United States Patent 9,180,095: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,180,095, titled "Formulation of Diclofenac," is a significant patent in the pharmaceutical industry, particularly in the area of pain management. This patent, issued on November 3, 2015, is held by iCeutica Pty Ltd and exclusively licensed to Iroko Pharmaceuticals, LLC. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) widely used for acute pain management. The patent in question addresses methods for producing particles of diclofenac using dry milling processes, which is a critical advancement in pharmaceutical formulation.
Scope of the Patent
Overview
The patent describes methods for producing particles of diclofenac with increased surface area, which can be scaled up to commercial production levels. This is achieved through dry milling processes that maintain the crystallinity of the active material without substantial change[4].
Key Innovations
- Dry Milling Process: The patent highlights the use of dry milling to produce particles of diclofenac with a particle size equal to or less than 2000 nm, and often less than 1000 nm. This process is innovative because it allows for the production of smaller particles without altering the crystallinity of the drug[4].
- Commercial Scalability: The method is designed to be scalable, making it viable for large-scale commercial production. This is a significant improvement over previous methods that were limited in their ability to scale[4].
Therapeutic Applications
The formulation of diclofenac as described in the patent has applications in various therapeutic areas, particularly in acute pain management. The smaller particle size enhances the bioavailability and efficacy of the drug, making it more effective for patients[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the method of producing diclofenac particles, the composition of the formulation, and the characteristics of the resulting particles.
- Method Claims: Claims related to the dry milling process, including the steps involved in producing the particles and the equipment used.
- Composition Claims: Claims describing the composition of the diclofenac formulation, including the particle size and the presence of any excipients or inactive ingredients.
- Characterization Claims: Claims specifying the physical and chemical characteristics of the resulting particles, such as their size and crystallinity[4].
Dependent Claims
Dependent claims further narrow down the scope of the independent claims by adding additional limitations or specifications. These claims might include specific details about the milling process, the materials used, or the properties of the final product.
Patent Landscape
Related Patents
The patent 9,180,095 is part of a family of related patents that cover various aspects of diclofenac formulation and production. Other patents in this family include:
- U.S. 8,999,387: This patent is a predecessor and covers similar methods for producing diclofenac particles.
- U.S. 9,017,721: Another related patent that claims priority to U.S. 8,999,387 and covers additional aspects of the formulation.
- U.S. 9,173,854: This patent also relates to the formulation of diclofenac and is part of the same patent family[5].
Litigation and Enforcement
The patents related to diclofenac formulation have been involved in several legal disputes. For instance, iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC have filed lawsuits against Lupin Limited and Lupin Pharmaceuticals, Inc. for alleged infringement of these patents, including U.S. 9,180,095. These lawsuits highlight the importance of these patents in protecting intellectual property in the pharmaceutical industry[5].
Global Dossier and International Implications
The Global Dossier service provided by the USPTO allows users to access file histories of related applications from participating IP Offices. This service can be useful in understanding the international patent landscape for diclofenac formulations and identifying potential conflicts or opportunities for collaboration[1].
Economic and Market Impact
Market Dominance
The exclusive licensing of these patents to Iroko Pharmaceuticals, LLC has allowed the company to maintain a strong market position for their product, ZORVOLEX® (diclofenac) Capsules. This market dominance is partly due to the innovative formulation and production methods protected by these patents[5].
Competitive Advantage
The unique formulation and production process described in U.S. 9,180,095 provide a competitive advantage in the market. The ability to produce smaller particles with increased bioavailability enhances the efficacy of the drug, making it more attractive to both healthcare providers and patients.
Key Takeaways
- Innovative Formulation: The patent describes a novel method for producing diclofenac particles using dry milling processes.
- Commercial Scalability: The method is scalable, making it suitable for large-scale commercial production.
- Therapeutic Applications: The formulation has significant applications in acute pain management.
- Related Patents: Part of a family of related patents covering various aspects of diclofenac formulation.
- Litigation and Enforcement: Involved in legal disputes to protect intellectual property.
- Market Impact: Provides a competitive advantage and contributes to market dominance.
FAQs
Q: What is the main innovation described in U.S. Patent 9,180,095?
A: The main innovation is the use of dry milling processes to produce diclofenac particles with increased surface area, which can be scaled up to commercial production levels.
Q: What are the therapeutic applications of the formulation described in the patent?
A: The formulation has significant applications in acute pain management due to the enhanced bioavailability and efficacy of the drug.
Q: Which companies are involved in the litigation related to this patent?
A: iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC are involved in lawsuits against Lupin Limited and Lupin Pharmaceuticals, Inc. for alleged infringement.
Q: How does the Global Dossier service relate to this patent?
A: The Global Dossier service allows users to access file histories of related applications from participating IP Offices, which can be useful in understanding the international patent landscape.
Q: What is the market impact of this patent?
A: The patent provides a competitive advantage and contributes to the market dominance of Iroko Pharmaceuticals, LLC for their product ZORVOLEX®.
Sources
- USPTO: Search for patents - USPTO.
- UNITED STATES PATENT AND TRADEMARK OFFICE: UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD.
- USPTO: Patent Claims Research Dataset - USPTO.
- Google Patents: US9180095B2 - Formulation of diclofenac - Google Patents.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT: IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ICEUTICA PTY LTD and IROKO PHARMACEUTICALS, LLC, Plaintiffs, v. LUPIN LIMITED and LUPIN PHARMACEUTICALS, INC., Defendants.
