United States Patent 8,992,982: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 8,992,982, titled "Methods for producing particles of indomethacin using dry milling processes," was granted on March 31, 2015, to Iceutica Pty Ltd. This patent revolves around the production and application of indomethacin, a nonsteroidal anti-inflammatory drug (NSAID), in a particulate form.
Background and Context
Indomethacin is widely used for its anti-inflammatory, analgesic, and antipyretic properties. However, its poor solubility and bioavailability have been significant challenges. The patent addresses these issues by introducing methods to produce indomethacin particles using dry milling processes, which enhance the drug's solubility and efficacy.
Scope of the Patent
The scope of this patent is broad and encompasses several key aspects:
Methods for Producing Particles
The patent describes various dry milling processes to produce indomethacin particles. These methods include using different types of mills, such as jet mills, ball mills, and pin mills, to reduce the particle size of indomethacin. This reduction in particle size improves the drug's surface area, thereby enhancing its solubility and bioavailability[2][5].
Compositions Comprising Indomethacin
The patent also covers compositions that include indomethacin in particulate form. These compositions can be formulated into various medicaments, such as tablets, capsules, and suspensions. The improved solubility of indomethacin in these compositions is crucial for better absorption and therapeutic efficacy.
Therapeutic Applications
The patent specifies the use of these particulate indomethacin compositions for treating various conditions, including inflammation, pain, and fever. The enhanced bioavailability of the drug in its particulate form makes it more effective in treating these conditions.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Method of Producing Particles
The first claim describes the method of producing indomethacin particles using dry milling processes. This claim specifies the type of mill used, the conditions under which the milling is performed, and the resulting particle size distribution[2].
Claim 2: Composition Comprising Indomethacin
This claim covers the composition that includes indomethacin in particulate form. It details the percentage of indomethacin in the composition and the other ingredients that can be included to enhance stability and efficacy[2].
Claim 3: Medicament Produced Using Indomethacin Particles
The third claim pertains to the medicaments produced using the particulate indomethacin. This includes various dosage forms such as tablets, capsules, and suspensions, and specifies the therapeutic uses of these medicaments[2].
Claim 4: Method of Treatment
This claim outlines the method of treating an animal, including humans, using a therapeutically effective amount of the particulate indomethacin composition. It specifies the conditions that can be treated and the dosage regimen[2].
Patent Landscape
The patent landscape surrounding US Patent 8,992,982 is complex and involves several related patents and technologies:
Related Patents
Other patents related to the production and application of particulate drugs, such as those using wet milling or other particle reduction techniques, are part of the broader patent landscape. For example, patents related to the use of dry milling for other drugs or the formulation of particulate compositions for improved bioavailability are relevant[1][3].
Competing Technologies
Competing technologies include other methods for improving the solubility and bioavailability of poorly soluble drugs, such as nanotechnology, lipid-based formulations, and amorphous solid dispersions. These technologies also aim to enhance the therapeutic efficacy of drugs like indomethacin but through different mechanisms[1].
Regulatory Environment
The regulatory environment plays a crucial role in the patent landscape. Patents must comply with FDA regulations, and the approval process for new drug formulations involves rigorous testing and evaluation. The FDA Orange Book, which lists approved drug products with therapeutic equivalence evaluations, is an important resource in this context[2].
Impact on the Pharmaceutical Industry
The impact of US Patent 8,992,982 on the pharmaceutical industry is significant:
Enhanced Drug Efficacy
The improved solubility and bioavailability of indomethacin in its particulate form enhance its therapeutic efficacy. This can lead to better patient outcomes and increased market demand for the drug.
Cost-Effective Production
The dry milling processes described in the patent can be more cost-effective than other methods of producing particulate drugs. This can reduce production costs and make the drug more accessible to a wider population.
Competitive Advantage
The patent provides Iceutica Pty Ltd with a competitive advantage in the market for NSAIDs. The unique method of producing particulate indomethacin can differentiate their product from others in the market.
Key Takeaways
- US Patent 8,992,982 covers methods for producing indomethacin particles using dry milling processes.
- The patent includes claims related to the production method, compositions, medicaments, and treatment methods.
- The patent landscape involves related patents, competing technologies, and regulatory compliance.
- The impact on the pharmaceutical industry includes enhanced drug efficacy, cost-effective production, and a competitive advantage.
FAQs
Q: What is the main focus of US Patent 8,992,982?
A: The main focus is on methods for producing indomethacin particles using dry milling processes to enhance solubility and bioavailability.
Q: What are the benefits of the particulate form of indomethacin?
A: The particulate form improves the drug's solubility and bioavailability, leading to better therapeutic efficacy.
Q: What types of mills are used in the production process?
A: The patent describes the use of jet mills, ball mills, and pin mills for reducing the particle size of indomethacin.
Q: What are the therapeutic applications of the particulate indomethacin compositions?
A: These compositions are used for treating inflammation, pain, and fever.
Q: How does this patent impact the pharmaceutical industry?
A: It enhances drug efficacy, provides a cost-effective production method, and gives the patent holder a competitive advantage in the market.
Sources
- Justia Patents: Indomethacine Per Se Or Ester Thereof Patents and Patent Applications.
- PharmaCompass: US Patent 8992982.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
- Unified Patents Portal: MX-2011011226-A.
