Understanding the Scope and Claims of United States Patent 10,471,067
Introduction
United States Patent 10,471,067, owned by Baudax Bio, Inc., is a significant patent in the pharmaceutical industry, particularly in the realm of intravenous injection formulations. This patent is central to ongoing litigation and intellectual property discussions, making a detailed analysis of its scope and claims crucial.
Patent Overview
The patent in question pertains to a specific formulation of an intravenous injection pharmaceutical dosage form. Here is a breakdown of the key components:
Liquid Dispersion Medium
The patent specifies a liquid dispersion medium that can be selected from a group consisting of water, an aqueous salt solution, safflower oil, ethanol, t-butanol, hexane, and glycol[2].
Active Ingredient
The active ingredient is meloxicam or a salt thereof, with particles having an effective average particle size of less than 200 nm. This nanoscale particle size is critical for the stability and efficacy of the formulation[2].
Surface Stabilizers
The patent includes polyvinylpyrrolidone and sodium deoxycholate as surface stabilizers adsorbed on the surface of the meloxicam particles. These stabilizers must be essentially free of intermolecular cross-linkages[2].
Independent Claims
The patent contains several independent claims that define the scope of the invention.
Claim 1
Claim 1 is particularly detailed and includes the following elements:
- A liquid dispersion medium selected from the specified group.
- Particles of meloxicam or a salt thereof with an average particle size of less than 200 nm.
- Polyvinylpyrrolidone and sodium deoxycholate as surface stabilizers.
- The meloxicam is present in an amount ranging from about 99.5% to about 0.001% by weight, based on the total combined weight of the meloxicam and the surface stabilizers[2].
Patent Scope and Breadth
The scope of a patent is often debated in terms of its breadth and clarity. For U.S. Patent 10,471,067, the scope is defined by the specific claims and the limitations set forth within those claims.
Metrics for Measuring Patent Scope
Research suggests that patent scope can be measured using metrics such as independent claim length and independent claim count. Narrower claims, like those in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Litigation and Infringement Allegations
The patent is currently involved in litigation with Axsome Therapeutics, Inc. Baudax Bio, Inc. alleges that Axsome's drug product candidate, AXS-07, infringes on U.S. Patents 8,512,727 and 10,471,067. The dispute centers on whether Axsome's proposed drug product, which is in a tableted form for oral administration, could still infringe on the patents due to its manufacturing process involving a soluble liquid intermediate[2].
Detailed Statement and Non-Infringement Assertions
Axsome Therapeutics has provided a Detailed Statement asserting that its proposed drug product does not infringe on the patents because it is a tableted formulation designed for oral administration. However, Baudax argues that this assertion is meritless, as the manufacturing process may still involve steps that infringe on the claims of the patents[1].
Implications for Innovation and Licensing
The validity and enforceability of this patent have significant implications for innovation and licensing in the pharmaceutical industry. Broad or overly broad patents can increase licensing and litigation costs, potentially diminishing incentives for innovation. However, the specific and narrow claims in this patent help to clarify the boundaries of the invention, which can facilitate clearer licensing agreements and reduce litigation risks[3].
Search and Examination Process
The examination process for this patent, like others, would have involved a thorough review of prior art and the narrowing of claims to ensure clarity and validity. Tools such as the USPTO's Patent Public Search and Global Dossier would have been utilized to ensure that the patent does not overlap with existing inventions[4].
Conclusion
Understanding the scope and claims of U.S. Patent 10,471,067 is essential for navigating the complex landscape of pharmaceutical patents. Here are the key takeaways:
- Specific Formulation: The patent specifies a unique formulation involving meloxicam particles with surface stabilizers in a particular liquid dispersion medium.
- Narrow Claims: The claims are detailed and narrow, which helps in clarifying the invention and reducing potential litigation.
- Litigation: The patent is involved in ongoing litigation with Axsome Therapeutics, highlighting the importance of precise claim construction.
- Implications for Innovation: The patent's validity and enforceability impact innovation and licensing costs in the pharmaceutical industry.
FAQs
Q: What is the main active ingredient in the formulation described by U.S. Patent 10,471,067?
A: The main active ingredient is meloxicam or a salt thereof.
Q: What is the significance of the particle size in the patent?
A: The particles of meloxicam must have an effective average particle size of less than 200 nm.
Q: Which surface stabilizers are used in the formulation?
A: Polyvinylpyrrolidone and sodium deoxycholate are used as surface stabilizers.
Q: Why is the litigation between Baudax Bio and Axsome Therapeutics significant?
A: The litigation is significant because it involves the interpretation of whether a tableted formulation can infringe on a patent for an intravenous injection formulation based on its manufacturing process.
Q: How can the scope of a patent be measured?
A: The scope of a patent can be measured using metrics such as independent claim length and independent claim count.
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXCorp.com
- Investors | Axsome Therapeutics, Inc. - Axsome Therapeutics Inc.
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO - USPTO.gov
