United States Patent 8,329,198: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,329,198, titled "Pharmaceutical compositions and related methods of delivery," is a significant patent in the pharmaceutical industry, particularly in the area of drug delivery systems. This patent, issued on September 11, 2012, addresses innovative methods and compositions for improving the delivery of pharmaceuticals, especially through oral administration.
Scope of the Patent
Pharmaceutical Compositions
The patent focuses on the development of pharmaceutical compositions that enhance the delivery of active pharmaceutical ingredients (APIs). These compositions are designed to improve the bioavailability, stability, and efficacy of the drugs. Key components include formulations using medium chain fatty acid salts, castor oil, and other specific chemical compounds like sodium tetradecanoate and sodium tridecanoate[1][4].
Methods of Delivery
The patent describes various methods of delivering these pharmaceutical compositions, including oral delivery systems. These methods are tailored to optimize the absorption and distribution of the drug within the body, often targeting specific release profiles to enhance therapeutic effects[1][4].
Claims of the Patent
Composition Claims
The patent includes claims related to the specific formulations of the pharmaceutical compositions. These claims detail the use of:
- Medium chain fatty acid salts
- Castor oil
- Sodium tetradecanoate and sodium tridecanoate
- Other chemical compounds like lithium, ammonium salts, and esters[1][4].
Method Claims
The method claims cover the processes for preparing these compositions and the techniques for their administration. This includes:
- Formulation processes involving mixing and encapsulation
- Specific dosing regimens and administration times, such as post-meal administration[1][4].
Patent Landscape
Current Status and Expiration
The patent is currently active, with an expiration date set for September 17, 2029. This timeline is crucial for both the patent holders and potential generic drug manufacturers, as it defines the period during which the patent holders have exclusive rights to the invention[5].
Related Patents and Litigation
The '198 patent is part of a larger portfolio of related patents held by Amryt Endo, Inc., including patents like '812, '246, '709, and others. These patents collectively protect various aspects of pharmaceutical compositions and delivery methods. Recent litigation, such as the case against Teva, highlights the importance of these patents in protecting intellectual property in the pharmaceutical industry[5].
Industry Impact
The '198 patent and its related patents have significant implications for the pharmaceutical industry, particularly in areas like diabetes, respiratory diseases, and cancer. Innovations protected by these patents can lead to more effective treatments and better patient outcomes. For instance, the success of drugs like semaglutide (Ozempic, Wegovy, Rybelsus) by Novo Nordisk underscores the potential for high-impact innovations in these areas[3].
Key Players and Patent Filings
Leading Patent Applicants
The U.S. pharmaceutical industry sees significant patent activity from major players such as the University of California, Roche, INSERM, Novartis, and Sanofi. These entities are consistently among the top patent applicants, reflecting their commitment to innovation in pharmaceuticals[3].
Patent Filings and Trends
In 2023, the U.S. pharmaceutical industry witnessed a substantial number of patent filings, with 21,235 U.S. patent applications published. The focus areas included vaccines, cancer treatments, and drugs for diabetes and respiratory diseases. This trend indicates a robust and dynamic patent landscape in the pharmaceutical sector[3].
Technological Innovations
Advanced Formulations
The '198 patent highlights the use of advanced formulations, such as those involving medium chain fatty acid salts and castor oil, to enhance drug delivery. These innovations are critical in improving the efficacy and patient compliance of pharmaceutical treatments[1][4].
Targeted Delivery Systems
The patent also covers methods for targeted delivery, ensuring that the drug is released in a controlled manner to maximize therapeutic effects. This includes post-meal administration and specific dosing regimens, which can significantly improve the bioavailability of the drug[1][4].
Economic and Regulatory Implications
Market Protection
The '198 patent and related patents provide market protection for the innovators, allowing them to recoup their investment in research and development. This protection is essential for encouraging further innovation in the pharmaceutical industry[5].
Regulatory Compliance
The patent holders must comply with regulatory requirements, such as those set by the FDA, to ensure that their products meet safety and efficacy standards. The litigation against Teva, for example, involves compliance with FDA regulations and the protection of intellectual property[5].
Conclusion
The United States Patent 8,329,198 is a pivotal patent in the pharmaceutical industry, focusing on advanced pharmaceutical compositions and delivery methods. Its scope and claims are designed to enhance drug delivery, particularly through oral administration. The patent landscape surrounding this invention is complex, involving multiple related patents and significant industry players. Understanding the implications of this patent is crucial for both innovators and generic drug manufacturers as they navigate the complex landscape of pharmaceutical intellectual property.
Key Takeaways
- The '198 patent covers innovative pharmaceutical compositions and delivery methods.
- Key components include medium chain fatty acid salts and castor oil.
- The patent is set to expire on September 17, 2029.
- Related patents protect a broad range of pharmaceutical innovations.
- Major industry players are actively filing patents in areas like diabetes, respiratory diseases, and cancer.
- Advanced formulations and targeted delivery systems are critical innovations.
FAQs
What is the main focus of the United States Patent 8,329,198?
The main focus of the patent is on pharmaceutical compositions and related methods of delivery, particularly enhancing oral delivery systems.
Who are the key players in the patent landscape related to this invention?
Key players include the University of California, Roche, INSERM, Novartis, and Sanofi, along with companies like Amryt Endo, Inc.
What are the expiration dates for the '198 patent and related patents?
The '198 patent expires on September 17, 2029, while other related patents have varying expiration dates up to December 28, 2040.
How does this patent impact the pharmaceutical industry?
The patent impacts the industry by protecting innovative drug delivery systems, encouraging further research and development, and ensuring market protection for innovators.
What are some of the advanced formulations covered by this patent?
The patent covers formulations using medium chain fatty acid salts, castor oil, and specific chemical compounds like sodium tetradecanoate and sodium tridecanoate.
What is the significance of the litigation involving this patent?
The litigation, such as the case against Teva, highlights the importance of protecting intellectual property in the pharmaceutical industry and ensuring compliance with FDA regulations.
Sources
- US8329198B2 - Pharmaceutical compositions and related methods of delivery - Google Patents
- United States Patent - googleapis.com
- 2023 U.S. Pharmaceuticals Patent Landscape - Parola Analytics
- US8329198B2 - Pharmaceutical compositions and related methods of delivery - Google Patents
- in the united states district court - RPX Insight
