Case 2:13-cv-00391-ES-JAD Document 187 Filed 11/23/15 Page 1 of 7 PageID: 2341
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`Chambers of
`Joseph A. Dickson
`United States Magistrate Judge
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`Martin Luther King, Jr. Federal Bldg.
`& U.S. Courthouse
`50 Walnut Street
`Newark, New Jersey 07102
`(973-645-2580)
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`LETTER ORDER
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`November 23, 2015
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`To all counsel of record via ECF
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`Re:
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`Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC, et al.
`Civil Action No.: 13-391(ES) (JAD)
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`Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc.
`Civil Action No. 10-6108 (ES) (JADl
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`Dear Counsel:
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`This will address Plaintiff Jazz Pharmaceuticals, Inc.' s ("Jazz") informal application, (ECF
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`No. 85), requesting that this Court compel Defendants Amneal Pharmaceuticals, LLC ("Amneal")
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`and Par Pharmaceutical, Inc. ("Par") to "produce all communications between [those] Defendants
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`and the U.S. Food and Drug Administration ("FDA") concerning their sodium oxybate ANDA
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`products-as is required by this Court's Local Patent Rules." (Id. at 1 ). 1 Specifically, Jazz seeks the
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`production of any correspondence and emails between those Defendants and the FDA regarding
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`the negotiation of a joint Risk Evaluation and Mitigation Strategy ("REMS") program between the
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`1 The Court notes that Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc., Civil Action No.
`10-6108 (ES) (JAD), is a related case insofar as most, if not all, of the patents at issue in that matter
`are also at issue in the cases consolidated under Civil Action No. 13-391. The parties in the Roxane
`matter had previously submitted the same dispute (i.e., concerning the application of L. Pat. R
`3.6(j) to communications with the FDA and featuring essentially identical arguments) to the Hon.
`Michael A. Hammer, U.S.M.J. (See ECF Nos. 360, 369, 378 in Civil Action No. 10-6108). As
`the Roxanne matter has recently been reassigned to this Court, the Court will simultaneously
`resolve the FDA communications issue with regard to Defendants Ameal, Par, and Roxane. Unless
`otherwise noted, all "ECF" references in this Letter Order pertain to Civil Action No. 13-391.
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`Case 2:13-cv-00391-ES-JAD Document 187 Filed 11/23/15 Page 2 of 7 PageID: 2342
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`Defendants and, ultimately, Jazz, and the FDA's apparent efforts to achieve a single, unified
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`REMS for all parties. This dispute centers on whether the documents in question "pertain" to
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`Defendants' ANDAs pursuant to L. Pat. R. 3.6(j), which reads:
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`Each party that has an ANDA application pending with the [FDA]
`that is the basis of the pending case shall: ( 1) notify the FD A of any
`and all motions for injunctive relief no later than three business days
`after the date on which such a motion is filed; and (2) provide a copy
`of all correspondence between itself and the FDA pertaining to the
`ANDA application to each party asserting infringement, or set forth
`the basis of any claim of privilege for such correspondence pursuant
`to L. Civ. R. 34.1, no later than seven days after the date it sends
`same to the FDA or receives same from the FDA.
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`Jazz argues that they do, and are therefore subject to disclosure under the Local Patent Rules. (ECF
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`No. 85 at 2) ("Defendants' ANDA products will require a REMS program to be approvable by the
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`FDA ... ").
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`Defendants Amneal and Par responded on October 16, 2014, (ECF No. 87), arguing that
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`the documents in question did not "specifically pertain" to those Defendants' ANDAs because
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`they did not reference any particular ANDA. (Id. at 2). Instead, Amneal and Par argued that those
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`documents "pertain[] to questions from the FDA to [Defendants] about ongoing negotiations
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`between them and Jazz geared towards the potential development of a single, shared REMS for
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`the distribution of sodium oxybate"
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`(ML) (emphasis in original) (noting that as the FDA
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`communications addressed only as-yet-unimplemented REMS, those communications could,
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`therefore, not be related to any claims or defenses in this action). Amneal and Par also contended
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`that disclosure would prejudice them, as it would allow Jazz to use the information against them
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`in various proceedings (i.e., by filing a "Citizen Petition" with the FDA, utilizing the information
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`to amend its claims in pending Covered Business Methods proceedings, or using it to improve its
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`negotiating position vis-a-vis Defendants on the shared REMS issue). (Id. at 3-4). Finally, Amneal
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`2
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`and Par asserted that because the FDA is, in effect, serving as a mediator in its efforts to broker a
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`single, shared REMS, Defendants' communications with the FDA should subject to a "mediation
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`privilege" (i.e., that information shared with a mediator should remain confidential in order to
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`promote candid communications going forward). (Id. at 5-6). In its October 16, 2014 letter to
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`Magistrate Judge Hammer in Civil Action No. 10-6108, Roxane made essentially the same
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`arguments. (ECF No. 369 in Civil Action No. 10-6108).
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`Jazz replied on October 24, 2014, (ECF No. 90), and argued for a broad application of L.
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`Pat. R. 3.6(j). Jazz also denied that Defendants would suffer prejudice, contending that the
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`Discovery Confidentiality Order entered in this case would protect Defendants from any
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`inappropriate use or disclosure of the documents. (Id. at 3). Jazz further argued that there was no
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`mediation privilege because, to the extent such a privilege exists at all, it could not apply here,
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`where the FDA is an "active participant" in the discussions. (Id. At 3-4). Finally, Jazz asserted
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`that the Court should reject Defendants' "one-sided" and "self-serving" statements regarding the
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`substance of the communications at issue. (Id. at 4-5). Defendants Amneal and Par filed a sur(cid:173)
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`reply challenging each of these points. (ECF No. 92).
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`By Order dated December 1, 2014, this Court required Defendants Amneal and Par to
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`submit the documents at issue for an in-camera review. (ECF No 97). Defendants did so on or
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`about December 3, 2014.
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`On January 8, 2015, this Court conducted a hearing in Civil Action No. 13-391 in order to
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`supplement its understanding of the purpose and operation of a REMS and its connection to this
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`case. On July 21, 2015, the Court held a second hearing related to this dispute. At that hearing,
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`this Court was joined by Magistrate Judge Hammer and counsel for Defendant Roxane
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`Laboratories, Inc. in Civil Action No. 10-6108.
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`On August 6, 2015, and at the Court's direction, Defendants provided the Court with
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`additional documents that they had exchanged with the FDA since their original in-camera
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`production in December 2014. On November 5, 2015, the Roxane matter was reassigned to this
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`Court.
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`After carefully reviewing the parties' submissions and hearing oral argument on this issue,
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`the Court finds that Jazz has the better position. The plain language of L. Pat. R. 3.6(j) requires
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`an ANDA applicant to produce "a copy of all correspondence between itself and the FDA
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`pertaining to the ANDA application to each party asserting infringement, or set forth the basis of
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`any claim of privilege for such correspondence ... " The parties have not submitted any case law
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`interpreting that clause and the Court has not located any through its independent research.
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`In its report regarding the 2011 amendments to this District's Local Patent Rules, the Patent
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`Rules Committee explained that "[i]t was also recommended that the ANDA filer be required to
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`advise the [FDA] of any motion for injunctive relief and supply the parties with relevant
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`communications with the FDA which concern the subject matter filed in the District Court. This
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`is intended to keep the FDA and parties apprised of any proceedings that may impact the ongoing
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`litigation." LITE, N.J. FEDERAL PRACTICE RULES (GANN), Comment 2 to L.Civ.R. 9.3
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`(GANN), at 160-61 (emphasis added).
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`It is worth noting that the Rule itself uses the word
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`"pertaining" while the comment explaining the Rule uses the phrase "relevant communications
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`which concern the subject matter filed in the District Court." (emphasis added). However, this
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`Court ultimately concludes that this is an insignificant distinction given the circumstances of this
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`case. The communications at issue here both pertain to and concern the subject matter of this
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`litigation.2 All parties agree that the product at the center of this case, Xyrem, will be not be sold
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`to the public without a REMS, which is required by the FDA. The parties also agree that at least
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`one of the underlying patents in the litigation support Jazz's current REMS. (Tr. of July 21, 2015
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`Hr'g at 9-12, ECF No. 159).3 Defendants argue that, given the limiting language contained in Rule
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`3.6(j), they are not required to produce the correspondence at issue. This Court disagrees. While
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`those communications do not appear to be directly relevant to the questions of infringement or
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`validity, they certainly pertain to and concern the central issue in these cases: Defendants'
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`ANDAs. Without the ANDAs, Defendants would not be engaged in REMS-related discussions
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`with the FDA. Moreover, as noted above, the Patent Rules Committee has clearly stated that the
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`purpose of Rule 3.6(j) is to keep the parties informed of relevant proceedings. Defendants'
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`position here undermines that goal.
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`Having found that the communications in question pertain to Defendants' ANDAs and are
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`otherwise discoverable, the Court also finds that Defendants have failed to establish that they
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`should be entitled to withhold those documents on the basis of privilege. While Defendants argue
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`that a mediation privilege applies, the Court finds that the FDA is not mediating anything. Rather,
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`the record is clear that the FDA would like to have a single REMS and is, itself, a stakeholder in
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`the process. The FDA may have some role in facilitating the discussions or in negotiating with
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`the parties. This is not, however, a process whereby the parties seek to accomplish a single joint
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`REMS and the FDA, independent of its own motives, is merely acting as a mediator. The content
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`of the documents themselves, which the Court has reviewed in-camera, bears this out,
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`''To have
`2 The American Heritage College Dictionary, Third Edition, defines "pertain" as:
`reference; relate." Similarly, it defines "concern" as: ''To have to do with or relate to."
`3 The Court notes that the parties also appear to agree that Jazz's REMS would still stand even if
`that patent is deemed invalid. (I!h at 12).
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`demonstrating that Defendants are working with both Jazz and the FDA to develop a shared
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`REMS. Accordingly, even assuming, without deciding, that a mediation privilege exists in this
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`Circuit, the Court finds that it would be inapplicable here. Finally, the Court rejects Defendants'
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`argument that the alleged prejudice they would suffer as a result of disclosure justifies an exception
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`to their obligation to produce the documents under L. Patent R. 3.6G).
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`CONCLUSION
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`For the reasons set forth above, this Court GRANTS Jazz's informal application to compel.
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`Defendants Amneal, Par and Roxane shall produce the documents in question on or before
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`December 8, 2015.
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`Finally, the Court notes that, after Jazz submitted a follow-up letter, dated September 30,
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`2015, reiterating its previous arguments, (ECF No. 165), Defendant Par submitted a response dated
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`October 9, 2015. (ECF No. 167). The versions of those documents placed on the public docket
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`for this matter were heavily redacted. (ECF Nos. 166, 168). Upon reviewing those redacted
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`filings, Defendants Watson Laboratories, (ECF No. 171), Sun Pharmaceutical Industries Ltd.,
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`Ohm Laboratories, Inc. and Ranbaxy Inc., (ECF No. 173), submitted letters disclaiming
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`knowledge regarding the discovery dispute contained therein (i.e., because the redactions rendered
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`Jazz's and Par's recent letters essentially unintelligible) and seeking assurances that they were not
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`the target of Jazz's informal application to compel.4 By letter dated October 26, 2015, Jazz argued,
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`in pertinent part, that any ruling on this issue should apply with equal force to all Defendants.
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`(ECF No. 179 at 2) ("[A] ruling by the Court rejecting Defendants' efforts to ignore the Local Rule
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`4 Defendant Amneal filed a similar letter on October 21, 2015. (ECF No. 174). This is certainly
`due to Amneal' s inability to glean the substance of the redacted versions of Jazz's and Par's recent
`submissions. As noted above, Amneal has been litigating this issue, alongside Par, for over a year.
`Any Order resolving this dispute would, therefore, naturally apply to Amneal as well.
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`should pertain to all Defendants for the reasons stated in Jazz's prior submissions."). The Court
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`finds that this dispute, from its outset, has involved Jazz's request to compel Par and Amneal (and,
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`with regard to Civil Action No. 10-6108, Roxane) to produce certain documents. (See ECF No.
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`85) ("We write to request that the Court compel Defendants Amneal Pharmaceuticals, LLC and
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`Par Pharmaceutical, Inc. (collectively, 'Defendants') to produce all communications between
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`Defendants and the U.S. Food and Drug Administration ... concerning their sodium oxybate
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`ANDA products."). Therefore, to the extent Jazz also wishes to compel production of similar
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`documents from Defendants Watson Laboratories, Sun Pharmaceutical Industries Ltd., Ohm
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`Laboratories, Inc. and/or Ranbaxy Inc., that issue is not properly before the Court. That being
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`said, however, the Court would ultimately reach the same conclusions in the event Jazz sought to
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`compel other defendants to produce the sort of documents discussed above with regard to Amneal
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`and Par. It would, therefore, be a waste of both the parties' and the Court's resources to engage in
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`another round of repetitive briefing. Counsel for Jazz shall, therefore, meet and confer with
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`counsel for Watson and counsel for Sun/Ohm/Ranbaxy with regard to Jazz's request for the
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`production of those Defendant's relevant communications with the FDA, and all counsel shall
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`engage in those discussions mindful of this Court's determinations with regard to similar
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`documents held by Defendants Amneal and Par. Counsel for Jazz shall submit a status report to
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`the Court with regard to this issue on or before December 18, 2015.
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`cc:
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`Hon. Esther Salas, U.S.D.J.
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`SO ORDERED
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