Pretrial Preparation

• Author: Kenneth Dorsney
• Pages: 329-350

329

chapter 14

Pretrial Preparation1

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 impact how witnesses will testify

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

backward from their post-trial briefs or closing arguments to guide their

decisions throughout the case.

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

lowing the close of fact and expert discovery, after summary judgment

motions have been decided and a Markman ruling has come down, when

the parties shift course and begin to formally prepare for trial. This chap-

ter 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 unique

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

dispositive motions have likely narrowed the issues in the case, the discov-

ery the parties exchanged inevitably leaves litigants with more relevant

information than is possible to present at trial. Selecting the best, most

1. Jack B. Blumenfeld, Karen Jacobs Louden, and Jeremy A. Tigan, Morris, Nichols,

Arsht & Tunnell LLP. Special thanks to Erich W. Struble and Megan Dellinger for their

assistance.

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330

persuasive evidence and tailoring it for presentation to the judge (and/or

jury) are essential.

In the two to three months prior to trial, there are many potential

avenues available to narrow issues for trial, some of which are described

below. Two key questions, however, should guide this process: (1) What

issues (both legal and factual) need to be proven? (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 issues and weak argu-

ments. 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 of proof and be careful not to eliminate issues or evidence nec-

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

case may last anywhere from eighteen months to three years or more,

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 to address these changes.2

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.3 The patentee must establish ownership of

enforceable title at the time the lawsuit began.4

2. See e.g., Therasense, Inc. v. Becton, Dickinson & Co., No. 2008-1511, 2011 WL

2028255 (Fed. Cir. 2011).

3. 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)).

4. 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)).