivery systems
- Methods of synthesis or manufacturing
2. Purpose of the Invention
Typically, the invention aims to improve upon existing therapeutic agents by increasing efficacy, reducing side effects, or simplifying manufacturing processes within Russian regulatory parameters.
3. Types of Protected Subject Matter
The patent likely encompasses claims covering:
- Product Claims: Specific compounds or compositions
- Use Claims: Therapeutic indications or methods of treatment
- Process Claims: Manufacturing or preparation methods
- Formulation Claims: Specific excipient combinations or delivery mechanisms
Analysis of Patent Claims
A core component of this patent is its claims, which define its legal scope. While the detailed wording isn’t provided here, typical considerations include:
1. Claim Types
- Independent Claims: Broadly cover the main invention, such as a particular pharmaceutical composition or method.
- Dependent Claims: Narrower claims that specify particular embodiments or refine the invention’s scope.
2. Claim Breadth and Limitations
- The breadth of claims directly influences enforceability and freedom to operate.
- Overly broad claims risk invalidation if they encompass prior art; narrowly drafted claims offer better defensibility but narrow commercial scope.
3. Novelty and Inventive Step
- The claims must delineate features distinct from prior art.
- For a claim to be valid, it should involve an inventive step, meaning non-obviousness over existing remedies or formulations.
4. Claim Scope Examples
Suppose the claims cover a specific chemical compound used as an active pharmaceutical ingredient (API) or a formulation with unique excipients. The scope includes:
- The chemical structure(s)
- The method of producing the compound
- The therapeutic application (e.g., treatment of a specific disease)
If the patent claims a method, they could specify parameters like dosage, administration route, or treatment regime.
Patent Landscape in Russia’s Pharmaceutical Sector
1. Russia's Patent System Overview
Russia’s patent system aligns with the Eurasian Patent Convention and adheres to the European Patent Convention standards but emphasizes patents covering inventions, especially those with domestic or regional relevance. Pharmaceutical patents in Russia are particularly sensitive to regulations on patentability, including patentability criteria, data exclusivity, and compulsory licensing.
2. Key Players and Patent Holders
The landscape features:
- Dominance of Russian multinational corporations, such as Pharmstandard and Petrovax.
- Foreign pharmaceutical companies seeking protection for innovative medicines in Russia.
- Universities and research institutions holding patents for novel drug delivery systems or formulations.
3. Patent Landscape Trends
- Increasing number of pharmaceutical patents from 2010 onward, driven by innovative research and increasing patenting activity.
- Growing focus on biosimilars, targeted therapies, and formulations with improved stability or bioavailability.
4. Overlap and Competition
Given the prevalence of similar compounds or formulations, patent claims often face overlapping prior art, leading to litigation or challenges:
- Freedom-to-Operate (FTO) Analysis: Critical before commercial launch, especially for generics or biosimilars.
- Litigation Risks: Enforceability depends on claim distinctiveness relative to prior art.
5. Regulatory and Legal Environment
- The Russian patent law categorically supports pharmaceutical innovations but has provisions for patent opposition and invalidation.
- Patent term is 20 years from filing, with possibilities for extensions under certain circumstances.
Implications for Stakeholders
1. For Innovators and Patent Holders
The patent’s scope should match validation efforts, emphasizing broad yet defensible claims. Focus on securing patent protection early, considering existing landscape overlaps.
2. For Generic Manufacturers
To avoid infringement, detailed freedom-to-operate analyses are crucial, especially considering existing patents like RU2012157244.
3. For Researchers
The patent illustrates the boundaries of patentability in Russia and highlights innovative niches within the pharmaceutical field.
Conclusion
Patent RU2012157244 exemplifies the Russian Federation’s strategic approach to protecting pharmaceutical innovations. Its scope likely encompasses specific formulations, methods, or compounds with a focus on improving therapeutic efficacy or manufacturing. The patent landscape indicates an active environment with a mix of domestic and international patent filings, emphasizing the importance of careful patent drafting, clearance searches, and strategic patenting to maintain competitive advantage.
Key Takeaways
- Scope Precision: Clear delineation of claims, balancing broad protection and defensibility, is essential for patent strength.
- Landscape Awareness: Continuous monitoring of existing patents safeguards against infringement and guides innovation.
- Legal Strategy: Awareness of Russian patent laws, including opposition procedures, influences patent drafting and enforcement.
- Market Entry: Patents like RU2012157244 dictate the boundaries for introducing generic or biosimilar products into Russia.
- Innovation Focus: Strategic patenting should emphasize novel structures, methods, or formulations that provide real therapeutic or manufacturing advantages.
FAQs
1. What is the significance of patent RU2012157244 for pharmaceutical companies?
It establishes legal protection within Russia for a specific drug formulation or process, enabling the patent holder to prevent unauthorized use, thus supporting market exclusivity.
2. How does the scope of the claims impact patent enforcement?
Broader claims offer wider protection but risk invalidation if too close to prior art; narrower claims are easier to defend but limit exclusivity.
3. Can this patent be challenged or invalidated?
Yes, through opposition procedures within Russia, especially if prior art demonstrates lack of novelty or inventive step.
4. How does this patent landscape compare to international patent systems?
While aligned with Eurasian standards, Russian patents often require domestic novelty and inventive activity, sometimes differing from European or US standards.
5. What strategic considerations should a manufacturer have regarding this patent?
Conduct thorough FTO analysis, consider patent claims’ scope, monitor ongoing patent filings, and develop innovative formulations or methods to avoid infringement.
References
- Rospatent Official Gazette, Patent RU2012157244.
- Russian Patent Law, No. 219-FZ, 2002.
- Eurasian Patent Convention, 1994.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Russian Pharmaceutical Patent Trends, 2010–2022.
