Extending the 30-Month FDA Stay in an ANDA Litigation

Fitzpatrick Case Update
July 9, 2009

Partner Dominick A. Conde and associate Kimberley A. Gavin’s article, “Extending the 30-Month FDA Stay in an ANDA Litigation,” considers how litigation conduct of the parties in a Hatch-Waxman ANDA litigation can provide grounds for extension of the 30-month FDA stay of approval of the generic manufacturer’s drug product. In Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc., Teva’s belated change to its proposed generic drug product and eleventh-hour production of documents formed the bases by which the district court extended the 30-month stay. Addressing the applicable standard for an extended stay period for the first time, the Federal Circuit affirmed the district court, recognizing that whether to shorten or extend the FDA stay is within the district court’s sound discretion. As a result, since each party controls its own litigation conduct, it can control whether an extension—or shortening—of the 30-month stay is warranted.

View Attachment (PDF)