Discovery

• Author: Kenneth L. Dorsney
• Pages: 213-225

213

chapter 10

Discovery

I. Introduction

Discovery in Abbreviated New Drug Application (ANDA) litigation pro-

ceeds in the same manner as discovery in non-ANDA patent litigation.1

That being said, there are few resources addressing discovery strategies

for patentees and generic drug companies in the litigation.2 Moreover,

there are few, if any, resources compiling various discovery issues that

have arisen in ANDA litigation and how those issues have been resolved

by the courts. This chapter focuses primarily on ANDA discovery strategy

and how courts have ruled on various ANDA-related discovery disputes.

Articles related to the use of particular discovery procedures in patent

litigation are abundant in the literature and are beyond the scope of this

chapter.3

Gerard M. O’Rourke, O’Rourke Law Office LLC.

1. See generally

FED. R. CIV. P.

26–39, 45. The Federal Rules do not exempt ANDA cases

from the rules, nor do the Federal Rules contain rules directed only at ANDA cases.

2. A resource discussing potential discovery strategies for the pioneering pharmaceutical

company is Paul A. Ragusa et al., 9(1) ANDA Litigation Discovery, Patent Strategy &

Management (June 2008). A resource discussing discovery strategies for the generic drug

company is the Patent Litigation Strategies Handbook (3d ed.), ch. 7. The Patent Litigation

Strategies Handbook contains sections on ANDA litigation from both the pioneering and

generic pharmaceutical companies perspectives. See chs. 7 and 8. However, the chapter on

litigation from the generic drug company perspective contains a more extensive discussion

on discovery than does the chapter on litigation from the pioneering company perspective.

Compare ch. 7, at 206–09, with ch. 8.

3. For example, the Patent Litigation Strategies Handbook has entire chapters devoted

to the following discovery issues: Protective Order (ch. 10); Joint Defense Privileges and

Agreements (ch. 11); Interrogatories and Requests for Admission (ch. 12); Document

Discovery (ch. 13); Electronic Discovery (ch. 14); Depositions (ch. 15); Attorney-Client

Privilege and Work-Product Doctrine (ch. 16); Foreign Discovery (ch. 17); Third Party

Discovery (ch. 18); and Confronting Discovery Problems (ch. 19).

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