United States Patent 9,649,318: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,649,318, hereafter referred to as the '318 patent, is a crucial component of the intellectual property portfolio related to the drug meloxicam, specifically the VIVLODEX® brand. This patent is owned by iCeutica Pty Ltd. and exclusively licensed to Iroko Pharmaceuticals, LLC. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to manage osteoarthritis pain. The '318 patent, along with the '734 patent, is listed in the FDA's Orange Book as covering the VIVLODEX® 5mg and 10mg formulations of meloxicam[2].
The Invention
The '318 patent pertains to specific formulations of meloxicam that have particular particle size distributions. These formulations are designed to enhance the bioavailability and efficacy of the drug. The patent claims cover the composition and method of manufacture of these formulations, ensuring that the meloxicam particles meet specific size criteria[2].
Claims of the Patent
The '318 patent includes several claims that define the scope of the invention. Here are some key aspects:
- Particle Size Distribution: The patent claims specify a particle size distribution, particularly a D(0.9) value, which is a measure of the particle size where 90% of the particles are below a certain size. The original application claimed a D(0.9) value of "less than 3000 nm," indicating a range of 0-3000 nm[2].
- Composition: The claims detail the composition of the meloxicam formulation, including the active ingredient, excipients, and other components.
- Method of Manufacture: The patent also covers the method of manufacturing these formulations, ensuring consistency and quality in the final product.
Prosecution History
The prosecution history of the '318 patent is crucial in understanding the scope and limitations of the claims. During the prosecution, the applicants made amendments and arguments that narrowed the scope of the claims. For instance, the applicants surrendered any particle size distributions with a D(0.9) below 1200 nm, which is significant in determining infringement through the doctrine of equivalents[2].
Infringement and Litigation
The '318 patent has been at the center of several Hatch-Waxman actions, where generic drug manufacturers have sought to market their own versions of meloxicam before the expiration of the patent. For example, Lupin Limited and Lupin Pharmaceuticals, Inc. filed an Abbreviated New Drug Application (ANDA) and sent a Paragraph IV Certification letter to the plaintiffs, asserting that the '318 patent is invalid and/or would not be infringed by their generic product[2].
Literal Infringement and Doctrine of Equivalents
In determining infringement, the court follows a two-step process: claim construction and comparison of the construed claims to the accused product. The court found that the plaintiffs are estopped from arguing that Lupin's ANDA products would infringe on the '318 patent claims through the doctrine of equivalents due to prosecution history estoppel[2].
Patent Landscape
The '318 patent is part of a broader patent landscape that includes other related patents such as the '734 patent. These patents collectively protect the VIVLODEX® brand and its unique formulations.
Related Patents
- United States Patent 9,526,734 ('734 Patent): This patent, along with the '318 patent, covers the VIVLODEX® formulations and has been involved in similar litigation regarding generic versions of meloxicam[2].
- Other Patents: The patent landscape for meloxicam formulations includes various other patents that cover different aspects of the drug's composition, method of manufacture, and use.
Impact on Generic Manufacturers
Generic manufacturers seeking to enter the market with their own versions of meloxicam must navigate the complex patent landscape. The '318 patent, along with other related patents, presents significant barriers to entry due to its specific claims and the prosecution history that limits the scope of infringement.
Paragraph IV Certifications
Generic manufacturers must submit Paragraph IV Certifications, asserting that the patents are invalid or will not be infringed by their products. This often leads to litigation, as seen in the cases involving Lupin and other generic manufacturers[2].
Conclusion
The '318 patent is a critical component of the intellectual property protecting the VIVLODEX® brand of meloxicam. Its specific claims regarding particle size distribution and method of manufacture define the scope of the invention and present significant challenges for generic manufacturers seeking to enter the market.
Key Takeaways
- The '318 patent covers specific formulations of meloxicam with defined particle size distributions.
- The patent has been involved in several Hatch-Waxman actions against generic manufacturers.
- Prosecution history estoppel limits the scope of infringement claims under the doctrine of equivalents.
- The patent landscape for meloxicam includes multiple related patents that collectively protect the VIVLODEX® brand.
Frequently Asked Questions
What is the '318 patent, and what does it cover?
The '318 patent covers specific formulations of meloxicam, particularly those with defined particle size distributions, and the method of manufacturing these formulations.
Why is the prosecution history of the '318 patent important?
The prosecution history is important because it shows the amendments and arguments made during the patent application process, which can limit the scope of infringement claims, especially under the doctrine of equivalents.
How does the '318 patent affect generic manufacturers?
The '318 patent presents a barrier to entry for generic manufacturers by requiring them to navigate complex patent claims and potentially litigate against the patent holders if they assert that their products do not infringe on the patent.
What is a Paragraph IV Certification, and how does it relate to the '318 patent?
A Paragraph IV Certification is a statement made by a generic manufacturer asserting that the patents listed in the Orange Book are invalid or will not be infringed by their product. This certification is often a precursor to litigation, as seen in cases involving the '318 patent.
Can the '318 patent be challenged or invalidated?
Yes, the '318 patent can be challenged or invalidated through various legal processes, including reexamination proceedings or litigation where the validity of the patent is contested.
Cited Sources:
- iCeutica Pty Ltd. v. Novitium Pharma LLC, Civil Action No. 18-599.
- Iceutica Pty Ltd. v. Lupin Ltd., Casetext.
- Patent Claims Research Dataset, USPTO.
- In re Cellect, United States Court of Appeals for the Federal Circuit.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT, Insight.RPXcorp.com.
