Pretrial Preparation

• Author: Kenneth L. Dorsney
• Pages: 405-426

405

chapter 17

Pretrial Preparation

As in any patent case, pretrial preparation begins long before the eve of

trial. As described in the preceding chapters of this book, every step from

the Abbreviated New Drug Application (ANDA) filer’s initial decision to

develop a generic drug through the submission of the pretrial order sets

the stage for what happens in the courtroom. Decisions made at the plead-

ings stage define the issues that will be tried to the judge or jury just

as questions posed during depositions dictate how witnesses will testify

at trial. Wise counsel keep this end-game in mind at all times and work

backward from their posttrial briefs or closing arguments to guide their

decisions throughout the case.

Notwithstanding this long-term view, there does come a point follow-

ing the close of fact and expert discovery, after summary judgment motions

have been decided and a Markman ruling comes down, when the parties

shift course and begin to formally prepare for trial. This chapter describes

that process, pointing out the opportunities presented and pitfalls to avoid.

I. Trial Plan and Themes

A. Narrowing the Issues

The end of fact and expert discovery often places counsel in a difficult

situation. Whereas the parties’ pleadings, contentions, expert reports, and

dispositive motions have somewhat narrowed the issues in the case, the

discovery the parties exchanged inevitably leaves litigants with too many

facts, too many documents, and too many witnesses to present at trial.

Selecting the best, most persuasive evidence and tailoring it for presenta-

tion to the judge (and/or jury) are essential.

In the months prior to trial, there are many potential avenues avail-

able to narrow the issues, many of which are described below. Two key

questions, however, should guide this process: (1) What issues (both legal

Jack B. Blumenfeld, Karen Jacobs, and Jeremy A. Tigan, Morris, Nichols, Arsht & Tunnell

LLP.

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CHAPTER 17

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and factual) need to be proven?; and (2) How do those issues fit into an

overall case theme? Taken together, the answers provide a good roadmap

for pretrial preparation.

For patentees and generics alike, it is important to take a razor to the

remaining issues in a case, cutting out extraneous information and weak

arguments. Although it is often difficult to let go of issues one has invested

time and effort in developing, if they are not persuasive and do not go to the

ultimate issues, they should be discarded. Conversely, if the other side is

likely to raise problematic issues or bad facts, plans to proactively address

them through direct evidence or motions in limine should be formulated.

B. Burdens of Proof

When narrowing issues, ANDA litigants should keep in mind their respec-

tive burdens and be careful not to eliminate issues or evidence necessary

to prove their case at trial. Further, given that the typical ANDA case may

last anywhere from 18 months to more than three years, litigants should

pay close attention to developments at the Supreme Court and the Federal

Circuit as the case unfolds, and amend their pleadings and contentions as

necessary if burdens change.1

1. Issues on Which the Patentee Bears the Burden of Proof

a. Ownership and Standing

Although not often disputed in ANDA cases, the patentee bears the bur-

den of proof on patent ownership and standing. To establish constitutional

standing to sue for patent infringement, a party must be a “patentee,” a

designation that includes both the person to whom the patent was issued

and any subsequent assignees.2 The patentee must establish ownership of

enforceable title at the time of commencement of the lawsuit.3

b. Infringement

The burden of proof for infringement also rests with the patentee. With

respect to allegations of direct infringement, both literal4 and by the

1. See, e.g., Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011).

2. 35 U.S.C. §100(d) (2006); In re Rosuvastatin Calcium Patent Litig., 719 F. Supp. 2d

388, 398 (D. Del. 2010) (citing Morrow v. Microsoft Corp., 499 F.3d 1332, 1339–40 (Fed. Cir.

2007)).

3. Abraxis Bioscience, Inc. v. Navinta, L.L.C., No. 07-1251, 2009 WL 904043, at *3

(D.N.J. Mar. 30, 2009) (citing Paradise Creations, Inc. v. UV Sales, Inc., 315 F.3d 1304,

1309 (Fed. Cir. 2003)).

4. In re Brimonidine Patent Litig., 666 F. Supp. 2d 429, 437 (D. Del. 2009) (citing Braun,

Inc. v. Dynamics Corp. of Am., 975 F.2d 815, 819 (Fed. Cir. 1992)); Glaxo Grp., Ltd. v.

Apotex, Inc., 268 F. Supp. 2d 1013, 1028 (N.D. Ill. 2003) (same); Biovail Corp. Int’l v. Andrx

Pharm., Inc., 158 F. Supp. 2d 1318, 1329 (S.D. Fla. 2000) (same).

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