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UNITED STATES DISTRICT COURT 

FOR 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. 

Civil Action No. 3:11-CV-00760-JAP-TJB 

Judge Joel A. Pisano 

Magistrate Judge Tonianne J. Bongiovanni 

JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT 

Pursuant to the Court’s May 11, 2011 Scheduling Order (D.I. 56), as amended 

July 26, 2011 (D.I. 77), and Local Patent Rule 4.3, Plaintiffs AstraZeneca AB, Aktiebolaget 

Hässle, AstraZeneca LP, KBI Inc. and KBI-E Inc. (collectively, “AstraZeneca”) and Defendants 

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

Holdings Co., Ltd. (collectively, “Hanmi”) hereby provide their Joint Claim Construction and 

Prehearing Statement for the asserted claims of U.S. Patent Nos. 5,714,504 (the “ ’504” patent) 

and 5,877,192 (the “ ’192” patent). 

A. Construction of Terms on Which the Parties Agree 

1. ’504 Patent Claim Terms 

The Parties have agreed to the construction of the below claim terms or phrases in 

the asserted claims of the ’504 patent. 

• “Pure” (claims 1, 2, 4, 6 and 7) should be construed in accordance with the Court’s 

ruling in AstraZeneca AB v. Dr. Reddy’s Labs., Ltd., Claim Construction Order, No. 

05-cv-05553-JAP-TJB at D.I. 246, 2010 WL 1981790, at *5–6 (D.N.J. May, 18, 

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2010) (henceforth, “AZ v. DRL”), to mean: sufficiently free from chemical impurities 

to permit its use in a pharmaceutical formulation. 

• “Substantially crystalline form” (claim 4) should be construed in accordance with 

the Court’s ruling in AZ v. DRL, at *8, to mean: sufficient crystallinity present to 

permit further optical purification of the enantiomer if required. 

2. ’192 Patent Claim Terms 

The Parties have agreed to the construction of the below claim terms or phrases in 

the asserted claims of the ’192 patent. 

• “Decreased interindividual variation in plasma levels (AUC)” (claims 1 and 13) 

should be construed in accordance with the Court’s ruling in AZ v. DRL, at *13, to 

mean: a reduced difference or deviation in blood levels of (–)-omeprazole, as 

measured by the area under the concentration-time curve, compared to the blood 

levels of omeprazole, as measured by the area under the concentration-time curve. 

• “Increased average plasma levels (AUC)” (claims 2 and 14) should be construed in 

accordance with the Court’s ruling in AZ v. DRL, at *14, to mean: greater blood 

levels of (–)-omeprazole, as measured by the area under the concentration-time 

curve, compared to the typical or usual blood levels for omeprazole, as measured by 

the area under the concentration-time curve. 

• “Less pronounced increase in gastrin levels” (claims 3 and 15) should be construed 

in accordance with the Court’s ruling in AZ v. DRL, at *15, to mean: a smaller 

addition to the amount of any of the hormones secreted in the pyloricantral mucosa of 

the stomach that stimulate secretion of stomach acid by the parietal cells as 

compared to the addition produced by omeprazole. 

• “Slow metabolisers” (claims 3, 4, 15 and 16) should be construed in accordance with 

the Court’s ruling in AZ v. DRL, at *16, to mean: individuals among a population that 

lack one or more drug metabolizing enzymes or express a mutant form of one or more 

drug metabolizing enzymes (here, the CYP2CI9 enzyme).

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• “Decreased CYP1A induction” (claims 4 and 16) should be construed in accordance 

with the Court’s ruling in AZ v. DRL, at *16–17, to mean: a reduced production of the 

drug metabolizing enzyme, CYP1A, in the liver, compared to omeprazole. 

 

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 The parties agree that the Court’s stated construction of this term in the AZ v. DRL reported 

decision contains an inadvertent error, and that this construction comports with the Court’s 

apparent intent. 

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• “An improved antisecretory effect” (claims 5 and 17) should be construed in 

accordance with the Court’s ruling in AZ v. DRL, at *17–18, to mean: an enhanced 

ability to decrease gastric acid secretion. 

• “Accelerated rate of healing and accelerated rate of symptom relief” (claims 6 

and 18) should be construed in accordance with the Court’s ruling in AZ v. DRL, at 

*19, to mean: a faster resolution of symptoms or effects of a disease, compared to 

omeprazole. 

• “Essentially devoid of its (+)-enantiomeric contaminant” (claim 23) should be 

construed in accordance with the Court’s ruling in AZ v. DRL, at *20, to mean: in at 

least 99.8% enantiomeric excess (here, (–)-omeprazole). 

B. Each Party’s Proposed Construction of Each Disputed Term 

The positions of the Parties on the construction of each disputed term in the 

asserted claims are set forth in Exhibits A and B (’504 patent) and C and D (’192 patent) 

attached hereto. These Exhibits include an identification of the presently known references from 

the intrinsic evidence that support each construction, as well as the presently known extrinsic 

evidence upon which each Party intends to rely to support its proposed construction. 

C. Identification of Terms Whose Construction Will Be Most Significant, CaseDispositive or Substantially Conducive to Promoting Settlement 

1. AstraZeneca’s Position Regarding the ’504 Patent Claim Terms 

There is no single term the construction of which will be dispositive of the dispute 

involving the asserted claims of the ’504 patent in its entirety. However, construction of the 

below terms may be significant to the resolution of this case. 

• “Alkaline salt” (claims 1, 2, 4, 6 and 7). This term has not been previously construed 

by the Court. Construction of this term would not be dispositive of the allegations 

concerning the ’504 patent, because if the claims are limited to specific salts as per 

Hanmi’s contentions, Hanmi still infringes under the doctrine of equivalents. 

• “(–)-Enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-

pyridinyl)methyl]sulfinyl]-1H-benzimidazole” alone (claims 1, 4, 6 and 7) and as 

modified by “optically pure” (claim 2). AstraZeneca has proposed that these terms 

be construed in accordance with the Court’s earlier ruling AZ v. DRL, at *6–8, to 

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mean: (–)-omeprazole in at least 94% enantiomeric excess, and in at least 98% 

enantiomeric excess, respectively. Hanmi has proposed different constructions. 

2. Hanmi’s Position Regarding the ’504 Patent Claim Terms 

Hanmi submits that certain claim terms are potentially dispositive. 

• “Alkaline salt” (claims 1, 2, 4 and 6–7). Hanmi agrees that the construction of the 

term “alkaline salt,” present in each of the asserted claims, will be significant to the 

resolution of this case. Construction of this term would be dispositive of the 

allegations concerning the ’504 patent, because if the claims are limited to specific 

salts as per Hanmi’s contentions, no asserted claim will be infringed, literally or 

under the doctrine of equivalents. 

• “(–)-Enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-

pyridinyl)methyl]sulfinyl]-1H-benzimidazole” (alone (claims 1, 4, 6 and 7) and as 

modified by “optically pure” (claim 2)). This term is relevant to Hanmi’s invalidity 

contentions and significant to resolution of this case. With due respect for the Court’s 

earlier constructions in AZ v. DRL at *6–7, where Hanmi was not a party, Hanmi will 

show that inclusion of specific numerical limitations is not necessary. 

3. AstraZeneca’s Position Regarding the ’192 Patent Claim Terms 

There is no single term the construction of which will be dispositive of the dispute 

involving the asserted claims of the ’192 patent in its entirety. However, construction of the 

below terms may be significant to the resolution of this case. 

• “Pharmaceutically acceptable salt” (claims 1–7, 10–19 and 21–23). The Court 

previously declined to construe this term in AZ v. DRL, at *21. Given the nature of 

Hanmi’s contentions, AstraZeneca believes construction of this term is warranted. 

Construction of this term would not be dispositive of the allegations concerning the 

’192 patent, because if the claims are limited to specific salts as per Hanmi’s 

contentions, Hanmi still infringes under the doctrine of equivalents. 

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• “Consisting essentially of the (–)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-

dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole” (claims 1–7, 10–19, 21 

and 22). AstraZeneca has proposed that this term be construed in accordance with the 

Court’s earlier ruling in AZ v. DRL, at *9–10, to mean: (–)-omeprazole in at least 

98% enantiomeric excess. Hanmi has proposed a different construction. 

4. Hanmi’s Position Regarding the ’192 Patent Claim Terms 

Hanmi submits that construction of the following terms are significant to 

resolution of this case and may well be dispositive. 

• “Pharmaceutically acceptable salt” (claims 1–7, 10–19 and 21–23). Hanmi agrees 

that the construction of the term “pharmaceutically acceptable salt”, present in each 

of the asserted claims, is a significant issue and may well be dispositive of the 

allegations concerning the ’192 patent, because if the claims are limited to specific 

salts as per Hanmi’s contentions, no asserted claim will be infringed by Hanmi, 

literally or under the doctrine of equivalents. In the alternative, should such a 

contention not be adopted, this term should be construed consistently with the new 

matter presented in the ’192 specification, which contains a broader disclosure of acid 

and alkaline salts. 

• As to the terms “consisting essentially of”, and “the (–)-enantiomer of 5-methoxy2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole”

(claims 1–7, 10–19, 21–23), as well as their combined usage, Hanmi proposes 

constructions relevant to invalidity of the asserted claims and which are significant to 

resolution of this case. With due respect for the Court’s earlier constructions s in AZ 

v. DRL at *9-10, where Hanmi was not a party, Hanmi will show that inclusion of 

specific numerical limitations is not necessary. 

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D. The Anticipated Length of Time Necessary for the Claim Construction Hearing 

AstraZeneca anticipates that a claim construction hearing, including argument and 

any witness testimony, can be completed in one day or less. 

Hanmi anticipates that a claim construction hearing based on argument can be 

completed in less than one day, but should the Court desire live testimony from what may be 

multiple expert witnesses, the hearing would take one to two days. 

E. Witnesses and their Proposed Opinions and Testimony

To the extent presently known, each witness that any Party proposes to call is 

identified in Exhibits A, B, C and D attached hereto, along with a summary of each such 

witness’s testimony including, for any expert, each opinion to be offered related to claim 

construction. 

Respectfully submitted, 

s/ John E. Flaherty s/Allyn Z. Lite 

John E. Flaherty 

Jonathan M.H. Short 

McCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Of Counsel: 

Henry J. Renk 

Bruce C. Haas 

Colleen Tracy 

Joshua I. Rothman 

FITZPATRICK, CELLA, HARPER 

 & SCINTO 

1290 Avenue of the Americas 

New York, New York 10104-3800 

(212) 218-2100 

Allyn Z. Lite 

Michael E. Patunas 

Mayra V. Tarantino 

LITE DEPALMA GREENBERG, LLC 

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 

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Errol B. Taylor 

Fredrick M. Zullow 

MILBANK, TWEED, HADLEY 

 & McCLOY LLP 

1 Chase Manhattan Plaza 

New York, New York 10005-1413 

(212) 530-5000 

Einar Stole 

COVINGTON & BURLING LLP 

1201 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

(202) 662-6000 

Attorneys for Plaintiffs 

ASTRAZENECA AB, 

AKTIEBOLAGET HÄSSLE, 

ASTRAZENECA LP, KBI INC. 

and KBI-E INC. 

Of Counsel: 

Mark Boland 

Michael R. Dzwonczyk 

Renita S. Rathinam 

SUGHRUE MION, PLLC 

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 

John B. Scherling 

SUGHRUE MION, PLLC 

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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