Case 1:15-cv-02865-RBK-JS Document 211-9 Filed 03/16/17 Page 1 of 20 PageID: 5060
`Case 1:15-cv—02865-RBK-JS Document 211-9 Filed 03/16/17 Page 1 of 20 PageID: 5060
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`
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`EXHIBIT H
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`EXHIBIT H
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`

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`Case 1:15-cv-02865-RBK-JS Document 211-9 Filed 03/16/17 Page 2 of 20 PageID: 5061
`
`Charles M. Lizza
`William C. Baton
`Jamie L. Lucia
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1250
`Newark, New Jersey 07102
`(973) 286-6700
`
`Attorneys for Plaintiffs
`Shire Development LLC,
`Shire Pharmaceutical Development Inc.,
`Cosmo Technologies Limited, and
`Nogra Pharma Limited
`
`Of Counsel:
`Edgar H. Haug
`Joseph V. Saphia
`Jessica H. Zafonte
`Bonnie Gaudette
`FROMMER LAWRENCE & HAUG LLP
`745 Fifth Avenue
`New York, New York 10151
`(212) 588-0800
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Civil Action No. 15-2865
`(RBK)(JS)
`
`(Filed Electronically)
`
`FILED UNDER SEAL
`
`SHIRE DEVELOPMENT LLC,
`SHIRE PHARMACEUTICAL
`DEVELOPMENT INC., COSMO
`TECHNOLOGIES LIMITED, and
`NOGRA PHARMA LIMITED,
`
`Plaintiffs,
`
`v.
`
`AMNEAL PHARMACEUTICALS
`LLC, AMNEAL
`PHARMACEUTICALS OF NEW
`YORK, LLC, AMNEAL
`PHARMACEUTICALS CO. (I) PVT.
`LTD., and AMNEAL LIFE
`SCIENCES PVT. LTD.,
`
`Defendants.
`
`PLAINTIFFS’ REPLY BRIEF IN SUPPORT OF ITS
`MOTION TO EXTEND THE 30-MONTH STATUTORY STAY
`
`

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`Case 1:15-cv-02865-RBK-JS Document 211-9 Filed 03/16/17 Page 3 of 20 PageID: 5062
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`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`ARGUMENT ................................................................................................... 3
`
`A. Amneal’s Limitation of Discoverable Information is
`Wrong .................................................................................................... 3
`
`B.
`
`Recent Discovery Reveals Additional Examples of
`Amneal’s Intentional Delay .................................................................. 4
`
`1.
`
`2.
`
`Amneal Intentionally Delayed the Production of
`Documents .................................................................................. 4
`
`Amneal Withheld the Deposition of Dr. Mani
`From Shire To Shield Its Commercial Activities ....................... 5
`
`C. Amneal’s FDA Missteps Do Not Excuse Its Discovery
`Delays .................................................................................................... 6
`
`1.
`
`The Case Law Cited By Amneal Is Inapposite ........................... 6
`
`D. Amneal Offers No Explanation for Its Conduct ................................... 8
`
`1.
`
`2.
`
`3.
`
`Amneal’s Document Production Delay ...................................... 8
`
`Amneal’s Failure to Identify Sufficient Kashiv
`Custodians Caused Delay and Necessitated Shire’s
`Requests For Additional Custodians ......................................... 10
`
`Shire Is Entitled to Discovery Concerning
`Amneal’s New Exhibit Batch ................................................... 11
`
`E. Amneal Has Been Uncooperative in Scheduling
`Depositions .......................................................................................... 11
`
`F.
`
`Shire Did Not Delay This Litigation ........................................................... 12
`
`G. Amneal Is Not Prejudiced By A 30-Month Stay
`Extension ............................................................................................. 13
`
`III. CONCLUSION .............................................................................................. 15
`
`1
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`

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`
`
`TABLE OF AUTHORITIES
`
`
`Cases
`Alcon Labs., Inc. v. Akorn, Inc.,
`No. 15-cv-285, 2016 U.S. Dist. LEXIS 2182 (D.N.J. Jan. 8, 2016) .................... 8
`
`Eisai Co., Ltd. v. Teva Pharmaceuticals USA, Inc.,
`247 F.R.D. 440 (D.N.J. 2007) ............................................................................... 3
`
`In re Brimonidine Patent Litig.
`No. 07-md-1866 GMS, 2008 U.S. Dist. LEXIS 92405
`(D. Del. Oct. 31, 2008) ......................................................................................... 7
`
`3M v. Alphapharm Pty. Ltd., No. 99-13, 2002 U.S. Dist. LEXIS 28843
`(D. Minn. Mar. 8, 2002)....................................................................................7, 8
`
`Sunovion Pharms. Inc., v. Sandoz, Inc.,
`No. 5:10-MD-1500-H(3), 2011 U.S. Dist. LEXIS 99077 (E.D.N.C.
`Sept. 1, 2011) ........................................................................................................ 7
`
`Statutes
`21 U.S.C. § 355(j)(5)(D)(i)(I)-(VI) ..........................................................................13
`
`Rules
`Fed. R. Civ. P. 26(b)(1) .............................................................................................. 3
`
`
`
`2
`
`

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`I.
`
`INTRODUCTION
`
`It is obvious from Amneal’s Opposition Brief and its behavior from the
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`inception of this case, that Amneal believes that its discovery obligations end with
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`the production of information only “directly” relevant to the “recipe of ingredients”
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`used in Amneal’s generic Lialda® Product as set forth in its ANDA submission to
`
`FDA. Amneal likewise wrongly considers any discovery requesting relevant
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`information beyond Amneal’s ANDA submission as merely “tangential” to the
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`merits of this case. Contrary to Amneal’s attempted misdirection in its Opposition,
`
`Shire reiterates in this Reply that the Court’s analysis of whether to extend the 30-
`
`month stay should focus on Amneal’s inexcusable discovery delays. Amneal’s
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`legally and factually incorrect beliefs have resulted in significant discovery delays,
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`wasted judicial resources, and severe prejudice to Shire.
`
`Shire’s Opening Brief is replete with examples of Amneal’s systematic
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`discovery delays. But more recently, after this Court, on January 4, 2017, ordered
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`Amneal to produce relevant discovery on a “rolling basis,” additional, and very
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`serious deficiencies in Amneal’s discovery have been uncovered. In documents
`
`
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`recently produced, but in Amneal’s possession for at least six months,
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`documents should have been produced before the Court’s Order required Amneal
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` Clearly, those
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`1
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`

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`
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` Whether
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`to do so by February 2017.
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`Amneal considers this information “tangential” or not, it should have been
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`produced to Shire on a rolling basis and represented honestly to this Court.
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`Instead, Amneal systematically delayed and hid relevant information regarding the
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`status of its ANDA with the intention of “running out” the 30-month stay clock so
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`it can launch-at-risk.
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` However, Shire’s motion is focused
`
`
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`entirely on Amneal’s discovery delays and those delays form the basis for Shire’s
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`request for an 11-month extension to the 30-month stay.
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`
`
`
`
` merely demonstrates that Amneal will not be prejudiced by an extension of
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`the 30-month stay.
`
`Amneal’s defense, as set forth in its Opposition, notably lacks any serious
`
`explanation for Amneal’s intentional delay in producing thousands of relevant and
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`responsive documents until it was ordered to do so by this Court. In fact,
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`Amneal’s Opposition does not deny any of the facts evidencing its discovery delay.
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`Amneal further fails to contest the legal precedent establishing that Amneal’s
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`2
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`

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`discovery delay is grounds to extend the 30-month stay. Amneal’s Opposition
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`instead exposes Amneal’s skewed view of the law and facts and confirms that the
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`30-month stay should be extended.
`
`II. ARGUMENT
`A. Amneal’s Limitation of Discoverable Information is Wrong
`Amneal has made it clear throughout the course of this litigation that it did
`
`not consider anything outside of its ANDA submission relevant discovery. That is
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`wrong. The language of Fed. R. Civ. P. 26(b)(1) is clear that “[p]arties may obtain
`
`discovery regarding any nonprivileged matter that is relevant to any party’s claim
`
`or defense and proportional to the needs of the case.” See also Eisai Co., Ltd. v.
`
`Teva Pharmaceuticals USA, Inc., 247 F.R.D. 440 (D.N.J. 2007). Amneal ignores
`
`that, in addition to infringement claims, Amneal has asserted every invalidity
`
`defense available under the patent laws. Additionally, discovery from Amneal’s
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`development team (Kashiv employees) that bears upon the function of the various
`
`excipients in Amneal’s ANDA product are clearly relevant to the infringement
`
`analysis. Indeed, because Amneal’s partner, Kashiv, was responsible for the
`
`development of Amneal’s ANDA product, discovery from multiple Kashiv
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`employees, both supervisors and scientists, is justified.
`
`3
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`

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`B.
`
`Recent Discovery Reveals Additional Examples of Amneal’s
`Intentional Delay
`
`1.
`
`Amneal Intentionally Delayed the Production of Documents
`
`Pursuant to the Court’s January 4, 2017 Order to produce documents,
`
`Amneal made a production on January 30, 2017 consisting of 14,467 documents,
`
`of which 11,391 pre-date August 31 , 2016. That production represents one-third of
`
`Amneal’s total production in this case. These documents could have and should
`
`have been produced to Shire on a rolling basis following the September 8, 2016
`
`court conference.
`
`Amneal’s January production made clear that Amneal had deliberately
`
`withheld documents that were highly relevant to this litigation.—
`
`AMN00301162 & attachment); Exhibit 2 (AMN00295140)_
`
`(Exhibit 1,
`
`1 “Exhibit _” refers to exhibits attached to the Declaration of Jessica H. Zafonte,
`Esq. in Support of Plaintiffs’ Reply Brief in Support of Its Motion to Extend the
`30-Month Statutory Stay, submitted concurrently herewith.
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`

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`
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`All of these documents were created months before they were produced and
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`intentionally withheld by Amneal.
`
`2.
`
`Amneal Withheld the Deposition of Dr. Mani
`From Shire To Shield Its Commercial Activities
`
`Shire noticed Dr. Narasimhan Mani, VP, Global Corporate Strategy and
`
`Business Development for deposition on May 26, 2016. (Exhibit 5, Deposition
`
`Notice of N. Mani). On August 17, 2016, Shire requested a date for the Mani
`
`deposition. (Exhibit 6, August 17, 2016 email from Zafonte to Kokabi). Amneal
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`did not respond. Shire repeated its request during a meet and confer on August 23,
`
`2016 and again Amneal ignored it. Shire renewed its request for the third time in
`
`November 2016 (not for the first time as Amneal misrepresents (Opp. Br. at 14))
`
`and was told that Dr. Mani would not be available until February 2017 due to the
`
`holidays and other work obligations. (See Exhibit 23 of Shire’s Opening Brief).
`
`On February 7, 2017, Dr. Mani testified that he had, in fact, been available for the
`
`past six months and that he was outside of his home state of New Jersey for only
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`two weeks out of the last five months. (Exhibit 7, Mani Dep. Tr. at 16:11-16).
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`5
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`

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` This indicates that Amneal did not want
`
`Shire to obtain such fact discovery from Dr. Mani during the time Amneal was
`
`withholding this information and this witness.
`
`C. Amneal’s FDA Missteps Do Not Excuse Its Discovery Delays
`Shire’s motion is not based on Amneal’s FDA missteps. Instead, it is
`
`Amneal’s egregious delays in producing documents and deponents that merit the
`
`extension of the 30-month stay and are the facts most relevant to the inquiry of
`
`whether a party “failed to reasonably cooperate in expediting the action.”
`
`However, Amneal’s delay in producing discovery concerning communications
`
`with FDA, batch records, test results, laboratory notebooks, etc.
`
`
`
`
`
`The Case Law Cited By Amneal Is Inapposite
`1.
`Amneal’s opposition brief relies solely on case law involving regulatory
`
`delays. Notably, Amneal does not make any legal argument concerning discovery
`
`delay as the grounds for an extension of the 30-month stay, and none of the case
`
`law cited by Amneal involves the type of failure to reasonably cooperate in
`
`expediting the action that has occurred in the present case.
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`6
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`

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`Amneal materially misconstrues the basis upon which the Court in In re
`
`Brimonidine Patent Litig. rendered its holding. No. 07-md-1866 GMS, 2008 U.S.
`
`Dist. LEXIS 92405 (D. Del. Oct. 31, 2008). Amneal cites this case solely for the
`
`proposition that identifying a new manufacturer is not indicative of failure to
`
`expedite the litigation. (Opp. Br. at 16). But, unlike the present case, in which
`
`Amneal intentionally delayed discovery, the Brimonidine court failed to find
`
`dilatory conduct and discovery antics, which are the foundation of a court’s 30-
`
`month stay extension analysis. 2008 U.S. Dist. LEXIS 92405, at *10.
`
`Amneal further relies on Sunovion Pharms. Inc., v. Sandoz, Inc., a case
`
`which undercuts its position. No. 5:10-MD-1500-H(3), 2011 U.S. Dist. LEXIS
`
`99077, at *3 (E.D.N.C. Sept. 1, 2011). In Sunovion, the 30-month stay was
`
`extended because Sandoz failed to reasonably cooperate in expediting the
`
`litigation. 2011 U.S. Dist. LEXIS 99077, at *3. It was only after Sandoz withdrew
`
`its Paragraph IV certification that the court vacated the order. Sunovion, 2011 U.S.
`
`Dist. LEXIS 99077, at *9-10.
`
`The facts in 3M v. Alphapharm Pty. Ltd. are also distinguishable from the
`
`present case. No. 99-13, 2002 U.S. Dist. LEXIS 28843, at *5-7 (D. Minn. Mar. 8,
`
`2002). Most importantly, FDA had already approved Alphapharm’s ANDA at the
`
`time the court heard the motion to extend the 30-month stay and the court
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`7
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`

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`concluded that it did not have the authority to order a non-party to withdraw its
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`approval of an ANDA. Id. at *6.
`
`Amneal cites Alcon Labs., Inc. v. Akorn, Inc. in passing, apparently only
`
`because that court denied Alcon’s motion to extend the 30-month stay. No. 15-cv-
`
`285, 2016 U.S. Dist. LEXIS 2182 (D.N.J. Jan. 8, 2016)). Amneal provides no
`
`further analysis as to why this holding should impact the present case. In
`
`particular, the Alcon plaintiff’s justification for extending the 30-month stay was
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`predicated on a stay of the underlying litigation, during which time Inter Partes
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`Review proceedings would occur. Alcon, 2016 U.S. Dist. LEXIS 2182, at *4-5.
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`The court denied the motion to extend the 30-month stay and found that no party
`
`had “failed to reasonably cooperate with expediting the proceedings.” Id. at *6.
`
`D. Amneal Offers No Explanation for Its Conduct
`Amneal’s Document Production Delay
`1.
`Amneal grossly exaggerates its cooperation in expediting the present
`
`litigation regarding document production. Amneal has produced 47,274
`
`documents to date. 2 As of the March 1, 2016, deadline for substantial completion
`
`of Amneal’s production, Amneal had only produced 10,098 documents. As of July
`
`
`2 Amneal is mistaken that it produced 325,000 documents. (Opp. Br. at 12). To
`date, Amneal has only produced 47,274 documents. Of these 47,274 documents,
`nearly 10,000 of these documents were withheld as privileged or deemed non-
`responsive by Amneal and produced with “slip sheets” in their place. Further,
`nearly 5,000 documents were duplicates of other documents in Amneal’s
`production.
`
`8
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`

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`31, 2016, Amneal had produced 24,733 documents. Between July 31 and October
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`13, 2016, only fifteen documents were produced. On October 27, 2016, Shire
`
`demanded the documents Amneal had promised to produce at this Court’s
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`September 8, 2016 conference. On November 15, 2016 Shire threatened to seek
`
`assistance from the Court if Amneal continued its delay. (Exhibit 16 to Shire’s
`
`Opening Brief). On December 2, 2016 Amneal produced 8,040 documents, all
`
`dated before April 2015. In fact, all documents produced by Amneal up to
`
`December 2016 were created on or before April 2015 – no documents concerning
`
`the manufacture or testing of Amneal’s new exhibit batch were produced before
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`December 2, 2016. On December 12, 2016, in anticipation of a conference with
`
`the Court, Shire set forth six pages of ongoing discovery delays. On December 16,
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`2016, Amneal produced a mere seven documents
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`
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`Only now, after the Court ordered Amneal to produce all outstanding documents,
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`has Amneal supplemented its production with 14,467 documents (11,391 of which
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`were created before August 31, 2016 and could have been produced earlier). To
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`date, Amneal has not yet obeyed the Court’s order to produce all documents
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`responsive to Shire’s document requests by February 1. The foregoing chronology
`
`demonstrates beyond doubt that Amneal has delayed producing relevant
`
`documents until faced with threatened or actual Court intervention. Amneal’s
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`9
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`production delays compel a conclusion that Amneal has not reasonably cooperated
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`in expediting the action.
`
`2.
`
`Amneal’s Failure to Identify Sufficient Kashiv
`Custodians Caused Delay and Necessitated Shire’s Requests
`For Additional Custodians
`
`Amneal complains in its brief about Shire’s requests for documents from
`
`additional Kashiv custodians. (Opp. Br. at 12). Yet, this was a problem of
`
`Amneal’s own creation. Amneal only identified three Kashiv custodians at the
`
`onset of this litigation, despite the fact that more than three dozen Kashiv
`
`employees
`
`
`
` Because of Amneal’s failure to choose sufficient Kashiv
`
`custodians, Shire was forced to seek third-party discovery from Kashiv. When
`
`Kashiv reproduced documents from the same three custodians, merely re-Bates
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`stamping and reproducing Amneal’s production, Shire was forced to move to
`
`compel discovery from Kashiv and to add Kashiv as a party, the latter of which
`
`could not be done until Amneal had belatedly produced the contract evidencing the
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`relationship between itself and Kashiv. If Amneal had provided sufficient Kashiv
`
`custodians in the first instance, it could have avoided the need to collect and
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`produce additional custodial documents today.
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`10
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`3.
`
`Shire Is Entitled to Discovery Concerning Amneal’s New
`Exhibit Batch
`
`Amneal’s production of samples from its new exhibit batch and new active
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`ingredient does not exonerate Amneal’s delay in the timely production of
`
`witnesses and document discovery
`
` (Opp. Br. at
`
`15). Remarkably, Amneal never proffers a reason why it waited nearly six months
`
`from the time it produced samples
`
`
`
`
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`
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`Furthermore, Amneal tries to feign good faith by agreeing to produce documents
`
`created after the date of the complaint. (Opp. Br. at 8). This is not a concession.
`
`Amneal has merely agreed to produce documents that were relevant to its new
`
`ANDA product and that it had an obligation to produce.
`
`E. Amneal Has Been Uncooperative in Scheduling Depositions
`Amneal repeatedly accuses Shire of refraining from taking the depositions of
`
`previously noticed custodians, specifically that of Dr. Dipen Desai, who was
`
`originally designated as Amneal’s corporate witness on all of Shire’s 30(b)(6)
`
`topics. (Opp. Br. at 14). But, Shire is not obligated to take a 30(b)(6) deposition
`
`until the relevant documents have been produced. Specifically, Shire
`
`understandably hesitated to take the deposition of Dr. Desai, the head of Kashiv’s
`
`formulation group,
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`
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`11
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` the overwhelming majority of which were not produced until
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`January 30, 2017. Further, Amneal would not agree to allow Shire to leave open
`
`the depositions of witnesses until Amneal’s production was complete. On the
`
`other hand, Shire sought to take the deposition of Dr. Mani, an Amneal witness
`
`
`
` yet, as described above, Amneal thwarted
`
`Shire’s attempts to take this deposition earlier.
`
`Shire Did Not Delay This Litigation
`
`F.
`Shire’s opening brief set forth specific instances of Amneal’s delay. Amneal
`
`did not contest those instances, but instead alleges delay by Shire. Shire did not
`
`delay by attempting to work through Amneal’s delays and by jointly requesting an
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`extension of fact discovery. Shire did not delay by negotiating ESI search terms.
`
`The negotiations were ongoing between the parties from January 15, 2016 to
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`January 27, 2016—and certainly did not span the course of two months. (Opp. Br.
`
`at 20). Amneal conveniently omits part of Exhibit 30 to its Opposition Brief, in
`
`which Amneal requested an extension of time to produce documents under the
`
`parties’ search term agreement. Finally, Shire’s motion to add Kashiv did not
`
`delay this litigation. (Opp. Br. at 20). Amneal failed to identify the proper number
`
`of Kashiv custodians in the first instance and then withheld the contract evidencing
`
`the relationship between Amneal and Kashiv such that Shire could not move to add
`
`Kashiv as a party sooner.
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`12
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`G. Amneal Is Not Prejudiced By A 30-Month Stay Extension
`Shire’s motion and declaration of Dr. Nicholas M. Fleischer, both of which
`
`detail the severity of the Form 483 received by Divi’s
`
`
`
`Amneal would not be prejudiced by an extension of the 30-month stay. Amneal
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`still has regulatory hurdles to overcome before it can obtain approval.
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` demonstrate that
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`
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` However, it is unclear whether the first ANDA filer is
`
`entitled to 180-day exclusivity in this instance. 21 U.S.C. § 355(j)(5)(D)(i)(I)-(VI).
`
`
`
`
`
`Amneal also misrepresents the Hatch-Waxman framework. Shire did not
`
`state that the 30-month stay must be “coterminous” with the end of the litigation.
`
`(Opp. Br. at 19). In fact, Shire explicitly stated that “[w]hile the 30-month stay is
`
`not intended to be coextensive with the completion of all Hatch-Waxman patent
`
`cases, it is meant to provide sufficient time for the parties to be well underway, if
`
`not complete, with their preparation for trial on the merits before a potential launch
`
`of the ANDA drug product.” (Opening Br. at 1). The remedy of extending a 30-
`
`month stay was created for cases such as this, where time was lost due to
`
`unreasonable delay.
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`13
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` Neither Amneal nor the declaration of Mr. Dormer dispute
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`the following opinions from Nicholas M. Fleischer: (1) the severe nature of FDA’s
`
`observations cited in the Form 483. (¶¶ 20-21);
`
`
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`
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`The only disagreement between Dr. Fleischer and Mr. Dormer is the severity of
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`FDA’s actions post-Divi’s receipt of the Form 483,
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`Amneal served Rule 45 subpoenas on Dr. Fleischer on January 30, 2017,
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`noticing the deposition for February 2, 2017.
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`14
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`Case 1:15-cv-02865-RBK-JS Document 211-9 Filed 03/16/17 Page 19 of 20 PageID: 5078
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`If Mr. Dormer is correct, and if Amneal is successful in obtaining approval
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`of its product from FDA after the current 30-month stay expires, Shire will need to
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`move for a preliminary injunction (because it is unclear whether a 180-day
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`exclusivity attaches in this case). If Dr. Fleischer is correct, the 30-month stay
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`should be extended to permit Shire additional time to take discovery
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` Further, Shire’s request to extend the 30-
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`month stay now complies with the Court’s preference that this issue be resolved
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`now. (Dkt. No. 158, Jan. 3. 2017 Hearing Tr. at 14)( “I couldn’t disagree with you
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`more. The issue can’t be put off. The issue has to be dealt with.”).
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`III. CONCLUSION
`Shire respectfully requests that this Court extend the 30-month stay by
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`eleven months or until Judge Kugler renders his opinion on the merits of the case,
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`whichever occurs first.
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`15
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`Case 1:15-cv-02865-RBK-JS Document 211-9 Filed 03/16/17 Page 20 of 20 PageID: 5079
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`Dated: February 14, 2017
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`Respectfully submitted,
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`OF COUNSEL:
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`Edgar H. Haug
`Joseph V. Saphia
`Jessica H. Zafonte
`Bonnie Gaudette
`FROMMER LAWRENCE & HAUG LLP
`745 Fifth Avenue
`New York, New York 10151
`(212) 588-0800
`EHaug@flhlaw.com
`JLief@flhlaw.com
`AWasson@flhlaw.com
`JZafonte@flhlaw.com
`
`
`
`By: s/ William C. Baton
` Charles M. Lizza
`William C. Baton
`Jamie L. Lucia
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`wbaton@saul.com
`jlucia@saul.com
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`Attorneys for Plaintiffs
`Shire Development LLC,
`Shire Pharmaceutical Development
`Inc., Cosmo Technologies Limited,
`and Nogra Pharma Limited
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`16
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