Mayra V. Tarantino 

mtarantino@litedepalma.com

December 26, 2012 

VIA ECF 

Honorable Tonianne J. Bongiovanni, U.S.M.J. 

U.S. District Court for the District of New Jersey 

Clarkson S. Fisher Building & U.S. Courthouse 

402 East State Street 

Trenton, New Jersey 08608 

Re: AstraZeneca AB, et al. v. Hanmi USA, Inc., et al. 

 Civil Action No. 11-cv-0760 (JAP)(TJB) 

Dear Judge Bongiovanni: 

This firm, along with Sughrue Mion, PLLC, represents the Hanmi Defendants 

(“collectively Hanmi”) in the above-captioned action. Hanmi respectfully submits this letter in 

response to the AstraZeneca Plaintiffs’ letter of Friday, December 21, 2012. 

Pretrial Schedule and Trial Date 

Hanmi first seeks to correct the record concerning the circumstances leading to the filing 

of Hanmi’s letter of December 20, 2012, requesting that the Court reset the pretrial schedule in 

view of the December 12, 2012 claim construction Order and Opinion (D.I. 259). 

On November 28, 2012, Your Honor directed the parties to meet and confer regarding the 

pretrial schedule, so as to reset expert reports to be due, e.g., 21 days from the claim construction 

ruling or that a further conference call be set with Your Honor immediately following the claim 

construction ruling to reset the dates (Nov. 28, 2012 Tr. 5-8). There was no contemplation of a 

“suspended” case schedule as AstraZeneca again proposes. Counsel for the parties met and 

conferred shortly thereafter, on December 5, 2012, with Hanmi proposing a fixed time following 

the ruling. AstraZeneca did not agree to any time frame for resetting the expert schedule and, 

following the December 12, 2012 issuance of the claim construction ruling, Hanmi on December 

13, 2012 again proposed a pretrial schedule in compliance with the Court’s directives (see Ex. A, 

Boland to Rothman December 13, 2012 letter). 

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Honorable Tonianne J. Bongiovanni, U.S.M.J 

December 26, 2012 

Page 2 

AstraZeneca again refused to respond to Hanmi’s proposed schedule. With a week 

having passed since the Court’s December 12 claim construction ruling, and still no response 

from AstraZeneca, Hanmi on December 19, 2012 again wrote to AstraZeneca enclosing a 

proposed joint letter to the Court with the proposed expert schedule, indicating that Hanmi 

intended to file unilaterally on December 20, 2012 absent receipt of AstraZeneca’s position on 

the expert schedule (Ex. B, Boland to Rothman December 19, 2012 letter). 

Since AstraZeneca refused to negotiate a pretrial schedule despite the December 5 meet 

and confer and Hanmi’s December 13 and 19 letters, Hanmi unfortunately was forced to submit 

a schedule unilaterally. AstraZeneca’s statement that, “without discussing it with AstraZeneca, 

Hanmi unilaterally sent its letter” (AstraZeneca’s December 21, 2012 letter to Court, p. 1) is 

incorrect and misleading. 

AstraZeneca’s December 21 letter effectively rejects an expert schedule altogether. The 

fact that AstraZeneca has enlisted Mylan in its efforts to delay this case should be given no 

weight since Mylan, as Hanmi’s competitor, has every interest in delaying Hanmi’s case lest 

Hanmi – having filed for FDA approval more than a year before Mylan – gain a commercial 

advantage over Mylan. In any case, based on the November 28 conference call with the Court, 

Hanmi understands that Judge Pisano is not inclined to try the Mylan and Hanmi cases together. 

The Court’s Markman rulings now emphasize the further distinctions between the Hanmi and 

Mylan cases. 

Alleged Remaining Claim Construction Issues 

AstraZeneca’s motion for reconsideration of the Court’s claim construction, filed late 

Friday, December 21, 2012, is certainly no basis to delay resetting the expert dates or trial. 

Hanmi will file its opposition shortly. 

While AstraZeneca again asserts that Hanmi’s October 15, 2012 Motion to Amend raises 

an issue of claim construction relating to “hydrates” and requires a further round of claim 

construction briefing, Hanmi disagrees. As counsel for the parties extensively discussed on 

December 5, as reflected in Hanmi’s letter to AstraZeneca counsel on December 13 (Ex. A, 

Boland to Rothman December 13, 2012 letter), throughout this action, AstraZeneca had taken the 

position that hydrates are encompassed by the claims at issue, but changed that position during 

the briefing on Motion for Summary Judgment No. 4. Hanmi’s amendments to its contentions 

merely serve to conform its contentions to the present case record, specifically in light of 

AstraZeneca’s position in its opposition brief, and the Court’s ruling on Motion for Summary 

Judgment No. 4. Hanmi relies on the present briefing on its Motion to Amend, and there is no 

need for “another round of claim construction briefing” on the hydrates issue. AstraZeneca 

already has Hanmi’s full position and evidence, which is set forth in the Motion to Amend briefs 

– hydrated forms of esomeprazole salts are outside the scope of all asserted clams of both patents 

at issue. See Ex. A, Boland to Rothman December 13, 2012 letter. 

 

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Honorable Tonianne J. Bongiovanni, U.S.M.J 

December 26, 2012 

Page 3 

No discovery is needed on the issue of hydrates, as AstraZeneca has Hanmi’s position in 

full, has responded in its opposition paper, and identified no need for any discovery necessary to 

respond to the motion. AstraZeneca’s reference to its requests for admission served November 

30, 2012 – ten days after the close of fact discovery and six weeks after the last date for serving 

written discovery – has nothing to do with the motion, as such requests belatedly and improperly 

seek discovery on various issues in the case. 

Lindberg and Kohl Depositions 

AstraZeneca correctly advised that in view of Hanmi’s agreement not to take now-retired 

inventor Lindberg’s deposition, his prior deposition transcripts are now inadmissible in the 

present action. This agreement reflects the Court’s indication that Hanmi’s right to crossexamination of the witness is a prerequisite to admissibility of prior case transcripts. 

With respect to the prior transcript of third party Kohl, AstraZenenca is unable to produce 

him for deposition by Hanmi, despite having previously used him as a Declarant in related 

proceedings. Thus, his transcript should be inadmissible in the present action. Hanmi does not 

intend to pursue involuntary discovery of Dr. Kohl through Hague-type proceedings in Germany, 

for the reasons set forth in Hanmi’s letter to AstraZeneca of December 20, 2012 (Ex. C, 

Rathinam to Rothman December 20, 2012 letter). In short, pursuant to the Hague Convention, a 

German national unwilling to appear voluntarily for deposition, as is Dr. Kohl, is not subject to 

compulsory attendance. The limited rights to take discovery in Germany of an unwilling 

German national in U.S. civil litigation fall far short of the deposition Your Honor ordered that 

Hanmi is entitled to. Therefore, the prior Kohl transcript is clearly inadmissible since 

AstraZenenca’s inability to produce Dr. Kohl for deposition denies Hanmi the fundamental right 

of cross examination. In any case, no depositions of either of these witnesses will be taking 

place, and thus no grounds for delay arise. 

Belated and Irrelevant Discovery of Hanmi 

With respect to AstraZeneca’s statements in section 5 at page 3 of its December 21 letter, 

such alleged need for belated discovery is no basis to delay setting the pretrial or trial schedules. 

As Hanmi’s December 13, 2012 letter to AstraZeneca (Ex. D, Dzwonczyk to Rothman 

December 13, 2012 letter) made clear, fact discovery closed long before these requests and the 

discovery served was not only out of time but also unaccompanied by any of the required 

procedural prerequisites to serving belated discovery. Moreover, the 30(b)(6) topics fail to seek 

information relevant to any issue in this case. 

Third Party Discovery of Parexel 

AstraZeneca waited until August 2012 to subpoena third party Parexel, despite knowing 

since April 2011 that Parexel submitted documents to the FDA on behalf of Hanmi. Any issues 

in completing this discovery should have been resolved long before the November 20, 2012 fact 

discovery cut-off. In any case, any such discovery will be duplicative of discovery AstraZeneca 

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Honorable Tonianne J. Bongiovanni, U.S.M.J 

December 26, 2012 

Page 4 

has taken directly from Hanmi during the discovery period concerning Hanmi’s accused products 

and proceedings before the FDA. Hanmi continues to have no objection to AstraZeneca 

deposing Parexel out of time and supplementing its submissions if necessary. However, 

AstraZeneca should not be permitted to use its own delays in seeking discovery from a third 

party and then following up on that discovery to delay the trial rights of a Hatch-Waxman 

defendant facing expiration of the 30-month stay in six months. 

Hanmi respectfully requests that its proposed pretrial schedule be adopted, and remains 

available to discuss the same with the Court if desired. 

Respectfully, 

 /s/ Mayra V. Tarantino 

Mayra V. Tarantino 

MVT:emp 

cc: Counsel of Record (via ECF) 

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EXHIBIT A

Case 3:11-cv-00760-JAP-TJB Document 261 Filed 12/26/12 Page 5 of 17 PageID: 9808
Mark Boland 

T 202.663.7949

mboland@sughrue.com

2100 Pennsylvania Avenue, NW

Washington, DC 20037-3213

T 202.293.7060

F 202.293.7860

www.sughrue.com

Washington, DC ~ Tokyo ~ Silicon Valley ~ San Diego

December 13, 2012

Via Email

Joshua I. Rothman, Esq.

FITZPATRICK, CELLA, HARPER & SCINTO

1290 Avenue of the Americas

New York, NY 10104-3800

Re: AstraZeneca AB et al. v. Hanmi USA, Inc. et al.,

Civil Action No. 11-00760 (JAP)(TJB)

Dear Josh:

This follows our conversation on December 5th about Hanmi’s Motion to Amend, and the 

proposal in your letter of December 7th including a schedule for additional claim construction 

briefing.

As I explained to you in detail, there is no need for another Markman track on the 

hydrates issue. Throughout the case AstraZeneca took the position that hydrates were 

encompassed by the claims at issue, but changed its position during the briefing on Motion for 

Summary Judgment No. 4. In light of AstraZeneca’s new position in its opposition brief and the 

Court’s ruling, the main issues raised by our request to amend is simple – if hydrates are outside 

the scope of the claims, we should be entitled to assert non-infringement due to the changed 

circumstances of the case; in any case, we have modestly amended our invalidity contentions to 

address the issue of “later-developed technology” expressed in your summary judgment 

opposition, but not in your prior contentions.

Since you have characterized our Motion as raising a claim construction issue, in terms of 

exchanging terms for construction, you have our position – on the present litigation record, 

hydrated forms of esomeprazole salts are outside the scope of all asserted clams of both patents 

at issue. You have our evidence too – that is summarized in the briefing on the pending Motion 

to Amend. Judge Bongiovanni advised us to address any discovery needed on the issue, but 

none is necessary since you have our position in full, and you have responded in your opposition 

paper. Thus, the opening two dates in your proposal are unnecessary, and the merits have 

already been briefed.

In a nutshell, you have proposed another Markman track – we appreciate that it is 

abbreviated – but you previously argued the need for this schedule as grounds to delay the trial 

date. If you truly believe that additional briefing is required as to whether or not hydrates are 

Case 3:11-cv-00760-JAP-TJB Document 261 Filed 12/26/12 Page 6 of 17 PageID: 9809
Joshua I. Rothman, Esq.

December 13, 2012

Page 2

covered by the claims, we will agree to your proposal of supplemental cross-briefs during the 

upcoming expert discovery period on the conditions that (1) AstraZeneca withdraws its 

opposition to the Motion to Amend, as you have represented, (2) you agree not to use any agreed 

proposal for further briefing as a basis to urge delay of the April / early May trial timeframe, and 

(3) you agree not to seek to delay the trial for other reasons, now that we have the Court’s 

Markman decision and fact discovery has concluded, except for a couple of wrap-up issues 

addressed in other communications. You can choose the cross-briefing dates to propose to the 

Court if you agree to these straightforward conditions; we only ask that they be limited to, e.g., 

ten pages each. 

We must emphasize, however, that if further briefing (on whether or not hydrates are 

inside or outside the scope of the asserted claims of the two patents) is suggested to the Court 

and adopted, Hanmi’s position will simply mirror the position taken in the Motion to Amend, 

and since you have already responded, such additional briefing will largely be redundant, and 

thus not in the interests of economy, and not likely to be agreed to by the Court since the issue is 

squarely teed up in briefs already before the Court.

In view of yesterday’s Markman decision, and Judge Bongiovanni’s admonition that the 

parties may need to condense the expert discovery schedule to accommodate the spring trial in 

view of the date of the decision, we propose that opening expert reports are due January 7th, 

responsive reports are due January 28th, reply reports are due February 11th, and expert 

depositions conclude by March 4th. This merely takes one week off of each current expert 

discovery deadline, would put the end-date the same as under the current scheduling order, and 

permit an orderly procession towards trial in April or early May, recognizing the expiration of 

the 30-month stay at the end of June and the Court’s stated desire to avoid any PI proceedings. 

Please let us know if we can agree on this schedule, apart from whether further hydrates briefing 

may occur. 

Very truly yours,

 

 

Mark Boland

cc: Counsel on email distribution list

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EXHIBIT B

Case 3:11-cv-00760-JAP-TJB Document 261 Filed 12/26/12 Page 8 of 17 PageID: 9811
Mark Boland 

T 202.663.7949

mboland@sughrue.com

2100 Pennsylvania Avenue, NW

Washington, DC 20037-3213

T 202.293.7060

F 202.293.7860

www.sughrue.com

Washington, DC ~ Tokyo ~ Silicon Valley ~ San Diego

December 19, 2012

Via Email

Joshua I. Rothman, Esq.

FITZPATRICK, CELLA, HARPER & SCINTO

1290 Avenue of the Americas

New York, NY 10104-3800

Re: AstraZeneca AB et al. v. Hanmi USA, Inc. et al.,

Civil Action No. 11-00760 (JAP)(TJB)

Dear Josh:

Further to our letter of December 13, 2012, we are disappointed that we have not heard 

back from you on our proposal for the expert discovery schedule. Since Judge Bongiovanni told 

us to promptly confer and get back to her on the schedule, we attach a draft of a proposed joint 

letter reflecting the schedule we proposed to you last week. If we do not have your position on 

the proposed expert discovery schedule set forth in the attached letter today, we plan to submit 

the letter on behalf of Hanmi tomorrow morning. 

Any other issues are separate from, and do not impact, the expert discovery schedule on 

which we were instructed to revert as soon as possible.

Very truly yours,

 

 

Mark Boland

cc: Counsel on email distribution list

Case 3:11-cv-00760-JAP-TJB Document 261 Filed 12/26/12 Page 9 of 17 PageID: 9812
Mayra V Tarantino

mtarantino@litedepalma.com

December 20, 2012

VIA ECF & FEDERAL EXPRESS

Honorable Tonianne J. Bongiovanni, U.S.M.J.

U.S. District Court for the District of New Jersey DRAFT JOINT LETTER

Clarkson S. Fisher Building & U.S. Courthouse

402 East State Street

Trenton, New Jersey 08608

Re: AstraZeneca AB, et al. v. Hanmi USA, Inc., et al.

Civil Action No. 11-cv-0760 (JAP)(TJB)

Dear Judge Bongiovanni:

This firm, along with Sughrue Mion, PLLC, represents the Hanmi Defendants 

(“collectively Hanmi”) in the above-captioned action. The Parties jointly respectfully submit 

this letter following the November 28, 2012 conference call with Your Honor and the Court's 

subsequent December 12, 2012 Opinion and Order on claim construction (D.I. 257, 258). 

The Parties propose the following schedule for expert discovery:

January 7, 2013 - Opening expert reports

January 28, 2013 - Responsive expert reports

February 11, 2013 - Rebuttal expert reports

March 4, 2013 - Expert depositions end

The Parties ask that Your Honor amend the current schedule (D.I. 230) by indicating that 

the above expert discovery schedule is “so ordered.”

Further, in light of the Court’s stated goal of an April or early May trial in view of the 

expiration of the 30-month stay on June 29, 2013, the Parties respectfully request the Court’s 

assistance in firming up the trial date and remaining pretrial dates in accordance with Judge 

Pisano’s calendar, so that appropriate logistical arrangements for trial can be made.

Respectfully,

Mayra V. Tarantino

Case 3:11-cv-00760-JAP-TJB Document 261 Filed 12/26/12 Page 10 of 17 PageID: 9813
Honorable Tonianne J. Bongiovanni, U.S.M.J.

December 20, 2012

Page 2

MVT:emp

cc: Counsel of Record (via ECF)

SO ORDERED this ______ day of December, 2012

__________________________________

Tonianne J. Bongiovanni, U.S.M.J.

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EXHIBIT C

Case 3:11-cv-00760-JAP-TJB Document 261 Filed 12/26/12 Page 12 of 17 PageID: 9815
Renita S. Rathinam Renita S. Rathinam 

T 202.857.3209 

rrathinam@sughrue.com 

2100 Pennsylvania Avenue, NW 

Washington, DC 20037-3213 

T 202.293.7060 

F 202.293.7860 

www.sughrue.com 

Washington, DC ~ Tokyo ~ Silicon Valley ~ San Diego

December 20, 2012 

Via Email 

Joshua I. Rothman, Esq. 

FITZPATRICK, CELLA, HARPER & SCINTO 

1290 Avenue of the Americas 

New York, NY 10104-3800 

Re: AstraZeneca AB et al. v. Hanmi USA, Inc. et al.,

Civil Action No. 11-00760 (JAP)(TJB) 

Dear Josh: 

This responds to several recent communications to our team. 

As a preliminary matter, we are disappointed by your refusal to directly respond to our 

December 13 and 19 proposals concerning the expert discovery schedule in this case. Given 

Judge Bongiovanni's directive to promptly propose a schedule, you left us no choice but to 

proceed unilaterally. 

With respect to your email to Mark Boland asking to meet and confer together with 

Mylan's counsel, the Court made clear in our November 28 phone conference that Judge Pisano 

is not inclined to try the Mylan and Hanmi cases together. The Court's Markman rulings now 

emphasize the further distinctions between the Hanmi and Mylan cases, as you are well aware. 

We have no intention of submitting any correspondence to the Court jointly with Mylan, or 

meeting and conferring together with you and Mylan's counsel since there are no joint issues on 

the table. 

With respect to your inquiry regarding pursuit of a deposition of Dr. Kohl through 

Hague-type proceedings in Germany, our position is squarely set forth in our last communication 

on this issue with you dated December 11, 2012. Pursuant to the Hague Convention, a German 

national unwilling to appear voluntarily for deposition, as is Dr. Kohl, is not subject to 

compulsory attendance. The limited rights to take discovery in Germany of an unwilling 

German national in U.S. civil litigation fall far short of the deposition Judge Bongiovanni 

ordered that Hanmi is entitled to. As you may know, attempts to compel the attendance of an 

unwilling German citizen for a U.S. style deposition in Germany can subject the requestor to 

criminal liability. Therefore, the prior Kohl transcript is clearly inadmissible since your inability

to produce Dr. Kohl for deposition denies us the fundamental right of cross examination. Your 

suggestion that any dates in this case need to be deferred based on the Kohl issue is, frankly, way 

Case 3:11-cv-00760-JAP-TJB Document 261 Filed 12/26/12 Page 13 of 17 PageID: 9816
Joshua I. Rothman, Esq. 

December 20, 2012 

Page 2 

out of line and a transparent attempt at yet another manufactured ground of delay. For all of the 

reasons we have told you, Hanmi cannot, and thus will not, proceed under the Hague Convention 

with respect to a cross examination deposition of Dr. Kohl. Should you seek to have the 

transcript admitted despite the above, we will object and move to preclude as necessary. 

With respect to your recent email request to Mike Dzwonczyk for a meet and confer on 

your belated 30(b)(6) topics and discovery requests, we do not see any need to meet and confer 

at all. As our December 13 letter to you made clear, fact discovery closed long before these 

requests and the discovery you served was not only out of time but also unaccompanied by any 

of the required procedural prerequisites to serving belated discovery. Moreover, the 30(b)(6) 

topics fail to seek information relevant to any issue in this case. 

 We continue to have no objection to you deposing Parexel out of time and supplementing 

your submissions, if necessary. 

 

Very truly yours, 

Renita S. Rathinam 

cc: see email distribution 

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EXHIBIT D

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~.·Sughrue SUGHRUE MION. PLLC 

Michael R. Dzwonczyk 

T 202.857.3233 

mdzwonczyk@sughrue.com 

Via Email 

Joshua I. Rothman, Esq. 

December 13, 2012 

FITZPATRICK, CELLA, HARPER & SCINTO 

1290 Avenue ofthe Americas 

New York, NY 10104-3800 

Dear Josh: 

Re: AstraZeneca AB et al. v. Hanmi USA, Inc. et al., 

Civil Action No. 11-00760 (JAP)(TJB) 

We write in response to your letter ofDecember 4, 2012. 

2100 Pennsylvania Avenue, NW 

Washington, DC 20037-3213 

T 202.293.7060 

F 202.293.7860 

www.sughrue.com 

First, there is no discovery issue raised by Hanrni's November 30 disclosure under L. Pat. 

R. 3.6(j), which requires that correspondence to the FDA be provided to you within 7 days of its 

filing. Fact discovery in this case closed on November 20, 2012, and nothing in Hanmi's 

November 30 disclosure belatedly raises a fact discovery issue. 

Second, Hanmi did not "admit infringement" of claims 8 and 9 of the '504 patent, as you 

stated. Rather, you know very well that Hanrni's proposed products do not contain the neutral 

form of (-)-omeprazole, and Hamni's Notice Letter to AstraZeneca of December 29, 2010 under 

21 C.F.R. § 314.95 (HAN0026234-HAN0026278) and the ensuing litigation record makes clear 

that Hanmi does not infringe Claims 8-9. Of course, the issue is moot because Claims 8-9 are 

not asserted in this litigation. Mark Boland advised that in your phone conference of 

December 5, you clarified that AstraZeneca is not seeking to assert Claims 8-9, consistent with 

all of your positions of record and representations to the Court. Rather, you advised during the 

call that any purported "admissions" with respect to Claims 8-9 were to be used in support of 

your allegations that Hanmi will induce infringement of the method aspects of Claims 6, 7 and 

1 0 of the '504 patent - not the product aspects of those claims. 

Yet nowhere in either of AstraZeneca's initial or amended infringement contentions does 

AstraZeneca allege that Hanmi practices the method aspects of Claims 6, 7 and 10 of the '504 

patent based on a theory that there has been an "admission" regarding Claims 8-9 in an October, 

2010 document submitted to the FDA. As such, your post-discovery letter of December 4 and 

your comments to Mr. Boland raise an entirely new theory of infringement, based on infonnation 

you have had for almost two years. 

Washington, DC- Tokyo- Silicon Valley- San Diego 

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--- -r,... Sughrue SUGHRUE MION. PLLC 

Joshua I. Rothman, Esq. 

December 13,2012 

Page2 

Because fact discovery has closed and the new theory you raise has not previously been 

identified and is belated, Hanmi will not provide a witness in response to AstraZeneca's new 

Rule 30(b)(6) Notice of Deposition and will not produce any additional documents. See 

concurrently transmitted Responses and Objections to AstraZeneca's Notice of Deposition under 

Rule 30(b )( 6). Hanmi will also seek to preclude the introduction of any evidence relating to 

AstraZeneca's new infringement theories. 

cc: (email distribution list) 

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