LITE DEPALMA GREENBERG, LLC

Allyn Z. Lite

Mayra V. Tarantino

Two Gateway Center, Suite 1201

Newark, NJ 07102

(973) 623-3000

alite@litedepalma.com

mtarantino@litedepalma.com

Attorneys for Defendants and CounterclaimPlaintiffs Hanmi USA, Inc., Hanmi 

Pharmaceutical Co., Ltd., Hanmi Fine 

Chemical Co., Ltd. and Hanmi Holdings Co., 

Ltd.

IN THE UNITED STATES DISTRICT COURT

THE DISTRICT OF NEW JERSEY

ASTRAZENECA AB, AKTIEBOLAGET 

HÄSSLE, ASTRAZENECA LP, KBI INC., 

and KBI-E INC.,

Plaintiffs and 

 Counterclaim Defendants,

v.

HANMI USA, INC., HANMI 

PHARMACEUTICAL CO., LTD., HANMI 

FINE CHEMICAL CO., LTD, and HANMI 

HOLDINGS CO., LTD.,

Defendants and 

 Counterclaim Plaintiffs. 

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Civil Action No. 11-760 (JAP)(TJB)

Hanmi’s Motion in Limine No. 5

(To Preclude Testimony Of Dr. Paul Bartlett As To The State Of The Art Regarding 

Gastric Acid Related Diseases)

Case 3:11-cv-00760-JAP-TJB Document 290-5 Filed 04/29/13 Page 1 of 8 PageID: 10280
1

Hanmi hereby moves in limine to preclude the testimony of Dr. Paul Bartlett regarding 

the state of the art of with respect to gastric acid related diseases, methods of inhibiting gastric 

acid secretion and gastric acid secretion inhibitors (collectively referred to herein as “gastric acid 

related diseases”) in 1993, and regarding any opinions or views of a person of ordinary skill in 

the art regarding these areas in the 1993 timeframe – sections VII (¶¶ 94-122), VIII (¶¶ 123-144) 

and IX-X (¶¶ 145-174) of his report (Ex. 6). 1

Dr. Bartlett lacks sufficient qualifications to testify about the state of the art of gastric 

acid related diseases in 1993 (or even today), including the knowledge of a person of ordinary 

skill and the research activities of companies back in that timeframe. For these reasons, he 

should be precluded from testifying at trial concerning any matters related to these topics. 

A. Background Facts

For most of his career – from 1973 until his retirement in 2003 – Dr. Bartlett performed 

no projects related to the development of a drug, much less any that focused on gastric acid 

related diseases. See Ex. 21, April 17, 2013 Deposition Transcript of Dr. Paul Bartlett, at pg. 14. 

In the summer of 1971, he worked for Sterling Winthrop, but he did not work on compounds 

related to the treatment of gastric acid related diseases. Id. at pp. 11, 13. None of the cases he 

has worked on in the last four years (listed on his CV) related to the gastric acid related drugs. 

(Id. at 17.) He does not recall having consulted on proton pump inhibitors (id. at 54-55), the 

class of drugs involved in this case. Of the approximately 180 articles on his publication list, 

none relate to drugs used in the treatment of gastric acid related diseases. He has never authored 

 1 Hanmi only seeks to preclude Dr. Bartlett’s testimony concerning the state of the art with 

respect to gastric acid related diseases and a person of ordinary skill’s understanding of the 

same during the relevant timeframe. Hanmi does not seek to preclude the entirety of Dr. 

Bartlett’s testimony. The same sections of Dr. Bartlett’s testimony sought to be excluded 

herein are also the partial subject of Hanmi’s Motion In Limine No. 2 because they are new 

theories not in AstraZeneca’s contentions.

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a publication related to proton pump inhibitors generally, or omeprazole or esomeprazole in 

particular. (Id. at 58.)

Although his expert report opines on many classes of compounds related to treating 

gastric acid related disorders, Dr. Bartlett conceded that the information in this section was 

provided to him by counsel in conjunction with another of AstraZeneca’s experts, Dr. Johnson:

Q. Dr. Bartlett, beginning on page 31 of your report, you have a section called 

“State of the art for treatment of gastric acid-related disorders.” If I could direct 

your attention to that portion of your report.

A. Okay.

Q. I’d like to know where you got the information for explaining of state of the art 

that you describe in this section of the report.

A. Well, this information came from counsel ultimately relying, as I point out 

here, on Dr. Johnson’s report because he’s detailing, I think, these areas that were 

in use or being investigated or followed at the time for treating disease. So I’m 

relying on Dr. Johnson for a lot of -- of this.

(Id. at 56.) Repeatedly, Dr. Bartlett confirmed that the information he relied upon for his report 

pertaining to the state of the art of gastric acid related diseases was provided largely by counsel 

or obtained indirectly from Dr. Johnson. (Id. at pp. 61; 65-66; 75; 77; 79; 80-81.) 

Dr. Bartlett never spoke with anyone (other than counsel) to inform his views about the 

state of the art of the treatment of gastric acid related diseases:

Q. Okay. Did you speak to anyone who informed your views with respect to the 

state of the art of the treatment of gastric acid related diseases other than counsel?

A. I did not.

(Id. at 57.) Importantly, Dr. Bartlett never spoke with Dr. Johnson. (Id. at 62; 76.) For many of 

the compounds Dr. Bartlett depicted as illustrative of the classes of gastric acid related diseases, 

Dr. Bartlett was unaware if many of them had been approved by the FDA, or commercialized. 

(Id. at 59; 60; 62; 73; 78; 80; 82.) Nor was Dr. Bartlett aware of their activity. (Id. at 73; 74; 

82.)

Dr. Bartlett purported to opine on work done at AstraZeneca, but his sole sources of 

information were several documents provided to him by counsel. (Id. at 164-65.) Dr. Bartlett 

Case 3:11-cv-00760-JAP-TJB Document 290-5 Filed 04/29/13 Page 3 of 8 PageID: 10282
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did not independently conduct any search to inform his views as to the research being done at 

AstraZeneca (id. at 149-150), nor did he speak with anyone at AstraZeneca to inform his views. 

Dr. Bartlett also purported to opine on the research efforts at Byk Gulden, but the sole basis of 

his information was provided to him by counsel in the form of a declaration prepared by a Byk 

Gulden employee. Dr. Bartlett did not rely on anything else. Nor did he speak with any one at 

Byk Gulden (id. at pp. 184; 188-89). Thus, the substance of section VIII of his report should be 

excluded.

Dr. Bartlett admitted he is not an expert in the pharmacokinetics and pharmacodynamics 

of proton pump inhibitors (the class of drugs to which esomeprazole belongs) (id. at. 100); nor is 

he an expert with regards to the clinical use of omeprazole or its pharmacology with respect to 

toxicity. (Id. at 101.) Although Dr. Bartlett eagerly concluded in his report that no motivation 

existed in 1993 to separate omeprazole’s enantiomers, he was unable to comment on the 

motivation supplied by certain FDA articles and guidelines, and stated he had no opinion on their 

impact to a person of ordinary skill in the art. (Id. at 122.)

Dr. Bartlett is a chemist, but that does not qualify him to opine on the state of the art of 

gastric acid related drugs in 1993, persons of skill working in that field, or what those persons 

would have known. 

B. Argument

The rules of evidence and case law make clear that in order to be qualified to opine as an 

expert in a field, the witness must actually have experience in the field itself, not simply 

familiarity with the field as a salesperson (or marketing executive). Under Fed. Rule Evid. 702, 

testimony is admissible only if it is both relevant and reliable. Kumho Tire Co. v. Carmichael, 

526 U.S. 137, 147 (1999). Only witnesses who are “qualified as an expert by knowledge, skill, 

experience, training or education, may testify thereto in the form of an opinion or otherwise.” 

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Rule 702. The Rule “establishes a standard of evidentiary reliability”’ and “requires a valid . . . 

connection to the pertinent inquiry as a precondition to admissibility. 526 U.S. at 149 (quoting 

Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 590, 592 (1993)). And “where such 

testimony’s factual basis, data, principles, methods, or their application are called sufficiently 

into question, . . . the trial judge must determine whether the testimony has ‘a reliable basis in the 

knowledge and experience of [the relevant] discipline.’” Kumho at 149 (quoting Daubert, 509 

U.S. at 592).

In Aloe Coal v. Clark Equip. Co, 816 F.2d 110 (Fed. Cir. 1987), the purchaser of a tractor 

shovel brought a negligence action against the manufacturer to recover its losses when the 

product was destroyed by a fire. 816 F.2d at 112. To show causation, the plaintiff relied solely 

on the expert testimony of a sales representative from another company whose position happened 

to acquaint him with the repair and replacement of damaged equipment. The Federal Circuit 

held that the district court had abused its discretion by allowing the witness to testify as an 

expert. Specifically, the Court explained that the proffered expert “was not an engineer” and 

“had no experience in designing construction machinery.” Further, he had “no knowledge or 

experience in determining the cause of equipment fires,” “no training as a mechanic,” and had 

“never operated construction machinery in the course of business.” In short, “[h]e was a 

salesman, who at times prepared damage estimates.” 816 F.2d at 114 -115.

Like the expert rejected by the court in Aloe Coal, Dr. Bartlett has no special knowledge 

or expertise on the state of the art of gastric acid related disease drugs in 1993, persons of skill 

working in that field, or what those persons would have known. He never worked in the field, 

never published in the field, never lectured in the field, never made a related drug, spoke to no 

one other than counsel to inform his views, and relied largely on materials provided to him by 

counsel.

Case 3:11-cv-00760-JAP-TJB Document 290-5 Filed 04/29/13 Page 5 of 8 PageID: 10284
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In short, Dr. Bartlett is a chemist but admittedly lacks knowledge of the state of the art of 

with respect to gastric acid related diseases during the relevant timeframe, and is thus, not 

qualified to offer opinions concerning anything to do with gastric acid related diseases and 

particularly, the state of the art in 1993, and what a person of ordinary skill in the art would have 

known, believed or expected with respect to the same at this time.

Dr. Bartlett’s testimony on this subject matter (sections VII-X of his report) should be 

precluded at trial for at least the reasons stated above.

Dated: April 29, 2013 LITE DEPALMA GREENBERG, LLC

s/Mayra V. Tarantino

Allyn Z. Lite

Mayra V. Tarantino

Two Gateway Center, Suite 1201

Newark, NJ 07102

(973) 623-3000

alite@litedepalma.com

mtarantino@litedepalma.com

SUGHRUE MION, PLLC

Mark Boland

Michael R. Dzwonczyk

Renita S. Rathinam

2100 Pennsylvania Ave., NW

Washington, DC 20037-3213

(202) 293-7060

mboland@sughrue.com

mdzwoncyzk@sughrue.com

rrathinam@sughrue.com

John B. Scherling

4250 Executive Square

Suite 900

La Jolla, CA 92037

(858) 795-1180

jscherling@sughrue.com

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Attorneys for Defendants and CounterclaimPlaintiffs Hanmi USA, Inc., Hanmi Pharmaceutical 

Co., Ltd., Hanmi Fine Chemical Co., Ltd. and 

Hanmi Holdings Co., Ltd.

Case 3:11-cv-00760-JAP-TJB Document 290-5 Filed 04/29/13 Page 7 of 8 PageID: 10286
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CERTIFICATE OF SERVICE

I hereby certify that on April 29, 2013, I caused a copy of the foregoing Hanmi’s Motion 

in Limine No. 5 (To Preclude Testimony Of Dr. Paul Bartlett As To The State Of The Art 

Regarding Gastric Acid Related Diseases) to be served upon the following counsel by 

electronic mail:

John E. Flaherty, Esq.

Jonathan M. H. Short

McCARTER & ENGLISH

Four Gateway Center

100 Mulberry Street

Newark, New Jersey 07102

(973) 622-4444

JFlaherty@mccarter.com

JShort@mccarter.com

Einar Stole

COVINGTON & BURLING LLP

1201 Pennsylvania Avenue, NW

Washington, DC 20004-2401

(202) 662-6000

EStole@cov.com

Henry J. Renk

Bruce C. Haas

Colleen Tracy

Joshua I. Rothman

FITZPATRICK, CELLA, 

HARPER & SCINTO

1290 Avenue of the Americas

New York, NY 10104-3800

(212) 218-2250

HRenk@fchs.com

BHaas@fchs.com

CTracy@fchs.com

JRothman@fchs.com

s/Mayra V. Tarantino

Mayra V. Tarantino

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