Experts

• Author: Kenneth Dorsney
• Pages: 155-179

155

chapter 8

Experts1

I. Introduction

An expert witness can be the key to delivering a convincing presentation

to the court in an Abbreviated New Drug Application (ANDA) case. Of

course, before the expert witness will be able to step anywhere near the

courtroom, the expert witness must survive the gauntlet that is pre-trial

scrutiny. The scrutiny begins by the party seeking the expert. It con-

tinues with the expert’s involvement in early discovery, preparation of

reports, and depositions, and then the expert may face motions in limine

to exclude her from testifying. If the expert survives this gauntlet, she will

be able to testify at trial. At trial is where the real scrutiny takes place.

The judge will measure the expert’s words, presentation, demeanor, and

anything else to decide whether the court will accept or reject the expert’s

opinions.

Federal Rule of Evidence 702 and the Supreme Court’s decision in

Daubert v. Merrell Dow Pharmaceuticals, Inc.2 provide the legal framework

for the admissibility of expert testimony. The law of the regional circuits,

rather than Federal Circuit law, is generally used by district courts to

rule on the admissibility of expert testimony and other evidentiary issued

in ANDA cases.3 Rule 702 permits the admission of expert testimony if

1. Alejandro Menchaca, Michael B. Harlin, and Thomas J. Campbell Jr., McAndrews,

Held & Malloy, Ltd.

2. 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993).

3. Evidentiary rulings are generally governed by regional circuit law. Odetics, Inc.

v. Storage Tech. Corp., 185 F.3d 1259, 1276 (Fed. Cir. 1999) (“Because these evidentiary

rulings raise procedural issues not unique to patent law, this court applies the law of the

regional circuit where appeals from the district court would normally lie.”); WMS Gaming

Inc. v. Int’l Game Tech., 184 F.3d 1339, 1361 (Fed. Cir. 1999). However, the determination

of whether material is relevant in a patent case is governed by Federal Circuit law when the

material relates to an issue of substantive patent law. See Midwest Indus., Inc. v. Karavan

Trailers, Inc., 175 F.3d 1356, 1359 (Fed. Cir. 1999). As a result, a given evidentiary issue

may involve the law of the Federal Circuit with regard to relevance and the law of the

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“scientific, technical, or other specialized knowledge will assist the trier of

fact to understand the evidence or to determine a fact in issue.”4

It is almost a given that patent litigation will involve technical experts,

and ANDA cases are certainly no exception. Most of the principles we dis-

cuss below are applicable to ANDA litigation as well as other areas of pat-

ent litigation, though we endeavor to point out differences between ANDA

cases and others.

A. Selection of Experts in ANDA Cases

The initial step in identifying an expert requires matching an expert’s

expertise with the issues to be addressed by the expert. Rule 702 provides

broadly for expert testimony. Courts, however, critically view an expert’s

credentials to confirm that they match the expected area of the proposed

testimony.5 As the “gatekeeper,” a court will not permit an expert to tes-

tify in areas where no expertise exists or where no expert testimony is

required.6 The expert’s qualification must fit the scientific or other special-

ized issue for which his opinion will be offered.

Identifying an expert with the appropriate expertise is only the first

step. The expert must be vetted for a full understanding of his or her

prior patents, publications, or writings. Otherwise, the retaining party

regional circuit with regard to reliability or other issues. Astra Aktiebolag v. Andrx Pharms.,

Inc., 222 F. Supp. 2d 423, 486 (S.D.N.Y. 2002); but see Micro Chem., Inc. v. Lextron, Inc.,

317 F.3d 1387 (Fed. Cir. 2003).

4. FED. R. EVID. 702.

5. Bone Care Int’l, LLC v. Pentech Pharms., Inc., 2009 U.S. Dist. LEXIS 7098

(N.D. Ill. Feb. 2, 2009) (“given that ‘[m]odern science is highly specialized,’ a court must

take care to confirm that a proposed expert is qualified to offer opinion testimony in

the specific area of his or her proposed testimony”). See also PDL Biopharma, Inc. v.

Sun Pharm. Indus., 2008 U.S. Dist. LEXIS 105464 (D.N.J. Dec. 11, 2008) (“To provide

testimony at trial, an expert must be qualified in the relevant technology.”); Mead Johnson

& Co. v. Premo Pharm Labs., 1980 U.S. Dist. LEXIS 15750, at *91–97 (D.N.J. 1980)

(“[E]ven [plaintiff’s experts] recognized the unique qualifications of defendant’s experts, and

in particular, Dr. Burger. His treatise was repeatedly referred to as ‘the bible of medicinal

chemistry’. The Court relied very heavily upon the opinions of Dr. Burger in reaching many

of the findings and conclusions contained herein and gave great weight to his testimony.”).

6. Bone Care Int’l, 2009 U.S. Dist. LEXIS 7098 (An expert with expertise in treating

metabolic bone disease was permitted to explain related prior art references, but was

excluded from testifying on the procedural background of the patent in suit and ancestor

applications. The court also limited the testimony of a patent law expert to Patent and

Trademark Office procedures, but not the law.) See also PDL Biopharma, Inc., 2008

U.S. Dist. LEXIS 105464 (“this Court recently explained that the rule prohibiting experts

from offering legal opinions is ‘so well established that it is often deemed a basic premise

or assumption of evidence law—a kind of axiomatic principle.’”); Proveris Sci. Corp. v.

Innovasystems, Inc., 536 F.3d 1256, 1267–1268 (Fed. Cir. 2008) (“we cannot say the district

court did not act within its discretion in finding Mr. Quinn [with expertise in satellite

design] unqualified to testify about laboratory equipment used in the development of drug

delivery devices”).