United States Patent 10,709,713: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 10,709,713, titled "Nanoparticulate Meloxicam Formulations," was granted to Baudax Bio, Inc. on July 14, 2020. This patent revolves around the development and application of nanoparticulate compositions of meloxicam, a non-steroidal anti-inflammatory drug (NSAID)[1].
Inventors and Assignee
The inventors listed for this patent are Eugene R. Cooper, Berwyn, PA; Tuula Ryde, Malvern, PA; John Pruitt, Suwanee, GA; and Laura Kline, Harleysville, PA. The assignee of the patent is Baudax Bio, Inc., Malvern, PA[1].
Scope of the Patent
Nanoparticulate Compositions
The patent is directed to nanoparticulate compositions comprising meloxicam particles with an effective average particle size of less than about 2000 nm. This reduction in particle size enhances the bioavailability and solubility of meloxicam, which can improve its therapeutic efficacy and reduce side effects associated with larger particle sizes[1].
Claims
The patent includes 10 claims that define the scope of protection for the nanoparticulate meloxicam formulations. Here are some key aspects of the claims:
- Claim 1: This claim is directed to a nanoparticulate composition comprising meloxicam particles with an average particle size of less than about 2000 nm.
- Claim 2: This claim specifies the composition where the meloxicam particles have an average particle size of less than about 1000 nm.
- Claim 3: This claim includes a method for making the nanoparticulate composition, involving the use of a milling process.
- Claim 4: This claim covers a pharmaceutical formulation containing the nanoparticulate meloxicam composition and at least one excipient.
- Claim 5: This claim is directed to a method of treating pain or inflammation using the nanoparticulate meloxicam composition[1].
Technical Details
Particle Size and Formulation
The patent emphasizes the importance of reducing the particle size of meloxicam to enhance its dissolution rate and bioavailability. The nanoparticulate compositions are achieved through various methods, including milling processes, which ensure that the particles are uniformly sized and distributed[1].
Pharmaceutical Formulations
The patent also covers various pharmaceutical formulations that can incorporate the nanoparticulate meloxicam, such as tablets, capsules, and suspensions. These formulations can include excipients to stabilize the nanoparticulate meloxicam and enhance its delivery[1].
Patent Landscape
Related Patents and Prior Art
The patent references several prior art documents and patents related to nanoparticulate formulations and methods for reducing particle size. These include patents by Liversidge et al., Davis et al., and others that have contributed to the development of nanoparticulate drug delivery systems[1].
Regulatory and Legal Context
Patents like US 10,709,713 are subject to the regulatory framework governed by the U.S. Patent and Trademark Office (USPTO) and the Federal Circuit. The scope of protection for such patents is determined by the language of the claims, which must be broad enough to cover the invention but not so broad as to be invalid or unenforceable[3].
Patent Term and Extensions
General Principles
Patents in the pharmaceutical industry, including those like US 10,709,713, can be subject to patent term extensions due to the lengthy regulatory approval process. The Hatch-Waxman Act allows for patent term extensions to compensate for the time spent in clinical development and FDA review, up to a maximum of five years[4].
Specific Considerations
For US 10,709,713, any potential patent term extension would depend on the time spent in clinical development and the New Drug Application (NDA) review period. The patent term extension provision calculates the extension based on half of the Investigational New Drug (IND) period and the full NDA period, subject to certain limitations and requirements[4].
Competitive Landscape
ANDA Litigation and Settlements
The pharmaceutical industry is often marked by litigation over generic versions of patented drugs. Patents like US 10,709,713 can be involved in Abbreviated New Drug Application (ANDA) litigation, where generic manufacturers seek to challenge the validity or enforceability of the patent claims. Settlements in such cases can allow generic manufacturers to enter the market under certain conditions, such as delayed entry or royalty payments[2].
Key Takeaways
- Nanoparticulate Formulations: The patent focuses on enhancing the bioavailability and solubility of meloxicam through nanoparticulate compositions.
- Claims and Scope: The patent includes 10 claims that define the scope of protection for these formulations, including methods of manufacture and pharmaceutical formulations.
- Regulatory Context: The patent is subject to USPTO and Federal Circuit regulations, and potential patent term extensions due to regulatory review periods.
- Competitive Landscape: The patent could be involved in ANDA litigation and settlements, influencing the market entry of generic versions.
FAQs
What is the main focus of United States Patent 10,709,713?
The main focus of this patent is on the development and application of nanoparticulate compositions of meloxicam, a non-steroidal anti-inflammatory drug (NSAID), to enhance its bioavailability and solubility.
Who are the inventors and assignee of this patent?
The inventors are Eugene R. Cooper, Tuula Ryde, John Pruitt, and Laura Kline, and the assignee is Baudax Bio, Inc.
What is the significance of reducing the particle size of meloxicam?
Reducing the particle size of meloxicam to less than about 2000 nm enhances its dissolution rate and bioavailability, potentially improving its therapeutic efficacy and reducing side effects.
Can the patent term of US 10,709,713 be extended?
Yes, the patent term can be extended under the Hatch-Waxman Act to compensate for the time spent in clinical development and FDA review, up to a maximum of five years.
How does ANDA litigation impact patents like US 10,709,713?
ANDA litigation involves generic manufacturers challenging the validity or enforceability of patent claims. Settlements can allow generic manufacturers to enter the market under certain conditions, such as delayed entry or royalty payments.
What are the key claims of this patent?
The patent includes claims for the nanoparticulate composition, methods of making it, and pharmaceutical formulations containing the nanoparticulate meloxicam.
Sources
- United States Patent and Trademark Office, "Nanoparticulate Meloxicam Formulations," US 10,709,713 B2.
- Robins Kaplan LLP, "ANDA Litigation Settlements | Hatch-Waxman."
- Indiana University Maurer School of Law, "Interpretation of Patent Process Claims in Light of the Narrowing Effect."
- NYU School of Law, "Recommendations for Statutory Reform of the Patent Term Extension System."
