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.

UNITED STATES DISTRICT COURT

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. 3:11-CV-00760-JAP-TJB

Judge Joel A. Pisano

Magistrate Judge Tonianne J. Bongiovanni

HANMI’S OPPOSITION TO ASTRAZENECA’S MOTION IN LIMINE TO PRECLUDE 

DEFENDANTS’ EXPERT ATWOOD FROM TESTIFYING ON MATTERS AS TO 

WHICH HE IS ALLEGEDLY NOT QUALIFIED AS AN EXPERT

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TABLE OF CONTENTS

I. Dr. Atwood Is Amply Qualified To Testify With Respect To Chemical Structures and 

Pharmaceutical Compounds and Topics Related Thereto ...................................................3

II. Dr. Atwood Has Ample Expertise In Each Specific Contested Area ..................................4

(1) Dr. Atwood has the requisite experience and understanding to provide helpful 

testimony on issues related to pharmacology ..........................................................5

(2) Dr. Atwood has the requisite experience and understanding to provide helpful 

testimony on issues related to clinical medicine......................................................7

(3) Dr. Atwood has the requisite experience and understanding to provide helpful 

testimony on issues related to Hanmi’s Product, The Prior Art, and Publications 

by the FDA...............................................................................................................8

(4) Dr. Atwood does not purport to provide a legal opinion on patent law, but may 

provide technical testimony within the framework of the patent laws..................10

(5) Dr. Atwood has the requisite experience and understanding to provide helpful 

comments on issues in this case – which do not include the “selection of a

therapeutic area and starting point for a drug discovery program” .......................11

III. Conclusion .........................................................................................................................14

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TABLE OF AUTHORITIES

Cases

Buzzerd v. Flagship Carwash of Port St. Lucie, Inc., 

669 F. Supp. 2d 514 (M.D. Pa. 2009)................................................................................. 2

First Marblehead Corp. v. House, 541 F.3d 36 (1st Cir. 2008) ..................................................... 1

Holbrook v. Lykes Bros. S.S. Co., Inc., 80 F.3d 777 (3rd Cir. 1996).............................................. 1

KSR Intl. Co., v. Teleflex, Inc., 550 U.S. 398 (2007)..................................................................... 9

Microfinancial, Inc. v. Premier Holiday’s Int’l, Inc., 385 F.3d 72 (1st Cir. 2004)........................ 3

Pineda v. Ford Motor Co., 520 F.3d 237 (3rd Cir. 2008) .............................................................. 2

Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333 (11th Cir. 2003)....................... 2

Smith v. Ford Motor Co., 215 F.3d 713 (7th Cir. 2000)................................................................. 2

U.S. v. Mulder, 273 F.3d 91 (2d Cir. 2001).................................................................................... 9

United States v. Vargas, 471 F.3d 255 (1st Cir.2006).................................................................... 1

Walker v. Soo Line R.R. Co., 208 F.3d 581 (7th Cir. 2000) ........................................................... 9

Watson v. United States, 485 F.3d 1100 (10th Cir. 2007) .............................................................. 2

Other Authorities

Weinstein's Federal Evidence § 702.04[1][a]................................................................................. 1

Rules

Fed. R. Evid. 702 ............................................................................................................................ 1

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AstraZeneca moves for blanket preclusion of certain testimony of expert Dr. Atwood that 

would be helpful to the Court, arguing that Dr. Atwood is not qualified to opine in the areas of 

(1) pharmacology, (2) clinical medicine, (3) FDA regulatory issues, (4) patent law, and (5) the 

selection of a therapeutic area and starting point for a drug discovery program (hereinafter 

referred to as the “contested areas”) (see D.I. 289-1, AstraZeneca’s Motion in Limine at pp. 4-5). 

AstraZeneca’s overly narrow and conclusory views are without merit.1 Dr. Atwood is 

fully qualified and has highly specialized expertise that is pertinent and integral to fundamental 

issues in this case, including inquiries in each of the contested areas as they relate to the 

determinations necessary to this proceeding. Dr. Atwood’s experience is highly relevant in 

analyzing the core issues of this case, and the Court will find his opinions to be helpful in 

deciding those issues. Fed. R. Evid. 702. 

A witness may qualify as an expert based on his or her knowledge, skill, training, 

experience or education in the field in question. Fed. R. Evid. 702; First Marblehead Corp. v. 

House, 541 F.3d 36, 41 (1st Cir. 2008) (“It is not required that experts be ‘blue-ribbon 

practitioners’ with optimal qualifications.”) (quoting United States v. Vargas, 471 F.3d 255, 262 

(1st Cir.2006)). Indeed even where a witness has educational and experiential qualifications in a 

general field related to the subject matter of the issue in question, it is an abuse of discretion for 

a trial court to exclude expert testimony solely on the ground that the witness is not qualified to 

render an opinion because the witness lacks expertise in specialized areas that are directly 

pertinent to the issues in question. Weinstein's Federal Evidence § 702.04[1][a]. 

 1 AstraZeneca’s arguments, though entirely misplaced, at best go to the weight of Dr. Atwood’s 

testimony, not its admissibility. See Holbrook v. Lykes Bros. S.S. Co., Inc., 80 F.3d 777, 782 (3rd Cir. 

1996).

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A court should consider a proposed expert’s full range of practical experience as well as 

academic or technical training when determining whether that expert is qualified to render an 

opinion in a given area. Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir. 2000). Expert 

status may be based on extensive experience, knowledge, skill, or on-the-job training, even in the 

absence of formal education. Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333, 

1343 (11th Cir. 2003). A witness’ self-estimation is a factor in assessing qualification, but is not 

dispositive. Watson v. United States, 485 F.3d 1100, 1105-06 (10th Cir. 2007) (An “automatic 

rule that no witness who denies having the requisite expertise may testify . . . would risk turning 

a substantive and serious examination . . . into a game of gotcha, allowing lawyers to set crossexamination traps for unwary individuals . . . . [I]t would hardly benefit the legal system to 

exclude from the stand self-deprecating individuals who rarely testify but have the expertise to 

do so in favor of those who are more extravagant and savvy to the legal system or who may 

make their living testifying in our courts.”); see also Pineda v. Ford Motor Co., 520 F.3d 237, 

244-45, 248-49 (3rd Cir. 2008) (despite expert’s testimony that he was not qualified as a 

warnings expert and did not purport to be one, his qualifications as an expert on glass were 

“unassailable” and allowed him to testify regarding effects of force on glass and adequacy of 

instructions and warnings in service manual; thus, the district court was found to have 

improperly concluded that the expert was not qualified to testify). 

Whether a particular person has sufficient expertise to testify as an expert witness 

depends on the facts of the particular case, the questions propounded to the witness and the 

witness’ specific qualifications. Buzzerd v. Flagship Carwash of Port St. Lucie, Inc., 669 F. 

Supp. 2d 514, 522 (M.D. Pa. 2009), aff’d, 397 F. Appx. 797 (3d Cir. 2010) (“[t]he issue with 

regard to expert testimony is not the qualifications of a witness in the abstract, but whether those 

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qualifications provide a foundation for a witness to answer a specific question.”) (internal 

quotation omitted); Microfinancial, Inc. v. Premier Holiday’s Int’l, Inc., 385 F.3d 72, 80-81 (1st 

Cir. 2004) (Fed. R. Evid. 702 inquiry is “flexible,” and “not so wooden as to demand an intimate 

level of familiarity with every component of a transaction or device as a prerequisite to offering 

expert testimony”). 

I. Dr. Atwood Is Amply Qualified To Testify With Respect To Chemical Structures 

and Pharmaceutical Compounds and Topics Related Thereto

Since 2007, Dr. Atwood has testified either at trial or by deposition in about fifty 

different cases. See D.I. 290-9, Expert Report of Jerry L. Atwood, Ph.D., dated February 19, 

2013, Exhibit 1 (Atwood curriculum vitae). In this regard, Dr. Atwood has provided his 

testimony in cases related to pharmaceuticals for both branded and generic pharmaceuticals. In 

addition, Dr. Atwood has consulted widely for industry, particularly in the fields of 

pharmaceutical chemistry and polymer chemistry. See D.I. 290-9, Expert Report of Jerry L. 

Atwood, Ph.D., dated February 19, 2013 at ¶ 11. 

Dr. Atwood is an expert in the fields of supramolecular chemistry, solid-state chemistry, 

crystal growth, crystal engineering, X-ray crystallography, organic chemistry, inorganic 

chemistry, and polymer chemistry.2

 Id. He also has significant experience in medicinal 

chemistry, principles of SAR, and structural modification. In this regard, Dr. Atwood is not only 

listed as an author on almost 700 publications in these fields, but he has served (and still serves) 

as an editor of numerous publications in these fields. Id. at ¶¶10-11. These areas are highly 

pertinent to resolving the fundamental issues of this case, and Dr. Atwood’s expertise cannot 

legitimately be questioned. Further, Dr. Atwood’s research involves characterization and 

 2 When reciting Dr. Atwood’s fields of expertise, AstraZeneca omits reference to organic chemistry (see 

D.I. 289-1 at p. 6), clearly one of the most fundamental fields pertinent to the issues in this case.

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manipulation of the intermolecular interactions of chemical compounds that are responsible for 

the complex molecular interplay mechanisms known to be prevalent in biological systems (see

Ex. 2, Reply Report of Jerry L. Atwood, Ph.D., dated April 8, 2013 (at ¶ 5)) and purification 

techniques and analyses (id. at ¶ 6). 

 Dr. Atwood is more than fully qualified to testify regarding the subject matter of, among 

other things, pharmaceutical compositions, such as those described and claimed in the ‘504 and 

‘192 Patents, the prior art relevant to the ‘504 and ‘192 Patents, and to provide any other 

opinions related to characterization and manipulation of chemical structures and pharmaceutical 

compounds. Id. at ¶ 6. Dr. Atwood’s opinions on these points will surely be helpful to the 

Court. Further, Dr. Atwood's vast experience establishes that he does have relevant expertise in 

each of these areas, which is the standard in this Court for determining admissibility of his 

opinions related to these areas. Indeed, under AstraZeneca’s standards, this Court would not be 

able to hear the testimony of any expert to the extent an aspect of a given claim happened to 

require knowledge of more than one applicable practice area. Such a position is unworkable and 

incorrect.

II. Dr. Atwood Has Ample Expertise In Each Specific Contested Area

 AstraZeneca’s reliance on select deposition excerpts to suggest that Dr. Atwood is not 

an expert in each contested area is misplaced and misleading. As discussed above, Dr. Atwood 

is more than qualified to testify as an expert regarding pharmaceutical compositions and to 

provide opinions related to chemical structures and pharmaceutical compounds. That alone 

should be sufficient to deny AstraZeneca’s motion. Dr. Atwood’s extensive full range of 

experience, education and training command recognition of expert status in the areas that are 

directly pertinent to the issues in question. 

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That Dr. Atwood has not claimed to be an expert in the areas as defined by AstraZeneca 

is not relevant. There is plainly no deficiency in terms of his ability to testify as to the subject 

matter specifically at issue in each such area. AstraZeneca’s own experts likewise recognize that 

one need not be a particular expert as defined by AstraZeneca with respect to the relevant aspects 

of the claims at issue. See, e.g., D.I. 294-6, Rebuttal Report of David A. Johnson on Validity 

dated March 25, 2013, ¶¶ 54-56 (agreeing with Dr. Atwood’s understanding of the 

pharmacokinetic and pharmacodynamic terms recited in the claims of the ‘192 Patent); Ex. 6, 

Deposition of Jerry L. Atwood, dated April 26, 2013 at 56:5-12; see also Ex. 2, Reply Report of 

Jerry L. Atwood, Ph.D., dated April 8, 2013 at ¶ 8 (an analysis of the pharmacodynamics and 

pharmacokinetics of the compounds in the prior art are not necessary, since they are the same 

compounds disclosed and claimed in the ‘504 and ‘192 Patents). Nonetheless, Hanmi briefly 

will address AstraZeneca’s contested areas.

(1) Dr. Atwood has the requisite experience and understanding to provide 

helpful testimony on issues related to pharmacology

Dr. Atwood does not hold himself out to be an expert practicing pharmacology on a day 

to day basis. The fundamental issues in this case, however, do not require such expertise. 

Dr. Atwood has not offered any position on the mechanism of action of (-)-omeprazole in 

treating diseases because the asserted claims are not directed to pharmacological mechanisms of 

action and do not require specialized expertise in pharmacology. The asserted claims of the ‘504 

and ‘192 Patents are directed to “pharmaceutical formulations” or methods of treating/production 

that comprise the pharmaceutical formulation, which “causes” or “elicits” certain biological 

effects. Even the “biological effect” claims of the ‘192 Patent (claims 1-6, 13-18) do not 

require any activities to be carried out by a pharmacologist, and do not require the expertise of a 

pharmacologist to understand such claims. AstraZeneca’s own witnesses, Dr. René Levy, 

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testified that those effects occur inherently after the claimed drug is ingested, and Dr. Atwood 

relied on statements that the biological effects are inherent in rendering his opinions. See, e.g., 

Ex. 13, Rebuttal Report of René H. Levy, dated March 25, 2013 at ¶¶ 49-51, 98; see also D.I. 

290-9, Expert Report of Jerry L. Atwood, dated February 19, 2013 at ¶¶137-139.

No specialized pharmacology expertise is required to read the “biological effects” 

language of certain claims and determine that language is nowhere present in any application 

prior to the 08/833,962 application leading to the ‘192 Patent. In fact, AstraZeneca’s witness, 

Dr. Levy, came to the same conclusion and confirmed the views of Dr. Atwood. See Ex.4, 

Deposition of René H. Levy, dated April 18, 2013 at 78:20-25; 111:3-112:17. Similarly, Dr. 

Atwood’s determination that there is no data in the ‘192 Patent that supports any use of the 

claimed neutral forms of (-)-omeprazole to treat diseases and achieve certain biological results 

does not take any particular expertise in pharmacology. Nor do any of Dr. Atwood’s opinions 

relate to the pharmacology underlying the claimed pharmacologic effects. The irrelevance of the 

pharmacology underlying the claimed biological effects to the present case is confirmed by the 

fact that AstraZeneca’s Dr. Levy never conducted any pharmacological testing of Hanmi’s 

product to form his views. See Ex.4., Deposition of René H. Levy, dated April 18, 2013 at 27:4-

28:2. Rather, he simply compared statements in Hanmi’s NDA to the claims of the patent. See, 

e.g., D.I. 294-4, Opening Report of René H. Levy, dated February 19, 2013 at ¶¶ 83-91.

With his extensive expertise in chemistry, Dr. Atwood understands concepts of 

pharmacology, uses pharmacological data in his own research, analyzes data, etc., and is entirely 

capable of providing helpful testimony to the court relating to the subject matter of the claims, 

which do not recite any steps to be carried out by a pharmacologist. See Ex. 6, Deposition of 

Dr. Atwood, dated April 26, 2013 at 11:13-20; 14:4-10; 18:13-20; 51:11-18. 

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(2) Dr. Atwood has the requisite experience and understanding to provide 

helpful testimony on issues related to clinical medicine

As Dr. Atwood’s testimony makes clear, one may understand and use information related 

to clinical studies without having the expertise to actually carry out clinical studies. See Ex. 6, 

Deposition of Dr. Atwood dated April 26, 2013, at 53:13-22. His experience in issues related to 

clinical medicine allow him to provide the Court with informed and helpful testimony on 

fundamental issues that may touch upon matters referred to in the claims. 

AstraZeneca states that Dr. Atwood testified on matters relating to clinical medicine, 

based on statements relating to “evaluating the significance of in vivo toxicity data on 

infringement under the doctrine of equivalents.” (D.I. 289-1, p. 4). On its face, that subject 

matter has nothing to do with clinical medicine, and the testimony relied upon by AstraZeneca 

demonstrates that it does not. In the supporting testimony AstraZeneca cites, Dr. Atwood 

reported on a toxicity study contained in Hanmi’s NDA comparing Nexium and Hanmi’s 

proposed product in male and female rats. See Expert Report of Jerry L. Atwood, dated March 

25, 2013 at ¶¶ 117-119. The NDA report shows Hanmi’s proposed product to be less toxic than 

Nexium in certain situations. Id. at ¶118. An understanding of the results of the rat toxicology 

studies contained in Hanmi’s NDA does not require expertise in clinical medicine as suggested 

by AstraZeneca. To begin with, clinical medicine pertains to the treatment of patients, not 

testing carried out on laboratory rats. In any event, Dr. Atwood is accustomed to reviewing in 

vivo biological studies.

Nor does Dr. Atwood’s rebuttal to Dr. Johnson’s and Dr. Bartlett’s opinions about “long 

felt need” require expertise in clinical medicine. The passages referred to by AstraZeneca in its 

motion point out Dr. Atwood’s views about the plain contradiction in the testimony of two 

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AstraZeneca witnesses. Nowhere does Dr. Atwood opine on aspects of the treatment of patients 

or of clinical medicine, and indeed no such expertise is required.

In testifying whether proton pump inhibitors were disclosed in any applications prior to 

the ‘192 Patent, no expertise in clinical medicine is required for Dr. Atwood to simply study the 

prior art applications and determine that proton pump inhibitors were not described anywhere. 

As AstraZeneca has conceded, the patents in suit are directed to persons of ordinary skill in the 

art who, according to AstraZeneca’s proposed definition, are not experts in clinical medicine. 

See, e.g., D.I. 294-1, Report of Stephen G. Davies, Phil on Infringement, dated February 19, 

2013, ¶ 29.

Finally, Dr. Atwood’s views regarding the biological limitations of aspects of certain 

claims of the ‘192 Patent are not based on the point of view of a clinician. As stated in his 

report, his views are based on a reading of the ‘192 Patent claims, and how a person of skill in 

the art would understand those claims. See Atwood Report dated February 19, 2013 at ¶¶ 12-13, 

22. A person of ordinary skill in the art is not an expert in clinical medicine, (Id. at 22), and it 

appears that neither Dr. Johnson, Dr. Davies, nor any other AstraZeneca witness has cited to the 

need for any specialized clinical expertise in understanding the subject matter of the “biological 

limitations” of the claims of the ‘192 Patent.

(3) Dr. Atwood has the requisite experience and understanding to provide 

helpful testimony on issues related to Hanmi’s Product, The Prior Art, and 

Publications by the FDA

Dr. Atwood does not hold himself out to be an expert in FDA regulatory issues nor does 

he provide opinions on a matter in this case that falls solely within this field. The fundamental 

issues in this case do not require such analysis. 

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For example, AstraZeneca cites to paragraph 116 of Dr. Atwood’s second report, where 

Dr. Atwood relies upon information provided to him about section 505(b)(2) FDA applications 

in forming his opinions about the differences between pharmaceutical salts from a chemical 

perspective. See e.g., D.I. 289-1, pp 4-5; D.I. 289-5, p. 46. Atwood’s reliance is entirely proper, 

since experts are permitted to rely on information provided to them in areas in which they are not 

experts. An expert appropriately may rely upon reports of others to formulate his opinion, and 

such reliance is often an indicia of reliability. See Walker v. Soo Line R.R. Co., 208 F.3d 581, 

588 (7th Cir. 2000) (“Indeed, courts frequently have pointed to an expert’s reliance on the 

reports of others as an indication that their testimony is reliable”); see also U.S. v. Mulder, 273 

F.3d 91, 102 (2d Cir. 2001) (“expert witnesses can testify to opinions based on hearsay or other 

inadmissible evidence if experts in the field reasonably rely on such evidence in forming their 

opinions”) (internal citation omitted). In addition, Dr. Atwood would certainly be permitted to 

rely on concepts of bioequivalence as provided to him by others in forming his opinion as an 

expert.

Finally, Dr. Atwood does not need to be an expert in FDA matters to comment on the 

meaning of the certain FDA policies to a person of ordinary skill in the art. As the Supreme 

Court has said in KSR, 

Common sense teaches, however, that familiar items may have 

obvious uses beyond their primary purposes, and in many cases a 

person of ordinary skill will be able to fit the teachings of multiple 

patents together like pieces of a puzzle. 

KSR Intl. Co., v. Teleflex, Inc., 550 U.S. 398, 420 (2007). 

Indeed, a POSA would consider published statements by the FDA and commentary 

thereupon regarding enantiomers in the same way as other prior art regarding enantiomers. 

AstraZeneca concedes that the disclosures of both the ‘192 and ‘504 Patents are directed to a 

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person of ordinary skill in the art, and nowhere in any of AstraZeneca’s proposed definitions of a 

POSA is FDA expertise required. See, e.g., D.I. 294-1, Report of Stephen G. Davies, Phil on 

Infringement, dated February 19, 2013, ¶29. It is indeed ironic that AstraZeneca seeks 

preclusion of Dr. Atwood’s testimony as an expert in FDA matters, when neither Dr. Atwood nor 

a person of ordinary skill in the art have been held out as having specialized knowledge in FDA 

matters.

(4) Dr. Atwood does not purport to provide a legal opinion on patent law, but 

may provide technical testimony within the framework of the patent laws

In his reports, Dr. Atwood has not held himself out to be an expert on patent law. Nor 

will Dr. Atwood provide legal opinions on patent law; rather, he will be applying his technical 

expertise in the framework of the pertinent patent issues. As a named inventor on at least 13 

patents, Dr. Atwood has an understanding of patents relevant to analyzing the fundamental issues 

of this case and has explained that his opinions are based on that working knowledge and his 

views as a chemist. See Ex. 6, Deposition of Dr. Atwood, dated April 26, 2013 at 181:21-182:2. 

Again, such testimony will help inform the Court on the pertinent issues in the case.

For example, Dr. Atwood’s views on the significance of Hanmi’s independent research of 

its esomeprazole strontium product do not require particular expertise in patent law. See Second 

Expert Report of Jerry L. Atwood, dated March 25, 2013 at ¶¶ 113-120. Rather, his opinions are 

based on his views as a chemist and his experience with the research and development process.

Second, nowhere has Dr. Atwood purported to interpret the Supreme Court’s WarnerJenkinson decision as a patent law expert. His comments relate his understanding of the case as 

a person of ordinary skill in the art would understand it, rather than from the perspective of a 

patent law expert. None of the other comments or testimony cited by AstraZeneca relates to Dr. 

Atwood holding himself out as a patent law expert; instead, he simply explains that while certain 

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legal standards have been provided to him, his application of the standards was based on his 

understanding that of a person of ordinary skill in the art would have had. Id. at ¶¶ 41-42.

It is undisputed that not a single one of AstraZeneca’s experts are lawyers, patent 

lawyers, or have expertise in patent law. But none of them hesitated on opining on such legal 

issues as enablement, written description, possession, infringement, the doctrine of equivalents, 

double patenting, and even issues such as priority dates and incorporation by reference. If 

Dr. Atwood’s testimony regarding his application of the doctrine of equivalents, and his views 

on the independent development of Hanmi’s product are precluded, then all of AstraZeneca’s 

witnesses testimony pertaining to legal or patent law matters should be precluded for identical 

reasons.

(5) Dr. Atwood has the requisite experience and understanding to provide 

helpful comments on issues in this case – which do not include the “selection 

of a therapeutic area and starting point for a drug discovery program”

The issues to which Dr. Atwood will testify in this case, however, do not relate to the 

area of “expertise” identified by AstraZeneca. In conjunction with his vast chemical experience, 

Dr. Atwood has expertise working with pharmaceutical compounds including, for example, 

lansoprazole, a well-known proton pump inhibitor compound. See Ex. 6, Deposition of Dr. 

Atwood, April 26, 2013, at 33:25-34:9; 42:24-43:22. He has a general knowledge of the field of 

compounds useful for inhibiting gastric acid production, including proton pump inhibitors. This 

general knowledge is highly pertinent to, and clearly helpful for understanding, what one of 

ordinary skill in the art would have appreciated from (and how they would have been guided by) 

the teachings of prior art references discussing other proton pump inhibitor compounds, such as 

Erlandsson and Kohl, and further supply ample basis for Dr. Atwood to provide expert testimony 

on issues related to his testimony in this case. Dr. Atwood has extensive specific knowledge, 

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experience, and understanding to provide helpful comments on issues related to the claims of the 

asserted patents, which is the standard in this Court for determining whether it is fair and helpful 

for the trier of fact to consider his opinions.

Importantly, there is no such field of expertise defined as “the selection of a therapeutic 

area and starting point for a drug discovery program.” (D.I. 289-1, p. 5). AstraZeneca has 

identified no degree programs in that area, has identified no journals or learned treatises directed 

to that topic, and none of its experts claim expertise in that field. None of its experts define a 

person of ordinary skill in the art as requiring knowledge of “the selection of a therapeutic area” 

or “starting points for a drug discovery program,” and so no expertise in those areas is required. 

Its seeming articulation of a field of pseudo-expertise has apparently been crafted to support its 

new argument that persons of skill in the art in 1993 would have no idea where to start in finding 

an improved agent for the treatment of gastric acid related diseases. AstraZeneca is wrong for a 

number of reasons.

First, the background section of the ‘504 Patent makes clear the patentee’s 

acknowledgment that omeprazole and lansoprazole were known in the prior art as effective 

agents for the treatments of gastric acid diseases, and that the enantiomers of omeprazole had 

been isolated in neutral form, but not as solids. See ‘504 Patent, col. 1, ll. 13-42. Omeprazole 

and lansoprazole are proton pump inhibitors. With that clear acknowledgment, a person of skill 

in the art would not have to choose between the many classes of gastric acid drugs that existed in 

1993, and so AstraZeneca’s false field of expertise is irrelevant in this case.

Second, nowhere in AstraZeneca’s March 19, 2012, amended infringement contentions 

and amended invalidity contentions did AstraZeneca posit that persons skilled in the art would 

have to begin by first selecting a therapeutic area and thereafter a starting point for a drug 

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discovery program. Rather, AstraZeneca was quite clear that persons skilled in the art would 

have already been working in the area of PPIs and would have selected PPIs other than (-)-

omeprazole as a starting point:

(See D.I. 297, AstraZeneca's Amended Responses to Hanmi's Invalidity Contentions, dated 

March 19, 2012 at pp. 21-22). AstraZeneca’s arguments that “expertise” would be required to 

first select a therapeutic area and then a starting point is squarely undermined by their earlier 

contentions that a POSA working in the area of PPIs in 1993 would have started with other

known PPIs rather than (-)-omeprazole. AstraZeneca has made clear that the selection to work 

in the PPI therapeutic area has already been made, and other known PPIs would provide a 

suitable starting point. 

AstraZeneca cannot now run from its earlier contentions by claiming that an illusory 

choice requires imaginary expertise.

 Finally, none of the claims of the asserted patents in suit relate to a starting point for a 

drug discovery program. The asserted claims relate to organic compounds and pharmaceutical 

formulations, and so expertise in organic chemistry and pharmaceutical formulation is more 

relevant. As further proof of the irrelevance of AstraZeneca’s false field of expertise, one or 

more of AstraZeneca’s experts have testified that the claimed compounds and formulations did 

Case 3:11-cv-00760-JAP-TJB Document 302 Filed 05/06/13 Page 16 of 19 PageID: 11836
14

not result from AstraZeneca’s drug discovery program. See e.g., Ex. 14, Deposition of Paul A. 

Bartlett, dated April 17, 2013 at 166:24-169:6. Apparently there was no interest at AstraZeneca 

in the project resulting in the claimed compounds, and so one of the inventors, Mr. von Unge, 

did the work on his own time. See id. and D.I. 294-5, Rebuttal Report of Paul A Bartlett on 

Validity, dated March 25, 2013, ¶¶136- 141. As such, neither “the selection of a therapeutic 

area” nor “the starting point for a drug discovery program” are relevant inquiries or fields of 

expertise in this case.

III. Conclusion

For the foregoing reasons, Hanmi respectfully requests that AstraZeneca's motion be 

denied. 

Dated: May 6, 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

Case 3:11-cv-00760-JAP-TJB Document 302 Filed 05/06/13 Page 17 of 19 PageID: 11837
15

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

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 302 Filed 05/06/13 Page 18 of 19 PageID: 11838
CERTIFICATE OF SERVICE

I hereby certify that on May 6, 2013, I caused a copy of the foregoing Hanmi's 

Opposition to AstraZeneca’s Motion In Limine To Preclude Defendants’ Expert Atwood 

From Testifying On Matters As To Which He Is Allegedly Not Qualified As An Expert 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

Case 3:11-cv-00760-JAP-TJB Document 302 Filed 05/06/13 Page 19 of 19 PageID: 11839