The Litigation Timeline

• Author: Kenneth L. Dorsney
• Pages: 79-94

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chapter 4

The Litigation Timeline

I. Introduction

The timeline in Abbreviated New Drug Application (ANDA) litigation

typically is driven by three time periods: 45 days to initiate a lawsuit, a

30-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 45 days to initiate a lawsuit

or it will lose the automatic 30-month stay of FDA approval for the generic

drug. This 45-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

experience in ANDA litigation and also has a patent group with lawyers

who have the appropriate technical background.

Richard L. Horwitz, Philip A. Rovner, David E. Moore, Jonathan A. Choa, Alan R.

Silverstein, Bindu A. Palapura, and Stephanie E. O’Byrne, Potter Anderson & Corroon LLP.

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1. Conflict Analysis

One of the unique aspects of ANDA litigation is that it involves a relatively

small number of players. There are only so many brands and so many

generics in the world, and those companies often appear in litigation

against each other. Consequently, many law firms have developed either a

brand practice or a generic practice.

2. The Brand’s Counsel Selection

Given the 45-day window to bring a lawsuit, a brand has to be in an almost

perpetual state of litigation readiness. Ideally, a brand will have retained

counsel prior to notice of a paragraph IV certification. Prior retention will

allow outside counsel to become familiar with the brand’s products and the

employees who will be essential in litigation.

Prior retention will also allow outside counsel to become familiar with

the brand’s document management systems and its document retention

policies. Today’s ANDA litigations are increasingly driven by electronically

stored information (ESI), and most brands generate a lot of it. Having

outside counsel on the ground floor will allow them to get a head start on

organizing and reviewing ESI for production during the litigation.

3. The Generic’s Counsel Selection

Generics also typically retain counsel prior to any ANDA litigation, and

often that counsel has worked on the paragraph IV certification. It is

important to have counsel on board as early as possible, so that at the

outset of litigation, a generic will not give the court any reason to move

out the trial date or extend the 30-month stay: it is vitally important that

generics not be seen as creating unnecessary delay.

One of the biggest sources of potential delay is discovery and the

production of ESI. Therefore, it is at least as important for generics to have

counsel that is familiar with their document management system and that

has the capacity and ability to review and produce a large amount of data

in a timely fashion.

B. Choosing a Forum

In addition to choosing counsel, choosing a forum is another important

decision for a company to make. Consideration of the benefits and

drawbacks of a given forum must take into account several different factors

including how the forum’s docket fits with the 30-month stay overall.

The initial forum is usually chosen by the brand because, under the

ANDA statute, the brand has the exclusive right to bring suit during the

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