United States Patent 10,792,271: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,792,271, titled "Topical formulations of chloroprocaine and methods of using same," is a significant patent in the field of pharmaceuticals, particularly in the development of topical anesthetic formulations. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Chloroprocaine
Chloroprocaine is a local anesthetic commonly used for short procedures due to its rapid onset and short duration of action. It is preferred in certain medical and dental procedures because of its minimal toxicity and quick metabolism.
Patent Overview
Publication and Status
The patent, US10792271B2, was granted on October 6, 2020, and is currently active, with an expiration date dependent on the patent term adjustments and any potential extensions[1][5].
Inventors and Assignees
The patent lists the inventors and assignees involved in the development of these topical formulations. Understanding the assignees can provide insight into the commercial and research interests behind the patent.
Scope of the Patent
Topical Formulations
The patent focuses on the development of topical formulations of chloroprocaine, which are designed to provide effective local anesthesia through skin application. These formulations are crucial for procedures that require surface anesthesia without the need for injections[1].
Manufacturing Process
A key aspect of the patent is the detailed manufacturing process, which emphasizes the importance of working in an oxygen-free environment purged with nitrogen to maintain the stability of chloroprocaine. This process ensures the formulation remains effective and safe for use[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the composition of the topical formulation, including the concentration of chloroprocaine, the type of vehicle used (e.g., hydroxyethyl cellulose), and other additives that enhance stability and efficacy[1].
Dependent Claims
Dependent claims further specify the invention by detailing particular aspects of the formulation, such as the pH range, viscosity, and methods of application. These claims help to narrow down the invention and protect specific embodiments of the topical formulation[1].
Key Components of the Formulation
Chloroprocaine Concentration
The patent specifies the optimal concentration of chloroprocaine in the topical formulation, ensuring a balance between efficacy and safety. This concentration is critical for achieving the desired anesthetic effect without causing adverse reactions[1].
Vehicle and Additives
The use of hydroxyethyl cellulose as a vehicle is highlighted, along with other additives that enhance the formulation's stability and user experience. These components are essential for the formulation's performance and shelf life[1].
Methods of Use
Application Techniques
The patent describes various methods of applying the topical formulation, including the duration of application and the areas of the body where it can be used. These methods are crucial for healthcare professionals to ensure the formulation is used effectively and safely[1].
Clinical Indications
The patent outlines the clinical indications for the use of these topical formulations, such as minor surgical procedures, dermatological treatments, and pain management. Understanding these indications helps in identifying the target market and potential applications[1].
Patent Landscape
Related Patents
The patent landscape surrounding US10792271B2 includes other patents related to local anesthetics and topical formulations. These patents may cover different aspects of anesthetic formulations, such as alternative active ingredients, different vehicles, or innovative application methods[4].
Competitors and Market Players
Companies involved in the development and marketing of local anesthetics and topical formulations are key players in this patent landscape. Understanding their patent portfolios and research directions can provide insights into market trends and potential competition[4].
Economic and Market Impact
Market Demand
The demand for effective and safe topical anesthetic formulations is significant, driven by the need for pain management in various medical and dental procedures. This patent addresses a specific segment of this market, offering a competitive edge to the assignees[3].
Licensing and Collaboration
The patent's commercial potential can be leveraged through licensing agreements or collaborations with other pharmaceutical companies. This can expand the reach of the formulation and generate revenue streams for the assignees[3].
Legal and Regulatory Considerations
Patent Eligibility
The patent's eligibility under 35 U.S.C. ยง 101 is a critical legal consideration. Ensuring that the claims are not deemed too broad or abstract is essential to maintain the patent's validity. The Alice test, as discussed in legal precedents, is a framework used to determine patent eligibility[2].
Regulatory Approvals
Before the formulation can be marketed, it must undergo regulatory approvals from bodies such as the FDA. The patent's claims and the formulation's safety and efficacy data will be scrutinized during this process[5].
Future Directions
Research and Development
Continued research and development in the field of topical anesthetics can lead to new formulations and methods of application. This patent serves as a foundation for further innovation, potentially leading to more effective and safer anesthetic options[1].
Market Expansion
As the market for topical anesthetics grows, the assignees of this patent can explore new markets and applications, further expanding the reach of their formulation. This could involve international marketing and distribution strategies[3].
Key Takeaways
- Topical Formulations: The patent focuses on the development of topical chloroprocaine formulations for local anesthesia.
- Manufacturing Process: The process must be conducted in an oxygen-free environment to ensure stability.
- Claims: The patent includes independent and dependent claims that define the composition and application methods.
- Market Impact: The formulation addresses a significant market demand for safe and effective topical anesthetics.
- Legal Considerations: The patent's eligibility and regulatory approvals are crucial for its commercial success.
FAQs
What is the primary active ingredient in the topical formulation described in US10792271B2?
The primary active ingredient is chloroprocaine, a local anesthetic.
Why is it important to manufacture the formulation in an oxygen-free environment?
Manufacturing in an oxygen-free environment purged with nitrogen is crucial to maintain the stability of chloroprocaine.
What is the role of hydroxyethyl cellulose in the formulation?
Hydroxyethyl cellulose serves as a vehicle in the topical formulation, enhancing its stability and user experience.
What are the clinical indications for the use of this topical formulation?
The formulation is indicated for minor surgical procedures, dermatological treatments, and pain management.
How does this patent impact the market for topical anesthetics?
The patent addresses a significant market demand for safe and effective topical anesthetics, providing a competitive edge to the assignees.
Sources
- US10792271B2 - Topical formulations of chloroprocaine and methods of using same - Google Patents
- SANDERLING MANAGEMENT LTD. v. SNAP INC - CAFC
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- US Patent 10792271 | US Patents | Expiry | Expiration | Dates - PharmaCompass
