United States Patent 11,273,131: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 11,273,131, titled "Pharmaceutical compositions with enhanced permeation," is a significant innovation in the field of pharmaceuticals. This patent, granted on March 15, 2022, addresses the enhancement of active component permeation in pharmaceutical compositions. Here, we delve into the technical field, background, claims, and the broader patent landscape surrounding this invention.
Technical Field
This patent falls under the technical field of pharmaceutical compositions, specifically focusing on the enhancement of permeation properties of active components. This area is crucial for improving the efficacy and bioavailability of drugs[1].
Background
The background of the patent highlights the need for improved permeation of pharmaceutical active components. Traditional formulations often face challenges such as limited bioavailability and variable absorption rates. The inventors have developed compositions that incorporate various enhancers and matrices to overcome these issues.
Key Components
- Pharmaceutically Active Components: The patent mentions several active components, including epinephrine, diazepam, and alprazolam. These components are integrated into a polymeric matrix to enhance their permeation properties[1].
- Polymeric Matrix: The matrix can include water-soluble polymers such as polyethylene oxide. This matrix plays a critical role in stabilizing the active component and facilitating its delivery[1].
- Enhancers and Modulators: The composition may include various enhancers such as modulatory agents of epithelial junction physiology, vasodilators, and selective transport-enhancing agents. These enhancers help in increasing the bioavailability of the active component[1].
Claims
The patent includes several claims that define the scope of the invention.
Independent Claims
- The patent claims pharmaceutical compositions that include a polymeric matrix, a pharmaceutically active component within this matrix, and an interacter that modifies the heat of solution to enhance transmucosal uptake[1].
- Another claim involves a multilayer film with at least one side where the edges are coterminous, containing the polymeric matrix and the active component[1].
Dependent Claims
- These claims further specify the types of polymers, enhancers, and active components that can be used. For example, the polymeric matrix can include polyethylene oxide, and the active component can be epinephrine or diazepam[1].
Figures and Drawings
The patent includes detailed figures and drawings that illustrate the composition and the experimental setup used to test the permeation properties.
- Figure 100: This figure shows a donor compound, a donor chamber, a membrane, a sampling port, a receptor chamber, a stir bar, and a heater/circulator. This setup is used to measure the permeation of the active component[1].
- Figure 200: This figure depicts a polymeric matrix containing the pharmaceutically active component and a permeation enhancer[1].
Experimental Data
The patent provides experimental data to support the claims, including studies on Yucatan miniature swine. These studies compare the permeation of different formulations, such as a 0.3 mg Epinephrine auto-injector (Epipen), a 0.12 mg Epinephrine IV, and a placebo film[1].
Patent Scope and Breadth
The scope of this patent is defined by its claims and the technical field it addresses. Here are some key aspects:
- Claim Length and Count: The patent's scope can be measured by the length and count of its independent claims. A narrower claim set, as seen in this patent, often indicates a more focused and specific invention, which can be beneficial for patent maintenance and litigation purposes[3].
- Forward Citations: The number of forward citations this patent receives can indicate its impact and relevance in the field. Higher forward citations suggest that the patent is being referenced and built upon by other inventors[3].
Broader Patent Landscape
Patent Search and Analysis
To understand the broader landscape, one can use tools provided by the USPTO, such as the Patent Public Search tool, Global Dossier, and the Patent and Trademark Resource Centers (PTRCs)[4].
- Global Dossier: This service allows users to view the file histories of related applications from participating IP Offices, providing a comprehensive view of the patent family and related applications[4].
- Common Citation Document (CCD): This tool consolidates prior art cited by all participating offices for the family members of a patent application, helping to visualize the search results on a single page[4].
Related Patents and Applications
Searching for related patents and applications can reveal trends and innovations in the field of pharmaceutical compositions. For instance, other patents focusing on permeation enhancers, polymeric matrices, and transmucosal delivery systems can provide insights into the evolving technology[4].
Legal and Policy Considerations
The legal and policy landscape surrounding patents is complex and evolving.
- Patent Quality Debates: There are ongoing debates about patent quality, with concerns over the breadth and clarity of patents. This patent, with its specific and detailed claims, aligns with the trend of narrower, more focused patents[3].
- Small Claims Patent Court: There have been discussions about establishing a small claims patent court to address issues related to patent litigation costs and complexity. This could impact how patents like 11,273,131 are enforced and litigated in the future[5].
Key Takeaways
- Enhanced Permeation: The patent introduces compositions that significantly enhance the permeation of pharmaceutical active components.
- Polymeric Matrix: The use of a polymeric matrix, such as polyethylene oxide, is crucial for stabilizing and delivering the active component.
- Experimental Validation: The patent includes experimental data from studies on Yucatan miniature swine to support its claims.
- Broader Landscape: The patent fits into a broader landscape of pharmaceutical innovations, with tools like the Global Dossier and CCD aiding in its analysis.
FAQs
What is the main focus of United States Patent 11,273,131?
The main focus of this patent is on pharmaceutical compositions that enhance the permeation properties of active components.
What types of active components are mentioned in the patent?
The patent mentions active components such as epinephrine, diazepam, and alprazolam.
What role does the polymeric matrix play in the composition?
The polymeric matrix, which can include polymers like polyethylene oxide, stabilizes the active component and facilitates its delivery.
How does the patent support its claims with experimental data?
The patent includes studies on Yucatan miniature swine comparing different formulations to demonstrate the enhanced permeation properties.
What tools can be used to analyze the broader patent landscape?
Tools such as the Patent Public Search, Global Dossier, and Common Citation Document (CCD) provided by the USPTO can be used to analyze the broader patent landscape.
Sources
- Pharmaceutical compositions with enhanced permeation - U.S. Patent 11,273,131.
- U.S. Patent and Trademark Office (USPTO) - USAGov.
- Patent Claims and Patent Scope - SSRN.
- Search for patents - USPTO.
- U.S. Patent Small Claims Court - ACUS.
