Will The Federal Circuit’s Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?

Citation data:

Vol: 16, Issue: 2, Page: 5

Publication Year:
Usage 34
Downloads 34
Repository URL:
Comfort, Claire K.
Food and Drug Administration; FDA; Abbreviated New Drug Application; ANDA; Eli Lilly v. Teva; Hatch-Waxman Act; Drug Price Competition and Patent Term Restoration Act; Andrx Pharmaceuticals Inc. v. Biovail Corp; Eli Lilly v. Zenith Goldline; Novartis v. Dr. Reddy’s Laboratories; Eli Lilly v. Barr Laboratories; Consumer Protection Law; Health Law and Policy
article description
The Hatch-Waxman Act provides a mandatory thirty-month stay on the Food and Drug Administration’s (FDA) approval of an Abbreviated New Drug Application (ANDA) when a patent infringement suit is filed. The Act includes a provision for a district court to shorten or extend the Act’s thirty-month stay on FDA approval if “either party to the action failed to reasonably cooperate in expediting the action”