Case 2:13-cv-00391-ES-JAD Document 366 Filed 06/20/17 Page 1 of 5 PageID: 7163
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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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`June 20, 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. We write in reply to the June 13, 2017 letter (ECF 363) submitted by
`Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively,
`“Jazz”) opposing Lupin’s request for an order compelling Jazz to produce documents related to
`settlement and license agreements, including Jazz’s three settlement and license agreements with
`Roxane, Wockhardt, and Ranbaxy.1
`
`As an initial matter, Jazz does not dispute that the documents Lupin is requesting are
`relevant. Nor can it since the requested documents are settlement and license agreements
`involving the same drug—Xyrem®—and the same 18 patents asserted against Lupin. Nor can
`Jazz argue there is any significant burden or expense—the documents are clearly available and
`not burdensome for Jazz to produce, and any concerns of confidentiality that Jazz or any other
`party alleges are subsumed by the Discovery Confidentiality Order (“DCO”). The inquiry should
`end there—Lupin has established that these documents are relevant to the claims at issue and
`Jazz has failed to argue otherwise.
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`Knowing arguments regarding relevancy fail, Jazz resorts to accusing Lupin of using its
`(clearly valid) requests as a “ruse” to try to “gain a competitive advantage during settlement
`
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`1 We also write in reply to the June 14, 2017 letter (ECF 364) submitted by Wockhardt Bio AG,
`Wockhardt USA LLC, and Wockhardt Ltd. (collectively, “Wockhardt”) and the June 14, 2017
`letter (ECF 365) submitted by Roxane Laboratories, Inc. (“Roxane”).
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`Case 2:13-cv-00391-ES-JAD Document 366 Filed 06/20/17 Page 2 of 5 PageID: 7164
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`Hon. Joseph A. Dickson, U.S.M.J.
`June 20, 2017
`Page 2
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`discussions.” (6/13/17 C. Lizza Letter, at 1).2 Jazz’s concerns fall flat. First, the DCO is more
`than sufficient to address any concerns regarding the use of highly confidential information. Jazz
`argues the requested documents contain “highly sensitive commercial information” that was
`“intended to be—and which should remain—confidential.” (6/13/17 C. Lizza Letter, at 1-2). But
`courts have routinely required production of settlement and license agreements despite any
`claims of confidentiality. Wyeth v. Orgenus Pharma Inc., No. 09-3235(FLW), 2010 WL
`4117157, at *4 (D.N.J. Oct. 19, 2010) (“recognizing that “license agreements relating to the
`patent-in-suit, and entered into in connection with settlement, are discoverable and that
`Plaintiff’s third party confidentiality concerns do not outweigh legitimate grounds to compel
`production”); Allergan, Inc. v. Teva Pharm. USA, Inc. No. 2:15-CV-1455-WCB, 2017 WL
`132265, at *3 (E.D. Tex. Jan. 12, 2017). Further, Wockhardt’s (6/14/17 S. Wiggins Letter, ECF
`364) and Roxane’s (6/15/17 B. Rose Letter, ECF 365) claims are similarly baseless, particularly
`where the DCO entered in this action—to which Wockhardt was a party—allowed for the
`sharing of codefendants highly confidential information. (12/19/2016 DCO at 9-10, 13, ECF 355
`(Clause 6.(b). permits Highly Confidential information produced by one Defendant to be
`disclosed to outside counsel attorneys for the other parties)); see also Allergan, 2017 WL
`132265, at *3 (“well-counseled parties who engage in settlement negotiations in multi-defendant
`cases such as this one will know that it is very possible that their settlement agreements will be
`discoverable by co-defendants who may be their competitors.”).
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`Second, there is no evidence or legal authority supporting Jazz’s assertion that production
`of relevant settlement and license agreements is improper or would require barring Lupin’s
`counsel from participating in settlement negotiations as Jazz requests (6/13/17 C. Lizza Letter, at
`4). See, e.g., Allergan, 2017 WL 132265, at *2 (rejecting argument that requested discovery was
`for the “improper purpose of aiding [the defendant] in settlement negotiations” and finding
`plaintiff failed to make the “showing of exceptional need” that would justify such restrictions on
`counsel).
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`I.
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`Jazz Does Not Deny the Requested Discovery Is Relevant.
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`Jazz does not dispute the requested documents are relevant to objective indicia of non-
`obviousness and Jazz’s request for injunctive relief. Instead, Jazz tries to hedge against
`production with empty representations to the Court—first that it does not plan to use the
`requested documents in its own case-in-chief, and second, that any request it will make for
`injunctive relief will be so far in the future that this Court should not order production now. Both
`arguments fail, as articulated below.
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`2 Jazz also alleges that “Lupin did not actively pursue discovery of these documents” until “Jazz
`settled its infringement claims against Roxane, the first ANDA-filer.” (6/13/17 C. Lizza Letter,
`at 2). As Lupin explained in its letter dated May 26, 2017 (ECF 354), Lupin pursued production
`of the requested discovery from its very first communication with Jazz regarding its written
`discovery responses on December 30, 2016 (and long before Jazz’s settlement with Roxane) and
`continually through these submissions to this Court. (5/26/17 M. Flax Letter, at 3, ECF 354).
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
`
`

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`Case 2:13-cv-00391-ES-JAD Document 366 Filed 06/20/17 Page 3 of 5 PageID: 7165
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`Hon. Joseph A. Dickson, U.S.M.J.
`June 20, 2017
`Page 3
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`As to invalidity, Jazz does not challenge that the requested discovery is relevant to “one
`of the ‘objective indicia of non-obviousness’” and “‘can shed light on the commercial success . .
`. of the patented feature.’” (6/13/17 C. Lizza Letter, at 2, ECF 363). Instead, Jazz asserts that
`because it does not intend to rely on the settlement documents or license agreements for support
`of its own commercial success arguments, it should not be required to produce them.
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`The requested documents are relevant regardless of whether Jazz intends to rely upon
`them. Allergan, 2017 WL 132265, at *2; Pfizer Inc. v. Apotex Inc., 731 F. Supp. 2d 754, 759
`(N.D. Ill. 2010) (despite patentee’s representation that it will not rely on licensing as a secondary
`consideration determining “[t]hese are precisely the kind of documents that discovery permits
`[the defendant] to demand and receive”). Similar to the case in Allergan, Jazz is not saying that it
`does not intend to argue commercial success, rather only that it “is not relying on licensing to
`show commercial success.” (6/13/17 C. Lizza Letter, at 2 (emphasis omitted)). Judge Bryson of
`the Federal Circuit, sitting by designation in Allergan, found that argument was not persuasive,
`as “the settlement agreement is 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; see also Wyeth, 2010 WL 4117157, at *4
`(recognizing license and settlement agreements involving the patents-in-suit are relevant to both
`“Plaintiffs’ patent validity claims and/or Defendants’ invalidity defenses”).
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`Jazz also attempts to minimize the relevance of any settlement documents and license
`agreements to secondary considerations arguing the “material provisions of the agreements are
`public knowledge” and any “non-public, confidential information” regarding “specific royalty
`rates or other financial terms . . . tied to particular patents or patents families . . . is not relevant.”
`(6/13/17 C. Lizza Letter, at 1, 3). But Jazz misses the point. The requested discovery could shed
`light on the importance of any particular patents to the settlement negotiations or the reasons for
`entering into a settlement or license agreement, which is particularly relevant where Jazz has
`readily admitted that it “is only arguing commercial success for one subgroup of the patents-in-
`suit.” (6/13/17 C. Lizza Letter, at 2); see also Am. Standard, Inc. v. Pfizer, Inc., No. 87-1-73-IP,
`1988 WL 156152, at *2 (S.D. Ind. July 8, 1988) (finding settlement and license agreements
`discoverable as they could reveal the parties “decided to settle for reasons other than paying
`tribute to [the Plaintiff’s] patent”).
`
`Further, Jazz makes a number of completely unsupported legal arguments, including that
`the case law only supports production of settlement and license agreements when damages are at
`issue. (6/13/17 C. Lizza Letter at 3). Not true. In fact, the court in Allergan addressed this exact
`argument made by the patentee and found (and listed) “a number of courts that have required the
`production of settlement agreements based at least in part on their relevance to issues of
`validity.” Allergan, 2017 WL 132265, at *2.3
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`3 Jazz also boldly states that the case law cited by Lupin is not relevant because “there is no
`indication the defendants in [the cases cited] had any information concerning the provisions of
`the settlement and license agreements at issue in those cases.” (6/13/17 C. Lizza Letter at 3). Not
`only does Jazz cite no support for its statement but publicly-available information contradicts
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
`
`

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`Case 2:13-cv-00391-ES-JAD Document 366 Filed 06/20/17 Page 4 of 5 PageID: 7166
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`Hon. Joseph A. Dickson, U.S.M.J.
`June 20, 2017
`Page 4
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`Similarly, Jazz does not deny that the requested discovery may be relevant to Lupin’s
`efforts to defend against Jazz’s claims for injunctive relief. Rather, Jazz again sidesteps the issue
`by claiming that it will not be necessary until “many years from now.” (6/13/17 C. Lizza Letter,
`at 4). First, the timing of any injunction hearing does not affect whether the documents are
`relevant to defending against Jazz’s claims for injunctive relief. Second, Jazz’s statements are
`pure conjecture and Lupin’s approval of its product will be decided by the U.S. Food and Drug
`Administration, not Jazz.4
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`II.
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`There Is No Heightened Standard For Production of Settlement Negotiations.
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`Jazz asserts that Lupin has not satisfied an alleged “heightened standard required for
`compelling the production of underlying negotiation and settlement documents.” (6/13/17 C.
`Lizza Letter, at 4). Again, Jazz is not denying that settlement documents are discoverable—nor
`could it—since multiple courts have clearly held as such. See, e.g., In re MSTG, Inc., 675 F.3d
`1337, 1348 (Fed. Cir. 2012); Memory Integrity, LLC v. Intel Corp., 308 F.R.D. 656, 659 (D. Or.
`2015) (“The contents of such negotiations might, for example, reveal comparable license
`agreements or limitations on the scope of the patents, either of which could be discoverable.”);
`Builders Flooring Connection, LLC v. Brown Chambless Architects, No. 2:11CV373-MHT,
`2014 WL 5307489, at *1 (M.D. Ala. Oct. 16, 2014) (noting Congress “did not take the additional
`step of protecting settlement negotiations from discovery”). Furthermore, other courts
`recognizing the discoverability of settlement documents following MSTG have not applied any
`so-called heightened standard. See Sciele Pharma, Inc. v. Lupin, Ltd., No. 09–37 (RBK/JS), 2013
`WL 12161442, at *2 (D. Del. Jan. 31, 2013) (finding no “explicit or implicit support in the case
`law” for a “heightened discovery burden”); Barnes & Noble, Inc. v. LSI Corp., No. C-11-2709
`EMC, 2013 WL 841334, at *2 (N.D. Cal. Mar. 6, 2013) (noting “other courts following MSTG
`have made no mention of a heightened showing requirement” for discovery of settlement
`negotiations).
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`Regardless, Lupin would be willing to forego production of the underlying settlement
`negotiation documents at this time, if Jazz agrees to produce the settlement and license
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`Jazz’s statement. For example, at the time of the decision in Wyeth, the patentee had previously
`settled with other generic challengers and at least some of the terms of the agreements, including
`the launch dates, were already publicly available; yet, the court ordered production of prior
`settlement and license agreements. (See, e.g., Ex. 1, Press Release: IMPAX Announces Final
`Settlement Of Generic
`EFFEXOR
`XR
`Patent
`Suit
`(July
`16,
`2008),
`http://investors.impaxlabs.com/Media-Center/Press-Releases/Press-Release-
`Details/2008/IMPAX-Announces-Final-Settlement-Of-Generic-EFFEXOR-XR-Patent-
`Suit/default.aspx); Wyeth, 2010 WL 4117157, at *4.
`4 Furthermore, Jazz’s suggestion that “Lupin is blocked by statute from launching its product
`until at least after Roxane’s 180-day market exclusivity, which will be years from now” (6/13/17
`C. Lizza Letter, at 3), is troubling given that could only be a result of the settlement agreement
`entered into by the parties that Jazz is refusing to produce.
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`
` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
`
`

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`Case 2:13-cv-00391-ES-JAD Document 366 Filed 06/20/17 Page 5 of 5 PageID: 7167
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`Hon. Joseph A. Dickson, U.S.M.J.
`June 20, 2017
`Page 5
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`agreements themselves, with the understanding that Lupin would not be prejudiced from later
`seeking the underlying negotiation documents if necessary.
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`*
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`*
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`For at least the reasons articulated above and in Lupin’s May 26, 2017 letter (ECF 354)
`to the Court, Lupin respectfully seeks an order compelling Jazz to produce documents related to
`settlement and license agreements.
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`We appreciate the Court’s continued attention to and consideration of this matter. If the
`Court would like to discuss the foregoing, we are available at the Court’s convenience for either
`a telephonic or in-person conference.
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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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`MEF
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` CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
` A PROFESSIONAL CORPORATION
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