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John E. Flaherty 

Jonathan M.H. Short 

McCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Attorneys for Plaintiffs/Counterclaim-Defendants 

AstraZeneca AB, Aktiebolaget Hässle, 

AstraZeneca LP, KBI Inc. and KBI-E Inc. 

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 

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

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 

ATTORNEY CONFIDENTIAL 

PURSUANT TO PROTECTIVE ORDER 

FILED UNDER SEAL

PLAINTIFFS’ MEMORANDUM IN SUPPORT OF THEIR MOTION TO 

AMEND THEIR DISCLOSURE OF ASSERTED CLAIMS 

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Plaintiffs seek leave to amend their Disclosure of Asserted Claims, to allege infringement 

of three additional claims of one of the two patents-in-suit; claims 3, 5, and 10 of the ‘504 patent. 

Amendment is necessary in light of additional invalidity contentions and defenses raised for the 

first time by Defendants in their Invalidity Contentions. 

This is a Hatch-Waxman case. Plaintiffs AstraZeneca AB, Aktiebolaget Hässle, 

AstraZeneca LP, KBI Inc. and KBI-E Inc. (collectively, “AstraZeneca”) allege that defendants 

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

Holdings Co., Ltd. (collectively, “Hanmi”) infringed two AstraZeneca patents by filing with the 

U.S. Food and Drug Administration (“FDA”) an Abbreviated New Drug Application (“ANDA”) 

seeking approval to market a generic version of AstraZeneca’s Nexium® esomeprazole 

magnesium product prior to the expiration of the patents. This action was commenced on 

February 9, 2011. 

On May 11, 2011, the Court issued a Letter Order setting the contention and claim 

construction schedule for the case (Doc. 56). On May 18, 2011, AstraZeneca served its 

Disclosure of Asserted Claims pursuant to Local Patent Rule 3.1. That Disclosure was based 

upon information available to AstraZeneca from the Notice Letter from Hanmi and in Hanmi’s 

Answer to the Complaint. A week later, on May 25, 2011, Hanmi served its 145-page Invalidity 

Contentions pursuant to Local Patent Rule 3.6(c). Those contentions contained allegations and 

defenses not disclosed in the Notice Letter or in the Answer to the complaint. These additional 

defenses and contentions could not have been foreseen from Hanmi’s more limited pre-suit 

Notice Letter and Answer and Counterclaims. 

Good cause exists for granting the motion. Asserting additional patent claims is proper 

and reasonable under the circumstances. The additional claims will allow AstraZeneca to fully 

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confront the expanded contentions and defenses Hanmi has now presented. Hanmi will not be 

prejudiced. The proposed amendment seeks to add infringement of three additional claims of 

one of the patents-in-suit. The claim construction process is just starting, and nothing beyond 

claim construction has yet been scheduled. On the other hand, AstraZeneca would be 

substantially prejudiced by denial of its motion and the inability to assert infringement of the 

three additional patent claims. 

Leave should be granted for AstraZeneca to amend its Disclosure of Asserted Claims. 

A. Legal Standard

This Court has recognized that “Rule 3.7 is not a straightjacket into which litigants are 

locked from the moment their contentions are served” and that “while the Local Patent Rules 

strive to have a party establish their contentions early on, it is important to recognize that 

preliminary infringement contentions are still preliminary.” See TFH Publications, Inc., v. 

Doskocil Mfg. Co., Inc., 705 F.Supp.2d 361, 366 (D.N.J. 2010) (quotation marks, citations, and 

brackets omitted). Indeed, courts construing rules identical to the New Jersey Local Patent Rules 

have held that they specifically contemplate amending infringement contentions: 

The Court has broad discretion to allow amendments to 

infringement contentions and considers four factors in rule on 

motions for leave to do so: (1) the explanation for the party’s 

failure to meet the deadline, (2) the importance of what the Court 

is excluding, (3) the potential prejudice if the Court allows the 

thing that would be excluded, and (4) the availability of a 

continuance to cure such prejudice. 

Mediostream, Inc. v. Microsoft Corp., Civil Action No. 2:08-cv-369-CE, 201 WL 4118589 at *1 

(E.D. Tex. Oct. 18, 2010).1

 Local Patent Rule 3.7 provides non-exhaustive examples of grounds 

for good cause, absent undue prejudice to the adverse party. These include disclosure of a 

 

1

 Because “both the District of New Jersey and the Eastern District of Texas have adopted verbatim their Local 

Patent Rules from the Northern District of California . . . it is appropriate to look to cases from those districts for 

guidance.” TFH Publications at 365-66 n.3. 

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contention by a Hatch-Waxman party asserting infringement under L.Pat.R. 3.6(g) that requires a 

response by the adverse party because it was not previously presented or reasonably anticipated. 

B. It Was Not Until May 25, 2011 that Hanmi First Disclosed Its Expanded Array of 

Defenses and Invalidity Contentions, Making It Impossible for AstraZeneca to Meet the 

Deadline to Assert All Claims

Because Hanmi waited until May 25, 2011 to disclose all of its invalidity contentions, 

Hanmi put AstraZeneca at a disadvantage. Without knowing all of Hanmi’s reasons why it 

contends the patents in suit are not valid, AstraZeneca could not identify all of the claims that it 

should assert. AstraZeneca should not be obligated to anticipate all possible challenges where 

Hanmi’s Notice Letter and Answer do not raise them.

For example, Hanmi argued for the first time in its Invalidity Contentions that the alleged 

claims were invalid on theories of indefiniteness and lack of written description. Neither 

Hanmi’s Notice Letter nor its Answer made any mention of indefiniteness or written description. 

Hanmi could have provided AstraZeneca with all of its Invalidity Contentions in its Notice Letter 

or Answer, but Hanmi chose not to fully disclose its defenses until after AstraZeneca had to list 

its asserted claims. 

C. Failure to Allow Amendment Will Unfairly Prejudice Plaintiff

Claim 1 of the ‘504 patent contains the limitation “alkaline salt”. Hanmi argues that the 

scope of “alkaline salt” is limited to six salts (Na

+

, Mg2+, Li+, K+, Ca2+ or N+(R)4 ). After 

receiving AstraZeneca’s Disclosure of Asserted Claims, Hanmi asserts for the first time in its 

Invalidity Contentions that if claims 1, 2, 4, 6, and 7 of the ‘504 patent read on “alkaline salts” 

other than the six salts mentioned above, a construction which would include the strontium used 

in Hanmi’s NDA product, then the claim is invalid for lack of written description under 35 

U.S.C. § 112. This is a new contention not found in the Notice Letter or the Answer. 

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AstraZeneca did not know that Hanmi was asserting a lack of written description defense 

when it served its Disclosure of Asserted Claims. If the court agrees with Hanmi that asserted 

claim 1 lacks written description, which we do not think will occur, claim 1 will be held invalid. 

However, claims 3, 5 and 10 that are the subject of this motion contain a list of alkaline salts. 

These claims would not be held invalid based on Hanmi’s argument that the term “alkaline salts” 

lacks written description. Fairness requires that AstraZeneca be permitted to assert these 

additional claims in response to Hanmi’s previously undisclosed defense. 

D. Defendant Hanmi Will Not Be Prejudiced If Leave To Amend Is Granted

There is no prejudice to Hanmi in allowing this amendment. Because claims 3, 5, and 10 

do not contain any claim terms that are not already in the asserted claims, no modification to the 

claim construction schedule is required. Rather the parties can supplement their contentions 

concurrently with the claim construction schedule, as set forth in the attached proposed schedule. 

E. There is Leeway in the Schedule to Allow the Requested Amendment

As mentioned above, the current schedule permits the proposed amendment to occur, as 

well as provide for service of limited supplemental contentions with no disruption to the Court’s 

schedule. 

* * * 

Given that AstraZeneca has demonstrated (1) the good cause for why the proposed 

amended claims were not previously asserted, (2) the importance of including the additional 

claims, and (3) the lack of prejudice to Hanmi if the claims are added, AstraZeneca respectfully 

request the Court grant AstraZeneca’s motion to amend the Disclosure of Asserted Claims and 

enter the proposed revised schedule, which is attached as Exhibit A to this Memorandum. 

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 Respectfully submitted, 

Dated: August 8, 2011 By: John E. Flaherty 

John E. Flaherty 

Jonathan M.H. Short 

McCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Attorneys for Plaintiffs 

ASTRAZENECA AB, AKTIEBOLAGET 

HÄSSL, ASTRAZENECA LP, KBI INC. 

and KBI-E INC.

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 

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 

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