Case 2:13-cv-00391-ES-JAD Document 354 Filed 05/26/17 Page 1 of 6 PageID: 7024
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO, P.C.
`COUNSELLORS AT LAW
`_____________
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`5 BECKER FARM ROAD
`ROSELAND, N.J. 07068 -1739
`PHONE (973) 994 -1700
`FAX (973) 994 -1744
`www.carellabyrne.com
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`JAMES T. BYERS
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`DONALD F. MICELI
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`A. RICHARD ROSS
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`CARL R. WOODWARD, III
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`MELISSA E. FLAX
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`DAVID G. GILFILLAN
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`G. GLENNON TROUBLEFIELD
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`BRIAN H. FENLON
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`LINDSEY H. TAYLOR
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`CAROLINE F. BARTLETT
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`May 26, 2017
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` FRANCIS C. HAND
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` AVRAM S. EULE
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` CHRISTOPHER H. WESTRICK*
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` ______
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` OF COUNSEL
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` *CERTIFIED BY THE SUPREME COURT OF
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` NEW JERSEY AS A CIVIL TRIAL ATTORNEY
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`RAYMOND J. LILLIE
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`WILLIAM SQUIRE
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`STEPHEN R. DANEK
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`DONALD A. ECKLUND
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`MEGAN A. NATALE
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`ZACHARY S. BOWER+
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`MICHAEL CROSS
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`CHRISTOPHER J. BUGGY
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`JOHN V. KELLY III
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`MICHAEL A. INNES
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`+MEMBER FL BAR ONLY
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`CHARLES C. CARELLA
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`BRENDAN T. BYRNE
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`PETER G. STEWART
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`JAN ALAN BRODY
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`JOHN M. AGNELLO
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`CHARLES M. CARELLA
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`JAMES E. CECCHI
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`JOHN G. GILFILLAN III (1936-2008)
`ELLIOT M. OLSTEIN (1939-2014)
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`JAMES D. CECCHI (1933-1995)
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`Via ECF
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`Hon. Joseph A. Dickson, U.S.M.J.
`United States District Court for the District of New Jersey
`Martin Luther King, Jr. Federal Building & U.S. Courthouse
`50 Walnut Street
`Newark, New Jersey 07101
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`Dear Judge Dickson:
`
`
`RE:
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`Jazz Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals, LLC et al.
`Civil Action No. 2:13-cv-391 (ES)(JAD) (Consolidated)
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`This Firm, together with Rakoczy Molino Mazzochi Siwik LLP, represents Lupin
`Limited, Lupin Pharmaceuticals, Inc. and Lupin Inc. (collectively, “Lupin”) in the above
`consolidated matter.1, 2
`
`Lupin respectfully submits this letter seeking an order compelling Plaintiffs Jazz
`Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, “Jazz”) to produce
`documents related to settlement and license agreements involving the same drug—Xyrem®—
`and the same 18 patents asserted against Lupin, including Jazz’s three settlement and license
`agreements with Roxane, Wockhardt, and Ranbaxy.
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`Such documents are responsive to Lupin’s First Set of Requests for the Production of
`Documents and Things (Nos. 1-108), served August 19, 2016 (“Lupin’s Requests”), as detailed
`more fully below. Such documents are also routinely produced in ANDA litigations. See, e.g.,
`Allergan, Inc. v. Teva Pharm. USA, Inc., No. 15-cv-1455-WCB, 2017 WL 132265, at *2 (E.D.
`Tex. Jan. 12, 2017). Jazz has refused to comply with Lupin’s legitimate requests, despite the
`clear relevance of the documents requested to Lupin’s defenses.
`
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`1 The defendants in the consolidated litigation include Lupin, Amneal Pharmaceuticals, LLC (“Amneal”); Par
`Pharmaceutical, Inc. (“Par”); and Watson Laboratories, Inc. (“Watson”). Wockhardt Bio AG, Wockhardt Limited
`and Wockhardt USA LLC (collectively, “Wockhardt”); and Sun Pharmaceutical Industries Limited, Ohm
`Laboratories Inc. and Ranbaxy Inc. (collectively, “Ranbaxy”) have reached settlement agreements with Jazz, as
`discussed herein.
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`2 Roxane Laboratories, Inc., Westward Pharmaceuticals Corp., Eurohealth (USA), Inc. and Hikma Pharmaceuticals
`PLC (collectively, “Roxane”) is the first ANDA-Filer for Xyrem®. Jazz sued Roxane in Jazz Pharmaceuticals, Inc.
`v. Roxane Laboratories, Inc., Civil Action No. 10-6108 (ES)(JAD) (D.N.J.), among others.
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`

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`Case 2:13-cv-00391-ES-JAD Document 354 Filed 05/26/17 Page 2 of 6 PageID: 7025
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`Hon. Joseph A. Dickson, U.S.M.J.
`May 26, 2017
`Page 2
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`Lupin has attempted to resolve this discovery dispute with counsel for Jazz, including as
`required under the Local Rules; however, the parties remain at an impasse. Given that the June
`23, 2017 close of fact discovery is fast approaching, Lupin is forced to seek relief from the
`Court.
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`I.
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`BACKGROUND.
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`Starting in November 2010, Jazz initiated suits against multiple parties with respect to
`their Abbreviated New Drug Application (“ANDA”) for a generic version of Xyrem®, including
`Roxane, Amneal, Par, Watson, Wockhardt, and Ranbaxy.
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`On September 1, 2015, Jazz filed its complaint against Lupin alleging infringement of
`18 patents, 16 of which are listed in the Orange Book with respect to Xyrem®. (See Complaint,
`Jazz Pharm., Inc. v. Lupin Ltd., Civil Action No. 15-6548 (ES)(JAD) (D.N.J. Sept. 1, 2015), D.I.
`1). The patents asserted against Lupin are the same patents asserted against Roxane, Amneal,
`Par, Watson, Wockhardt and Ranbaxy. On January 14, 2016, the Court consolidated the Lupin
`action with the action pending against Amneal, Par, Watson, Wockhardt and Ranbaxy.
`(1/14/2016 Order, D.I. 200).
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`Subsequently, Jazz reached agreements with Wockhardt and Ranbaxy that resulted in the
`termination of those parties. (See, e.g., 4/25/2016 Stipulation and Order of Dismissal (D.I. 271);
`5/18/2016 Stipulation and Order of Dismissal (D.I. 292)).
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`Lupin served discovery requests on Jazz on August 19, 2016, including the following
`requests for production of settlement and license agreements related to Xyrem®, the patents-in-
`suit, and the related Xyrem® litigations (e.g., those noted above):
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
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`

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`Case 2:13-cv-00391-ES-JAD Document 354 Filed 05/26/17 Page 3 of 6 PageID: 7026
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`Hon. Joseph A. Dickson, U.S.M.J.
`May 26, 2017
`Page 3
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`(Ex. 1, Lupin’s Requests at 23). Jazz served Objections and Responses to Lupin’s First Set of
`Requests for the Production of Documents and Things (Nos. 1-108) (“Jazz’s Responses”) (Ex.
`2), objecting that these requests seek “documents and information that are not relevant to any
`claim or defense currently in this action and [are] not proportional to the needs of the case.” (Ex.
`2, Jazz’s Responses at 70-75).
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`Lupin sent a December 30, 2016 letter to Jazz objecting, among other things, to Jazz’s
`refusal to produce documents related to settlements and licensing and further explaining the
`relevance of such documents. (Ex. 3, 12/30/16 N. White Letter at 7-8). During a January 17,
`2017 meet and confer, Lupin reiterated its requests and subsequent correspondence and again
`requested Jazz produce documents regarding settlement and license agreements. Jazz indicated
`that it would not produce such documents despite Lupin’s position, but would consider case law
`cited by Lupin.
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`On April 5, 2017, Jazz announced that it had reached a settlement with Roxane. (Ex. 4,
`Press Release: Jazz Pharmaceuticals Reaches Settlement with Hikma Pharmaceuticals Related to
`Xyrem
`Patent
`Litigation
`(April
`5,
`2017),
`http://investor.jazzpharma.com/
`phoenix.zhtml?c=210227&p=irol-newsPageArticle&ID=2260197; see also Ex. 5, 4/11/2017
`Stipulation and Order of Dismissal, Jazz Pharm., Inc. v. Roxane Labs., Inc., Civil Action No. 10-
`6108 (ES)(JAD) (D.N.J.), D.I. 508).
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`On April 12, 2017, Lupin sent a letter to Jazz again requesting production of documents
`relating to the settlement and license agreements, and specifically regarding the recent settlement
`between Jazz and Roxane. (Ex. 6, 4/12/2017 J. Marx Letter). During an April 25, 2017 meet and
`confer, Lupin again explained the relevance of the settlement and license agreement documents,
`yet Jazz refused to confirm that it would produce the requested discovery. On May 1, 2017,
`Lupin sent a follow-up letter to Jazz, requesting, once again, the production of the settlement and
`license agreement from the Roxane litigation and discussing relevant case law holding
`production of such settlement and license agreements is proper in ANDA litigation. (Ex. 7,
`5/1/2017 J. Marx Letter). On May 22, 2017, the parties met and conferred to discuss several
`outstanding discovery disputes, including the production of documents relating to the settlement
`and license agreement between Jazz and Roxane. During the meet and confer, Jazz affirmatively
`refused to produce any documents relating to settlement and license agreements, including those
`between Jazz and Roxane, again asserting that the information sought was not relevant.
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`II.
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`JAZZ SHOULD BE COMPELLED TO PRODUCE DOCUMENTS RELATING
`TO SETTLEMENT AND LICENSE AGREEMENTS.
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`Contrary to Jazz’s assertion, the requested documents are directly relevant to several
`pending issues in this case, including, but not necessarily limited to, Lupin’s invalidity defenses,
`including obviousness, and Jazz’s claims for injunctive relief. In fact, these types of documents
`are routinely produced in patent litigations.
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`Under Federal Rule Civil Procedure 26(b)(1), a party may obtain discovery “regarding
`any nonprivileged matter that is relevant to any party’s claim or defense.” See also Kopacz v.
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
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`

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`Case 2:13-cv-00391-ES-JAD Document 354 Filed 05/26/17 Page 4 of 6 PageID: 7027
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`Hon. Joseph A. Dickson, U.S.M.J.
`May 26, 2017
`Page 4
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`Delaware River & Bay Auth., 225 F.R.D. 494, 497 (D.N.J. 2004) (“Courts have construed Rule
`26 liberally, creating a broad range for discovery which would ‘encompass any matter that bears
`on or that reasonably could lead to other matter that could bear on, any issue that is or may be in
`the case.’” (citation omitted)).
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`Courts have applied this maxim and routinely compelled discovery of settlement
`agreements, while adhering to the tradition of construing the requirement of relevancy “liberally
`and with common sense, rather than in terms of narrow legalisms.” Key Pharm., Inc. v. ESI-
`Lederle, Inc., Case No. 96-cv-1219, 1997 WL 560131, at *3 (E.D. Pa. Aug. 29, 1997) (citing 8
`Charles A. Wright, Arthur R. Miller, & Richard L. Marcus, Federal Practice and Procedure
`§ 2008 at 107 (1994)) see also Wyeth v. Orgenus Pharma Inc., No. 09-cv-3235 (FLW), 2010 WL
`4117157, at *4 (D.N.J. Oct. 19, 2010) (granting ANDA Filer’s motion to compel production of
`license and settlement documents related to the settlement of other litigation based on the
`patents-in-suit); Allergan, 2017 WL 132265, at *1-2 (surveying cases nationwide, including the
`District of New Jersey, compelling production of settlement and license agreements and ordering
`production of same).
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`Such settlement and licensing documents are relevant to issues of validity of the patents-
`in-suit. See, e.g., Wyeth, 2010 WL 4117157 at *4; Allergan, 2017 WL 132265 at *2 (citing “a
`number of courts” that “have required the production of settlement agreements based at least in
`part on their relevance to issues of validity”); Datapoint Corp. v. PictureTel Corp., Case No. 93-
`cv-2381, 1998 WL 51356, at *1-3 (N.D. Tex. Jan. 23, 1998). Documents regarding settlement
`and license agreements are also relevant to Jazz’s claims for injunctive relief. See Datapoint,
`1998 WL 51356, at *1-3 (ordering production of settlement agreement in part because it was
`relevant to damages issues); Tyco Healthcare Grp. LP, v. E-Z-EM, Inc., No. 2:07-cv-262, 2010
`WL 774878, at *2 (E.D. Tex. Mar. 2, 2010) (same); Datatreasury Corp. v. Wells Fargo & Co.,
`No. 2:06-cv-72, 2010 WL 903259, at *2 (E.D. Tex. Mar. 4, 2010) (same).
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`Moreover, “information . . . need not be admissible in evidence to be discoverable.” FED.
`R. CIV. P. 26(b)(1). Indeed, with respect to settlement agreements specifically, courts have noted
`the distinction between the standards for discoverability and for admissibility and have rejected
`parties’ attempts to conflate the two. See Wyeth, 2010 WL 4117157, at *4 (citing the relevant
`portions of Fed. R. Civ. P. 26(b)(1)).
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`As such, under the Federal Rules, Lupin is entitled to discovery of documents that are
`relevant to these issues.
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`A.
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`The Requested Documents Are Relevant to Lupin’s Invalidity Defenses.
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`The requested documents are directly relevant to Lupin’s invalidity defenses in this
`litigation. Lupin has asserted in its required disclosures in this case that the asserted claims of the
`patents-in-suit are invalid for being obvious. In assessing obviousness of patent claims, Courts
`often rely on what the Supreme Court has termed “indicia of obviousness or non-obviousness,”
`also called secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
`Licenses and settlement agreements are often considered by the courts in assessing the
`obviousness of patent claims, because they can shed light on the commercial success or lack
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
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`

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`Case 2:13-cv-00391-ES-JAD Document 354 Filed 05/26/17 Page 5 of 6 PageID: 7028
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`Hon. Joseph A. Dickson, U.S.M.J.
`May 26, 2017
`Page 5
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`thereof, of the patented feature. In addition, licenses and settlement agreements may provide
`evidence of an absence of nexus between the marketed product and the purportedly novel feature
`of the patent. See, e.g., SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1358-
`1359 (Fed. Cir. 2000). Courts have thus concluded that settlements and license agreements are
`relevant to a defendant’s invalidity defenses. See, e.g., Wyeth, 2010 WL 4117157 at *4 (D.N.J.
`Oct. 19, 2010); Datapoint, 1998 WL 51356, at *2 (rejecting plaintiff’s Fed. R. Evid. 408 and
`chilling effect objections, and holding that “[b]ecause [defendant] asserts several invalidity
`defenses, the license is discoverable in connection with this defense.”)
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`Here, Jazz has asserted secondary considerations, also known as objective indicia, in
`rebutting Lupin’s invalidity defenses. For example, in Jazz’s Response to Lupin’s Invalidity
`Contentions Jazz stated that “[s]econdary considerations of nonobviousness also support the
`validity of [the patents-in-suit], including commercial success, long-felt need, skepticism of
`others, copying, third-party praise and awards, failure of others, and unexpected results.” (See,
`e.g., Ex. 8, 8/12/2016 Jazz’s Response to Lupin’s Invalidity Contentions at 58). Further,
`settlement and license agreements are “potentially relevant to commercial success regardless of
`whether [Jazz] plans to exploit it, since it is possible that the defendants may wish to make use of
`that evidence.” Allergan, 2017 WL 132265, at *2 (E.D. Tex. Jan. 12, 2017).
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`Therefore, Lupin requests production of the requested documents as they are relevant to
`Lupin’s invalidity defenses and proportional to the needs of the case, including considering the
`importance of the issues at stake in the action. See FED. R. CIV. P. 26(b)(1).
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`B.
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`The Requested Documents Are Relevant to Jazz’s Claims for Injunctive
`Relief.
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`The requested documents are also relevant to Lupin’s efforts to defend against Jazz’s
`claims for injunctive relief. Jazz has requested that the Court grant “[p]reliminary and permanent
`injunctions enjoining Lupin . . . from making, using, selling, offering to sell, and/or importing
`Lupin’s Proposed Product until after the expiration of the patents-in-suit, or any later expiration
`of exclusivity to which Plaintiffs are or become entitled.” (Ex. 9, First Amended Complaint for
`Patent Infringement at 35, Jazz Pharm., Inc. v. Lupin Ltd., Civil Action No. 15-6548 (ES)(JAD)
`(D.N.J. Dec. 22, 2015), D.I. 15).
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`It is well-settled law that licenses and settlement agreements are relevant in considering
`whether irreparable harm has occurred or will occur. See, e.g., Georgia-Pacific Corp. v. U.S.
`Plywood Corp., 318 F. Supp. 1116 (S.D.N.Y. 1970) (setting forth the oft-cited “Georgia-Pacific
`factors”). While Jazz now argues that documents relating to settlement and license agreements,
`including the agreement between Jazz and Roxane, Wockhardt, and Ranbaxy, are not relevant to
`the current proceeding, this is flatly inconsistent with positions taken by Jazz when seeking
`discovery from Lupin. For example, Jazz’s Notice of Deposition of Lupin Pursuant to Fed. R.
`Civ. P. 30(b)(6), served January 24, 2017 (“Jazz’s 30(b)(6) Notice”), includes topics that go to
`injunction-related discovery. (See, e.g., Ex. 10, Jazz’s 30(b)(6) Notice, Topic Nos. 9, 10 (“The
`potential market for a generic Xyrem® product, including, but not limited to, any analysis or
`projections concerning the sale of Xyrem® or a generic Xyrem® product” and “Lupin’s plans
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
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`

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`Case 2:13-cv-00391-ES-JAD Document 354 Filed 05/26/17 Page 6 of 6 PageID: 7029
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`Hon. Joseph A. Dickson, U.S.M.J.
`May 26, 2017
`Page 6
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`and strategy to develop, sell, distribute, promote, make available, or market Lupin’s ANDA
`Product”).
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`Lupin has shown that the requested documents are relevant to Jazz’s claims for injunctive
`relief. Therefore, this Court should compel Jazz to produce the settlement agreements and
`licenses without further delay.
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`III. CONCLUSION.
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`For at least the foregoing reasons, Lupin is entitled to discovery regarding settlement and
`license agreements, including the settlement and license agreements between Jazz and Roxane,
`Wockhardt, and Ranbaxy. As such, Lupin respectfully requests that the Court compel Jazz to
`produce all settlement and licensing documents responsive to Lupin’s Request Nos. 72-78, and
`specifically to produce the settlement and license agreements between Jazz and Roxane,
`Wockhardt, and Ranbaxy.
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`We appreciate the Court’s acceptance of this submission, and we thank the Court for its
`consideration in the matter. If the Court would like to discuss the foregoing, we are available at
`the Court’s convenience.
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`Respectfully submitted,
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`CARELLA, BYRNE, CECCHI,
`OLSTEIN, BRODY & AGNELLO
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`/s/ Melissa E. Flax
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`MELISSA E. FLAX
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`Counsel of Record (via E-mail)
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`So Ordered this ___day of ________. 2017
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`___________________________________
`HON. JOSEPH A. DICKSON, U.S.M.J.
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`MEF
`Cc:
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
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