Detailed Analysis of the Scope and Claims of United States Patent 6,784,197
Introduction
United States Patent 6,784,197, titled "2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses," was granted to UCB S.A. on August 31, 2004. This patent is significant in the pharmaceutical field, particularly for the treatment of neurological disorders.
Patent Overview
The patent describes a class of compounds known as 2-oxo-1-pyrrolidine derivatives, their synthesis, and their therapeutic applications. These compounds are particularly suited for treating neurological disorders such as epilepsy[2][4].
Claims of the Patent
The patent includes multiple claims that define the scope of protection for the 2-oxo-1-pyrrolidine derivatives.
Independent Claims
The independent claims outline the core inventions, including the chemical structure of the compounds, their preparation methods, and their therapeutic uses. Here are some key aspects:
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Chemical Structure: The claims specify the general formula of the 2-oxo-1-pyrrolidine derivatives, including various substituents such as alkyl, aryl, heterocycle, and oxy derivatives. These substituents can be further modified with halogen, cyano, thiocyano, azido, cyclopropyl, acyl, and phenyl groups[1][4].
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Preparation Methods: The patent details several methods for synthesizing these compounds, including the use of activated esters and specific reaction conditions[1].
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Therapeutic Uses: The claims emphasize the use of these compounds in treating neurological disorders, with a particular focus on epilepsy[2][4].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular embodiments of the independent claims. These include specific substituents, stereochemical configurations, and detailed preparation steps.
Scope of Protection
Chemical Name and Structural Formula
The patent protects both specific compounds and classes of compounds defined by their chemical names and structural formulas. For a compound to fall within the protection scope, it must match the specified chemical name or structural formula, including any functional groups and stereochemical configurations[3].
Functional Groups and Stereochemistry
Any changes in the functional groups or stereochemical configurations can result in a different compound that does not infringe on the patent. For example, if the patent claims a specific molecular configuration, other configurations are not considered to be within the protection scope[3].
Patent Landscape and Infringement Analysis
Freedom to Operate (FTO) Analysis
Conducting an FTO patent search and infringement risk analysis is crucial for any new drug development that may involve similar compounds. This involves:
- Identifying Obstacle Patents: Determining which existing patents could pose a risk of infringement.
- Technical Feature Comparison: Analyzing the technical features of the target patent and comparing them with the target drug to assess infringement risk.
- Literal Infringement and Doctrine of Equivalents: Evaluating whether the target drug falls within the literal scope of the claims or if it is equivalent to the claimed invention[3].
Patent Term and Expiration
The patent term for U.S. Patent 6,784,197 has expired, which means that the protected compounds and methods are now in the public domain. However, any extensions or adjustments to the patent term due to regulatory review, such as those related to the approval of BRIVIACT® (brivaracetam), would have been considered during its active period[5].
Therapeutic Applications
The 2-oxo-1-pyrrolidine derivatives are primarily used for treating neurological disorders, with a significant focus on epilepsy. These compounds have shown promise in managing seizures and other related conditions.
Conclusion
United States Patent 6,784,197 provides comprehensive protection for a class of 2-oxo-1-pyrrolidine derivatives, their synthesis, and their therapeutic applications. Understanding the scope and claims of this patent is essential for any pharmaceutical company developing similar compounds to ensure compliance and avoid infringement.
Key Takeaways
- The patent protects 2-oxo-1-pyrrolidine derivatives with specific substituents and stereochemical configurations.
- The compounds are primarily used for treating neurological disorders, especially epilepsy.
- The patent term has expired, making the protected inventions public domain.
- FTO analysis is crucial to determine infringement risk for similar compounds.
- Changes in functional groups or stereochemistry can avoid infringement.
FAQs
Q: What is the primary therapeutic application of the compounds described in U.S. Patent 6,784,197?
A: The primary therapeutic application is the treatment of neurological disorders, particularly epilepsy.
Q: How are the 2-oxo-1-pyrrolidine derivatives synthesized according to the patent?
A: The synthesis involves the use of activated esters and specific reaction conditions as detailed in the patent.
Q: What is the significance of the structural formula in determining patent infringement?
A: The structural formula, including functional groups and stereochemical configurations, must be matched exactly to fall within the protection scope of the patent.
Q: Has the patent term for U.S. Patent 6,784,197 expired?
A: Yes, the patent term has expired, making the protected inventions public domain.
Q: Why is Freedom to Operate (FTO) analysis important for new drug development?
A: FTO analysis helps determine whether a new drug infringes on existing patents, ensuring compliance and avoiding legal issues.
Sources
- United States Patent and Trademark Office - US 6,784,197 B2.
- Unified Patents - US-6784197-B2 - 2-oxo-1-pyrrolidine Derivatives, Processes for ...
- Kangxin - How to conduct FTO patent search and infringement risk analysis in the pharmaceutical field.
- Google Patents - US6784197B2 - 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses.
- Regulations.gov - RECEIVED CDER 8-4-2016 - Patent term extension application for U.S. Patent No. 6,784,197.
