Understanding the Scope and Claims of United States Patent 9,808,468: A Detailed Analysis
Introduction
United States Patent 9,808,468, titled "Formulation of meloxicam," is a significant patent in the pharmaceutical industry, particularly for the management of osteoarthritis pain. This patent, held by iCeutica Pty Ltd and Egalet US Inc., covers specific formulations of meloxicam, a nonsteroidal anti-inflammatory drug (NSAID). Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent in question, US 9,808,468, was granted for unit dosage forms of meloxicam that contain either 5 mg or 10 mg of the active ingredient. These formulations are designed to provide effective pain relief and have desirable pharmacokinetic properties[4].
Scope of the Patent
The scope of a patent is defined by its claims, which outline the specific aspects of the invention that are protected. For US 9,808,468, the claims focus on the formulation and composition of meloxicam capsules.
Key Claims
- The patent claims cover meloxicam capsules with specific particle size measurements and compositions that include excipients.
- The claims specify that the meloxicam particles can be measured in the presence of excipients, which is crucial for the pharmaceutical composition[1][4].
Claim Construction and Interpretation
Claim construction is a critical aspect of patent litigation, as it determines the scope of protection. In the context of US 9,808,468, the claim construction has been a point of contention.
Particle Size Measurements
The patent claims indicate that particle size measurements can be made on meloxicam particles in the presence of excipients. This interpretation is supported by expert declarations and briefs submitted by the plaintiffs, which clarify that the measurements are not necessarily generated from an 'excipient-free' population of meloxicam particles[1].
Composition Requirements
The claims also specify that the pharmaceutical composition need not contain exactly 5 mg or 10 mg of meloxicam, as long as the meloxicam particles collectively have a total mass of 5 mg or 10 mg, respectively. This includes compositions where the active ingredient is significantly less than the total mass, with the remainder being excipients[1].
Patent Landscape
The patent landscape for meloxicam formulations is complex, with multiple players involved in developing and marketing similar products.
Hatch-Waxman Act
The Hatch-Waxman Act allows generic drug manufacturers to file Abbreviated New Drug Applications (ANDAs) for approval to market generic versions of patented drugs before the expiration of the relevant patents. This has led to litigation, such as the case between iCeutica Pty Ltd and Novitium Pharma LLC, where the defendant filed an ANDA for meloxicam capsules, prompting a patent infringement lawsuit[1].
Competing Patents and Applications
The USPTO's Patent Claims Research Dataset provides insights into the broader patent landscape, including claims and scope measurements for various patents. This dataset can help identify overlapping claims and potential areas of conflict between different patents[3].
Patentability Requirements
For a patent to be granted, the invention must meet specific requirements outlined in Title 35 of the U.S. Code.
Novelty, Non-Obviousness, and Utility
The invention must be novel, non-obvious, and useful. In the case of US 9,808,468, the unique formulation and composition of meloxicam capsules meet these criteria by providing effective pain relief and desirable pharmacokinetic properties[5].
Filing and Prosecution
The process of filing and prosecuting a patent involves several steps, including the submission of a specification, drawings, oath or declaration, and claims.
Types of Patent Applications
The most common type of patent application relevant to pharmaceuticals is the utility patent. Applicants can file provisional applications to establish an early filing date, followed by a non-provisional application within 12 months[5].
Litigation and Enforcement
Patent litigation often arises when generic manufacturers attempt to enter the market before the expiration of the original patent.
iCeutica Pty Ltd v. Novitium Pharma LLC
In this case, the defendant's attempt to market meloxicam capsules led to a Hatch-Waxman action. The litigation centered on the validity and scope of the asserted patents, including US 9,808,468. The court's analysis highlighted the importance of claim construction and the plaintiffs' position on particle size measurements and composition requirements[1].
Impact on the Pharmaceutical Industry
The patent landscape for meloxicam formulations has significant implications for the pharmaceutical industry.
Generic Competition
The ability of generic manufacturers to file ANDAs and challenge the validity of patents can lead to earlier market entry and increased competition. However, this also underscores the importance of robust patent protection for innovative formulations[1].
Innovation and Research
Patents like US 9,808,468 incentivize innovation by providing exclusive rights to the inventors. This encourages further research and development in pharmaceuticals, leading to better treatments and formulations[5].
Key Takeaways
- Scope and Claims: The patent covers specific formulations of meloxicam capsules with defined particle size measurements and compositions.
- Claim Construction: The claims are interpreted to include measurements in the presence of excipients and allow for compositions with varying amounts of active ingredient.
- Patent Landscape: The patent is part of a complex landscape involving Hatch-Waxman actions and competing patents.
- Patentability Requirements: The invention must be novel, non-obvious, and useful.
- Litigation and Enforcement: Patent litigation is common in the pharmaceutical industry, particularly around generic competition.
FAQs
Q: What is the main subject of United States Patent 9,808,468?
A: The main subject is the formulation of meloxicam capsules for the management of osteoarthritis pain.
Q: What are the key claims of US 9,808,468?
A: The key claims cover meloxicam capsules with specific particle size measurements and compositions that include excipients.
Q: How does the Hatch-Waxman Act impact the patent landscape for meloxicam formulations?
A: The Hatch-Waxman Act allows generic manufacturers to file ANDAs, leading to potential litigation over patent infringement.
Q: What are the requirements for a patent to be granted in the United States?
A: The invention must be novel, non-obvious, and useful.
Q: How does patent litigation affect the pharmaceutical industry?
A: Patent litigation can delay or prevent generic competition, but it also protects innovative formulations and encourages further research and development.
Sources
- iCeutica Pty Ltd. v. Novitium Pharma LLC, Civil Action No. 18-599.
- U.S. Patent and Trademark Office (USPTO) | USAGov.
- Patent Claims Research Dataset - USPTO.
- US9808468B2 - Formulation of meloxicam - Google Patents.
- Patents | The Maryland People's Law Library.
