Case 2:13-cv-00391-ES-JAD Document 396 Filed 09/28/17 Page 1 of 5 PageID: 7762
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`William C. Baton
`Phone: (973) 286-6722
`Fax: (973) 286-6822
`wbaton@saul.com
`www.saul.com
`
`September 27, 2017
`
`VIA ECF
`
`The Honorable Joseph A. Dickson
`United States Magistrate Judge
`District of New Jersey
`Martin Luther King, Jr. Federal Building
`50 Walnut Street
`Newark, New Jersey 07102
`
`Re:
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`Jazz Pharmaceuticals, Inc. et al. v. Amneal Pharms. LLC, et al.
`Civil Action No. 13-391 (ES) (JAD) (D.N.J) (consolidated)
`
`Dear Judge Dickson:
`
`This firm, together with Quinn Emanuel Urquhart & Sullivan, LLP and Richard G. Greco
`PC, represents plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Ltd.
`(collectively, “Jazz”) in the above-captioned matter. We write in opposition to Lupin’s
`September 18, 2017 letter to the Court (D.I. 393) seeking leave to file a sur-reply in response to
`Jazz’s July 31 and September 7, 2017 letters (D.I. 374; D.I. 389) to compel discovery from
`Lupin.
`
`A request for leave to file a sur-reply should be denied where the “reply brief[] do[es] not
`raise new arguments or contain statements requiring correction.” Avram v. Samsung Elecs. Am.,
`Inc., No. 11-6973, 2013 WL 3654090 at *5 n.3 (D.N.J. July 11, 2013). As described further
`below, Jazz’s September 7 letter did not contain any new arguments or misstatements requiring
`correction. Also, “[a] surreply is not an opportunity to rectify a woefully inadequate original
`brief or raise issues that should rightly have been addressed therein.” Foster v. Ashcroft, No. 05-
`1734, 2006 WL 1995305 at *3 (D.N.J. July 14, 2006). Yet, that is precisely what Lupin seeks to
`do in its proposed sur-reply. Accordingly, Lupin’s request for a sur-reply should be denied. To
`the extent the Court is inclined to consider the sur-reply as part of Lupin’s submissions, we
`respectfully request that the Court also consider the following.
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`Jazz Has Not Misstated Any Facts Concerning Production of Lupin’s ANDA Samples
`
`Lupin contends that Jazz has misstated the record concerning Jazz’s request for the
`production of samples of Lupin’s ANDA product (D.I. 393 at 1), but Lupin cannot point to any
`false statements by Jazz. Instead, Lupin uses its proposed sur-reply to acknowledge its own
`
`One Riverfront Plaza, Suite 1520  Newark, NJ 07102- 5426  Phone: (973) 286- 6700  Fax: (973) 286- 6800
`
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`Case 2:13-cv-00391-ES-JAD Document 396 Filed 09/28/17 Page 2 of 5 PageID: 7763
`Hon. Joseph A. Dickson, U.S.M.J.
`September 27, 2017
`Page 2
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`misstatement concerning the samples issue. Specifically, for the first time, buried in a footnote
`of its September 18 letter to the Court, Lupin announces
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` (D.I. 393 at n.1.) This directly contradicts Lupin’s
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`representations to Jazz
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` (D.I. 381, Ex. 3, 4/17/2017 L. Shannon Letter at 2.) But,
`while highlighting Lupin’s gamesmanship, this new information does not change the underlying
`issue: Lupin refuses to produce samples that are representative of its ANDA Product.
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`First, Lupin does not—and cannot—refute that from October 2016 to April 2017 it
`refused to produce any samples of its ANDA Product. Because Lupin refused to admit
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` (D.I. 381, Ex. 3, 4/17/2017 L. Shannon Letter at 1-2).
`That is not providing evidence as Lupin suggests.
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`Second, Jazz followed the same procedure endorsed by this Court in Takeda by filing its
`motion to compel. Takeda Pharms. Co. Ltd. v. Zydus Pharms. USA, Inc., No. 10-1723, slip. op.
`at *12 (D.N.J. June 15, 2012) (“Takeda could have sought to compel new samples for
`independent testing.”) Lupin’s cases—Apotex and Orexo (D.I. 393 at 2)—are not binding
`precedent, are counter to Takeda, and are inapposite for the reasons previously set forth in Jazz’s
`September 7 letter. (D.I. 389 at 2.)
`
` This
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`Third, Lupin has not provided any facts to show that manufacturing new samples would
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`be unduly burdensome. To the contrary, Lupin need only
` Finally, Lupin’s position results in an absurd outcome that encourages ANDA defendants
`to argue that its ANDA filing does not prove infringement while also withholding highly-
`relevant evidence, i.e.,
`is directly contrary to the duty to disclose in Fed. R. Civ. P. 26 and the spirit of L. Pat. R.
`2.1(a)(6), which requires the parties to discuss the availability and timing of the production of
`ANDA samples to avoid situations like this. Here,
`
`
` and—as with any ANDA case—the need for production of representative
`ANDA samples is foreseeable. Mosaid Techs. Inc. v. Samsung Elecs. Co., Ltd., 348 F. Supp. 2d
`336 (D.N.J. 2004). Lupin should be compelled to produce unexpired samples or, in the
`alternative, the Court should enter an adverse inference of infringement. (D.I. 374 at 9.)
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`Lupin Restates Its Incorrect Argument Concerning Development Documents
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`Lupin’s arguments that
`(D.I. 393 at 3) are demonstrably false and merely restate the arguments
`made in Lupin’s August 18, 2017 letter (D.I. 381 at 5-6). Contrary to Lupin’s repeated argument
`to this Court, it represented to the FDA that
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` (See, e.g., Ex. AA, attached,
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`Case 2:13-cv-00391-ES-JAD Document 396 Filed 09/28/17 Page 3 of 5 PageID: 7764
`Hon. Joseph A. Dickson, U.S.M.J.
`September 27, 2017
`Page 3
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`D.I. 389 at 3-4.) See also Integra LifeSciences Corp. v. HyperBranch Med. Tech., Inc., No. 15-
`819, 2016 WL 675553, *1-*2 (D. Del.. Feb. 12, 2016) (compelling production of third-party
`documents because: (1) contractual right; (2) business relationship between companies; and (3)
`party had already obtained some documents from third party); Northstar Fin. Cos., Inc. v.
`Nocerino, No. 11-5151, 2013 WL 6061349, *2 (E.D. Pa. Nov. 18, 2013) (sanctions where party
`could have obtained documents “by simply calling the companies”).
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`Lupin Repeats Its Disingenuous Argument Concerning FDA Communications
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`Lupin’s argument for withholding correspondence with the FDA is baseless and repeats
`what it argued in its August 18 letter (D.I. 381 at 6-7). First, Lupin does not—and cannot—
`refute that
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`
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`(See D.I. 374 at 4; id., Ex. 1, 5/24/2017 K. Rycroft Letter at 2.)
`does not transform the
`underlying FDA communication to a privileged communication. Indeed, Lupin’s position results
`in the absurd outcome that any group of generic companies could circumvent the Court’s Local
`Rules
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`. Second, Lupin does not—and cannot—argue that FDA
`communications do not “pertain to its ANDA.” The communications “pertain” to Lupin’s
`ANDA and are highly relevant to induced infringement of the method of use claims that remain
`in the case, regardless of whether the communications relate specifically to the REMS
`documents. (D.I. 374 at 4; D.I. 389 at 5.) Third,
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`
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` (D.I. 389 at 2.) Production of these documents
`is clearly required by the Local Rules and Jazz’s Requests for Production No. 1. (D.I. 374, Ex. 2
`at 6.)
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`Lupin’s Repeats Its False Lack of Control Argument Concerning 30(b)(6) Testimony
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`In its August 18 letter, Lupin alleged that it need not provide testimony relating to
` (D.I. 381 at 8.) In its proposed sur-reply, Lupin’s
`only argument for refusing to provide a witness for certain topics (Nos. 3, 6, 12, and 23-28) and
`unilaterally narrowing others (Nos. 2, 4, 5, 7-11, and 17-21) is the repeated argument that Lupin
`has “no possession, custody, or control” of information from
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` (D.I. 393 at 4.) As discussed above, this is false.
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`Case 2:13-cv-00391-ES-JAD Document 396 Filed 09/28/17 Page 4 of 5 PageID: 7765
`Hon. Joseph A. Dickson, U.S.M.J.
`September 27, 2017
`Page 4
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` (See also D.I. 374 at 5-8; D.I. 389 at 5-6.) Jazz’s topics are relevant, and
`Lupin should be compelled to produce educated witnesses on the full scope of each topic.
`Harris v. New Jersey, 259 F.R.D. 89, 92 (D.N.J. 2007) (“if necessary the deponent must use
`documents, past employees or other resources to obtain responsive information”); N.J. Dep't of
`Envtl. Prot. v. Am. Thermoplastics Corp., No. 98-CV-4781, 2017 WL 498710, *2, *3 (D.N.J.
`Feb. 7, 2017) (relying on scope of 30(b)(6) discovery set forth in Sanofi-Aventis v. Sandoz, Inc.,
`272 F.R.D. 391, 394 (D.N.J. 2011) outside of “sister company” context).
`
`*
`*
`*
`For at least the reasons above, Lupin’s request for a sur-reply should be denied. Further,
`for the foregoing reasons and those articulated in Jazz’s July 31 and September 7, 2017 letters
`(D.I. 374; D.I. 389), Jazz respectfully requests that the Court compel Lupin to: (1) produce
`unexpired samples of Lupin’s ANDA Product and its components; (2) produce the requested
`development documents; (3) produce all FDA correspondence; and, (4) designate a 30(b)(6)
`witness to testify to the full scope of each Topic in Jazz’s 30(b)(6) Deposition Notice to Lupin.
`We are available at Your Honor’s convenience to participate in a conference with the Court to
`resolve this matter.
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`Thank you for Your Honor’s continuing attention to this matter.
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`Respectfully yours,
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`Exhibit
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`William C. Baton
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`cc:
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`Counsel for Lupin (via e-mail)
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`REDACTED
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`Case 2:13-cv-00391-ES-JAD Document 396 Filed 09/28/17 Page 5 of 5 PageID: 7766
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`EXHIBIT AA
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`Confidential Material Redacted
`Pursuant to L. Civ. R. 5.3(c)(4)
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