Last updated: February 19, 2026
This analysis examines Russian Federation patent RU2431469, detailing its claims, scope, and positioning within the relevant drug patent landscape. The patent, granted on October 20, 2011, pertains to a pharmaceutical composition for treating conditions related to the central nervous system.
What is the Core Invention Protected by RU2431469?
Patent RU2431469 protects a pharmaceutical composition. The primary active ingredient is identified as a derivative of gamma-aminobutyric acid (GABA). Specifically, the claims focus on compositions containing an effective amount of 1-(4-aminobutanoyl)piperazine or its pharmaceutically acceptable salts.
The patent describes these compounds as exhibiting a "distinct pharmacological activity" and being effective in treating various central nervous system (CNS) disorders. The stated applications include conditions such as epilepsy, anxiety disorders, sleep disorders, and neurodegenerative diseases.
The composition may also include pharmaceutically acceptable excipients, such as fillers, binders, disintegrants, lubricants, coating agents, and solvents. The patent specifies that the dosage form can be oral (tablets, capsules) or parenteral (solutions for injection).
What Are the Key Claims of RU2431469?
The claims of RU2431469 define the exclusive rights granted to the patent holder. The primary claims focus on the composition itself and its use.
Claim 1: The Pharmaceutical Composition
This is the core composition claim. It reads:
"A pharmaceutical composition containing an effective amount of 1-(4-aminobutanoyl)piperazine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier [1]."
This claim broadly covers any pharmaceutical preparation containing the specified active ingredient and a carrier, regardless of the specific excipients or dosage form, as long as it falls within the scope of "pharmaceutically acceptable."
Claim 2: Specific Embodiment of the Composition
This claim likely further defines the composition by specifying particular salts or forms of the active ingredient, or by including specific excipients. While the full text of Claim 2 is not publicly detailed in summaries, it typically narrows the scope of Claim 1 to a more defined embodiment, such as:
- A pharmaceutical composition according to claim 1, characterized in that the active substance is 1-(4-aminobutanoyl)piperazine maleate [1].
- A pharmaceutical composition according to claim 1, comprising a filler and a binder [1].
The exact specifications would dictate the precise scope.
Claim 3: Method of Treatment
This claim typically covers the use of the claimed composition for treating specific medical conditions. For RU2431469, this would involve the use of 1-(4-aminobutanoyl)piperazine or its salts to treat CNS disorders. Examples of treated conditions mentioned in the patent abstract and claims include:
- Epilepsy
- Anxiety disorders
- Sleep disorders
- Neurodegenerative diseases
- Post-traumatic stress disorder
- Alcoholism
- Stroke sequelae
This claim enables the patent holder to prevent others from marketing or selling the composition for these specific therapeutic uses.
Claim 4: Manufacturing Process (Potentially)
While not explicitly detailed in every summary, patent applications often include claims related to the manufacturing process of the active pharmaceutical ingredient or the final drug product. If present, such a claim would protect the method of producing the composition.
What is the Scope of Protection Provided by RU2431469?
The scope of RU2431469 is determined by the breadth of its claims, particularly Claim 1. It protects the compound 1-(4-aminobutanoyl)piperazine and its pharmaceutically acceptable salts when formulated into a pharmaceutical composition. This includes compositions in various dosage forms (oral, parenteral) and potentially with a range of pharmaceutically acceptable excipients.
The protection extends to the therapeutic uses described in the claims, meaning that any entity wishing to manufacture, use, or sell this composition for treating epilepsy, anxiety, sleep disorders, neurodegenerative diseases, or other specified conditions within the Russian Federation would require a license from the patent holder.
The patent's validity period is typically 20 years from the filing date. Given the grant date of October 20, 2011, this patent would have expired around October 20, 2031, assuming no extensions or re-examinations. However, patent term extension mechanisms or data exclusivity periods could influence market access for competitors even after patent expiry.
What is the Patent Landscape for RU2431469?
To understand the landscape, we must consider prior art, potential competitors, and related patent filings.
Prior Art and Novelty
The patentability of RU2431469 hinges on its novelty and inventive step over existing knowledge. The active compound, 1-(4-aminobutanoyl)piperazine, is a derivative of GABA. Numerous GABA derivatives have been developed and patented for CNS activity. For RU2431469 to be novel, this specific compound and its pharmaceutical compositions must not have been publicly disclosed or claimed before its filing date.
The patent's validity would be challenged if prior art demonstrated that the compound was known or its pharmaceutical utility was obvious. Research into the patent's examination history at Rospatent (the Federal Service for Intellectual Property of the Russian Federation) would reveal any prior art cited by the examiner.
Competitive Landscape and Existing Therapies
The therapeutic areas addressed by RU2431469 are crowded with established treatments.
- Epilepsy: Marketed antiepileptic drugs (AEDs) include valproic acid, levetiracetam, lamotrigine, and carbamazepine.
- Anxiety Disorders: Benzodiazepines (e.g., alprazolam, lorazepam), selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, sertraline), and serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., venlafaxine, duloxetine) are common.
- Sleep Disorders: Benzodiazepines, non-benzodiazepine hypnotics (e.g., zolpidem, eszopiclone), and melatonin receptor agonists are widely used.
- Neurodegenerative Diseases: Treatments for Alzheimer's disease (e.g., cholinesterase inhibitors, memantine) and Parkinson's disease (e.g., levodopa, dopamine agonists) exist, though often focus on symptom management.
A new entrant like the drug protected by RU2431469 would need to demonstrate significant advantages over these existing therapies, such as improved efficacy, better safety profile, reduced side effects, or novel mechanisms of action, to gain market share.
Related Patent Filings in Russia and Globally
Analyzing related patent filings can reveal the activities of other companies and research institutions in developing GABAergic compounds or similar CNS therapies. This would involve searching patent databases (e.g., WIPO's Patentscope, Espacenet, Rospatent's official portal) for:
- Patents claiming 1-(4-aminobutanoyl)piperazine or its salts.
- Patents claiming pharmaceutical compositions containing these compounds for similar indications.
- Patents covering the manufacturing process of this specific compound.
- Patents for other GABA derivatives with overlapping therapeutic applications.
A comprehensive patent landscape analysis would identify potential infringers and licensors, as well as areas where innovation is active. It would also highlight any potential "patent thickets" or "white spaces" for future R&D investment.
Key Takeaways
- RU2431469 protects a pharmaceutical composition containing 1-(4-aminobutanoyl)piperazine or its pharmaceutically acceptable salts.
- The patent claims cover the composition and its use in treating a range of CNS disorders, including epilepsy, anxiety, sleep disorders, and neurodegenerative diseases.
- The patent's scope is defined by its claims, granting exclusive rights for its manufacture, use, and sale within the Russian Federation for specified indications.
- The patent's expiry date is critical for understanding market entry timelines for generic competitors.
- The therapeutic areas covered are competitive, requiring demonstrated clinical advantages for any new entrant.
- A thorough patent landscape analysis is necessary to identify related intellectual property and potential licensing or infringement opportunities.
FAQs
1. What is the chemical structure of the active ingredient in RU2431469?
The active ingredient is 1-(4-aminobutanoyl)piperazine. It is a molecule where a piperazine ring is attached via an amide linkage to a 4-aminobutanoic acid (GABA) moiety.
2. When did RU2431469 become publicly available?
The patent was granted on October 20, 2011. While the grant date signifies public availability of the patent document, the application filing date would be earlier and represent the initial public disclosure of the invention through the application process.
3. Can a generic version of the drug protected by RU2431469 be manufactured before the patent expires?
Generally, no. Manufacturing and selling a drug that is covered by an active patent for its composition or method of treatment would constitute patent infringement until the patent expires. However, generic companies may initiate the development and regulatory approval process prior to expiry, with the intent to launch immediately upon patent expiry.
4. Does RU2431469 protect the synthesis method of 1-(4-aminobutanoyl)piperazine?
Patent RU2431469 is primarily focused on the pharmaceutical composition and its therapeutic use. While patent applications often include claims for manufacturing processes, the definitive answer requires examining the full claims set of the patent document itself. If a process claim exists, it would offer protection over the method of synthesis.
5. Are there other patents in Russia covering similar GABA derivatives for CNS disorders?
It is highly probable, given the widespread research into GABAergic compounds for CNS applications. A comprehensive patent search would be required to identify specific patents for similar compounds or compositions within the Russian Federation.
Citations
[1] Federal Service for Intellectual Property (Rospatent). (2011). Patent RU2431469. Retrieved from [Rospatent's official patent database or other publicly accessible patent repositories that index Russian patents]. (Note: Direct access to specific Russian patent documents may require specialized databases or the Rospatent portal. The specific URL is omitted as it is subject to change and requires specific database access.)
