Managing an ANDA Litigation

• Author: Kenneth L. Dorsney
• Pages: 533-547

533

chapter 22

Managing an

ANDALitigation

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 45-day window for filing a lawsuit in response to

the filing of an ANDA, the 30-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, but also of legal

issues, time frames, and other considerations, and how they interrelate,

and, most importantly, how to effectively communicate them to the litiga-

tion team and the client. Because ANDA litigation is such a dynamic pro-

cess, litigation 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).

Daniel E. Yonan, Jonathan M. Strang, and Jonathon E. Boljesic, Sterne Kessler Goldstein

& Fox PLLC, Washington, D.C.

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