Detailed Analysis of the Scope and Claims of United States Patent 10,603,293
Introduction
United States Patent 10,603,293, titled "Solid-Forming Anesthetic Formulations for Pain Control," was granted to Crescita Therapeutics Inc. on March 31, 2020. This patent is significant in the field of pharmaceuticals, particularly for pain management. Here’s a detailed analysis of its scope, claims, and the broader patent landscape.
Background
The patent involves the development of solid-forming anesthetic formulations designed to improve topical delivery of active ingredients through the skin. This technology is part of Crescita's MMPE™ (Multi-Matrix Porous Emulsion) technology, which enhances the penetration and efficacy of active pharmaceutical ingredients (APIs)[4].
Scope of the Patent
Technical Overview
The patent covers formulations that use synergistic combinations of specific pharmaceutical excipients listed on the FDA’s Inactive Ingredient Guide. These formulations are designed to improve the topical delivery of anesthetics, potentially increasing their penetration into or through the skin, and thereby enhancing their efficacy. The technology also aims to reduce the concentration of APIs and the frequency of dosing[4].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Composition Claims: These claims describe the specific combinations of excipients and APIs used in the formulations.
- Method Claims: These claims outline the methods for preparing and applying the solid-forming anesthetic formulations.
- Use Claims: These claims specify the intended uses of the formulations, such as pain control and management.
Detailed Claims Analysis
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. For example:
- Claim 1 might describe the composition of the solid-forming anesthetic formulation, including the specific excipients and APIs.
- Claim 2 could outline the method of preparing the formulation.
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. For instance:
- Claim 3 might specify a particular ratio of excipients to APIs.
- Claim 4 could describe a specific method of application.
Claim Scope and Limitations
The scope of the claims is crucial as it defines what is protected under the patent. For example, if a claim is too broad, it may be challenged for lack of specificity. Conversely, if it is too narrow, it may not provide adequate protection against infringement.
Patent Landscape
International Protection
The MMPE™ technology and related formulations have been protected through patents issued in 21 countries, including the United States. Additional patent applications are pending in several other countries, ensuring global intellectual property protection until at least 2036[4].
Related Patents and Applications
- Peel and DuraPeel™ Patents: Crescita also holds patents for Peel and DuraPeel™ technologies, which are related to topical delivery systems. These patents have been issued in several countries and are pending in others, further solidifying Crescita's position in the market[4].
Competitor Analysis
The patent landscape in the field of topical anesthetic formulations is competitive. Other companies and researchers are also developing similar technologies. For instance, the European Patent Office (EPO) and other international patent offices have numerous patents and applications related to topical delivery systems, which could potentially impact the market share of Crescita's technology[1].
Search and Analysis Tools
To conduct a thorough analysis of the patent landscape, several tools and resources can be utilized:
- USPTO Patent Public Search: This tool allows for comprehensive searches of U.S. patents and published patent applications, helping to identify prior art and related patents[1].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, which can be useful in understanding the global patent family and potential challenges[1].
- Patent Claims Research Dataset: This dataset from the USPTO provides detailed information on claims from U.S. patents and applications, which can help in analyzing the scope and trends of patent claims[3].
Legal and Regulatory Considerations
Patent Litigation
In the event of disputes, understanding the legal framework is crucial. For instance, the concept of a small claims patent court has been explored to address lower-stakes patent disputes more efficiently[2].
Regulatory Compliance
The FDA’s Inactive Ingredient Guide plays a significant role in the formulation of these anesthetic products. Compliance with FDA regulations and guidelines is essential to ensure the safety and efficacy of the products.
Key Takeaways
- Technological Innovation: The patent represents a significant innovation in topical anesthetic formulations, enhancing efficacy and reducing dosing frequency.
- Global Protection: The technology is protected through a robust international patent strategy.
- Competitive Landscape: The market is competitive, with several other companies and researchers developing similar technologies.
- Regulatory Compliance: Adherence to FDA guidelines and regulations is critical for the success of these products.
FAQs
What is the main innovation of United States Patent 10,603,293?
The main innovation is the development of solid-forming anesthetic formulations that improve the topical delivery of active ingredients through the skin, enhancing their penetration and efficacy.
How does the MMPE™ technology work?
The MMPE™ technology uses synergistic combinations of specific pharmaceutical excipients to improve the topical delivery of APIs, potentially increasing their penetration and reducing the concentration and dosing frequency.
In which countries is the patent protected?
The patent is protected in 21 countries, including the United States, with additional applications pending in several other countries.
What are the potential benefits of this technology?
The technology offers potential benefits such as increased penetration of APIs, improved efficacy, lower API concentration, and reduced dosing frequency.
How can one conduct a thorough analysis of the patent landscape for this technology?
One can use tools like the USPTO Patent Public Search, Global Dossier, and the Patent Claims Research Dataset to conduct a comprehensive analysis of the patent landscape.
Sources
- USPTO: Search for patents - USPTO
- ACUS: U.S. Patent Small Claims Court
- USPTO: Patent Claims Research Dataset
- BioSpace: Crescita Reports First Quarter 2020 Results
