United States Patent 10,463,673: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,463,673, titled "Nanoparticulate meloxicam formulations," is a significant patent in the pharmaceutical industry, particularly in the field of pain management. This patent, owned by Baudax Bio, Inc., covers innovative formulations of meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), and is crucial for understanding the current patent landscape in this area.
Background of Meloxicam
Meloxicam is a widely used NSAID for managing moderate to severe pain. The development of nanoparticulate formulations of meloxicam has enhanced its bioavailability and efficacy, making it a valuable advancement in pain therapy.
Patent Overview
Issuance and Ownership
The patent was issued on November 5, 2019, by the United States Patent and Trademark Office (USPTO) and is listed in the FDA's Orange Book, which catalogs approved drug products with therapeutic equivalence evaluations[2][5].
Patent Title and Description
The patent is titled "Nanoparticulate meloxicam formulations" and describes compositions comprising meloxicam particles with an effective average particle size of less than 2,000 nanometers. This nanoparticulate form improves the solubility and bioavailability of meloxicam, enhancing its therapeutic effects[1].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Key claims include:
- Composition Claims: These claims describe the nanoparticulate meloxicam compositions, including the particle size and the methods of preparation.
- Method Claims: These claims cover the methods of treating pain using the nanoparticulate meloxicam formulations.
- Formulation Claims: These claims specify the various formulations in which the nanoparticulate meloxicam can be administered, such as injectable solutions[1].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims build upon the independent claims and provide additional specificity. For example, a dependent claim might specify a particular particle size range or a specific method of administration[3].
Patent Landscape
Related Patents
The patent is part of a family of patents related to nanoparticulate meloxicam formulations. Other patents in this family include U.S. Patent Nos. 10,471,067, 10,709,713, 10,881,663, and 11,458,145. These patents collectively cover various aspects of the formulation, method of use, and specific applications of nanoparticulate meloxicam[2][5].
Litigation and Infringement
The patent has been involved in several litigation cases, particularly regarding patent infringement. For instance, Baudax Bio has filed lawsuits against companies like Slayback and Axsome Therapeutics for submitting New Drug Applications (NDAs) to the FDA that allegedly infringe on the claims of this patent[2][5].
Impact on the Pharmaceutical Industry
Innovation and Efficacy
The nanoparticulate meloxicam formulations covered by this patent have significantly improved the efficacy and safety profile of meloxicam. This innovation has provided healthcare professionals with a more effective tool for managing pain, especially in patients who may have difficulty with traditional oral or injectable formulations[1].
Market Competition
The patent's listing in the Orange Book and its involvement in litigation highlight its importance in the market. Companies seeking to develop or market similar formulations must navigate the patent landscape carefully to avoid infringement. This can lead to increased licensing and litigation costs, which can impact innovation and competition in the industry[3].
Metrics for Measuring Patent Scope
Claim Length and Count
Research has shown that the scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process. This suggests that the claims in U.S. Patent 10,463,673 are well-defined and specific, contributing to its strength and enforceability[3].
Expiration and Future Implications
Patent Expiration
The patent is set to expire, although the exact date is not specified in the provided sources. However, related patents like U.S. Patent No. 10,471,067 are noted to expire on February 24, 2024. The expiration of these patents will open up the market for generic or similar formulations, potentially changing the competitive landscape[5].
Future Developments
As the patent landscape evolves, future developments may include new formulations or methods that build upon or circumvent the existing patents. Companies will need to continue innovating while ensuring compliance with existing intellectual property rights.
Key Takeaways
- Nanoparticulate Formulations: The patent covers innovative nanoparticulate meloxicam formulations that enhance bioavailability and efficacy.
- Claims and Scope: The patent includes specific claims regarding composition, method of use, and formulation, defining its scope and enforceability.
- Patent Landscape: The patent is part of a family of related patents and has been involved in litigation cases regarding infringement.
- Impact on Industry: The patent has improved pain management options and influences market competition and innovation.
- Metrics and Analysis: The patent's scope is well-defined, with narrower claims contributing to its strength.
FAQs
What is the main subject of U.S. Patent 10,463,673?
The main subject of U.S. Patent 10,463,673 is nanoparticulate meloxicam formulations, which are designed to improve the bioavailability and efficacy of meloxicam.
Who owns U.S. Patent 10,463,673?
U.S. Patent 10,463,673 is owned by Baudax Bio, Inc.
What are the key claims of the patent?
The key claims include composition claims, method claims, and formulation claims related to nanoparticulate meloxicam.
How does the patent impact the pharmaceutical industry?
The patent has improved pain management options and influences market competition and innovation by setting a high standard for meloxicam formulations.
What are the implications of the patent's expiration?
The expiration of the patent will open up the market for generic or similar formulations, potentially changing the competitive landscape in the pharmaceutical industry.
Sources
- US10463673B2 - Nanoparticulate meloxicam formulations - Google Patents
- Case 3:23-cv-03794 Document 1 Filed 07/14/23 - Insight.RPXCorp
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXCorp
