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. 4

(To Preclude AstraZeneca From Attempting To Introduce Evidence Alleging Invalidity or 

Unenforceability of Hanmi’s Patents)

Case 3:11-cv-00760-JAP-TJB Document 290-4 Filed 04/29/13 Page 1 of 7 PageID: 10273
1

Hanmi hereby moves in limine to preclude AstraZeneca from introducing evidence or 

argument alleging invalidity or unenforceability of Hanmi’s patents relating to its esomeprazole 

strontium tetrahydrate product.

A. Context of Relevance of Hanmi’s Patents

Whether AstraZeneca can prove infringement by Hanmi’s proposed product or its use 

under the doctrine of equivalents will be a core issue at trial. It is undisputed that Hanmi’s 

product, which is a strontium salt, is outside the literal scope of the asserted claims based on the 

Court’s Markman rulings on “alkaline salt” (‘504 patent) and “pharmaceutically acceptable salt” 

(‘192 patent). D.I. 257, Opinion dated December 2012, pp. 5-8 and 11-14.

Proof of infringement under the doctrine of equivalents requires the patentee to show that 

there be an insubstantial difference between the limitations of the claim and the accused product, 

on an element-by-element basis. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 

17, 29, 39-41 (1997). Factors to be considered in assessing the substantiality of the differences 

include: (1) whether persons skilled in the art would have known of the interchangeability of an 

ingredient not contained in the patent with one that was; (2) evidence of copying; (3) efforts to 

design around the claims of a patent; and (4) evidence of independent development. Id. at 29, 

39-41.

In support of its position that substantial differences exist, Hanmi intends to introduce its 

own patents covering its strontium salt product (U.S. Patents 8,106,076 (Ex. 29) and 7,576,219 

(D.I. 111-10)) as well as the process used to manufacture the active ingredient (U.S. Patent 

7,888,511 (Ex. 30)). See D.I. 220, May 24, 2012 letter, M. Tarantino to Judge Pisano regarding 

Hanmi patents; see, e.g., Ex. 17, Second Expert Report of Wayne J. Genck, section II at pp. 39-

48; Ex. 18, Second Expert Report of Jerry L. Atwood, pp. 30-37. As explained therein, Hanmi’s 

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‘076 product patent was obtained directly over the two AstraZeneca patents-in-suit, while both 

the ‘076 and ‘219 patents refer to the ‘504 patent in the background section.

Hanmi’s separate patenting of its strontium salt is highly relevant evidence on the 

“substantial differences” factors set forth in Warner-Jenkinson. Although separate patenting is 

not dispositive of substantial differences, it is relevant and entitled to due weight. Zygo Corp. v. 

Wyko Corp., 79 F.3d 1563, 1570 (Fed. Cir. 1996). In Festo Corp. v. Shoketsu Kinzoku Kogyo 

Kabushiki Co., the Federal Circuit stated,

[W]hen a device that incorporates the purported equivalent is in fact the subject of 

a separate patent, a finding of equivalency, while perhaps not necessarily legally 

foreclosed, is at least considerably more difficult to make out. But there is a 

strong argument that an equivalent cannot be both unobvious and insubstantial.” 

493 F.3d 1368, 1379-80 (Fed. Cir. 2007) (internal footnotes omitted).1

B. AstraZeneca’s Improper Deposition Tactics Should Be Barred At Trial

The evidence at trial will establish Hanmi’s patenting of its strontium salt directly over 

the two AstraZeneca patents-in-suit. Those facts cannot be disputed. Because AstraZeneca 

cannot dispute that at least the ‘076 Hanmi patent covers the accused product and was expressly 

granted over the ‘504 and ‘192 patents-in-suit, AstraZeneca resorts to slinging mud at Hanmi and 

its patents. AstraZeneca should be prevented from seeking to introduce evidence alleging 

“invalidity” or “unenforceability” of Hanmi’s patents relating to its esomeprazole strontium 

tetrahydrate product.

 1 See also the concurring opinion in Roton Barrier, Inc. v. Stanley Works, in which Judge Nies wrote 

that “a second patent, depending on its subject matter, may be relevant to the issue of whether the 

changes [in an accused device] are substantial,” and that “[a] substitution in a patented invention 

cannot be both nonobvious and insubstantial.” 79 F.3d 1112, 1128 (Fed. Cir. 1996) (Nies, J., 

additional views).

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In more than one deposition, counsel for AstraZeneca has insisted on lines of questioning 

of Hanmi’s fact and expert witnesses, asserting that Hanmi’s ‘219 patent is “invalid,” or is 

unenforceable due to “inequitable conduct.” See Ex. 19, Selected Excerpts from the September 

29, 2012 Deposition Transcript of Kwee Hyun Suh, at pp. 251-290 (questions suggesting that 

one statement in Hanmi’s ‘219 patent relating to optical purity was incorrect and that Hanmi 

allegedly concealed information from the Patent Office, despite testimony that the statement is 

correct in context); Ex. 20, Selected Excerpts from the April 25, 2013 Deposition Transcript of 

Wayne Genck, at pp. 199-203 (asking him to “assume” that Hanmi’s ‘219 patent is invalid and 

unenforceable for inequitable conduct, and how that would affect his views). Besides being 

baseless, any such speculation is irrelevant to any issue in the case. The Patent Office’s decision 

to grant the Hanmi patents over the AstraZeneca patents-in-suit is what is relevant to the issue of 

whether the differences are substantial ones. Hanmi’s patents are presumed to be valid, 35 

U.S.C. § 282, and speculative questioning of Hanmi’s witnesses on some ill-defined, 

unsupported and unproven theory of “invalidity” should be barred.

Allegations of “inequitable conduct” are serious charges, and AstraZeneca should be 

precluded from making any such unsupported allegations at trial, particularly in light of the 

Federal Circuit’s extremely high standards for showing materiality and intent to deceive. See, 

e.g., 1st Media v. Electronic Arts, 694 F.3d 1367, 1374-75 (Fed. Cir. 2012) (“[K]nowledge of the 

reference and knowledge of materiality alone are insufficient after Therasense to show an intent 

to deceive. Moreover, it is not enough to argue carelessness, lack of attention, poor docketing or 

cross-referencing, or anything else that might be considered negligent or even grossly negligent. 

To sustain a charge of inequitable conduct, “clear and convincing evidence must show that the 

applicant made a deliberate decision to withhold a known material reference.”); see also Exergen 

Case 3:11-cv-00760-JAP-TJB Document 290-4 Filed 04/29/13 Page 4 of 7 PageID: 10276
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Corp. v. Wal-Mart Stores Inc. and S.A.A.T. Systems, 575 F.3d 1312, 1329 (Fed. Cir. 2009) (a 

pleading of inequitable conduct under Rule 9(b) must include sufficient allegations of 

underlying facts from which a court may reasonably infer that a specific individual (1) knew of 

the withheld material information or of the falsity of the material misrepresentation, and 

(2) withheld or misrepresented this information with a specific intent to deceive the PTO).

AstraZeneca apparently wishes to engage in a “smear campaign” against Hanmi at trial –

a trial which will already be complicated enough based on issues properly in the case. The 

validity and enforecability of Hanmi’s patents are not issues for trial in this case. Furthermore, 

AstraZeneca has proffered no expert testimony on its irrelevant theories nor presented any bases 

in its contentions. It is well-established that the scope of an expert’s opinions at the trial is 

limited to the opinions disclosed in that expert’s report. See, e.g., O2 Micro Int’l, Ltd. v. 

Monolithic Power Sys., Inc., 467 F.3d 1355, 1368-69 (Fed. Cir. 2006) (affirming district court’s 

exclusion of expert opinions concerning matters not disclosed in the opening expert reports). See 

also Northlake Mktg & Supply, Inc. v. Glaverbel, S.A., No. 92 C 2732, 1996 U.S. Dist. LEXIS 

19306, at *5-6, *11 (N.D. Ill. Dec. 17, 1996) (granting motion in limine to exclude expert from 

testifying on matters not set out in his initial report). Thus, AstraZeneca has no basis upon which 

to found any argument or examination of witnesses concerning the validity and enforceability of 

Hanmi’s patents. 

For all of these reasons, any argument or evidence at trial, including attempted 

examination of Hanmi witnesses at trial who will testify about Hanmi’s patents, should not be 

permitted with respect to any AstraZeneca unsupported allegations of invalidity or 

unenforceability, which simply are not issues properly in the case in any event.

Case 3:11-cv-00760-JAP-TJB Document 290-4 Filed 04/29/13 Page 5 of 7 PageID: 10277
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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 290-4 Filed 04/29/13 Page 6 of 7 PageID: 10278
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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. 4 (To Preclude AstraZeneca From Attempting To Introduce Evidence 

Alleging Invalidity or Unenforceability of Hanmi’s Patents) 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 290-4 Filed 04/29/13 Page 7 of 7 PageID: 10279