Managing an ANDA Litigation

• Author: Kenneth Dorsney
• Pages: 535-549

535

chapter 19

Managing an ANDA

Litigation1

I. Introduction

As with all complex patent litigation, strategic planning and aggressive

cost management are essential to the successful management of any

Abbreviated New Drug Application (ANDA) litigation. However, unlike

other patent litigation, the strategy, cost, and even timing of an ANDA

lawsuit are constantly in flux due to issues unique to ANDA litigation such

as Food and Drug Administration (FDA) approval(s), first-to-file status,

settlements, antitrust/Federal Trade Commission (FTC) issues, or entry of

additional generic competition. Moreover, as discussed in earlier chapters,

these litigations are further complicated by time periods unique to ANDA

litigation: the forty-five-day window for filing a lawsuit in response to the

filing of an ANDA, the thirty-month stay of FDA approval for the generic,

and the 180-day exclusivity period for the first generic to file an ANDA

with a Paragraph IV certification.

Management of these complicated litigations, therefore, requires not

only an understanding of the entire ANDA landscape, legal issues, time-

frames, and other considerations, but also how they interrelate and, most

importantly, how to effectively communicate them to the litigation team

and the client. Because ANDA litigation is such a dynamic process, litiga-

tion counsel must be in constant communication with the client about:

(1) the time frame(s) for entry of the generic’s product in the market;

(2) the litigation cost; and (3) the likelihood of prevailing (i.e., through a

victory at trial or a favorable settlement).

1. H. Keeto Sabharwal, Daniel E. Yonan, Jennifer S. Bisk, and Jonathan M. Strang,

Sterne Kessler Goldstein & Fox, Washington, D.C.