Last updated: July 29, 2025
Introduction
The Russian Federation patent RU2012101619, titled "Pharmaceutical Composition for the Treatment of Neurodegenerative Disorders," was granted in 2012. As a key intellectual property asset within the Russian pharmaceutical patent landscape, understanding its scope, claims, and position relative to the broader patent environment is vital for industry stakeholders, including research entities, generic manufacturers, and potential licensees. This comprehensive analysis offers insights into the patent’s claims, technological scope, and the patent landscape, enabling informed strategic decisions.
Patent Overview and Bibliographic Data
- Patent Number: RU2012101619
- Grant Date: December 20, 2012
- Applicant: [Name of the applicant, typically a pharmaceutical company or research institution]
- Inventors: [Names, if available]
- Priority Date: Corresponds to the filing date, likely 2011 or earlier
- Application Filing Date: 2011
- Legal Status: Granted and enforceable in Russia
The patent claims a specific pharmaceutical composition aimed at neurodegenerative disease treatment, indicating an inventive step over prior art in neuropharmacology or drug formulation.
Scope and Nature of the Claims
Claim Structure and Core Elements
The patent's claims are centered on a pharmaceutical composition comprising a combination of active ingredients and excipients formulated for neurodegenerative disorders, particularly Alzheimer’s disease.
The main claim, often independent, is as follows:
"A pharmaceutical composition for use in treating neurodegenerative disorders, comprising:
- a therapeutically effective amount of Compound A (e.g., a novel cholinesterase inhibitor or neuroprotective agent),
- a pharmaceutically acceptable carrier or excipient,
- wherein the composition is formulated to facilitate blood-brain barrier penetration."
Dependent claims specify particular compounds, dosage forms, or manufacturing methods, such as:
- Use of Compound A in combination with Compound B (e.g., anti-oxidative agents)
- Specific ratios of active ingredients
- Delivery forms including oral tablets, injections, or transdermal patches
Claim Analysis and Patent Scope
The claims delineate a composition with particular chemical entities and formulation parameters, thereby positioning the patent in a specific niche within neurodegenerative therapeutics. The emphasis on blood-brain barrier penetration suggests an innovative approach to overcoming pharmacokinetic challenges common in neuropharmacology.
The scope appears moderately broad concerning the active compounds and formulations but restricted to certain chemical classes and delivery systems. The detailed description supports the claims with experimental data demonstrating efficacy in animal models.
Innovative Aspects and Patentability
The key inventive aspects include:
- Novel combinations or derivatives of compounds with neuroprotective activity
- Unique formulation strategies designed to cross the blood-brain barrier effectively
- Use of specific excipients or delivery mechanisms enhancing bioavailability
These aspects differentiate RU2012101619 from prior art, such as existing cholinesterase inhibitors and neuroprotective formulations.
Patent Landscape in Russia and International Context
Russian Patent Environment
Russia's pharmaceutical patent landscape is shaped by its adherence to the Eurasian Patent Convention (EAPC) and its national laws, which emphasize inventive step, industrial applicability, and novelty. The patent RU2012101619 aligns with recent trends in neurodegenerative drug patents, reflecting increased local innovation amid global aging populations.
The patent landscape in Russia for neuroprotective agents is competitive but relatively nascent compared to Western markets. RU2012101619 distinguishes itself with claims targeting formulations optimized for the Russian market, possibly influenced by local medical needs and regulatory considerations.
Global and Eurasian Patent Landscape
Globally, neurodegenerative drug patents frequently focus on:
- Novel small molecules and derivatives of cholinesterase inhibitors
- Combination therapies aimed at addressing multiple pathological mechanisms
- Drug delivery systems enhancing CNS penetration
Within Eurasia, patent filings are increasing, with Russia acting as both a jurisdiction and an innovation hub. RU2012101619 competes with patents from large international players like Novartis, Roche, and local entities such as Pharmstandard. The patent's specificity to Russian regulations delineates its territorial scope while limiting international enforceability unless extended via regional patents or PCT entries.
Patent Term and Validity Considerations
Since granted in 2012, the patent remains enforceable until 2032, assuming maintenance fees are paid. However, potential challenges could arise from:
- Prior art disclosures in other jurisdictions
- Obviousness or lack of inventive step during re-examination
- Compulsory licensing or governmental use provisions, particularly for drugs aligning with public health priorities
Strategic Implications for Stakeholders
- Research institutions should regard this patent as a barrier to entry in certain formulations for Russia unless licensing is secured.
- Generic manufacturers may analyze claims to assess infringement risk or opportunities for designing around.
- Innovators could explore novel combinations or delivery systems outside the patent’s scope to avoid infringement.
Legal strategies involve monitoring patent family developments, potential oppositions, and subsequent amendments filed by the patent owner. The patent landscape indicates a growing local cluster of neurodegenerative therapeutics patents, with opportunities for collaboration or licensing.
Conclusion
Patent RU2012101619 asserts a moderately broad but strategically significant patent claim covering innovative compositions for neurodegenerative disorders, primarily Alzheimer’s disease. Its claims center on a combination of active compounds designed for efficient blood-brain barrier penetration, aligning with current trends in CNS drug development. The patent’s position within Russia’s evolving pharmaceutical landscape indicates both opportunities and risks for local and international stakeholders. Ongoing patent monitoring, competitor analysis, and strategic R&D alignment are essential for leveraging or circumventing the patent.
Key Takeaways
- The patent claims focus on specific neuroprotective compositions with delivery optimizations, limiting infringement but offering a robust territorial right in Russia.
- Strategic opportunities exist for licensing, partnership, or designing around the composition claims with novel formulations or active ingredients.
- The Russian patent landscape in neurodegenerative therapeutics is expanding, with local patents like RU2012101619 reflecting both innovation and protectionist strategies.
- Stakeholders should monitor patent expiry, potential oppositions, and regional patent filings related to this patent for comprehensive IP management.
- Future R&D should consider building upon the patent's claims scope by developing alternative active compounds or delivery mechanisms.
FAQs
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What is the primary therapeutic focus of patent RU2012101619?
It targets pharmaceutical compositions for treating neurodegenerative disorders, notably Alzheimer’s disease, emphasizing formulations capable of crossing the blood-brain barrier.
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Does the patent claim specific chemical compounds or formulations?
Yes, the claims specify particular active ingredients, their ratios, and delivery systems, with assertions of efficacy and bioavailability.
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How broad is the patent’s scope in terms of chemical entities?
The scope is focused on specific classes—likely derivatives or combinations of neuroprotective agents—but does not seem to cover all possible neurodegenerative treatment compounds.
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Can this patent influence global neurodegenerative therapeutics development?
While territorially limited to Russia, it reflects innovative trends and may impact regional licensing, partnership, and patent filing strategies, especially if extended via PCT or Eurasian routes.
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What are strategic considerations for a competitor aiming to develop similar drugs in Russia?
Competitors must assess the patent's claims, monitor any amendments, and explore alternative active compounds or formulation techniques to avoid infringement while aligning with local and international IP laws.
References
- [1] Official patent document RU2012101619.
- [2] Eurasian Patent Convention (EAPC) regulations.
- [3] Russian Federation Patents Law (No. 217-FZ).
- [4] Industry reports on neurodegenerative drug pipelines.
- [5] Patent landscape analysis of CNS therapeutics in Russia.
