Trial

• Author: Kenneth L. Dorsney
• Pages: 427-480

427

chapter 18

Trial

I. Introduction

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

ters have discussed Abbreviated New Drug Application (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 his or her opportunity to present his

or her entire case, introducing the evidence and arguments 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

physical evidence, trial motions, and closing arguments.

Rudolf E. Hutz, Reed Smith LLP; Jeffrey B. Bove, RatnerPrestia; Mary W. Bourke, Kristen

Healey Cramer, Womble, Carlyle Sandridge & Rice LLP

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CHAPTER 18

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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 or her 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 himself or herself or in the case that he or 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 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 under-

lying scientific theories, and the pertinent patent law than anyone else in

the courtroom. This includes knowing more than the clients, the fact wit-

nesses, the expert witnesses, the judge, and, of most importance, the oppo-

nent and his or her witnesses. You must demonstrate throughout 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 nature, ANDA

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II. The Trial Plan 429

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, backward and forward.

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 100 percent right. But it does mean that you have sat

down with your trial team and with your client, discussed the reasonable

objectives of the trial and its likely outcome, and you 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 his or 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, suc-

cess is doubtful.

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

and admit to the weaknesses of his or her 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 he or she would have settled long

before trial. Know your case’s weaknesses and admit to them, quickly and

directly. A quick admission 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

throughout the trial. Most judges want to understand and reach the right

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