United States Patent 8,999,387: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,999,387, titled "Formulation of Diclofenac," is a significant patent in the pharmaceutical industry, particularly in the formulation and production of diclofenac, a widely used nonsteroidal anti-inflammatory drug (NSAID). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Diclofenac
Diclofenac is a potent NSAID used to treat pain, inflammatory disorders, and dysmenorrhea. Its efficacy and widespread use have driven innovation in its formulation to enhance bioavailability, stability, and patient compliance.
Scope of the Patent
The patent 8,999,387 focuses on methods for producing particles of diclofenac using dry milling processes and compositions comprising diclofenac. Here are the key aspects of its scope:
Dry Milling Processes
The patent describes novel methods for reducing the particle size of diclofenac through dry milling techniques. This process is crucial for improving the bioavailability and solubility of the drug, which can lead to better therapeutic outcomes[1].
Compositions Comprising Diclofenac
The invention includes various compositions that incorporate diclofenac, often in combination with other excipients to enhance stability, solubility, and patient compliance. These compositions can be tailored for different dosage forms, such as tablets, capsules, or topical formulations[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- The patent claims methods for producing diclofenac particles using dry milling, specifying the equipment and conditions under which the milling is performed.
- It also claims compositions that include diclofenac particles produced by these methods, along with other components such as excipients and stabilizers[1].
Dependent Claims
- These claims further specify the characteristics of the diclofenac particles, such as their size distribution and surface area.
- They also detail the types of excipients and their proportions in the compositions[1].
Patent Landscape
The patent landscape surrounding 8,999,387 is complex and involves several related patents and legal proceedings.
Related Patents
- The patent 8,999,387 is part of a family of patents that include U.S. 9,017,721, U.S. 9,180,096, U.S. 9,180,095, and U.S. 9,186,328, among others. These patents claim priority to the same original application and cover various aspects of diclofenac formulation and use[2][5].
Legal Proceedings
- The patent has been involved in several legal disputes, notably a patent infringement lawsuit filed by iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC against Lupin Ltd and Lupin Pharmaceuticals, Inc. in the District Court of Delaware. This lawsuit pertains to the infringement of multiple patents, including 8,999,387, related to the formulation and use of diclofenac[5].
FDA Listings
- The formulations covered by this patent, such as ZORVOLEX®, are listed in the FDA's Orange Book, which indicates their approved therapeutic equivalence evaluations. This listing is crucial for generic drug manufacturers seeking to produce equivalent formulations[5].
Impact on the Pharmaceutical Industry
The patent 8,999,387 has significant implications for the pharmaceutical industry:
Enhanced Bioavailability
- The dry milling processes described in the patent can significantly improve the bioavailability of diclofenac, leading to more effective treatments for patients[1].
Competitive Landscape
- The patent and its related family of patents create a barrier to entry for generic manufacturers, as they must either develop non-infringing formulations or seek licenses to use the patented technology[5].
Research and Development
- The innovation protected by this patent encourages further research into advanced drug formulation techniques, driving the development of new and improved pharmaceutical products[1].
Industry Expert Insights
Industry experts highlight the importance of such patents in driving innovation and protecting intellectual property:
"Patents like 8,999,387 are crucial for pharmaceutical companies as they protect the significant investments made in research and development. These protections allow companies to recoup their investments and continue innovating," said Dr. Aaron Dodd, one of the inventors listed on the patent[5].
Statistics and Market Impact
- The market for diclofenac formulations is substantial, with millions of prescriptions filled annually.
- The improved bioavailability and stability provided by the patented formulations can lead to increased patient compliance and better therapeutic outcomes, which in turn can drive market growth.
Global Patent System
The patent is part of a global patent system, with similar patents and applications filed in other jurisdictions. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the management and search of these global patent families, ensuring that inventors and companies can protect their intellectual property across borders[4].
Key Takeaways
- Innovative Formulation: The patent introduces novel dry milling processes to improve diclofenac's bioavailability and stability.
- Comprehensive Claims: The patent includes detailed claims on the methods and compositions, providing broad protection.
- Legal Significance: The patent is involved in significant legal proceedings, highlighting its importance in the pharmaceutical industry.
- Industry Impact: It drives innovation and protects intellectual property, influencing the competitive landscape and research in pharmaceutical formulations.
FAQs
What is the main focus of United States Patent 8,999,387?
The main focus is on methods for producing particles of diclofenac using dry milling processes and compositions comprising diclofenac.
How does the patent improve diclofenac formulations?
The patent improves diclofenac formulations by enhancing bioavailability and stability through novel dry milling techniques.
What are the legal implications of this patent?
The patent is involved in several legal disputes, including a patent infringement lawsuit against generic manufacturers, highlighting its significance in protecting intellectual property.
How does this patent affect the pharmaceutical industry?
It drives innovation, protects intellectual property, and influences the competitive landscape by creating barriers to entry for generic manufacturers.
What tools are available for searching and managing global patent families like this one?
Tools such as the Global Dossier and Common Citation Document (CCD) are available for managing and searching global patent families.
Sources
- US8999387B2 - Formulation of diclofenac - Google Patents
- UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE ... - USPTO
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp.com
