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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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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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