A Day Late, A Buck Short: Or How to Lose PTE Without Really Trying By Sara W. Koblitz —

https://www.thefdalawblog.com/2026/11/a-day-late-a-buck-short-or-how-to-lose-pte-without-really-trying/?utm_source=rss&utm_medium=rss&utm_campaign=a-day-late-a-buck-short-or-how-to-lose-pte-without-really-trying One of the most stringent rules that must be followed to obtain a patent term extension (PTE) after drug approval is the submission of an application for said PTE within 60 days. As we noted in an earlier post, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the U.S. Patent and Trademark Office (PTO) within the statutory 60-day window (see, e.g., here), the most famous of which concerns U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin). In 2024, that’s exactly what happened when Taiho Pharmaceutical Co. Ltd. (“Taiho”) submitted its PTE application for LYTGOBI a day late—on November 29th instead of November 28th—arguing that a corrected approval letter dated October 5, 2022 superseded the original approval letter from September 30, 2022. Unfortunately for Taiho, that argument did not prevail.