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” (hereinafter “the modification provision”). The federal district courts have on the whole been very conservative in their interpretation of the modification provision. The district courts have, to date, seldom exercised their power to alter the obligatory thirty-month stay. In a recent case, Eli Lilly v. Teva, the Federal Circuit held that a district court’s decision to modify the statutory thirty-month stay is within the discretionary powers of that particular district court, may be based on a party’s uncooperative discovery practices before the court, and will only be reviewed for an abuse of discretion. In the wake of the Eli Lilly decision, it is now likely that the modification provision will become more liberally interpreted and frequently invoked by some of the district courts.
Claire K. Comfort, WILL THE FEDERAL CIRCUIT’S ELI LILLY V. TEVA DECISION LEAD TO EFFORTS TO ABUSE THE MODIFICATION PROVISION OF THE HATCH-WAXMAN ACT?,Richmond Journal of Law & Technology, Volume XVI, Issue 2, (2009)