Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 1 of 6 PageID: 839
`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 1 of 6 PageID: 839
`
`
`
`600 SOUTH AVENUE WEST e WESTFIELD, NEW JERSEY 07090
`
`T: 908.654.5000 w F: 908.654.7866 a WWW.LDLI(M.COM
`
`
`CHINA: UNIT 3405A - TEEM TOWER o 208 TIANHE ROAD 0 TIANHE DESTRICT
`
`GUANGZHOU, GUANGDONG 510620 a CHINA - T: +86 20 3810-3788 - F: +86 20 3810-3789
`
`
`[N’I‘ELLECTUAL PROPERTY LAW
`
`Paul H. Kochanski
`908.518.6314
`
`PKochanski@ldlkm.com
`
`October 16, 2014
`
`
`Document Filed Electronically
`
`The Honorable Joseph A. Dickson, U.S.M.J.
`United States District Court
`
`Martin Luther King, Jr. Federal Building
`50 Walnut Street, 2D
`
`Newark, NJ 07102
`
`
`
`Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC, et al.
`
`
`
`Civil Action No. 13—cv—39l— iS-JA ) (consolidated)
`
`Re:
`
`Dear Judge Dickson:
`
`
`
`I, along with my co-counsel Sterne, Kessler, Goldstein& Fox P.L.L.C., represent
`efendant Amneal Pharmaceuticals LLC (“Amneal”) in the above—referenced matter. Counsel
`for Defendant Par Pharmaceutical, Inc. (“Par”), Saiber LLC and Arent FOX LLP, also join in this
`letter. We write to oppose Jazz’s October 8, 2014 letter (“Jazz’s Letter”) asking the Court to
`compel Amneal and Par to produce a specific communication fi'om the US. Food and Drug
`Administration (“F )A”) to Amneal, Par, and Roxane Laboratories, Inc., dated September 10,
`2014 (collectively, "Defendants"). Amneal and Par request that the Court find that Jazz is not
`entitled to production of the FDA letter to the Defendants, nor any responses from the
`)efendants to the FDA to that letter.1
`
`
`
`
`
`
`
`Jazz argues that the subject communication should be produced under this Court’s Local
`Patent Rules, which require production of any FDA correspondence concerning an accused
`Abbreviated New Drug Application (“ANDA”). As a preliminary matter, Amneal and Par are
`mindful of their obligations under the Local Patent Rules and, accordingly, it was Amneal and
`Far who proactively notified Jazz of the existence of the subject FDA letter and Amneal and
`Par's position that the letter need not be produced. For the reasons discussed below, the Local
`Patent Rules, however, do not apply to this communication because the FDA letter or
`subsequent, related communications thereafter do not pertain to any of the parties’ pending
`ANDA applications. Rather, the FDA letter relates to ongoing negotiations with the FDA about
`the possibility of a single, shared Risk Evaluation and Mitigation Strategy (“REMS”), which
`may or may not be implemented.
`
`
`
`
`1 hi this respect, on October 8, 2014, the ANDA applicants responded substantively to the F )A’s
`request. Neither Amneal nor Par have produced that subsequent communication to Jazz and also
`requests that the Court find that Jazz is not entitled to production of that correspondence.
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 2 of 6 PageID: 840
`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 2 of 6 PageID: 840
`
`Page 2
`
`The Honorable Joseph A. Dickson
`October 16, 2014
`
`
`Alternatively, even assuming arguendo that the Local Patent Rules do apply to this FDA
`letter or any subsequent, related correspondence thereto, the nature of the communication and
`extreme prejudice that would be suffered by Amneal and Par by its disclosure to Jazz far
`outweighs any prejudice that Jazz allegedly would suffer from lack of its disclosure. As such, the
`Court has a sound rationale to provide Amneal and jar relief from the Local Patent Rules, should
`it detemiine that “he communication does fall within them.2
`
`
`
`
`
`
`
`
`
`
`T ' E OCAL PATENT RULES DO NOr
`
`
`
`
`APPLY TO T i E SUBJECT COMMUNICATION
`
`
`
`
`
`
`I.
`
`
`
`
`
`
`
`
`Local Patent Rule 360') requires “[e]ach party that has an AN A application pending
`
`with the Food and Drug Administration (“FDA”) that is the basis of the pending case shall
`provide a copy of all correspondence between itself and the FDA pertaining to the ANDA
`application to each party asserting infringement.” L. Pat. R. 360') (emphasis added).
`
`
`
`
`
`The key phrase is “pertaining to the ANDA.” The subject communication from the F )A
`
`to Amneal and Par does not specifically pertain to the ANDAs filed by Amneal and Par (ANUA
`
`
`Nos. 203631 and 205403, respectively) that are at issue in this case because it does not reference
`
`
`
`
`any AN )A number or the contents of those ANDAs.3 That the F )A letter was provided to both
`Amneal and Par jointly is further evidence that it does not relate to any ANDA application. Had
`it been regarding either company’s ANDA, it Would have been provided to that company alone
`
`because the FDA does not disclose the existence or contents of a party’s ANDA until approval.
`See Louisiana Wholesale Drug Co. v. Sanofi—Aventis, 07 CV 7343 (HB), 2008 WL 4580016, at
`*1 (S.D.N.Y. Oct. 14, 2008) (“The FDA is required to keep the existence and contents of
`ANDAs confidential unless and until the agency approves them”). Consequently, neither the
`EDA letter nor any subsequent communications thereto could possibly fall within the scope of
`
`Rule 3.60).
`
`Instead, this FDA communication—which was labeled “for ANDA applicants only”——
`pertains to questions from the FDA to Amneal, Par, and Roxane about ongoing negotiations
`between them and Jazz geared towards the potential development of a single, shared REMS for
`the distribution of sodium oxybate.4 Because the FDA communication deals with a yet to be
`
`approved or
`implemented REMS,
`it
`is therefore not
`related to any claims (e. g.,
`non—
`infringement) or defenses (e. g., invalidity) in this action.
`Jazz’s arguments to the contrary
`demonstrate how eager Jazz is to get its hands on this sensitive communication to gain an unfair
`advantage in the parties’ ongoing negotiations for a single, shared REMS before the FDA. If the
`
`
`
`
`2 Amneal and Par are willing to provide the Court with the subject communication from the
`F )A, and Defendants’ response, for in camera review.
`
`3 The REMS programs described in Amneal’s and Par’s ANDAs are separate and unrelated to
`the ongoing negotiations for the potential development of a single, shared REMS.
`
`4 lmportantly, the FDA has been acting as a mediator between the parties in these negotiations.
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 3 of 6 PageID: 841
`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 3 of 6 PageID: 841
`
`Page 3
`
`
`The Honorable Joseph A. Dickson
`October 16, 2014
`
`FDA intended for Jazz to have the letter, it would have sent Jazz a copy. As such, Rule 3.60)
`does not apply to the subject communication.
`
`For at least these reasons, Jazz’s request should be denied.
`
`
`
`
`
`
`
`
`
`S iOUL’) THE COURT DETERMINE THAT LOC i
`
`
`
`
`
`
`
`
`PATENT RULE 3.6(j) DOES APPLY, DEFENJANTS
`
`
`
`
`
`SHOULD 3E GRANTED RELIEF FROM THE RULE
`
`
`
`
`
`II.
`
`
`
`
`
`Assuming arguendo that Rule 3.60) applies-which Amneal and Par maintain that it
`does not—the court should grant Amneal and Par relief from complying with the rule for
`(1) reasons of faiiness and lack of prejudice to Jazz and/or (2) on the basis of evidentiary
`privilege.
`
`A.
`
`
`
`
`
`
`Amneal And Par Will Be Prejudiced By Disclosure Of ’ ‘he Subject FDA
`
`Communication, While Jazz Will Not Be Pre'udiced By Its Non-Disclosure
`
`This Court “can depart from the strictures of its own local procedural rules where (1) it
`has a sound rationale for doing so, and (2) doing so does not unfairly prejudice a party who has
`relied on the local rule to [its] detriment.” US. v. Eleven Vehicles, Their Equip. and Accessories,
`200 F.3d 203, 215 (3d Cir. 2000). And this Court has previously granted relief from the Court's
`Local Rules “with due consideration of the circumstances of the dispute.” Hitachi Capital Am.
`Corp. v. Nussbaum Sales Corp, Civil Action No. 09-cv—731, 2010 WL 1379804, at >k3 ( ).N.J.
`March 30, 2010) (Salas, D.J.). Here, due consideration of the circumstances of the dispute should
`direct the Court to deny Jazz’s reqUest.
`
`
`
`
`The Court has a sound rationale for doing so. As discussed above, the subject FDA
`communication bears no relation to any claim or defense in this action.
`Instead,
`the
`communication relays questions from the FDA—who is functioning as a mediator between the
`parties—about the ongoing negotiations between Jazz, Amneal, Par, and Roxane to advance the
`
`FDA’s desire to establish a single, shared REMS program for all sodium oxybate products.
`Disclosure of the contents of this particular FDA communication, and Amneal’s and Par’s
`‘esponses thereto, would greatly prejudice Amneal and Par in the context of these negotiations.
`Disclosure will reveal the FDA’s thinking—as a mediator—on the matter. In addition, and just as
`importantly, compelled disclosure of this letter and any subsequent, related communication will
`have a chilling effect such that it will prevent Amneal and Par from engaging in open and
`
`productive negotiations over potential adoption of single, shared REMS.
`
`
`
`to use the
`Additionally, allowing Jazz access to this communication will allow it
`infomiation learned from Amneal’s and Par’s communications with the FDA about
`the
`development of a single, shared REMS to then file Citizen Petitions with the FDA or engage in
`other regulatory actions that could harm Par’s and Amneal’s ability to negotiate against Jazz. As
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 4 of 6 PageID: 842
`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 4 of 6 PageID: 842
`
`
`
`
`The Honorable Joseph A. Dickson
`October 16, 2014
`
`Page 4
`
`
`
`
`such, ANDA sponsors such as Amneal and Par would be unfairly prejudiced.5 Likewise, Jazz
`
`
`
`
`could use the pending Covered 3usiness Methods (“C 3M”) proceedings currently before the
`United States Patent and Trademark Office to gain an additional unfair tactical advantage. Jazz’s
`present litigation counsel, serves as its counsel in these CBM proceedings, Where Jazz will have
`the opportunity to offer amendments to the claims of its patents that allegedly cover Jazz’s
`
`REMS program for distribution of sodium oxybate.
`Jazz’s claims that
`the Discovery
`Confidentiality Order (“ )CO”) in this case will serve to protect the communication are of no
`import because Jazz’s counsel can use the information—once disclosed—40 draft claim
`amendments based on Amneal’s and Par’s responses and comments on the ongoing negotiations
`among the parties and with the FDA. Thus, ordering the production of the FDA communication
`and subsequent, related communications would serve to only thwart the purpose of the DCO.
`
`
`
`
`Conversely, Jazz will suffer no unfair prejudice fi‘om withholding such communications.
`The FDA letter, and Amneal’s and Par’s responses thereto, have no effect on Amneal’s and Par’s
`
`non—infringement and invalidity positions because it does not relate to the filed ANDA
`applications but rather relates to the ongoing negotiations for potential REMS proposals that may
`never be incorporated into Amneal’s or Par’s AN )A. In the event that such REMS proposals do
`become part of Amneal’s and Par’s ANDAs, then production would unquestionably be mandated
`by Local Rule 3.6(j). Producing such communications at this time, however, is premature and
`would be unfairly prejudicial to Amneal and Par. Furthermore, the communication and related
`responses have no bearing on imminent approval of the relevant AN )As.
`
`
`
`
`
`
`
`Production will do no more than confer a unfair tactical advantage on Jazz in the ongoing
`negotiations—Jazz would unfairly benefit from learning Amneal’s and Par’s communications
`and negotiations with FDA and the potential outcomes of these negotiations. Consequently,
`production of this FDA communication and subsequent, related correspondence would do no
`more than provide Jazz an unfair tactical advantage, thereby allowing it to disrupt and frustrate
`the ongoing negotiations with FDA.
`
`
`
`Again, Jazz’s claims that the )CO in this case will serve to protect the communication
`misses the point because the DCO seeks to protect disclosure of information to non—litigants.
`Jere, Jazz’s counsel in this litigation is also representing Jazz in the FDA proceedings, and
`would unfairly earn an unfair tactical advantage in those negotiations being mediated by the
`
`*‘_)A.
`
`
`
`
`
`Consequently, taking due consideration of the circumstances surrounding the current
`dispute, the Court has a sound rationale for denying Jazz’s request in this narrow instance.
`Eleven Vehicles, 200 F.3d at 215; Hitachi, 2010 WL 1379804 at >“3. And doing so would not
`unfairly prejudice Jazz to its detriment. Eleven Vehicles, 200 F.3d at 215.
`
`
`
`5 In fact, Amneal’s and Par’s concern is far from speculative. Indeed, Jazz has already filed a
`
`
`
`
`Citizen Petition with the FDA over its R *MS program attempting to thwart AN A sponsors
`from filing ANDA applications on its sodium oxybate REMS. See EX. A, Dec. 13, 2012 Letter
`from Janet Woodcock to Philip Honerkamp.
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 5 of 6 PageID: 843
`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 5 of 6 PageID: 843
`
`Page 5
`
`
`The Honorable Joseph A. Dickson
`October 16, 2014
`
`B.
`
`Alternatively, Evidentiary Privilege Supports
`
`Granting Amneal And Par Relief From Rule 3.69 it
`
`the nature of the
`In addition to the prejudice to Amneal and Far discussed above,
`communication—as that of one between a mediator and parties to the 1nediation—-—serves to
`further support relief from Rule 3.6(j) based on a mediation privilege. The Supreme Court in
`Jafi’ee v. Redmond, 518 US. l (1996), held that under Rule 501 of the Federal Rule of Tvidence,
`district courts may recognize “new” evidentiary privileges where “reason and experience”
`dictate. Jaflee provided four factors to consider when determining if a communication such as
`this should be subject to an evidentiary privilege: (1) whether the asserted privilege is “rooted in
`the imperative need for confidence and trust”; (2) whether the privilege would serve public ends;
`(3) whether the evidentiary detriment caused by an exercise of the privilege is modest; and
`(4) whether denial of the privilege would. frustrate a parallel privilege adopted by the states.
`Id.
`at 9-13.
`
`
`
`
`
`Here, all the factors for evidentiary privileges set forth in Rule 501 of the Federal Rules
`of Evidence and pertinent Supreme Court authority amply support recognizing a privilege in the
`mediation context. And the existence of a mediation privilege from applying these factors has
`been recognized by another court in this circuit. See Sheldone v. Pennsylvania Turnpike Comm,
`104 F. Supp. 2d 511 (W.D. Pa. 2000).
`
`Confidentiality is essential to the mediation process. And this has been recognized by
`federal courts. See, e. g., Lake Utopia Paper Ltd. v. Connelly Containers, Inc, 608 F.2d 928, 930
`(2d Cir.l979) (stating that participants to a mediation must rely on its confidential procedures to
`prevent “counsel [from]
`feel[ing] constrained to conduct themselves in a cautious, tightlipped,
`non—committal manner more suitable to poker players in a high—stakes game than to adversaries
`attempting to arrive at a just resolution of a civil dispute”). As such, preventing disclosure of the
`subject communication is rooted in an imperative need for confidence and trust.
`
`
`
`
`Moreover, denying Jazz’s request on this basis also serves public ends. The FDA is
`charged with safeguarding the public against dangerous and harmful medicines. In accordance
`with that goal, the F )A has determined that it is in the public interest to have a single shared
`
`REMS program for all sodium oxybate products. And in furtherance of that goal, the FDA is
`presiding over negotiations between Arrmeal, Par, and Roxane on the one hand, and Jazz on the
`other with respect to the development of a single shared R 4MS program. Jazz’s desire to obtain
`confidential communications between Amneal and Par and the FDA as a mediator undermines
`that purpose. And it would force Amneal and Par to become less candid in responses to the F )A
`going forward and prevent the FDA from making a neutral assessment of the relative strengths
`and weaknesses of the opposing positions.
`
`
`
`
`
`
`
`Third, the evidentiary detriment caused by an exercise of a privilege here is modest. As
`discussed above, the subject communication has no bearing on any current claims or defenses in
`
`this action. It has no bearing on the content of the subject ANDAs. And it has no bearing on the
`imminent approval of the subject ANDAs. Thus, non—disclosure of the subject communication
`
`

`

`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 6 of 6 PageID: 844
`Case 2:13-cv-00391-ES-JAD Document 87 Filed 10/16/14 Page 6 of 6 PageID: 844
`
`Page 6
`
`
`The Honorable Joseph A. Dickson
`October 16, 2014
`
`places no detriment on the Court or Jazz. And to date, Amneal and Far have produced all other
`
`correspondence with the FDA concerning their respective sodium oxybate ANDAs.
`
`
`
`
`Finally, granting Jazz’s request will frustrate parallel privileges adopted by the states.
`Nearly all of the states have adopted a mediation privilege—including New Jersey. See *‘xhibit
`B, Appendix at 757. “The states” ‘promise[s] of confidentiality' regarding mediation ‘would have
`little value if the [participants] were aware that the privilege would not be honored in
`federal
`court.m Sheldone, 104 F. Supp. 2d. at 515 (quoting Jafi’ee, 518 US. at 13) (alterations in
`original). “Thus, a ‘[d]enial of the [mediation] privilege
`would frustrate the purposes of the
`state legislation that was enacted to foster’ confidentiality in the mediation process.” Id.
`
`The Court should grant Amneal and Far relief from Rule 3.6U)—should the Court
`determine the rule applies.6
`
`
`
`
`
`
`
`.
`
`
`CONCLUSION
`
`I
`
`
`
`For the reasons discussed above, Amneal and Par respectfully request that the Court deny
`Jazz’s request.
`
`Respectfully submitted,
`
`
`
`
`
`11 FRN 4R, DAVID, LITTENBERG,
`
`K§UV1HOLZ & MENTLIK, LLP
`Attorneys for Defendant Amneal Pharmaceuticals, LLC
`
`
`
`
`
`PHK/pk
`Enclosure
`
`6*”
`
`cc:
`
`
`The Honorable Esther Salas, U.S.'D.J.
`Counsel of Record (via ECF)
`
`6 The mediation privilege discussed above also applies to any attempts by Jazz to obtain the
`subject communication or information related to the communication through discovery requests.
`
`