Merck’s 12 Year Patent Reissue Period Upheld On Appeal — For Bridion®

We have followed sugammadex for about 17 years now -- first at old SGP under Fast Fred Hassan, and later at Merck. The blockade candidate saw over 12 years shaved from its US patent/market exclusivity period via multiple "do over" FDA reviews (the companies' own fault -- for presenting inadequate data from poorly designed studies).

Now a court of appeal has held Merck may "reclaim" that lost time / revenue, under Hatch-Waxman. Here's that bit, from the National Law Review:

. . .Merck owns a patent that is directed to a class of 6-mercapto-cyclodextrin derivatives. Four months after the patent issued, Merck applied to the US Food & Drug Administration (FDA) for approval of sugammadex, which it intended to market as Bridion®. During FDA’s review of Merck’s new drug application (NDA), Merck filed a reissue application that included narrower claims. The reissue application issued and included all the original claims and 12 additional claims. FDA regulatory review continued throughout the examination of the reissue application and extended almost two years beyond the date the patent reissued. In all, the FDA regulatory review lasted nearly 12 years. . . .

To be sure, this is a multi-billion dollar win for Merck. Onward.

नमस्ते