United States Patent 8,153,689: A Detailed Analysis
Overview of the Patent
United States Patent 8,153,689, titled "Pleuromutilin derivatives for the treatment of diseases mediated by microbes," was issued on April 10, 2012. This patent is assigned to Nabriva Therapeutics AG and involves the development of pleuromutilin derivatives, which are a class of antibiotics.
Inventors and Assignees
The inventors listed on this patent include Rosemarie Mang, Werner Heilmayer, Rudolf Badegruber, Dirk B. Strickmann, Rodger Novak, Mathias Ferencic, and Atchyuta Rama Chandra Murty Bulusu. The assignee is Nabriva Therapeutics AG, a company specializing in the development of novel antibiotics[5].
Claims and Scope
The patent includes several claims that outline the specific pleuromutilin derivatives and their uses. Here are the key aspects:
Chemical Structure
The patent describes pleuromutilin derivatives of a specific formula (I), which are detailed in the patent document. These derivatives are modifications of the pleuromutilin core structure, designed to enhance their antimicrobial properties[5].
Therapeutic Use
The primary claim is that these pleuromutilin derivatives are effective in the treatment of diseases mediated by microbes. This includes a wide range of bacterial infections, making these compounds valuable in the fight against antibiotic-resistant bacteria[5].
Synthesis and Preparation
The patent also covers the processes for the preparation of these pleuromutilin derivatives. This includes various synthetic routes and methods to produce these compounds efficiently and with high purity[5].
Patent Expiration Dates
The patent 8,153,689 is set to expire on March 19, 2028. This expiration date is crucial for understanding the timeline during which Nabriva Therapeutics AG holds exclusive rights to these pleuromutilin derivatives[2].
Regulatory Review and Patent Term Restoration
The regulatory review period for the drug product associated with this patent, XENLETA (lefamulin), has been a subject of interest for patent term restoration. The FDA has verified the key dates for the regulatory review period, including the effective date of the investigational new drug application (October 17, 2009), the initial submission of the new drug application (December 19, 2018), and the approval date (August 19, 2019). These dates are used to determine the eligibility and extent of patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984[1][4].
Petitions and Redetermination
The FDA allows for petitions regarding the accuracy of the dates published and whether the applicant acted with due diligence during the regulatory review period. Any interested person can submit comments or petitions within specified timelines, which must comply with FDA regulations[1][4].
Related Patents
There are other patents related to pleuromutilin derivatives and their applications, such as U.S. Patent 8,071,643, which also deals with pleuromutilin derivatives and is set to expire on January 16, 2029. These patents collectively protect the intellectual property of Nabriva Therapeutics AG in the field of antibiotic development[2].
Impact on the Pharmaceutical Industry
The development and patenting of pleuromutilin derivatives like those described in U.S. Patent 8,153,689 are significant for the pharmaceutical industry. These compounds represent a new class of antibiotics that can address the growing issue of antibiotic resistance. The exclusive rights granted by this patent allow Nabriva Therapeutics AG to commercialize these drugs, such as XENLETA, without generic competition until the patent expires[2].
Conclusion
U.S. Patent 8,153,689 is a critical piece of intellectual property for Nabriva Therapeutics AG, protecting their innovative work on pleuromutilin derivatives. The patent's scope includes the chemical structure, therapeutic use, and synthesis of these compounds, making it a valuable asset in the fight against bacterial infections.
Key Takeaways
- Patent Scope: Covers pleuromutilin derivatives for treating microbial diseases.
- Inventors and Assignees: Developed by a team of scientists and assigned to Nabriva Therapeutics AG.
- Patent Expiration: Set to expire on March 19, 2028.
- Regulatory Review: Key dates verified by FDA for patent term restoration.
- Related Patents: Part of a broader portfolio of patents on pleuromutilin derivatives.
- Industry Impact: Significant for addressing antibiotic resistance and commercializing new antibiotics.
Frequently Asked Questions (FAQs)
Q: What is the main subject of U.S. Patent 8,153,689?
A: The main subject is pleuromutilin derivatives for the treatment of diseases mediated by microbes.
Q: Who are the inventors of this patent?
A: The inventors include Rosemarie Mang, Werner Heilmayer, Rudolf Badegruber, Dirk B. Strickmann, Rodger Novak, Mathias Ferencic, and Atchyuta Rama Chandra Murty Bulusu.
Q: What is the expiration date of this patent?
A: The patent is set to expire on March 19, 2028.
Q: How does the regulatory review period affect this patent?
A: The regulatory review period is used to determine the eligibility and extent of patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984.
Q: Are there any related patents to U.S. Patent 8,153,689?
A: Yes, there are related patents such as U.S. Patent 8,071,643, which also deals with pleuromutilin derivatives.
Sources:
- Federal Register/Vol. 86, No. 205/Wednesday, October 27, 2021
- Generic Xenleta Availability - Drugs.com
- Patent Applications and the Performance of the U.S. Patent and Trademark Office (USPTO)
- Federal Register/Vol. 86, No. 205/Wednesday, October 27, 2021
- United States Patent - googleapis.com
