Detailed Analysis of the Scope and Claims of United States Patent 11,590,081
Introduction to Patent 11,590,081
United States Patent 11,590,081, titled "Extended Release Amphetamine Tablets," is a utility patent granted for a new and useful invention related to pharmaceutical formulations. This patent, assigned to a specific entity, describes a novel composition and method for delivering amphetamine in an extended release format.
Overview of the Invention
The patent describes an oral amphetamine extended release solid dose formulation, which includes a combination of an uncoated amphetamine-cation exchange resin complex. This formulation is designed to provide both immediate and modified release components of amphetamine, ensuring a therapeutic effect that lasts for an extended period, typically up to 12-18 hours[4].
Claims of the Patent
Independent Claims
The claims of the patent are crucial as they define the scope and boundaries of the invention. For Patent 11,590,081, the independent claims typically include:
- Composition Claims: These claims describe the specific composition of the extended release amphetamine tablets, including the use of cation exchange resins and the ratio of immediate to modified release components.
- Method Claims: These claims outline the method of treating patients with disorders for which amphetamines are approved, using the described extended release composition.
Dependent Claims
Dependent claims further specify and narrow down the scope of the independent claims. For example:
- Specific Formulations: Claims may specify the exact proportions of different amphetamine salts (e.g., dextroamphetamine sulfate, dextroamphetamine saccharate) and the type of cation exchange resin used.
- Release Profiles: Claims may detail the specific release profiles, such as the duration of the therapeutic effect and the methods for assessing in vitro dissolution[4].
Scope of the Invention
The scope of the invention is defined by the claims and is critical for understanding what is protected under the patent.
Immediate and Modified Release Components
The patent covers a composition that includes both immediate and modified release components. The immediate release component provides a rapid onset of action, while the modified release component ensures a sustained therapeutic effect over several hours[4].
Use of Cation Exchange Resins
The use of cation exchange resins is a key aspect of the invention. These resins bind to the amphetamine, allowing for a controlled release of the active ingredient. The patent specifies that the modified release component may contain a blend of different modified release, pH-independent, barrier-coated amphetamine-cation exchange resin complexes[4].
Patent Landscape
Prior Art
The patent landscape for amphetamine formulations is extensive, with several prior patents and publications relevant to this invention. For example, U.S. Pat. No. 4,996,047 and U.S. Pat. No. 2,990,332 describe earlier uses of ion exchange resins with amphetamine. Additionally, U.S. Reissue patents 41,148 and RE 42,096 describe oral pulsed dose amphetamine delivery systems[4].
Competing Patents
Other patents in the field of extended release pharmaceutical formulations may compete with or complement this invention. For instance, patents related to other controlled release technologies or different active ingredients could be relevant.
Importance of Patent Claims and Scope
Measuring Patent Scope
The scope of a patent, as defined by its claims, is a critical factor in patent quality debates. Metrics such as independent claim length and independent claim count can be used to measure patent scope, which in turn affects the patent's validity and the incentives for innovation[3].
Impact on Innovation
Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process. This can encourage innovation by providing clearer boundaries and reducing the risk of litigation and licensing costs[3].
Practical Applications and Benefits
Therapeutic Benefits
The extended release amphetamine tablets described in this patent offer several therapeutic benefits, including a prolonged therapeutic effect and the potential for improved patient compliance due to reduced dosing frequency.
Manufacturing and Formulation
The patent provides detailed information on the composition and method of manufacturing these tablets, which can be valuable for pharmaceutical companies looking to develop similar formulations.
Key Takeaways
- Composition and Method: The patent describes a specific composition and method for extended release amphetamine tablets using cation exchange resins.
- Claims and Scope: The claims define the scope of the invention, including both immediate and modified release components.
- Prior Art and Competing Patents: The patent landscape includes several prior patents and publications related to amphetamine formulations.
- Impact on Innovation: The patent's scope and claims can influence innovation by providing clear boundaries and reducing litigation risks.
FAQs
What is the main innovation of United States Patent 11,590,081?
The main innovation is the development of an extended release amphetamine tablet formulation using cation exchange resins, providing both immediate and sustained therapeutic effects.
How does the use of cation exchange resins contribute to the invention?
The cation exchange resins bind to the amphetamine, allowing for a controlled release of the active ingredient, which is crucial for the extended release profile of the tablets.
What are the therapeutic benefits of this invention?
The extended release formulation offers a prolonged therapeutic effect, potentially improving patient compliance by reducing the need for frequent dosing.
How does this patent fit into the broader patent landscape for amphetamine formulations?
This patent builds upon prior art related to ion exchange resins and amphetamine delivery systems, offering a novel composition and method that complements existing technologies.
What metrics can be used to measure the scope of this patent?
Metrics such as independent claim length and independent claim count can be used to measure the scope of this patent, which is important for assessing patent quality and innovation incentives[3].
Sources
- USPTO Search: Find existing patents, published patent applications and other published patent documentation.
- USA.gov - U.S. Patent and Trademark Office: The agency responsible for granting U.S. patents and registering trademarks.
- SSRN - Patent Claims and Patent Scope: Metrics for measuring patent scope based on claim language.
- Google Patents - Extended Release Amphetamine Tablets: Detailed description of the patent.
- University of Minnesota - Patents and Patentability: Tutorial on patents, including types and parts of a patent.
