LITE DEPALMA GREENBERG, LLC

Allyn Z. Lite

Michael E. Patunas

Mayra V. Tarantino

Two Gateway Center, 12th Floor

Newark, New Jersey 07102

Telephone: (973) 623-3000

Facsimile: (973) 877-3872

alite@litedepalma.com

mpatunas@litedepalma.com

mtarantino@litedepalma.com

Attorneys for Defendants 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

DEFENDANTS’ MEMORANDUM OF LAW IN SUPPORT OF MOTION FOR 

SUMMARY JUDGMENT NO. 5: NON-INFRINGEMENT OF UNASSERTED CLAIMS 

OF U.S. PATENT NO. 5,714,504

Case 3:11-cv-00760-JAP-TJB Document 104-2 Filed 10/11/11 Page 1 of 6 PageID: 962
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TABLE OF CONTENTS

I. INTRODUCTION AND BRIEF SUMMARY.................................................................1

II. ARGUMENT ..................................................................................................................1

A. Claims 8 And 9 Are Not Infringed And AstraZeneca Does Not Contend 

Otherwise.............................................................................................................1

B. Claims 3, 5 And 10 ..............................................................................................2

III. CONCLUSION ...............................................................................................................2

Case 3:11-cv-00760-JAP-TJB Document 104-2 Filed 10/11/11 Page 2 of 6 PageID: 963
Defendants Hanmi USA, Inc., Hanmi Pharmaceutical Co., Ltd., Hanmi Fine Chemical 

Co., Ltd. and Hanmi Holdings Co., Ltd. (collectively “Hanmi”) respectfully submit this 

Memorandum in Support of their Motion for Summary Judgment No. 5: Non-infringement of 

Unasserted Claims of U.S. Patent No. 5,714,504 (“the ’504 patent”) in this Hatch-Waxman 

patent infringement action brought by Plaintiffs AstraZeneca AB, Aktiebolaget Hässle, 

AstraZeneca LP, KBI Inc. and KBI-E Inc. (collectively “AstraZeneca” or “plaintiffs”). 

I. INTRODUCTION AND BRIEF SUMMARY

This motion is straightforward, based on undisputed facts, and is ripe for summary 

judgment.

The ’504 patent contains ten claims. SOF ¶ 12. In its May 18, 2011 Disclosure of 

Asserted Claims, AstraZeneca asserted that Hanmi would infringe five of them claims 1, 2, 4 

and 6-7. SOF ¶5.1 Hanmi requested a covenant not to sue with respect to the unasserted claims, 

but AstraZeneca rejected Hanmi’s request. SOF ¶ 7.

AstraZeneca belatedly sought to assert three additional claims of the ’504 patent, claims 

3, 5 and 10, via Motion to Amend Their Disclosure of Asserted Claims filed August 8, 2011. 

D.I. 81-82. Hanmi opposed on August 22, 2011 (D.I. 86), and the motion is pending. SOF ¶ 8.

II. ARGUMENT

A. Claims 8 And 9 Are Not Infringed And AstraZeneca Does Not Contend 

Otherwise

AstraZeneca has not ever asserted claims 8 or 9 against Hanmi, yet refuses to grant a 

covenant not to sue (SOF ¶¶ 6, 7), thus necessitating the instant motion. The reason claims 8 and 

9 were not asserted is clear unlike the other claims of the ’504 patent which require a salt form 

 1 “SOF” refers to the contemporaneously filed Local Rule 56.1 Statement of Undisputed 

Material Facts in Support of Defendants’ Motions for Summary Judgment Nos. 3-5 for 

Invalidity and Non-infringement of United States Patent No. 5,714,504.

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of (-)-omeprazole, claims 8 and 9 are method claims which call for administration of the free 

base form of (-)-omeprazole. SOF ¶ 12. Hanmi’s proposed product contains (-)-omeprazole 

strontium, which is a salt. SOF ¶ 2.

There being no factual or legal basis that would support a charge of infringement of 

claims 8 and 9, and since no timely assertion of such a charge was made by AstraZeneca, 

summary judgment of non-infringement should be granted.

B. Claims 3, 5 And 10

Hanmi’s position as to claims 3, 5 and 10 is contingent on the Court’s denial of 

AstraZeneca’s motion to belatedly assert these claims. See D.I. 81-82 and Hanmi’s opposition at 

D.I. 86. Should the Court not grant AstraZeneca’s motion, claims 3, 5 and 10 will be out of the 

case and summary judgment of non-infringement would be in order on the grounds that Hanmi’s 

strontium salt product is outside the scope of those claims, which are directed to different salts.2

III. CONCLUSION

AstraZeneca was obligated to make its infringement allegations in May 2011. As to any 

claims of the ’504 patent AstraZeneca chose not to assert, Hanmi should not have to incur further 

business uncertainty. Accordingly, Hanmi respectfully requests that the Court enter judgment 

finding no infringement of claims 8 and 9, and contingently asserted claims 3, 5 and 10, of the 

’504 patent for the reasons set forth herein.

Dated: October 11, 2011 LITE DEPALMA GREENBERG, LLC

 2

 Should the Court grant AstraZeneca’s pending motion, Hanmi will contest infringement and 

validity of claims 3, 5 and 10 on the merits. Hanmi notes that if AstraZeneca’s pending 

motion is granted, claims 3, 5 and 10 of the ’504 patent would be subject to the same grounds 

of invalidity asserted against claims 1, 2, 4 and 6-7 in each of Hanmi’s concurrently filed 

Motions for Summary Judgment Nos. 3 and 4.

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Allyn Z. Lite

Michael E. Patunas

Mayra V. Tarantino

Two Gateway Center, 12th Floor

Newark, New Jersey 07102

Telephone: (973) 623-3000

Facsimile: (973) 877-3872

alite@litedepalma.com

mpatunas@litedepalma.com

mtarantino@litedepalma.com

Of Counsel:

SUGHRUE MION, PLLC

Mark Boland

Michael R. Dzwonczyk

Renita S. Rathinam

2100 Pennsylvania Ave., NW

Washington, DC 20037-3213

Telephone: (202) 293-7060

Facsimile: (202) 293-7860

mboland@sughrue.com

mdzwoncyzk@sughrue.com

rrathinam@sughrue.com

SUGHRUE MION, PLLC

John B. Scherling

4250 Executive Square

Suite 900

La Jolla, CA 92037

Telephone: (858) 795-1180

Facsimile: (858) 795-1199

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 October 11, 2011, I caused a copy of the foregoing 

DEFENDANTS’ MEMORANDUM OF LAW IN SUPPORT OF MOTION FOR SUMMARY 

JUDGMENT NO. 5: NON-INFRINGEMENT OF UNASSERTED CLAIMS OF U.S. PATENT 

NO. 5,714,504 to be served upon the following counsel through the Court’s ECF system and via 

mail:

John E. Flaherty, Esq.

McCARTER & ENGLISH

Four Gateway Center

100 Mulberry Street

Newark, New Jersey 07102

(973) 622-4444

jflaherty@mccarter.com

Henry J. Renk

FITZPATRICK, CELLA, HARPER & SCINTO

1290 Avenue of the Americas

New York, NY 10104-3800

(212) 218-2250

HRenk@fchs.com

Errol B. Taylor

Fredrick M. Zullow

MILBANK, TWEED, HADLEY & McCLOY LLP

1 Chase Manhattan Plaza

New York, New York 10005-1413

(212) 530-5000

ETaylor@milbank.com

FZullow@milbank.com

By: 

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