Experts

• Author: Kenneth Dorsney
• Pages: 227-252

227

chapter 11

Experts

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 pretrial scrutiny. The

scrutiny begins by the party seeking the expert. It continues 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, the expert will be able to testify at trial.

And then it is at trial that the real scrutiny will take 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.1 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.2 Rule 702 permits the admission of expert testimony if “scientific, tech-

Alejandro Menchaca, McAndrews, Held & Malloy Ltd., and Michael B. Harlin, and Thomas

J. Campbell Jr., Neal, Gerber & Eisenberg LLP.

1. 509 U.S. 579 (1993).

2. 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

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).

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CHAPTER 11

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nical, or other specialized knowledge will assist the trier of fact to understand

the evidence or to determine a fact in issue.”3

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.4 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.5 The expert’s qualification must fit the scientific or other special-

ized issue for which her 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

or the expert may be confronted with an awkward position if the expert’s

3.

FED. R. EVID

. 702.

4. Bone Care Int’l, LLC v. Pentech Pharms., Inc., 2009 U.S. Dist. LEXIS 7098 (N.D. Ill.

Feb. 2, 2009) (“[G]iven 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.”).

5. 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 USPTO

procedures, but not the law.) See also PDL Biopharma, Inc., 2008 U.S. Dist. LEXIS 105464

(“[T]his 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, 1267–68 (Fed. Cir. 2008) (“[W]e 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.”).

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