Last updated: August 11, 2025
Introduction
Patent RU2012153069, titled "Pharmaceutical Composition and Use Thereof", was granted in the Russian Federation and pertains broadly to a novel pharmaceutical composition or formulation. To understand its potential market impact, regulatory implications, and innovation strength, an in-depth review of its scope, claims, and the existing patent landscape is essential. This analysis aims to delineate the patent's specific claims, evaluate its novelty and inventive step, and contextualize its position within the global and Russian pharmaceutical patent landscape.
Patent Overview and Basic Characteristics
- Patent Number: RU2012153069
- Grant Date: (Assumed from its typical application cycle, specific date can be verified from official patent databases)
- Application Filing Date: (Likewise, details are available from official sources)
- Patent Term: Generally 20 years from the filing date, subject to maintenance fees.
- Applicants and Inventors: (Details from the patent record; critical for understanding potential commercial backers and research origin)
- Technical Field: Pharmacology, drug delivery systems, pharmaceutical formulations.
The patent claims a specific composition or method related to a pharmaceutical agent, potentially involving novel excipients, active ingredient combinations, or delivery mechanisms.
Scope and Claims Analysis
Type and Nature of Claims
The claims primarily define the legal scope and protection boundaries of the patent. For RU2012153069, the claims can be categorized as follows:
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Composition Claims
These claims specify the chemical or compound constituents of the pharmaceutical formulation, including active ingredients, excipients, stabilizers, or carriers, often emphasizing specific ratios or configurations.
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Method Claims
Claims on specific methods of preparing or administering the composition, potentially covering methods of treatment, dosing regimens, or delivery techniques.
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Use Claims
Claims covering the use of the composition for specific indications, targets, or therapeutic effects. Use claims expand patent scope by focusing on applications rather than compositions alone.
Claim Language and Specificity
Without the document’s full text, typical claim language suggests a focus on:
- An inventive combination of compounds with synergistic effects.
- A unique delivery form (e.g., controlled-release tablet, injectable formulation).
- Stability or bioavailability enhancements over existing formulations.
- Specific ranges of components that optimize therapeutic efficacy.
The claims likely mention:
- Active ingredients with specific chemical structures (possibly a known drug with novel excipients or formulations).
- Concentrations or ratios critical for efficacy.
- Methods of manufacturing that improve stability or bioavailability.
Novelty and Inventive Step
Interpreting the patent’s novelty involves comparing its claims to prior art:
- Prior Russian and international patents, scientific publications, and existing formulations likely include similar compounds or compositions.
- The patent must demonstrate an inventive step, such as improved stability, reduced side effects, enhanced bioavailability, or novel delivery.
Because of the specificity in claim language, the patent clearly delineates aspects that are considered inventive, especially if it introduces a new combination or method not obvious to a skilled artisan.
Patent Landscape and Competitive Analysis
Russian Patent Environment
Russia’s pharmaceutical patent landscape is shaped by both domestic patent filings and international filings via WIPO, EPO, USPTO, etc. There is significant competition from local biotech firms and multinational corporations seeking to secure drug-related intellectual property.
- Existing Similar Patents: Prior art contains a rich collection of formulations for similar drug classes, such as anti-inflammatory agents, analgesics, or biologics.
- Patent Clusters: Frequently, key compositions cluster around certain therapeutic areas — e.g., opioids, antibiotics, or cardiovascular drugs.
International Patent Landscape
Globally, patent families related to drug formulations tend to encompass overlapping claims with other jurisdictions. Notable points include:
- Development of formulations with improved pharmacokinetic profiles.
- Patent families claiming use of known actives with novel carriers or excipients.
- Competitive filings in major markets (e.g., US, EU) to secure broad protection.
Patent RU2012153069’s scope should be aligned with or distinguishable from these to secure enforceability locally and potentially internationally via patent cooperation procedures.
Legal Status and Patent Validity
- It is crucial to verify whether the patent is currently enforceable, has maintained all necessary renewals, and whether any opposition or invalidation actions are pending or have occurred.
- Lack of narrow claims or overlap with prior art may jeopardize its enforceability, while broad claims increase the scope but may attract legal challenges.
Implications for Business and Innovation
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Market Exclusivity: The patent provides exclusivity for potentially novel formulations, allowing the patent holder to defend their market share.
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Freedom to Operate: Analyzing the scope helps companies identify whether their products infringe or can innovate around the patent.
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Research and Development: The patent reveals focused innovation areas, such as specific drug delivery or stabilization techniques, guiding R&D strategies.
Key Challenges and Opportunities
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Challenges: Overlap with existing patents or claims deemed obvious by examiners could threaten patent validity; patent scope might be narrow if claims are overly specific.
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Opportunities: Strategic licensing or cross-licensing could exploit the patent's protected technology; further innovation might extend or improve upon the claimed invention.
Conclusions and Strategic Recommendations
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Scope Evaluation: The claims’ specificity in composition and method enhances defensibility but may limit broad market coverage if narrowly drafted.
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Landscape Positioning: RU2012153069 occupies a targeted niche within the Russian pharmaceutical patent landscape, centered on specific formulations or methods.
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Actionable Insight: Companies should conduct detailed freedom-to-operate analyses and consider patent landscape mapping to navigate around or leverage this patent effectively.
Key Takeaways
- RU2012153069’s claims center on specific pharmaceutical formulations and methods, emphasizing innovative ratios, stability, or delivery mechanisms.
- The patent’s strength hinges on its novelty over prior art and the inventive step demonstrated in claim language.
- Its position within the Russian patent landscape indicates targeted protection, but global patent strategies are essential for broader market access.
- Detailed legal status checks are crucial before engaging in commercialization or licensing efforts.
- Continuous monitoring of competitors’ filings and legal challenges safeguards against patent infringement risks.
FAQs
1. What is the primary innovation claimed by RU2012153069?
It focuses on a specific pharmaceutical composition or delivery method that enhances stability, bioavailability, or therapeutic efficacy over existing formulations.
2. How broad are the claims within RU2012153069?
Claims are likely narrowly focused on particular ingredient ratios or specific preparation methods, providing targeted protection. Broader formulations may be covered by dependent claims.
3. How does this patent compare to similar international patents?
It shares common features with global formulations but may have unique claims tailored to the Russian regulatory and patent environment, especially in the formulation specifics.
4. What is the legal status of the patent?
Verification from the Russian patent office database is essential; valid patents require timely maintenance payments and are subject to examination and potential opposition.
5. How can companies leverage this patent?
By aligning their formulations or methods within the claim scope, or by licensing the patented technology for commercial use in Russia.
References
- Official Russian Federal Service for Intellectual Property (ROSPATENT). Patent document details for RU2012153069.
- International Patent Classification (IPC) codes relevant to pharmaceutical compositions.
- Industry reports on Russian pharmaceutical patent trends.
