To obtain a patent extension for a drug like tigecycline injection, the process typically involves applying for a Patent Term Extension (PTE) through the United States Patent and Trademark Office (USPTO) under 35 U.S.C. 156. This extension is intended to compensate for the time lost during the regulatory approval process. The extension can be granted if certain conditions are met, such as demonstrating that the patent covers the approved product and that the product has been subject to regulatory review before being marketed.
In the case of tigecycline injection, the manufacturer would need to follow the guidelines set by the USPTO and provide the necessary documentation to support their application for a patent extension. This documentation may include details on the regulatory review process, the patent coverage of the drug, and other relevant information.
It is important to note that obtaining a patent extension is a complex process that requires careful attention to detail and compliance with the regulations set forth by the USPTO. Companies seeking a patent extension for a drug like tigecycline injection would typically work closely with legal counsel and patent experts to navigate the process successfully.
Sources:
[1] https://www.drugpatentwatch.com/p/tradename/TIGECYCLINE
[2] https://www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4037176/