Litigation Timeline

• Author: Kenneth Dorsney
• Pages: 75-88

75

chapter 4

Litigation Timeline1

I. Introduction

The timeline in Abbreviated New Drug Application (ANDA) litigation typi-

cally is driven by three time periods: forty-five days to initiate a lawsuit,

a thirty-month stay of Food and Drug Administration (FDA) approval

for the generic, and 180 days of exclusivity for the first generic to file an

ANDA with a Paragraph IV certification. Many of the logistical decisions

made in an ANDA lawsuit will be based on consideration of one or more

of these three time periods. This chapter describes the litigation timeline

and analyzes issues that parties and their counsel may encounter during

an ANDA litigation.

II. Logistics Following Receipt of the Notice Letter

After receiving the notice letter, the brand has forty-five days to initiate

a lawsuit or it will lose the automatic thirty-month stay of FDA approval

for the generic drug. This forty-five-day period (for both the brand and the

generic) means that the analysis and actions described below should be

prepared as part of the ordinary course of business and available as soon

as the litigation begins.

A. Selecting Counsel

One of the most important decisions a company can make is its selection of

counsel. Given the complexity and time commitment of most ANDA cases,

most brands and generics will likely hire outside counsel that has previous

1. Richard L. Horwitz, Philip A. Rovner, David E. Moore, Jonathan A. Choa, & Eric B.

Fugett, M.S., Potter Anderson & Corroon LLP.