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 

RELIANCE ON EVIDENCE OF EXPERIMENTS PERFORMED BY MR. BRACKEEN 

FOR WHICH SAMPLES AND DOCUMENTATION HAVE NOT BEEN PRODUCED

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AstraZeneca seeks to preclude Hanmi from offering at trial evidence of experiments 

performed by Mr. Marcus Brackeen replicating several examples described in the prior art Kohl 

reference (DE 455). AstraZeneca also seeks preclusion of other Hanmi experts from relying on 

Mr. Brackeen’s work. AstraZeneca bases its motion in limine on the alleged refusal by Hanmi 

and Mr. Brackeen to produce “critical underlying documentation” and “samples” concerning the 

work in question. 

But neither Hanmi nor Mr. Brackeen has refused to produce documentation or samples 

underlying the experiments subject to Mr. Brackeen’s February 19 report; rather, as discussed in 

Section A below, Hanmi and Mr. Brackeen have produced all materials in their custody and 

control relied upon by Mr. Brackeen in preparing his February 19, 2013 report. 

Moreover, the testimony and evidence in question constitutes reliable expert testimony as 

to Mr. Brackeen’s own work, is entirely permissible, and will be helpful to the Court. Fed. R. 

Evid. 702. As discussed below, there is no basis to preclude Mr. Brackeen, Dr. Atwood or any 

other Hanmi expert from relying on Mr. Brackeen’s experimental work.

Nor would AstraZeneca be prejudiced by introduction of the testimony and evidence. 

AstraZeneca has known of Mr. Brackeen’s work for years and has offered multiple declarations 

in prior proceedings challenging Mr. Brackeen’s testimony based on the very same data Hanmi 

relies on in this case. AstraZeneca has never stated in any other forum that it was unable to 

respond to the same data. Hanmi has relied on nothing new, and Dr. Davies has again already 

submitted two responsive reports in the present action. None of AstraZeneca’s arguments 

provide a basis to preclude reliance on Mr. Brackeen’s work. That AstraZeneca questions the 

veracity of Mr. Brackeen’s testimony is not grounds for blanket exclusion to Hanmi’s detriment; 

at most AstraZeneca’s arguments go to the weight of the evidence, not its admissibility. 

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Finally, AstraZeneca’s preclusion arguments are disingenuous, given that its papers and 

expert reports rely heavily upon the work of others as reported in similar declarations, as well as 

documentation and samples – none of which have been provided to Hanmi in this action despite 

Hanmi’s discovery requests. 

If the Court is inclined to preclude Hanmi’s reliance on Mr. Brackeen’s work based on 

absence of original samples and documentation concerning other projects, the same standard 

should be applied to AstraZeneca. Basic fairness demands that AstraZenenca not be permitted to 

rely on Declarations and testimony of Drs. Kohl and Dr. Larsson, who also replicated certain 

examples of the Kohl prior art reference. None of the underlying work or samples was provided 

to Hanmi. Nor should AstraZeneca’s Dr. Davies be permitted to testify about the work of 

anyone who purportedly failed in attempting to replicate the examples of the Kohl reference.

A. Hanmi And Mr. Brackeen Have Produced All Materials Relied Upon By 

Mr. Brackeen In Their Custody And Control

Several years ago, Mr. Brackeen replicated Examples 4 and 5 of the DE’ 455 prior art 

reference, successfully obtained products, and prepared a Declaration reporting his results. The 

Declaration and supporting data were submitted in European Opposition proceedings involving a 

counterpart patent to the ‘504 and ‘192 patents in suit here.1

 AstraZeneca responded to 

Mr. Brackeen’s European Declaration by submitting a number of its own Declarations 

attempting to show Kohl’s examples could not be successfully replicated. Those Declarations 

were authored by, e.g., Dr. Kohl and Dr. Larsson, and Dr. Davies offered his own meta-

 1 The disclosure of DE ‘455, as well as the reproducibility of the methods disclosed therein – shown by 

Mr. Brackeen, and independently by others (Drs. Hornchen and Kirschning see Ex. 7-9), to produce 

the enantiomers of omeprazole having an optical purity greater than required by the patent claims (at 

least 94% enantiomeric excess (or “ee”) and at least 98% ee) – were the subject of European 

Opposition Nos. 1020460 and 1020461. See e.g., Reply Report of Jerry L. Atwood, dated April 8, 

2013, ¶¶12-28, 55-59.

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opinions commenting on the work of other declarants. All Declarations and exhibits became part 

of the European Opposition proceeding file, and all were – and are – a matter of public record.

In this case, Hanmi relies on all of Mr. Brackeen’s work as contained in the public 

European Opposition file. Nothing else. AstraZeneca has had it for years and has challenged 

Mr. Brackeen’s work in its own public filings. Mr. Brackeen has not conducted new tests and 

generated new samples; rather, Mr. Brackeen describes his earlier work and data in his February 

19, 2013 report (Ex. A to AstraZeneca March 18, 2013 letter to Court, Brackeen Report at ¶¶ 11-

13), which is the subject of AstraZeneca’s present motion in limine. 

AstraZeneca’s assertion that there has been a refusal to provide complete discovery 

concerning this work by Mr. Brackeen is false. (See Hanmi’s April 9, 2013 letter to Judge 

Bongiovanni, p. 2.)2 As Hanmi has repeatedly advised AstraZeneca, Hanmi has produced all 

responsive documentation in Hanmi’s custody and control relied upon by Mr. Brackeen in his 

February 19, 2013 report. Such materials were produced prior to, and otherwise in connection 

with Mr. Brackeen’s February 19 report. (Hanmi’s April 9, 2013 letter to Judge Bongiovanni, p. 

2.) Included in these materials is all underlying documentation, including Mr. Brackeen’s 

laboratory notebooks, analytical data and pertinent certificates of analysis. (See Ex. 5 to Hanmi 

April 9, 2013 letter to Court; Ex. A to AstraZeneca March 18, 2013 letter to Court, Brackeen 

 2 On March 18, 2013 AstraZeneca filed a letter motion to compel discovery of documentation and 

samples underlying the work that Mr. Brackeen did for Teva. Hanmi submitted its letter brief in 

opposition on April 9, 2013. On May 1, 2013 Magistrate Judge Bongiovanni issued a letter order that, 

among other things, granted AstraZeneca's motion and ordered that Hanmi “either produce the 

underlying documents or [it] will be precluded from relying on Mr. Brackeen's report.” (May 1, 2013 

Letter Order at 6.) Following that order, on May 5, 2013, Hanmi again informed AstraZeneca that 

Hanmi and Mr. Brackeen have produced all materials in their custody and control underlying the work 

subject of Mr. Brackeen’s February 19 report that he is permitted to release pursuant to his 

commitment to Teva. Accordingly, Hanmi and Mr. Brackeen have fully complied with their 

discovery obligations. Hanmi further respectfully submits that, for the reasons set forth herein, 

preclusion of Mr. Brackeen’s testimony is unwarranted under the circumstances herein and, insofar as 

such a motion is necessary, moves for relief from Magistrate Judge Bongiovanni’s order to the 

contrary. 

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Report, see, e.g., paragraphs 1, 11-13, 23, 24 and 38, Exhibit 2.) AstraZeneca and its experts are 

more than adequately positioned to respond to the same, and they have done so. AstraZeneca 

can cross examine Mr. Brackeen at trial, as well as any witness relying on his work, if they 

choose to do so. Notably, AstraZeneca, as a party to the prior proceedings, is also aware that the 

actual samples that Mr. Brackeen prepared are the proprietary material of a non-party, Teva 

Pharmaceuticals, who has not consented to their production here. AstraZeneca was free to take 

third party discovery of Teva, but elected not to do so. (See Hanmi’s April 9, 2013 letter to 

Judge Bongiovanni, p. 2.) 

Moreover, the “critical documentation” AstraZeneca complains of has nothing to do with 

Mr. Brackeen’s experimental work, but instead constitutes NMR spectra obtained by 

Mr. Brackeen in connection with unrelated projects. (AstraZeneca March 18, 2013 letter to 

Court, p. 2, footnote 1; Ex. 5 to Hanmi April 9, 2013 letter to Court.) AstraZeneca’s pursuit of 

these materials is irrelevant to the issues in this case, and is designed solely to create a basis to 

preclude Mr. Brackeen’s testimony about successfully replicating examples of the DE ‘455 

reference. AstraZeneca’s intrusive discovery tactics imposed discovery obligations on Hanmi 

and Mr. Brackeen falling well outside the scope of discovery permitted by the Federal Rules, and 

cannot support its present motion to preclude.

B. Reliance By Mr. Brackeen And Other Experts On Mr. Brackeen’s Earlier 

Experimental Work Is Permissible And Will Be Helpful To The Court

Mr. Brackeen’s testimony concerning the methodology used and the reproducibility of 

the DE ‘455 reference was admitted and affirmatively considered in the earlier European 

Opposition proceedings. (Decision of the European Patent Office (“EPO”) revoking the

European Patent 1020461, July 29, 2011; Brackeen Report at paragraphs 43-45.) 

Notwithstanding AstraZeneca’s challenges, Mr. Brackeen’s work was credited as a faithful 

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reproduction of the DE ‘455 references in Europe, and will be helpful to the Court here for the 

same reasons. 

AstraZeneca has not pointed and cannot point to any analytical gap in the assessment of 

the fit between Mr. Brackeeen’s specific opinions (similarly independently reached by Drs. 

Kirshning and Hornchen (see Ex. 7, Final Report of Dr. Ulrich Hörnchen, April 2010, submitted 

in the European Opposition proceeding; Ex. 8-9 Test Reports into the Preparation of (R)-

Omeprazole and (S)-Omeprazole according to DE 40 35 455 A1, written by Dr. Andreas 

Kirschning, March 2010 and August 2010, submitted in the European Opposition proceeding; 

see also Ex. 2, Atwood Reply Report at pp. 5-10)), and the data, principles, and methods from 

which those opinions were derived. See Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir. 

2000). When fit can be shown, the court should admit the expert’s opinion, leaving for the trier 

of fact the question of whether to credit the testimony. Id. (“soundness of the factual 

underpinnings of the expert’s analysis and the correctness of the expert’s conclusions based on 

that analysis are factual matters to be determined by the trier of fact”). 

It is improper for AstraZeneca to ask this Court to make premature ultimate conclusions 

as to the propriety and persuasiveness of the proffered evidence. See Quiet Tech. DC-8, Inc. v. 

Hurel-Dubois UK Ltd., 326 F.3d 1333, 1341 (11th Cir. 2003) (“it is not the role of the district 

court to make ultimate conclusions as to the persuasiveness of the proffered evidence”) (citations 

omitted)). The trial court’s role as gatekeeper is not intended to serve as a replacement for the 

adversary system. See ID Security Sys. Canada, Inc. v. Checkpoint Sys., Inc., 249 F. Supp.2d 

622, 692 (E.D. Pa. 2003) (quoting Advisory Committee Notes to amended Rule 702 (the 

“sufficient facts or data [component of Rule 702] is not intended to authorize a trial court to 

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exclude an expert’s testimony on the ground that the court believes one version of the facts and 

not the other”)).

Mr. Brackeen’s testimony responds directly to AstraZeneca’s non-enablement allegations 

and will permit a full understanding of the DE ‘455 reference (Fed. R. Evid. 702; 4 Weinstein's 

Federal Evidence § 702.03), as opposed to only analyses selected by, and favorable to, 

AstraZeneca. 

Likewise, Dr. Atwood’s testimony concerning Mr. Brackeen’s work is entirely 

permissible and will be helpful to the Court. Experts routinely rely on the work of others, and 

that reliance is not objectionable as hearsay. Fed. R. Evid. 703. An expert witness may rely 

upon hearsay information if that information is “of a type reasonably relied upon by experts in 

the particular field in forming opinions or inferences upon the subject.” Id., see U.S. v. Mulder, 

273 F.3d 91, 102 (2d Cir. 2001) (“[E]xpert 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”). An expert appropriately may rely upon reports of others to formulate his 

opinion, and such reliance is often an indicia of reliability. Walker v. Soo Line R.R. Co., 208 

F.3d 581, 588 (7th Cir. 2000).

Moreover, AstraZeneca itself recognizes that the work of others may be pertinent and 

helpful, as its showing of non-enablement is largely based on the testimony and work of others. 

(See Section D, below.) 

Hanmi is entitled to present, and the Court should fairly have the benefit of hearing both 

parties and their experts on this issue. 

C. Presentation Of Mr. Brackeen’s Testimony At Trial Presents No Prejudice To 

Astrazeneca 

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AstraZeneca suggests that reliance by Mr. Brackeen on his own previous work – admitted 

and considered in a prior proceeding – is improper here simply because such work was done for 

another party. Such an objection is misplaced. That the work was done for another party is 

irrelevant and, if anything, only underscores the objective nature of the results and its probative 

value in this case. 

Moreover, AstraZeneca’s own expert, Dr. Davies, provided several declarations in the 

course of the European Proceedings on the very same Brackeen work it seeks to preclude here. 

(Ex. 6 to Hanmi April 9, 2013 letter to Court, Declaration of Stephen G. Davies dated April 4, 

2011; Ex. 7 to Hanmi April 9, 2013 letter to Court, Declaration of Stephen G. Davis dated 

December 3, 2010.) Dr. Davies has never conducted his own experiments on the Kohl DE '455 

patent examples, but rather opines solely on the work of others. And in this action, Dr. Davies 

has again readily opined on Mr. Brackeen’s work, offering many of the same responses he 

offered in Europe, against other parties. Dr. Davies never stated in any of his expert reports in 

this case that he needed a sample of Mr. Brackeen’s product to complete his analysis, or that he 

required more data than Mr. Brackeen provided. Nowhere does Dr. Davies state that his 

opinions were incomplete without the additional information AstraZeneca’s counsel argues was 

withheld, and nowhere did Dr. Davies provide an opinion or conclusion that was contingent on 

the receipt of additional information. As a result, AstraZeneca is in no way prejudiced by 

testimony regarding Mr. Brackeen’s work years ago, as set forth in his February 19 report. 

D. AstraZeneca Should Be Precluded From Relying On Testimony and Evidence For 

Which It Has Not Produced Samples And Documentation of Experimental Work

Throughout this action, AstraZeneca has consistently relied on the testimony, 

declarations, and experimental work of third parties in support of its efforts to show that the DE 

455 reference is non-enabling. Even Dr. Davies and its other experts rely on declarations and 

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experimental testing by, e.g., Kohl, Larsson, Senn-Bilfinger, etc. that was carried out years ago 

in conjunction with the European opposition proceedings. Ironically, AstraZeneca seeks to 

preclude the same types of materials from Mr. Brackeen that it and its experts expressly rely on 

in the present case. 

There is no serious dispute that the European Opposition proceedings and the testimony 

of declarants concerning their work has long been a part of this case. (See D.I. 113-2, 

AstraZeneca July 25, 2011, Responses to Hanmi’s Invalidity and D.I. 133, 176, 207, 

AstraZeneca Markman briefing incorporating by reference as if fully set forth therein numerous 

declarations discussing declarant and third party experimental work (see below); see also D.I. 

87-1, Hanmi’s May 25, 2011 Non-infringement and Invalidity Contentions and Ex. 10, Hanmi’s 

Preliminary Claim Construction and Supporting Evidence charts citing EP Oppositions at p. 5 

(the entirety of the EP Proceedings as of August 25, 2011 was produced to AstraZeneca on that 

date (see Ex. 11)).) Consistent with that fact, AstraZeneca’s papers and expert reports are 

riddled with citation to the prior testimony and work of its own witnesses and third parties, the 

documentation and samples of which have not been produced to Hanmi in the course of this 

action. By way of example: 

AstraZeneca’s July 25, 2011 Responses to Hanmi’s Invalidity Contentions, incorporating 

all of the following by reference as though set forth therein (see D.I. 113-2, p. 1, n.1; see 

also p. 5, n. 19, 20):

o Andersson Canadian Affidavit, February 17, 2009 (AZ0002251649-775) 

o Larsson EPO Declaration, November 4, 2008 (AZ0002237724-34) 

o Kohl EP Declaration, September 5, 2008 (AZ0002357049-126) ;

o Kohl Canadian Affidavit, February 13, 2009 (AZ0002252004-78)); 

o Senn-Bilfinger EP Declaration, September 23, 2008 (AZ0002237753-58)) 

o Lindberg Israel Declaration, August 17, 2004 (AZ0001323665-711));

o Davies Canadian Affidavit, February 17, 2009 (AZ0002252395-475) Davies EU 

Declaration April 8, 2009 (AZ0002270355-66) (id.); 

o Davies Denmark Declaration November 17, 2009 (AZ0002279031-95); 

o Davies EPO Declaration December 3, 2010 (AZ0005144446-483); 

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o Levy EP Opinion (May 19, 2006) and Response submission (December 6, 2006), 

(AZ0002291364-403; AZ0001543419-423); 

o Levy Canadian Affidavit, February 17, 2009 (AZ0002251835-943)

 

AstraZeneca’s Markman submissions of November 7, 2011 (D.I. 133), January 6, 2012 

(D.I. 176), March 19, 2012 (D.I. 207)

o Andersson Declaration, February 12, 1997 (AZ0005000153-166)

o Larsson Declaration, November 7, 2008 (AZ0002237724-734) D.I. 208-10 -

D.I. 208-14

o Senn-Bilfinger Declaration , September 23, 2008(AZ0002237753-758) D.I. 

208-1)

o Kohl Declaration, September 5, 2008 (AZ0002357049-065) D.I. 208-2- D.I. 

208-7)

AstraZeneca’s Expert Reports

o Von Unge EPO Declaration, November 5, 2008 (AZ0002251165- AZ000225121 

(Davies Rebuttal Report, p. 28; Bartlett Rebuttal Report, pp. 49-50) 

o Von Unge EPO Declaration, August 29, 2012 (Davies Rebuttal Report, p. 60)

o Senn Bilfinger EPO Declaration, September 23, 2008 (Davies Rebuttal Report, 

pp. 31)

o Davies EU Declaration, April 8, 2009 (AZ0002270356- AZ0002270366) (Davies 

Rebuttal, p. 31)

o Davies Denmark Declaration, November 16, 2009 (AZ0002279031-

AZ0002279095) (Davies Rebuttal Report, p. 31)

o Davies EPO Declaration, December 3, 2009 (Davies Rebuttal Rep. p. 31).

o Davies EPO Declaration, April 4, 2011(Davies Rebuttal Report, p. 31). 

o Kohl Canadian Declaration, September 5, 2008 (AZ0002252004-

AZ0002252078), Davies Rebuttal Report, p. 31)

o Kohl Declaration, September 5, 2008 (AZ0002525288-AZ0002525307) (Bartlett 

Report, pp. 48-49) 

o Larsson EPO Declaration November 4, 2008 (Davies Rebuttal Report, p.50). 

(AZ0002237724-AZ0002237734)

o Astra Analytical Report, H 199/18 Magnesium, January 19, 1999 (Byrn Opening 

Report, p. 40)

o Astra Physicochemical data, H 199/18 magnesium trihydrate, October 14, 1998

(Byrn Opening Report, p. 40)

o Select excerpts von Unge lab notebook, H199/18 (with English translation) 

AZ0000386558 - AZ0000386559 (Byrn Rebuttal Report, pp. 20, 26)

o Select excerpts von Unge lab notebook, H199/18 AZ0000389819 (Byrn Rebuttal 

Report, pp. 20, 26)

Under these circumstances, AstraZeneca’s motion to preclude reliance on Mr. Brackeen’s 

testimony and prior work, while at the same time intending to proceed with its own reliance on 

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the prior work and testimony of select others, for which original samples and underlying 

experimental work documentation have not been produced to Hanmi is disingenuous and 

epitomizes trial by ambush. APP Pharms. LLC v. Ameridose, LLC, 2011 WL 6325975, *1 

(D.N.J. Dec. 6, 2011). Such tactics have severely prejudiced Hanmi. If AstraZeneca had not, 

through its reliance on the work of others throughout this case, effectively concealed its plan to 

block presentation of EP declarant testimony and work performed by these individuals, Hanmi 

could have sought to independently have this work replicated and pressed AstraZeneca to do the 

same for all of the above identified evidence it seeks to rely pursuant to its improper discordant 

standards. Neither AstraZeneca or any of its witnesses have produced samples that form the 

basis of all of the experimental work reported upon in the declarations relied upon by 

AstraZeneca’s witnesses. Nor has AstraZeneca produced any data underlying its declarants’ 

experiments beyond what was contained in the public record of the European opposition 

proceedings. If AstraZeneca’s motion in limine is granted, fairness demands that same standard 

apply to AstraZeneca and that it be precluded from relying on, or presenting at trial, the 

foregoing testimony and evidence. 

If the Court is inclined is to grant AstraZeneca's motion to exclude, Hanmi requests that 

the aforementioned materials and testimony be excluded. 

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

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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

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

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

Hanmi Holdings Co., Ltd.

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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 Reliance On Evidence of 

Experiments Performed by Mr. Brackeen For Which Samples and Documentation Have 

Not Been Produced 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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