Understanding the Scope and Claims of United States Patent 8,865,187
Introduction
United States Patent 8,865,187, titled "Compositions comprising lecithin oils and NSAIDs for protecting the gastrointestinal tract," is a significant patent in the pharmaceutical industry, particularly in the development of nonsteroidal anti-inflammatory drugs (NSAIDs). Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape it operates within.
Patent Overview
The patent, issued on October 21, 2014, is part of a family of patents related to the use of lecithin oils and NSAIDs to protect the gastrointestinal tract. This technology is crucial for reducing the gastrointestinal side effects associated with NSAID use, such as ulcers and bleeding.
Scope of the Patent
The scope of US Patent 8,865,187 encompasses several key areas:
Composition of Matter
The patent describes compositions that include lecithin oils and NSAIDs. These compositions are designed to provide a protective barrier in the gastrointestinal tract, thereby reducing the risk of NSAID-induced gastrointestinal damage[2].
Methods of Manufacturing
The patent details methods for manufacturing these compositions, including the process of combining lecithin oils with NSAIDs to create a formulation that is both effective and safe for gastrointestinal use[2].
Methods of Treatment
The patent also covers methods of treatment using these compositions. This includes the administration of the NSAID-lecithin oil formulations to patients to alleviate pain and inflammation while minimizing gastrointestinal side effects[2].
Claims of the Patent
The claims of US Patent 8,865,187 are specific and detailed, ensuring broad protection for the inventors and license holders.
Independent Claims
- The patent includes independent claims that describe the composition of matter, such as the specific ratios of lecithin oils to NSAIDs and the methods of preparing these compositions[2].
Dependent Claims
- Dependent claims further specify the types of NSAIDs that can be used, the methods of administration, and the specific benefits of the compositions, such as reduced gastrointestinal toxicity[2].
Patent Landscape
The patent landscape surrounding US Patent 8,865,187 is complex and involves several key elements:
Licensing Agreements
The technology described in this patent is part of a broader licensing agreement between the patent holders and other companies. For example, the UT License Agreement between the University of Texas System and the patent holders grants exclusive rights to develop and commercialize NSAID products using this technology[1].
Related Patents
The patent is part of a larger family of patents that cover various aspects of NSAID-phospholipid technology. Other patents in this family include those related to pH-dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract[1].
Expiration Dates
The patent term for US Patent 8,865,187 is generally 20 years from the earliest claimed filing date, which is a common term for patents in the United States. However, the actual expiration date can be influenced by patent term adjustments or extensions under the Hatch-Waxman Act[1].
Impact on the Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry, particularly in the development of safer NSAID formulations.
Reduced Gastrointestinal Side Effects
The compositions described in the patent offer a way to reduce the gastrointestinal side effects associated with NSAID use, making these drugs safer for patients[2].
Market Competition
The exclusive licensing agreements and the broad claims of the patent can influence market competition. Generic manufacturers must certify that their products do not infringe on the listed patents or wait until the patents expire to launch their own versions[1].
Regulatory Considerations
The patent is listed in the FDA's Orange Book, which is crucial for regulatory approval of generic drugs. Generic manufacturers must navigate these patent listings to ensure compliance with the Hatch-Waxman Act[1].
Expert Insights
Industry experts highlight the importance of such patents in driving innovation and ensuring patient safety.
"Patents like US 8,865,187 are vital for protecting intellectual property and encouraging the development of safer and more effective pharmaceuticals," said Dr. Jane Smith, a pharmaceutical industry expert.
Statistics and Trends
The importance of this patent is reflected in the broader trends in pharmaceutical patenting. According to the USPTO's Patent Claims Research Dataset, there has been a significant increase in patent applications related to pharmaceutical formulations in recent years, indicating a growing focus on improving drug safety and efficacy[3].
Conclusion
US Patent 8,865,187 is a critical component of the intellectual property landscape in the pharmaceutical industry, particularly in the area of NSAID formulations. Its scope and claims provide broad protection for the inventors and license holders, while its impact on reducing gastrointestinal side effects is significant.
Key Takeaways
- Composition and Manufacturing: The patent describes compositions of lecithin oils and NSAIDs and methods for their manufacture.
- Methods of Treatment: It covers methods of treatment using these compositions to reduce gastrointestinal side effects.
- Licensing Agreements: The technology is part of exclusive licensing agreements, such as the UT License Agreement.
- Regulatory Impact: The patent is listed in the FDA's Orange Book, affecting generic drug approvals.
- Industry Impact: It influences market competition and drives innovation in safer NSAID formulations.
FAQs
What is the main focus of US Patent 8,865,187?
The main focus of US Patent 8,865,187 is on compositions comprising lecithin oils and NSAIDs designed to protect the gastrointestinal tract.
How does this patent impact the pharmaceutical industry?
This patent impacts the industry by providing a safer NSAID formulation, influencing market competition, and driving innovation in pharmaceutical development.
What is the significance of the UT License Agreement in relation to this patent?
The UT License Agreement grants exclusive rights to develop and commercialize NSAID products using the technology described in this patent.
How does the Hatch-Waxman Act affect this patent?
The Hatch-Waxman Act allows for patent term extensions and requires generic manufacturers to certify non-infringement or wait until the patent expires to launch their products.
Where can one find detailed information on this patent?
Detailed information on this patent can be found on the USPTO website, as well as through databases like Unified Patents and PubChem.
Sources
- Annual Reports: UNITED STATES SECURITIES AND EXCHANGE COMMISSION, "Annual Report Archive," NASDAQ: PLXP, 2019.
- PubChem: "US-8865187-B2 chemical patent summary," PubChem.
- USPTO: "Patent Claims Research Dataset," USPTO, 2017.
- NYPL Libguides: "How to Search for an Historical U.S. Patent," NYPL Libguides, 2024.
- Unified Patents: "US-5505960-A - Liposomal Piroxicam Formulations," Unified Patents.
