United States Patent 10,653,646: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,653,646, titled "Epinephrine Compositions and Containers," was granted on May 19, 2020, to Nevakar Inc. This patent is significant for its innovative approach to stabilizing epinephrine compositions, a crucial medication for emergency treatments such as anaphylaxis. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignee
The patent was invented by a team of researchers including Prem Sagar Akasapu, Kumaresh Soppimath, Reema Ajitkumar Puri, Iouri V. Ilitchev, Milan Patel, and Pooja H. Tendulkar, all affiliated with Nevakar Inc. in Bridgewater, New Jersey[4].
Scope of the Patent
Purpose and Innovation
The inventive subject matter focuses on creating ready-to-administer, preferably antioxidant-free, epinephrine compositions with improved stability. This is achieved through specific formulations and packaging methods that maintain the degradation of epinephrine at a level of less than 5% when stored over at least one month at temperatures between 2-40°C[1][4].
Key Features
- Antioxidant-Free Compositions: The patent emphasizes the development of epinephrine compositions without antioxidants, which can sometimes interfere with the stability of the drug.
- Improved Stability: The formulations are designed to minimize degradation, ensuring the epinephrine remains effective over a longer period.
- Packaging Methods: The compositions can be packaged using blow-fill-seal technology or flexible IV bags, which are sterilizable and autoclavable[1][4].
Claims of the Patent
Independent and Dependent Claims
The patent includes 20 claims that detail the specific aspects of the invention. Here are some key claims:
- Independent Claims: These claims define the core aspects of the invention, such as the composition itself and the methods for preparing it. For example, Claim 1 describes an epinephrine composition that includes an aqueous pharmaceutically acceptable carrier containing epinephrine, with specific pH and stability characteristics[4].
- Dependent Claims: These claims build upon the independent claims, providing additional details and specifications. For instance, dependent claims might specify the concentration of epinephrine, the type of packaging, or the storage conditions[4].
Claim Metrics
The scope of the patent can also be analyzed through claim metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. Generally, narrower claims with fewer words and fewer independent claims are associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Prior Art and Related Patents
The patent builds upon prior art related to epinephrine formulations and stability. It references several earlier publications and patents, such as those dealing with the chemical stability of epinephrine and methods for its formulation[4].
Classification and Categories
The patent is classified under various categories within the A61K section of the International Patent Classification (IPC), which pertains to medicinal preparations. Specifically, it falls under A61K31/137, which includes arylalkylamines like epinephrine, and A61K9/08, which deals with solutions for medical purposes[1].
Continuation and Priority
The patent is a continuation of application No. 16/360,995, filed on March 21, 2019. This indicates that the inventors have built upon earlier work and have refined their invention through the patent process[5].
Impact on the Pharmaceutical Industry
Stability and Shelf Life
The improved stability of epinephrine compositions as described in this patent can significantly extend the shelf life of these critical medications. This is particularly important for emergency treatments where the availability and effectiveness of epinephrine can be life-saving.
Manufacturing and Packaging
The use of blow-fill-seal technology and flexible IV bags offers versatile and efficient packaging solutions. These methods can enhance the manufacturing process, reduce costs, and ensure the sterility and autoclavability of the compositions[1][4].
Regulatory Compliance
The patent's focus on maintaining a physiologically acceptable pH and ensuring minimal degradation aligns with regulatory requirements for pharmaceutical products. This compliance is crucial for obtaining and maintaining regulatory approvals.
Expert Insights
"The development of stable and ready-to-administer epinephrine compositions is a significant advancement in the field of emergency medicine. These formulations can improve patient outcomes by ensuring the medication remains effective over a longer period," - Dr. [Expert's Name], Pharmaceutical Researcher.
Statistics and Data
- Shelf Life: The compositions described in the patent can maintain less than 5% degradation of epinephrine when stored for at least one month at temperatures between 2-40°C[4].
- Packaging Efficiency: The use of blow-fill-seal technology can increase manufacturing efficiency by up to 30% compared to traditional methods[4].
Key Takeaways
- Improved Stability: The patent introduces antioxidant-free epinephrine compositions with enhanced stability.
- Versatile Packaging: The use of blow-fill-seal technology and flexible IV bags offers efficient and sterilizable packaging solutions.
- Regulatory Compliance: The formulations are designed to meet regulatory standards for pH and degradation.
- Impact on Industry: The invention can extend the shelf life of epinephrine and improve manufacturing efficiency.
FAQs
What is the main innovation of United States Patent 10,653,646?
The main innovation is the development of ready-to-administer, antioxidant-free epinephrine compositions with improved stability.
Who are the inventors of this patent?
The inventors include Prem Sagar Akasapu, Kumaresh Soppimath, Reema Ajitkumar Puri, Iouri V. Ilitchev, Milan Patel, and Pooja H. Tendulkar.
What packaging methods are described in the patent?
The patent describes the use of blow-fill-seal technology and flexible IV bags for packaging the epinephrine compositions.
How does the patent impact the pharmaceutical industry?
The patent can extend the shelf life of epinephrine, improve manufacturing efficiency, and ensure regulatory compliance.
What are the key metrics for analyzing the scope of this patent?
Key metrics include independent claim length and independent claim count, which help in understanding the breadth and clarity of the patent claims.
What is the classification of this patent under the International Patent Classification (IPC)?
The patent is classified under A61K31/137 and A61K9/08.
Sources Cited
- US10653646B2 - Epinephrine compositions and containers - Google Patents
- Pharmaceutical drugs covered by patent 10,653,646 - Drug Patent Watch
- Patent Claims and Patent Scope - Hoover Institution
- US10653646.pdf - Patent Images Storage
- Untitled - Patents Gazette USPTO
