United States Patent 9,017,721: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,017,721, titled "Formulation of Diclofenac," is a significant patent in the pharmaceutical industry, particularly in the area of pain management. This patent, issued to iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC, introduces innovative methods for producing diclofenac particles, enhancing its therapeutic efficacy.
Background and Context
Diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), is commonly used for pain relief in both acute and chronic conditions. However, its poor water solubility hampers its dissolution and absorption, leading to a slower onset of therapeutic effects. The patent addresses this issue by introducing a dry milling process to produce particles with increased surface area, thereby improving dissolution and absorption rates[1].
Scope of the Patent
Therapeutic Applications
The patent is primarily focused on the formulation of diclofenac, but its applications extend beyond this specific drug. It covers methods for producing particles of biologically active materials, including therapeutic or pharmaceutical compounds, nutraceuticals, nutritional compounds, complementary medicinal products, and even agricultural chemicals like pesticides, fungicides, or herbicides[1].
Commercial Scale Production
A key aspect of the patent is the scalability of the dry milling process. It allows for the production of particles with sizes equal to or less than 2000 nm, and often less than 1000 nm, at a commercial scale. This scalability is crucial for widespread adoption in various industries[1].
Claims of the Patent
Method of Production
The patent claims a method for producing particles of diclofenac using dry milling processes. This method ensures that the crystallinity of the active material remains unchanged or is not substantially changed, which is vital for maintaining the drug's efficacy[1].
Particle Size and Surface Area
The claims specify that the particles produced have an increased surface area, which enhances the dissolution rate of diclofenac. This faster dissolution leads to quicker absorption and a more rapid onset of the therapeutic effect[1].
Broad Applicability
The patent claims are not limited to diclofenac but also cover other biologically active compounds. This includes natural products like spices (e.g., turmeric containing curcumin), seeds (e.g., flax seed containing ALA), cocoa, coffee, herbs, and other plant materials[1].
Patent Landscape
Related Patents and Applications
The patent 9,017,721 is part of a larger family of patents related to the formulation and production of diclofenac and other biologically active compounds. Other patents in this family include U.S. 8,999,387, U.S. 9,180,096, U.S. 9,173,854, U.S. 9,180,095, and U.S. 9,186,328. These patents collectively cover various aspects of the production and application of these formulations[2][5].
Litigation and Infringement
The patent has been involved in several legal proceedings, including a patent infringement lawsuit filed by iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC against Lupin Ltd. and Lupin Pharmaceuticals LLC. This lawsuit highlights the importance and value of the patent in the pharmaceutical industry[5].
Impact on the Pharmaceutical Industry
Enhanced Therapeutic Efficacy
The dry milling process described in the patent significantly improves the therapeutic efficacy of diclofenac by enhancing its dissolution and absorption rates. This makes the drug more effective for both acute and chronic pain management[1].
Market Competition
The issuance of this patent and its related family of patents has significant implications for market competition. Companies like Lupin Ltd. and Lupin Pharmaceuticals LLC have faced legal challenges for potential infringement, indicating the patent's strategic importance in the market[5].
Future Implications and Applications
Expanding Therapeutic Areas
The technology described in the patent can be applied to various therapeutic areas beyond pain management. It has potential applications in nutraceuticals, nutritional compounds, and even agricultural chemicals, making it a versatile innovation[1].
Global Patent System
The patent is part of the global patent system, with implications for international intellectual property rights. The Global Dossier service provided by the USPTO facilitates access to related applications and file histories from participating IP Offices, aiding in the management and enforcement of such patents globally[4].
Key Takeaways
- Improved Formulation: The patent introduces a dry milling process that enhances the dissolution and absorption rates of diclofenac.
- Commercial Scalability: The method is scalable to commercial production levels.
- Broad Applicability: The technology can be applied to various biologically active compounds beyond diclofenac.
- Litigation and Infringement: The patent has been involved in significant legal proceedings, highlighting its value in the pharmaceutical industry.
- Future Implications: The technology has potential applications in multiple therapeutic and industrial areas.
FAQs
What is the main innovation of United States Patent 9,017,721?
The main innovation is the use of a dry milling process to produce particles of diclofenac with increased surface area, enhancing its dissolution and absorption rates.
What are the therapeutic applications of this patent?
The patent is primarily used for pain management, both acute and chronic, but its applications extend to other biologically active compounds, including nutraceuticals and agricultural chemicals.
Why is the scalability of the dry milling process important?
Scalability to commercial production levels ensures that the method can be widely adopted and implemented, making the drug more accessible and effective on a larger scale.
What other patents are related to U.S. 9,017,721?
Related patents include U.S. 8,999,387, U.S. 9,180,096, U.S. 9,173,854, U.S. 9,180,095, and U.S. 9,186,328, which collectively cover various aspects of the production and application of these formulations.
What legal challenges has this patent faced?
The patent has been involved in a patent infringement lawsuit filed by iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC against Lupin Ltd. and Lupin Pharmaceuticals LLC.
Sources
- US9017721B2 - Formulation of diclofenac - Google Patents
- UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE ... - Exparte
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- Search for patents - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp
