Trial

• Author: Kenneth Dorsney
• Pages: 351-405

351

chapter 15

Trial1

I. Introduction

The trial is the single most important event of the litigation. Prior chap-

ters have discussed ANDA litigation from the initial patent evaluation and

decision to sue, through discovery and the preparation, submission, and

approval of the pretrial order. Those significant events usually identify

the issues and define the universe of what the trial lawyer can introduce

at trial. And it is at trial where, for the first time, the trial lawyer has her

opportunity to present her entire case, introducing the evidence and argu-

ments that will spell success or failure.

During the trial, which is under increasing time constraints as more

and more judges impose strict limits on trial time, the patent trial lawyer

must make many critical and almost instantaneous decisions, which will

have enormous potential impact on the ultimate outcome. A trial of an

ANDA case shares many common elements with the trial of other patent

litigations, since the involved science usually predominates. The trial law-

yer must therefore have a thorough mastery of the technical aspects of the

case and the complexities of the patent law. The decisions that must be

made during trial can only be made correctly if the issues have been thor-

oughly researched before trial and a strategy/game plan has been devised

long before opening argument.

A successful trial requires early identification of the issues and careful

planning of how the documentary and testimonial evidence will be pre-

sented. What follows is a discussion of how timed trials are planned and

conducted including opening statements, the order of proof, examination of

fact and expert witnesses, and the presentation of documentary and physi-

cal evidence, trial motions, and closing arguments.

1. Rudolf E. Hutz, Jeffrey B. Bove, Mary W. Bourke, and Kristen Healey Cramer,

Connolly Bove Lodge & Hutz LLP.

CHAPTER 15

352

In many minds, the typical ANDA trial lacks the human drama of a

criminal trial where an individual’s freedom, and perhaps even his or her

life, hang in the balance. After all, most ANDA trials boil down to a matter

of market exclusivity. But a well-tried ANDA case should rise above mere

technology and market entry or patent exclusivity. It should personalize

the issues and place the science in the context of the advance in the art,

the progress of technology, and either the appropriate reward to the pat-

entee or the freedom of the generic company to use that which varies little,

if at all, from what went before. Patent trials involve people—inventors,

investors, stockholders, workers, and consumers. Never let the trier of fact

forget that his decision will have a significant impact on both the winner

and loser. It is not merely about exclusivity and money.

Patent trial lawyers face many of the same issues that trial lawyers

face in any complex business litigation: how best to present a logical,

understandable story through knowledgeable, appealing witnesses and

documentary/demonstrative evidence to obtain a favorable result. What

follows should aid that endeavor.

II. The Trial Plan

A. Attitude and Approach

The greatest need of a lawyer in the trial of any case, whether patent or

otherwise, is confidence. The greatest handicap is uncertainty and a lack of

confidence, either in herself or in the case that she is about to present. You

cannot be an effective advocate if you do not believe that your position is

correct and fair. If you do not believe that your client should and will win,

you are in serious trouble even before trial starts. And if you no longer care

who wins at the end of the trial, if it is just another trial among many, then

perhaps you should consider an alternative line of work.

Confidence in your case is normally based upon proper preparation,

knowledge, and a well-planned and executed trial strategy. The majority of

patent trials are won or lost by adequate or inadequate preparation before

the trial begins. Before every trial, all attorneys involved in trying the

case should know (or feel they know) more about the applicable facts, the

underlying scientific theories, and the pertinent patent law than anyone

else in the courtroom. This includes knowing more than the clients, the

fact witnesses, the expert witnesses, the judge, and, of most importance,

the opponent and his or her witnesses. You must demonstrate through-

out the trial that you are the one authoritative source of information on

which the judge can rely in support of a fair result. Due to their scientific

II. The Trial Plan 353

nature, Abbreviated New Drug Application (ANDA) cases present special

comprehension problems for the less-experienced judge, and he or she will

need help every step of the way. Every statement that you make during

trial must be correct and supportable, and this can happen only if you have

mastered the science, the facts, and the applicable patent law, backwards

and forwards.

Confidence in the case does not mean that you accept everything your

client says or that your client has never made mistakes. It does not mean

that your client is one hundred percent right. But it does mean that you

sat down with your trial team and with your client, discussed the reason-

able objectives of the trial and its likely outcome, and are confident that

you can achieve your objectives.

If you do not, however, believe sincerely that your client should achieve

the goals set after all of the evidence is in, then you should urge that either

someone else try the case or urge settlement. And, if your client does not

believe that you are the right attorney to tell her story to the judge leading

to a successful result, then the client should get another lawyer involved.

Confidence means not only confidence in yourself and your case but also

the confidence of the client in you. Without that, and without thorough

mastery of the facts and law on which confidence is based, success is

doubtful.

Despite the strength of his conviction, a trial lawyer must see and

admit to the weaknesses of his case. If the case were perfect, it probably

would not go to trial. Your opponent will have something to talk about and

points to be made, or she would have settled long before trial. Know your

case’s weaknesses and admit to them, quickly and directly. A quick admis-

sion defuses your opponent’s strengths. Whenever possible, be the first to

raise and then concede the weaknesses of your case. Having done so, do

not let your opponent dwell on what you have conceded. And do not permit

your opponent to emphasize the weaknesses in your case by disputing the

inevitable.

Fight only the battles that you can win at trial. You should dictate the

scientific, factual, and legal battleground where you want to fight, and you

should focus the judge’s attention on the issues you can win. If you have

no issues that you can win, and win decisively, and if those issues having

been won do not lead to victory, then the case does not belong in the court-

room. By conceding weak points and focusing on the issues of your choice

(namely the issues you should win), you will increase your credibility—and

credibility is your stock in trade, particularly in ANDA cases where many

judges are unfamiliar with science, the Hatch-Waxman Act, and even the

language patent attorneys use so frequently. They are looking for help