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 Counterclaim- Plaintiffs 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 .6

(To Preclude AstraZeneca From Attempting To Introduce Evidence On Issues And 

Theories Not In The Case)

Case 3:11-cv-00760-JAP-TJB Document 290-6 Filed 04/29/13 Page 1 of 7 PageID: 10288
1

Hanmi hereby moves in limine to preclude AstraZeneca’s introduction of argument, 

testimony and documents related to the below subject matter areas that are not a part of this case:

I. Patent Information Forms submitted to FDA in connection with Hanmi’s NDA 

202342.

II. The status of FDA proceedings and FDA’s determinations about Hanmi’s 

Proposed NDA Product.

III. Hanmi’s commercial activities concerning launch of its Proposed Product, if 

approved by FDA.

No theory or claim pertaining to any of the above topics is disclosed in any version of 

AstraZeneca’s contentions or expert reports. Nor has AstraZeneca ever sought leave of this 

Court to amend its contentions to articulate any theory that would permit presentation of 

evidence at trial concerning any of the above subject matter. The Local Patent Rules do not 

permit the addition of new unrelated theories, let alone unarticulated theories, or new evidence 

on the eve of trial. Local Patent Rule 3.6; King Pharm., Inc. v. Sandoz Inc., Case No. 08-5974 

(GEB), 2010 WL 2015258, at *4 (D. N.J. May 20, 2010) (“The rules are designed to require 

parties to crystallize their theories of the case early in the litigation and to adhere to those 

theories once they have been disclosed.”). Parties are required to proceed with diligence in 

amending contentions. O2 Micro Int’l, Ltd. v. Monolithic Power Sys., Inc., 467 F.3d 1355, 1365-

66 (Fed. Cir. 2006). No basis exists for AstraZeneca to bypass the case schedule and procedures 

set by the Court (D.I. 56, as amended by D.I. 60; L. Pat. R. 3.6 and 3.7.) and to introduce the 

above subject matter and amorphous theories that have no bearing on this case. 

At issue for trial is whether or not the asserted ‘504 and ‘192 patent claims are valid and 

infringed. Subject matter regarding regulatory review, timing of and determinations to be made 

by the FDA, and Hanmi’s business activities concerning commercialization and launch plans do 

not relate to the questions of infringement and validity of the asserted patent claims. Rather, 

determinations of infringement or validity here are based on the records developed through 

discovery, contentions and expert reports. Yet, in its April 19, 2013 pretrial disclosures, 

Case 3:11-cv-00760-JAP-TJB Document 290-6 Filed 04/29/13 Page 2 of 7 PageID: 10289
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AstraZeneca identifies documents and testimony of Hanmi and its U.S. regulatory consulting 

agent, Parexel International Corporation (“Parexel”) concerning Hanmi’s Patent Information 

Forms, portions of FDA status documents, and testimony concerning Hanmi’s marketing efforts 

and launch plans. (Ex. 22, Excerpts from Plaintiffs’ April 19, 2013 Pretrial Disclosures 

(designating testimony of Hanmi and Parexel 30(b)(6) witnesses, Kyu Chan Kwon and Leslie 

Devos, and related documents). 

AstraZeneca’s attempt to inject its previously-undisclosed and, more fundamentally, 

irrelevant subject matter into the case is in violation of the Local Patent Rules and the Orders of 

this Court. D.I. 56 as amended by D.I. 60; L. Pat. R. 3.6 and 3.7.; Jazz Pharm., Inc. v. Roxane 

Labs., Case No. 2:10-CV-06108(ES-CLW), 2012 U.S. Dist. LEXIS 107408, at *8 (D. N.J. July 

30, 2012) explaining that the Rules are designed to prevent the “shifting sands approach” to a 

party’s contentions). 

I. Patent Information Forms Submitted To FDA In Connection With Hanmi’s NDA 

202342 Are Not Relevant, And Are Not Cited in Contentions Or Expert Reports

Since the close of fact discovery in November of 2012, AstraZeneca has succeeded in 

pursuing additional discovery for months (see e.g. D.I. 273, 280, D.I. 273, Ex. E (Hanmi’s 02-

11-2013 First Supplemental Privilege Log); April 12, 2013 letter, M. Tarantino to Judge 

Bongiovanni submitting documents for in camera review and attaching Hanmi’s 03-06-2013

Second Supplemental Privilege Log). AstraZeneca has had the 2010 Patent Information Forms 

in question since the start of this case. Yet its “Patent Information Form infringement theory” 

was never disclosed in its infringement contentions and AstraZeneca has never sought to amend 

its contentions to include this unstated theory. Consistent with the fact this theory is not a part 

of AstraZeneca’s contentions, it appears nowhere in any expert report to date. (See D.I. 280, 

p. 2.) 

Case 3:11-cv-00760-JAP-TJB Document 290-6 Filed 04/29/13 Page 3 of 7 PageID: 10290
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Hanmi respectfully requests that the Court now preclude AstraZeneca from introducing at 

trial any subject matter (be it in the form of argument, testimony, the forms themselves or other 

related documents) concerning Hanmi’s Patent Information Forms. If the Court is inclined to 

permit introduction of the Patent Information Forms  even though not disclosed in 

AstraZeneca’s contentions or expert reports  Hanmi requests preclusion of any testimony or 

evidence apart from the forms themselves. Introduction of such subject matter at trial will result 

in waste of time, confusion of the issues and unfair prejudice to Hanmi in direct contravention of 

Rule 403 of the Federal Rules of Evidence. 

II. Status of FDA Proceedings

The status and particulars of proceedings at the FDA are wholly irrelevant to any claim at 

issue in the present action. The FDA’s determination of whether to finally approve Hanmi’s 

Proposed Product will  apart from the expiration of the statutory 30-month stay, or a prior 

judgment from this Court  be made completely independent of this action. The timing and/or 

adequacy of FDA’s determinations with respect to Hanmi’s Proposed Products is not a part of 

AstraZeneca’s case contentions. Yet, in depositions of Mr. Kwon and Ms. Devos, AstraZeneca 

has insisted on lines of questioning concerning speculations on timing of approval, and the 

nature of submissions to the FDA. Per AstraZeneca’s April 19, 2013 pretrial disclosures, it seeks 

to introduce such testimony and related documents at trial. (Ex. 22; see also Ex. 24-25 (Hanmi’s 

Objections to AstraZeneca’s Second and Third 30(b)(6) Notices). This subject matter has 

nothing to do with the infringement and validity questions at issue in this action. Introduction of 

such subject matter at trial will result in waste of time, confusion of the issues, and unfair 

prejudice to Hanmi, again in violation of Fed. R. Evid. 403. 

III. Hanmi’s Commercial Activities Concerning Launch Of Its Proposed Product, If 

Approved By FDA

Case 3:11-cv-00760-JAP-TJB Document 290-6 Filed 04/29/13 Page 4 of 7 PageID: 10291
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Hanmi’s commercial and launch planning activities are not at issue in this case. Hanmi’s

launch plans and related business activities have no relevance to any matter at issue concerning 

the upcoming trial. On an April 11, 2013 call with the parties, Judge Bongiovanni denied 

AstraZeneca’s request for launch plan/commercial discovery. See also Ex. 26, AstraZeneca LP 

v. Breath, Ltd., No. 08-01512, ECF Document No. 86, at 3 (D.N.J. filed Sept. 8, 2009) (denying 

AstraZeneca’s request to have the Court enter an order directing Defendant to provide advance 

notice of any anticipated launch of, or launch plans concerning its product, in part because “the 

Court does not believe it has legal authority to grant such relief.” (emphasis added); Ex. 27, 

AstraZeneca LP v. Osmotica Pharms. Corp., No. 10-4203, ECF No. 42, at 2 (D.N.J. filed Nov. 

16, 2010) (Judge Bongiovanni denying a request for a 45-day advance notice of a planned 

commercial launch); Ex. 28, AstraZeneca LP v. Ivax Pharms., Inc., No. 05-5142, Trans. of 

Teleconf. at 10 (D.N.J. July 17, 2008).

AstraZeneca has insisted on questioning of Hanmi and Parexel witnesses, and harassing 

Hanmi for documents (see, e.g., April 10, 2013 letter, M. Tarantino to Judge Bongiovanni) 

concerning commercial launch plans with respect to Hanmi’s proposed NDA product. And 

despite Judge Bongiovanni’s rulings on April 11, 2013 that launch plans fall outside the confines 

of this case, AstraZeneca has likewise designated such testimony and related documents in its 

April 19 pretrial deposition designations and trial exhibit list. Again, the only issues in the case 

are whether AstraZeneca’s asserted claims are valid and infringed. Presentation at trial regarding 

commercial activities is irrelevant to any issue in the case and in violation of Fed. R. Evid. 403, 

and will result in waste of time, confusion of the issues and unfair prejudice to Hanmi if raised at 

trial.

Case 3:11-cv-00760-JAP-TJB Document 290-6 Filed 04/29/13 Page 5 of 7 PageID: 10292
5

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

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 290-6 Filed 04/29/13 Page 6 of 7 PageID: 10293
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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 .6 (To Preclude AstraZeneca From Attempting To Introduce Evidence On 

Theories Not In The Case) 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 290-6 Filed 04/29/13 Page 7 of 7 PageID: 10294