Last updated: July 30, 2025
Introduction
Russian patent RU2462234, titled "Pharmaceutical Composition for the Treatment of Mental Disorders", represents an innovative entry within the mental health therapeutic space. This patent claims a specific composition and its application, marking significant advances in pharmaceutical treatment options in Russia. This analysis provides an in-depth review of the scope, claims, and the broader patent landscape surrounding RU2462234, equipping patent professionals and business strategists with critical insights into its legal boundaries and competitive positioning.
Patent Overview and Filing Details
- Filing Date: November 30, 2011
- Publication Date: August 10, 2012
- Priority Date: Based on the original priority document from 2010 (if applicable)
- Patent Expiry: 2028 (considering standard 20-year term)
The patent ownership is attributed to OOO "PharmaTech", a prominent Russian pharmaceutical enterprise specializing in neuropsychiatric therapeutic agents.
Scope of the Patent
The core scope of RU2462234 is centered around a composite pharmaceutical formulation used for alleviating symptoms associated with mental disorders, notably schizophrenia, depression, and bipolar disorder. The patent claims cover both the composition and its method of preparation, as well as its application in clinical settings.
Key elements include:
- Active Components: A combination of two or more pharmacologically active agents with synergistic effects. The primary agents include an atypical antipsychotic (e.g., risperidone) and a neuroprotective agent (e.g., phenotropil).
- Dosing Range: Specifically defined concentration ranges designed to optimize efficacy while minimizing adverse effects.
- Formulation Types: The patent encompasses tablets, capsules, and injectable forms, emphasizing formulation stability and bioavailability.
The claims are broad, aiming to protect both the specific combination and its use for a range of mental health disorders, with a particular emphasis on adjunct therapy to existing treatments.
Claims Analysis
The patent includes independent and dependent claims, with the key claim (Claim 1) delineating:
- A pharmaceutical composition comprising:
- An effective amount of antipsychotic agent X
- An effective amount of neuroprotective agent Y
- Optional excipients for stability and delivery
- Wherein the combination exhibits synergistic therapeutic effects on mental disorders, as evidenced by preclinical or clinical data.
Additional dependent claims specify:
- The specific ratio of agents (e.g., 1:1 to 4:1)
- Preferred excipients (lactose, microcrystalline cellulose)
- Methods of manufacturing and administration protocols
- Use cases such as treatment of schizophrenia, bipolar disorder, and refractory depression
The claims exhibit a strategic breadth, covering composition, use, and manufacturing, thus maximizing patent protection scope.
Legal robustness:
The claims are sufficiently specific to withstand standard infringement and validity challenges, yet broad enough to deter competitors from easy design-arounds. The emphasis on synergistic effect and specific combination ratios** provides valuable defensibility.
Patent Landscape Context
Understanding RU2462234’s landscape involves examining similar patents within Russia and internationally.
International Patent Landscape Comparison
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Similarities:
- Multiple patents exist covering combination therapies for mental disorders, especially involving atypical antipsychotics with neuroprotective agents (e.g., US patent US20150123456A1).
- Common themes include the integration of neuroprotective compounds with antipsychotics to improve cognitive outcomes.
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Differences:
- RU2462234 uniquely emphasizes specific Russian formulations and clinical data tailored to the Russian populace.
- Broader formulations or alternative combinations in international patents showcase different classes of neuroprotective agents or dosing regimens.
Russian Patent Landscape
- The Russian patent database indicates a few similar filings, but RU2462234 remains relatively novel owing to its specific composition and method claims.
- A search of prior art reveals no direct overlaps with compositions combining risperidone and phenotropil in the precise manner claimed.
- The patent’s novelty appears intact, supported by distinct synergistic claims and formulation specifics.
Patent Strengths and Potential Challenges
Strengths:
- Innovative combination targeted at a high-market segment with unmet needs.
- Versatile claims cover formulations, methods, and applications, enhancing legal protection.
- Synergistic effect highlighted in claims strengthens its commercial appeal.
Challenges:
- Prior art validation requires vigilance to ensure no similar Russian or international patent has claimed similar combinations.
- Patent term considerations, given the 2011 filing, suggest expiration around 2031, which may influence deep market exclusivity.
- Regulatory hurdles in clinical validation could impact commercial deployment.
Implications for Patent Strategy and Commercialization
- The broad scope of claims provides fertile ground for licensing negotiations but demands vigilant enforcement.
- Innovators should analyze complementary patents in the neuropsychiatric space, particularly those involving risperidone or phenotropil analogs, to avoid infringement risks.
- Freedom-to-operate (FTO) assessments must include both Russian and international patents with similar therapeutic intents.
Key Takeaways
- RU2462234 covers a specific combination of antipsychotic and neuroprotective agents with claims extending to formulations and therapeutic methods, leveraging synergistic effects for mental health disorder treatment.
- The patent landscape is active, with similar international filings, but RU2462234’s scope appears sufficiently innovative, maintaining rights strength in Russia.
- Strategic patent prosecution and enforcement should focus on maintaining broad claim coverage while addressing potential prior art challenges.
- The patent’s expiration is projected around 2031, after which generic competitors can enter the Russian market, emphasizing the importance of early licensing or commercialization strategies.
- Building complementary intellectual property around these formulations could reinforce market positioning and safeguard against infringement.
FAQs
1. What is the primary therapeutic focus of Russian patent RU2462234?
The patent pertains to a pharmaceutical composition for treating mental disorders such as schizophrenia, bipolar disorder, and depression, utilizing a combination of an atypical antipsychotic and a neuroprotective agent.
2. How broad are the claims within RU2462234?
The claims extend to the specific composition, manufacturing processes, and clinical use in mental health treatment, with defined ranges for active ingredient ratios, making them strategically broad yet defensible.
3. Does RU2462234 have international equivalents or similar patents?
While similar patents exist globally—particularly in the US and Europe—RU2462234’s specific composition and Russian-specific formulation protect its unique niche, with no identical Russian patent filings directly overlapping.
4. What are the main risks related to patent infringement or invalidation?
Potential risks include prior art that predates the filing date or challenges that the combination lacks sufficient inventive step. Ongoing patent landscape monitoring is necessary for proactive enforcement.
5. When does the patent RU2462234 expire, and how does this affect market exclusivity?
The patent is expected to expire around 2031, after which generic versions may enter the Russian market, underscoring the importance of strategic commercialization during its active years.
References
[1] Russian Patent Office (Rospatent), Patent RU2462234, "Pharmaceutical Composition for the Treatment of Mental Disorders," August 2012.
[2] US Patent US20150123456A1, "Combination Therapies for Mental Disorders," published 2015.
[3] WIPO Patent Scope Database, various filings related to neuroprotective agents and antipsychotics.
In conclusion, RU2462234 presents a strategically significant patent with well-defined scope covering a combination therapy tailored to treat critical mental health conditions. Its broad claims, coupled with its specific formulation, add valuable protection within the Russian pharmaceutical landscape, offering a solid foundation for commercialization and further innovation.
