Tips for Protecting Hatch-Waxman Stay After Lilly, Alcon

When brand pharmaceutical companies file for infringement against a generic company under the Hatch-Waxman Act, they expect the automatic 30-month stay of Food and Drug Administration (FDA) approval of a generic drug will prevent it from going to market until the suit has been settled. However, as Faegre Baker Daniels partner Tim Grimsrud, counsel Amy Hamilton, and associates Andrew McCoy and Linzey Erickson wrote in a Law360 article, recent district court proceedings in Eli Lilly v. Accord Healthcare Inc. and Alcon Labs. Inc. v. Akorn Inc. demonstrate “a real risk to the protections of the 30-month stay.”

“In particular, if Hatch-Waxman litigation is stayed pending inter partes review (IPR) but the 30-month regulatory stay is not extended, there is a significant risk that a generic could launch ‘at risk’ before the merits of the underlying litigation are resolved,” the article said. "Accordingly, Lilly and Alcon show that when a brand company is faced with a motion to stay district court litigation in view of an IPR, the most effective strategy for protecting the 30-month regulatory stay is to prevent a litigation stay in the first place. This article provides practical pointers for brand companies opposing motions to stay litigation after Lilly and Alcon.”