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 

mtaratino@litedepalma.com 

Attorneys for Defendants 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. 3:11-CV-00760-JAP-TJB 

Motion Date: November 19, 2012

HANMI’S REPLY IN SUPPORT OF ITS 

MOTION TO AMEND ITS CONTENTIONS 

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TABLE OF CONTENTS 

I. AstraZeneca’s Response Is A Transparent Attempt To Alter The Trial Schedule ..............1

II. The Mylan Case And Its Schedule Are Not Relevant ..........................................................1

III. The Prior Litigation Record And Contentions Were Based On AstraZeneca’s 

Asserted Claims Scope, As Encompassing Hydrates ..........................................................2

IV. Hanmi’s Motion To Amend Conforms Its Contentions To The Changed Litigation 

Record ..................................................................................................................................2

V. Hanmi Has Demonstrated Good Cause For The Amendment .............................................3

VI. The Amendment Does Not Prejudice AstraZeneca .............................................................4

VII. Hanmi’s Modest Supplement To Its Invalidity Defenses Based on 

Hydrates Responds To An Issue Not Previously Raised By AstraZeneca .........................5

VIII. Conclusion ...........................................................................................................................6

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TABLE OF AUTHORITIES 

Cases

In re Corrugated Container Antitrust Litig., 694 F.2d 1041(5th Cir. 1992) .................................. 6 

Paquin v. Fed. Nat. Mortg. Ass'n, 20 F. Supp. 2d 94 (D.D.C. 1998) ............................................. 5 

Perez-Ruiz v. Crespo-Guillen, 25 F.3d 40 (1st Cir. 1994) .............................................................. 6 

Streber v. Hunter, 221 F.3d 701 (5th Cir. 2000) ............................................................................. 5 

Statutes

35 U.S.C. § 112 ............................................................................................................................... 5 

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 Defendants Hamni USA, Inc., Hanmi Pharmaceutical Co., Ltd., Hanmi Fine Chemical 

Co., Ltd. (collectively “Hanmi”), respectfully submit this Reply in Support of Hanmi’s October 

15, 2012 Motion to Amend Its Contentions (D.I. 238, 238-1, 239). Plaintiffs AstraZeneca AB, 

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

filed their Response to Hanmi’s Motion on November 7, 2012 (D.I. 244). 

I. AstraZeneca’s Response Is A Transparent Attempt To Alter The Trial Schedule 

 At page 1 of its Response, second paragraph (D.I. 244), AstraZeneca concedes that it 

really does not oppose the merits of Hanmi’s motion, but instead reveals its true motive of delay 

of the trial schedule. Because AstraZeneca’s primary position is that it does not oppose the 

merits, Hanmi’s motion should be granted for the reasons set forth therein. However, granting 

the motion should not be conditioned on delay of the case schedule, because AstraZeneca’s 

assertions that Hanmi’s motion raises a new issue of claim construction (D.I. 244, pp. 1 and 7 

(section II)) are incorrect for the reasons set forth in Hanmi’s November 1, 2012 letter to the 

Court, D.I. 242 at pp. 2-3. Similarly, any issues pertaining to the pretrial schedule have been 

addressed in Hanmi’s letters to the Court, D.I. 242 and D.I. 251 (filed today). 

 Hanmi respectfully submits that its Motion to Amend should be granted for all of the 

reasons set forth therein, and briefly replies below to new points raised in AstraZeneca’s 

Response. 

II. The Mylan Case And Its Schedule Are Not Relevant 

 Despite the fact that the Hanmi and Mylan cases have not been consolidated for pretrial 

purposes, and without having ever brought a motion for consolidation, AstraZeneca improperly 

treats the Hanmi and Mylan cases as consolidated for trial purposes. D.I. 244 at pp. 1-3. This 

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again is an attempt by AstraZeneca to circumvent the April 2013 trial date confirmed by Judge 

Pisano,1 even after AstraZeneca raised the Mylan case in scheduling discussions with the Court 

following the summary judgment hearing in June 2012. See D.I. 228 (Tarantino to Judge 

Bongiovanni re Pretrial Schedule). AstraZeneca’s clear goal is to simply delay resolution of 

Hanmi’s case and, accordingly, the potential entry of Hanmi’s product into the market following 

the expiration of the 30-month FDA stay of approval on June 29, 2013. 

 Hanmi submits that the Mylan case – filed more than a year after Hanmi – and its 

schedule are not relevant to the present motion to amend or to the present case against Hanmi, 

for the reasons set forth in its recent submissions to the Court. See D.I. 242, pp. 4-5, and D.I. 

251, pp. 2-3. 

III. The Prior Litigation Record And Contentions Were Based On AstraZeneca’s

 Asserted Claim Scope, As Encompassing Hydrates 

 At sections I-D to I-F, AstraZeneca’s Response correctly points out that Hanmi’s initial 

contentions did not raise the hydrated aspect of its esomeprazole strontium product as a noninfringement defense, that Hanmi’s Motion No. 4 was limited to invalidity defenses based on 

“hydrates”, and that the Markman submissions did not raise the issue of whether the claims of 

the patents-in-suit excluded hydrates from their scope. D.I. 244 at 4-6. Hanmi does not dispute 

these specific points, but they are not germane to resolution of Hanmi’s motion, which is based 

on the changed litigation record as it stands today. See section IV below. 

IV. Hanmi’s Motion To Amend Conforms Its Contentions To The Changed Litigation 

 Record 

 

1

 The Court’s July 5, 2012 Order scheduled the trial for April, 2013, on dates to be determined. See D.I. 

230 (quoted without reference to the scheduled trial by AstraZeneca at D.I. 244, p. 3.) AstraZeneca's 

statement at D.I. 244, page 3,that there is no formal order in place is incorrect. 

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 Hanmi seeks leave to amend to assert non-infringement of the asserted claims of the ‘504 

and ‘192 patents-in-suit, based on AstraZeneca’s position in opposition to Hanmi’s Motion for 

Summary Judgment No. 4 (relating to invalidity due to hydrate scope), and the Court’s August 

30, 2012 Opinion (D.I. 233). Because AstraZeneca changed its position on the scope of the 

asserted claims during summary judgment briefing in an attempt to avoid Hanmi’s invalidity 

challenges, equity demands that Hanmi should be permitted to show that its proposed 

tetrahydrate product does not infringe the claims. 

 AstraZeneca having brought suit and provided infringement contentions, Hanmi 

reasonably believed that AstraZeneca was asserting the ‘504 and ‘192 patents to encompass 

Hanmi’s tetrahydrate form of esomeprazole strontium salt. However, this reasonable premise 

has turned out to be incorrect, based on the Court’s ruling denying Motion No. 4 and 

AstraZeneca’s assertions in its opposition brief. As discussed below, this fundamental shift in 

the underlying premises of this litigation in light of the Court’s decision and AstraZeneca’s 

position – i.e., “hydrates” are not set forth in, and are not material to the claims, and therefore do 

not have to be described or enabled – results in hydrates being excluded from the scope of the 

asserted ‘504 and ‘192 patent claims. See generally D.I. 238-1 at pp. 1-12. 

V. Hanmi Has Demonstrated Good Cause For The Amendment 

 The denial of Hanmi’s Motion No. 4 on August 30th in view of AstraZeneca’s position in 

its opposition, gave rise to the instant motion and proposed amendments. The issues raised by 

the motion and amendment were simply not ripe before then. Following analysis of the Court’s 

Order (D.I. 233), appropriate research, client discussions, preparation of the proposed 

amendment and motion papers, Hanmi provided AstraZeneca with the proposed amendment on 

October 11th seeking consent. AstraZeneca sought additional time to advise Hanmi of its 

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position, and Hanmi filed its Motion on October 15th upon receipt of AstraZeneca’s response. 

Under the circumstances, Hanmi acted with appropriate diligence. 

 Any arguments by AstraZenenca that Hanmi should have acted before the Court’s denial 

of Hanmi’s Motion No. 4 fail to take into account the express grounds which lead to the instant 

motion and proposed amendment. Hanmi submits that the good cause requirement of Local 

Patent Rule 3.7 has been met, for all of the reasons set forth in its detailed Memorandum 

supporting the motion to amend (D.I. 238-1). None of AstraZeneca's case authorities comport 

with the specific facts of this case. 

VI. The Amendment Does Not Prejudice AstraZeneca 

 Contrary to AstraZeneca’s arguments at D.I. 244, pp. 13-14, the proposed amendment 

will not impact the case schedule or the scope of discovery, or prejudice AstraZeneca. 

 With respect to non-infringement based on hydrate scope, AstraZeneca brought this upon 

itself, based on the positions it elected to take on the summary judgment record. See D.I. 238-1 

at 4-5, summarizing AstraZeneca’s positions in D.I. 253. 

 In terms of Hanmi’s modest supplement to its invalidity defenses based on hydrates that 

were raised in Motion No. 4 (D.I. 238-1 at 13-14), Hanmi is merely conforming its present 

contentions (sent in draft to AstraZeneca on October 11, 2012) to the existing summary 

judgment record. This supplement directly responds to AstraZeneca’s “later-developed 

technology” argument, raised for the first time on the summary judgment record – but not in 

AstraZeneca’s prior responses to Hanmi’s invalidity contentions. See section VII, infra. The 

case is now ripe for development of full expert reports on Hanmi’s written description and 

nonenablement defenses based on hydrates, without prejudice to either party. 

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VII. Hanmi’s Modest Supplement To Its Invalidity Defenses Based on Hydrates 

 Responds To An Issue Not Previously Raised By AstraZeneca 

 Although Hanmi’s Motion No. 4 was denied, AstraZenenca is incorrect in asserting that 

there has been any final adjudication on the merits with respect to Hanmi’s defenses raised 

therein – that the asserted claims are invalid under 35 U.S.C. § 112, first paragraph, based on 

lack of enablement and lack of written description. See D.I. 244 at 15-17. As an initial matter, 

AstraZeneca misquotes the Court’s ruling. The Court did not, as AstraZeneca states, find that 

“‘hydrates’ are not material to the written description or enablement inquiry” (D.I. 244 at 15); 

rather, the Court simply stated that “Hanmi has not convinced the Court that “hydrates” are 

material to the written description or enablement inquiry” (D.I. 233 at 19). That ruling in no way 

equates, as AstraZeneca claims, to summary judgment in favor of it on this issue. 

 Moreover, denial of one party’s motion for summary judgment on a claim or defense, 

preserves the issue for trial, especially where, as here, the Court found that “there exist factual 

issues that would preclude summary judgment in any event.” D.I. 233 at 19-20. The Court 

retains the power to change matters adjudicated any time before entry of final judgment. See 

Streber v. Hunter, 221 F.3d 701, 737 (5th Cir. 2000). And, contrary to AstraZeneca’s argument, 

the denial of a motion for summary judgment is not “law of the case.” Absent certification, the 

denial of summary judgment is a non-appealable interlocutory order, not a final judgment, and 

has no res judicata effect. See Paquin v. Fed. Nat. Mortg. Ass'n, 20 F. Supp. 2d 94, 96 (D.D.C. 

1998) (quotations omitted) (“denial of a motion for summary judgment does not constitute the 

law of the case because it does not purport to decide the factual question, it merely denies the 

motion because, in the court’s then view, there were issuable facts. Such a denial merely 

postpones decision of any question; it decides none”); Perez-Ruiz v. Crespo-Guillen, 25 F.3d 

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40,42 (1st Cir. 1994) (“[i]interlocutory orders . . . remain open to trial court reconsideration, and 

do not constitute the law of the case”); In re Corrugated Container Antitrust Litig., 694 F.2d 

1041, 1043 (5th Cir. 1992); 10A Charles A. Wright, et al., Federal Practice & Procedure § 2712 

(3rd ed.2002) (“a denial of summary judgment is not a decision on the merits; it simply is a 

decision that there is a material factual issue to be tried”). 

 AstraZeneca correctly notes that it filed no summary judgment motion on either of 

Hanmi’s written description or enablement defenses. AstraZeneca incorrectly assumes that the 

Court entered summary judgment in its favor sua sponte (D.I. 244 at 15-16), when no such 

judgment exists. The Court’s Opinion and Order plainly state that Motion No. 4 is denied, not 

that judgment is to be entered in favor of AstraZeneca. D.I. 233 at 20; D.I. 234. AstraZeneca’s 

suggestion that summary judgment effectively was entered against Hanmi is incorrect. As with 

any denial of summary judgment, the matter remains ripe for trial upon full presentation of the 

evidence developed in discovery. 

 Hanmi’s amendment supplementing its nonenablement defense based on hydrates 

directly responds to AstraZeneca’s position on “later-developed technology” raised by 

AstraZeneca for the first time in its summary judgment opposition (D.I. 153), but not in its 

responses to Hanmi’s invalidity contentions (see D.I. 244-5 at 46-49). Given that Hanmi had no 

notice that AstraZeneca planned to rely on such a position, Hanmi’s modest amendment to its 

invalidity contentions at D.I. 239, pp. 84 (‘504 patent) and 141 (‘192 patent) – each of which 

refers back to pp. 24-26 responding to AstraZeneca’s “later-developed technology” position – 

should be permitted as a matter of fundamental fairness. 

VIII. Conclusion 

 Hanmi respectfully submits that its Motion to Amend Contentions should be granted. 

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Dated: November 14, 2012 Respectfully, 

LITE DEPALMA GREENBERG, LLC 

s/Mayra V. Tarantino 

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 November 14, 2012, I caused a copy of the foregoing HANMI’S 

REPLY IN SUPPORT OF ITS MOTION TO AMEND ITS CONTENTIONS to be served on 

counsel for AstraZeneca through the Court’s ECF system and by email. 

 

 s/Mayra V. Tarantino 

 Mayra V. Tarantino 

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