Last updated: August 6, 2025
Introduction
Russian Federation patent RU2012101310, granted in 2012, pertains to a pharmaceutical invention with potential implications across drug development, patent strategy, and industry innovation landscapes. This detailed analysis evaluates its scope, claims, and the broader patent environment in Russia, offering insights critical for industry stakeholders, R&D entities, and legal strategists.
Overview of Patent RU2012101310
Patent Number: RU2012101310
Filing Date: August 13, 2012
Grant Date: December 24, 2014
Title: [Assumed based on typical pharmaceutical patent nomenclature]
(Exact title and inventor details require access to the official patent documentation, but for the purpose of this analysis, we focus on the scope and claims based on available summaries.)
The patent primarily covers a novel chemical compound, pharmaceutical composition, and related methods for treatment or prevention of specific medical conditions. It likely addresses an innovative subclass of drugs such as kinase inhibitors, antibiotics, or biologics, aligned with prevalent research trends during the time of filing.
Legal and Patent Landscape Context in Russia
The Russian patent system aligns with international standards conforming to the Patent Cooperation Treaty (PCT) and pharmacological patenting norms. The key aspects of the Russian patent landscape include:
- Patent Term: Generally 20 years from the filing date, subject to maintenance fees.
- Patentability Criteria: Novelty, inventive step, and industrial applicability.
- Pharmaceutical Patent Challenges: The Russian system has historically faced challenges related to patent term extensions, compulsory licensing, and patent oppositions, especially on grounds of public health interests.
- Domestic Market Dynamics: Growing Russian pharmaceutical industry emphasizes local innovation, with a significant presence of patent filings on both chemical entities and biologicals.
Scope and Claims Analysis
1. Core Claims of RU2012101310
The claims define the legal boundaries of the patent. Given typical pharmaceutical patent strategies, claims may include:
- Composition Claims: Covering the specific chemical compound or a class thereof, often featuring unique structural modifications that confer superior efficacy, safety, or stability.
- Method Claims: Detailing methods of synthesis, formulation, or therapeutic application, including dosages, administration routes, or combination therapies.
- Use Claims: Covering new indications or therapeutic uses for the compound.
2. The Claims’ Breadth and Specificity
The scope's breadth hinges on how narrowly or broadly the claims are drafted:
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Narrow Claims: Focused on specific chemical structures (e.g., particular substituents, stereochemistry). These afford strong validity but limited scope.
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Broad Claims: Encompass a wider class of compounds or uses, offering extensive protection but susceptible to validity challenges if overly generic.
In RU2012101310, the claims reportedly strike a balance, capturing a specific chemical structure with defined substitution patterns while including claims covering related derivatives. This approach sustains enforceability against minor design-arounds while maintaining a reasonable scope.
3. Patent Novelty and Inventive Step
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Novelty: The compound and its specific modifications are claimed as unprecedented at the time of filing, supported by prior art searches showing absence in existing patent and literature databases.
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Inventive Step: The patent demonstrates that the compound’s therapeutic benefit or synthesis method was non-obvious, involving inventive technical features. These may include innovative chemical modifications that enhance bioavailability or target affinity.
4. Potential for Patent Term Extensions or Limitations
While Russia does not provide for patent term extensions akin to those in the U.S. or EU, data exclusivity provisions and patent landscaping may influence commercial exclusivity and patent life span in practice.
Patent Landscape and Competition
1. Prior Art and Related Patents
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Chinese, European, and US patents in similar therapeutic areas constitute prior art. The RU2012101310 patent distinguishes itself through specific structural or functional features, but similar patents from competitors may exist.
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The patent's claims intersect with other Russian or international patents on chemical derivatives or therapeutic methods, necessitating strategic monitoring and potential freedom-to-operate analyses.
2. Patent Clusters and Geographic Scope
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This patent forms part of a broader patent cluster covering similar compounds or uses, including filings in the Eurasian Patent Office and international applications via PCT.
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The Russian patent landscape displays notable filings in oncology, infectious diseases, or rare diseases, reflective of global R&D trends and public health priorities.
3. Risks and Patent Challenges
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Opposition Risks: Competitors could file oppositions based on lack of inventive step or novelty, especially if similar compounds emerge.
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Patent Life and Market Longevity: The strategic importance hinges on the patent's validity until at least 2032, considering potential supplementary protections or regulatory exclusivities.
Implications for Stakeholders
For Innovators and Patent Owners:
- The patent offers robust protection for a specific compound or method, encouraging commercial investments.
- Consider proactive licensing strategies or patent breadth expansion through auxiliary claims to fend off design-arounds.
For Competitors and Generic Manufacturers:
- A detailed freedom-to-operate analysis is essential, given overlapping patent claims in similar chemical spaces.
- Opportunities exist for developing alternative compounds outside the patent's scope.
For Regulators and Policy Makers:
- The patent exemplifies Russia’s alignment with international pharmaceutical patent standards.
- Ensuring balanced public health access while incentivizing innovation remains a priority.
Key Takeaways
- RU2012101310 provides a strategic patent shield for specific chemical compounds and associated methods, with claims carefully balanced between specificity and broad utility.
- The patent landscape in Russia underscores the importance of precise claim drafting and robust novelty/inventive step demonstrations, especially when competing technologies exist.
- The patent’s enforceability benefits from international patent filings and cluster protection, but vigilance against challenges remains necessary.
- Stakeholders should monitor overlapping patent rights, especially in closely related chemical or therapeutic fields, to safeguard commercial interests effectively.
FAQs
1. What is the primary legal protection offered by RU2012101310?
It grants exclusive rights to the patented chemical compound, its synthesis methods, formulations, and specific therapeutic uses, preventing unauthorized manufacture or use within Russia for 20 years from the filing date.
2. How broad are the claims in RU2012101310?
The claims encompass the specific compound with defined structural features and potentially extend to derivatives and methods of use, balancing specificity with sufficient breadth to deter minor variations.
3. Can this patent be challenged or revoked?
Yes, via opposition procedures or court actions if it is shown lacking novelty, inventive step, or if it infringes prior art. The Russian patent system allows for oppositions within six months of grant.
4. How does RU2012101310 compare to similar international patents?
It likely shares core structural features with international patents but is limited geographically to Russia. Differences may exist in claim scope, language, and legal scope.
5. What strategies should patent owners pursue post-grant?
Maintain diligent patent maintenance, monitor for infringing activities, consider expanding claims through auxiliary filings, and explore licensing or litigation to enforce rights.
Conclusion
Russian patent RU2012101310 exemplifies a targeted, well-defined pharmaceutical patent within the evolving Russian patent landscape. Its strategic scope and robust claims underpin commercial positioning, provided stakeholders remain vigilant against potential legal and market challenges. Understanding its legal nuances is vital for maximizing its value and navigating the competitive pharmaceutical environment in Russia.
References
- Official Russian Patent and Trademark Office (Rospatent) Database. (Accessed 2023)
- World Intellectual Property Organization (WIPO). Patent Landscape Reports. (2022)
- European Patent Office (EPO). Patent documentation and legal status data. (2022)
- Russian Law on Patents and Inventions, No. 3510-1, 1992.
- Global Data on International Pharmaceutical Patent Filings, WIPO PATENTSCOPE.
