Discovery

• Author: Kenneth Dorsney
• Pages: 141-153

141

chapter 7

Discovery1

I. Introduction

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

ceeds in the same manner as discovery in non-ANDA patent litigation.2

That being said, there are few resources addressing discovery strategies

for patentees and generic drug companies in the litigation.3 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.4

1. Gerard M. O’Rourke, RatnerPrestia.

2. 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.

3. A resource discussing potential discovery strategies for the pioneering

pharmaceutical company is Paul A. Ragusa et al., ANDA Litigation Discovery, Patent

Strategy & Management, vol. 9, no. 1, June 2008. A resource discussing discovery strategies

for the generic drug company is the Patent Litigation Strategies Handbook, 3d, Chapter 7.

The Patent Litigation Strategies Handbook contains sections on ANDA litigation from both

the pioneering and generic pharmaceutical companies’ perspectives. See Chapters 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 Chapter 7, pp. 206–209 with Chapter 8.

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

to the following discovery issues: Protective Order (Chapter 10); Joint Defense Privileges

and Agreements (Chapter 11); Interrogatories and Requests For Admission (Chapter 12);

Document Discovery (Chapter 13); Electronic Discovery (Chapter 14); Depositions (Chapter

15); Attorney-Client Privilege and Work-Product Doctrine (Chapter 16); Foreign Discovery

(Chapter 17); Third Party Discovery (Chapter 18); and Confronting Discovery Problems

(Chapter 19).