Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 1 of 23 PageID: 11121
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`CFAD VI 1044 - 0001
`CFAD VI v. CELGENE
`IPR2015-01103
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`

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`Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 2 of 23 PageID: 11122
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`Hon. Susan D. Wigenton, U.S.D.J.
`September 3, 2014
`Page 2
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` Thus, litigating those claims now would result in a
`substantial misuse of the Court’s and the parties’ resources. For all of these reasons, and as
`described further below, the Court should grant Celgene’s request.
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`A.
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`Legal Standard
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`Rule 42(b) states that, “[f]or convenience, to avoid prejudice, or to expedite and
`economize, the court may order a separate trial of one or more separate issues, claims,
`crossclaims, counterclaims, or third-party claims.” Fed. R. Civ. P. 42(b). The decision to
`bifurcate is within the Court’s “broad discretion,” and is made on a “case-by-case basis.” Ricoh
`Co. v. Katun Corp., No. 03-2612, 2005 WL 6965048, at *1 (D.N.J. Jul. 14, 2005); see also Barr
`Lab., Inc. v. Abbott Lab., 978 F.2d 98, 115 (3d Cir. 1992). Due to their complexity, patent cases
`are routinely bifurcated to promote efficiency and simplify issues. 8 Moore’s Fed. Prac. 3d
`§ 42.24[3], at n.5; Ricoh, 2005 WL 6965048, at *1 (“In the context of patent cases, experienced
`judges use bifurcation and trifurcation both to simplify the issues [] and to maintain
`manageability.”).
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`B.
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`Background
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`This litigation involves eighteen patents covering various aspects of Celgene’s Revlimid®
`product. The active ingredient in Revlimid® is lenalidomide. Lenalidomide may cause fetal
`harm when administered to a pregnant female at certain stages of gestation, or when a pregnant
`female is exposed via administration to a male. Accordingly, the FDA required a REMS for
`Revlimid® as a condition of approving the drug for marketing. The FDA will similarly not
`approve a generic version of Revlimid® without an acceptable REMS. See 21 U.S.C. § 355-
`1(i)(1)(B)(i)-(ii). The Revlimid® REMS is covered by the asserted claims of the REMS patents.
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`In 2010, Natco filed an Abbreviated New Drug Application (“ANDA”) seeking FDA
`approval to market a generic version of Revlimid®.
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`To gain FDA approval for its proposed generic product, Natco must either use the same
`REMS as Revlimid®, or certify to the FDA that: (1) the burden of using the same REMS
`outweighs the benefits; or (2) parts of the Revlimid® REMS are patented (or trade secrets) and
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`3 Natco has stipulated that it will infringe the asserted claims of the REMS patents. D.I. 305.
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`CFAD VI 1044 - 0002
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`Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 3 of 23 PageID: 11123
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`Hon. Susan D. Wigenton, U.S.D.J.
`September 3, 2014
`Page 3
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`Natco has been unable to obtain a license. See 21 U.S.C. § 355-1(i)(1)(B)(i)-(ii).
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`C.
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`Bifurcation Will Promote Judicial Economy and
`Reduce the Risk of Prejudice
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`Celgene requests bifurcation of trial on all claims related to the REMS patents, as well as
`a stay of expert discovery on those claims,
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` Under the current
`circumstances, Rule 42 strongly favors bifurcation.
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`First, bifurcation will promote judicial economy. Natco—by way of its request that the
`Court order Celgene to reduce the number of asserted claims—recognizes that removing the
`REMS patents from the current dispute will ease the burden on the Court and the parties, and
`will promote judicial economy. See D.I. 317. Indeed, bifurcation and stay of the REMS patents
`would eliminate the need to litigate disputes pertaining to 101 asserted patent claims. Depending
`on the outcome of the parties’ claims regarding the other patents-in-suit, it may be unnecessary
`to address the REMS patents separately. Therefore, bifurcation will allow the case to move
`forward more efficiently.
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`Second, as alluded to above, litigation of the REMS patents may ultimately be
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`unnecessary.
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` Further, there are other patents-in-suit that expire later than the REMS patents.
`If Celgene prevails on the later-expiring patents, litigation of the REMS would be moot. This
`again strongly favors of bifurcation.4
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`Third, bifurcation will minimize prejudice to the parties.
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`4 Another court in this district recently bifurcated and stayed proceedings concerning patents
`covering a REMS with the same single, shared REMS requirements as Revlimid. See Jazz
`Pharmaceuticals, Inc. v. Roxane Laboratories, Inc., No. 10-6108 (D.N.J March 24, 2014) (Salas,
`J.) (D.I. 316, D.I. 270, attached hereto as Exhibit C); Jazz Pharmaceuticals, Inc., 2013 Annual
`Report 5 (2014), available at http://www.sec.gov/Archives/edgar/data/1232524/
`000123252414000012/jazz1231201310k.htm (last visited Sept. 3, 2014)
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`CFAD VI 1044 - 0003
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`Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 4 of 23 PageID: 11124
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`Hon. Susan D. Wigenton, U.S.D.J.
`September 3, 2014
`Page 4
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`Expert discovery on the REMS patents will involve several experts who would not be
`involved in any of the other pending issues in this case.
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` See, e.g., Sanofi-Aventis
`Deutschland GmbH v. Glenmark Pharm. Inc., No. 07-5855, 2010 WL 2428561, at *16 (D.N.J.
`June 9, 2010) (finding that plaintiffs’ unrebutted accusation of copying “weighs in favor of” non-
`obviousness).
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` In re Cyclobenzaprine
`Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1081-82 (Fed. Cir. 2012)
`(“Evidence that others tried but failed to develop a claimed invention may carry significant
`weight in an obviousness inquiry.”)
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`And as discussed above, if Natco truly believes that it is currently being required to litigate an
`unreasonable number of patent claims, bifurcating the REMS patents would at least partially
`address that concern.
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`5
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`CFAD VI 1044 - 0004
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`Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 5 of 23 PageID: 11125
`Case 2:10—cv—O5197—SDW—SCM Document 344 Filed 09/03/14 Page 5 of 23 Page|D: 11125
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`Hon. Susan D. Wigenton, U.S.D.J.
`September 3, 2014
`Page 5
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`Finally, the same reasons that support bifurcation also support staying expert discovery
`on the REMS patents. See Akzona Inc. v. E.I. Du Pont de Nemours & C0., 607 F. Supp. 227, 232
`(D. Del. 1984) (“It is implicit in [Federal Rule] 42(b) that a trial judge who grants bifurcation has
`the power to limit discovery to issues relevant to the first trial.”). The factual issues underlying
`the claims pertaining to the REMS patents are separate and distinct from those underlying the
`remaining patents—in—suit, which are directed to com ounds, formulations, ol mor hs, and
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`methods of treating patients, not REMS.
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`>l<>l<>l<
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`For the foregoing reasons, Celgene respectfully requests that the Court bifurcate the
`claims relating to the REMS patents.
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`Respectfully yours,
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`CIJ~«»v@«a l~o%i~
`
`Charles M. Lizza
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`Exhibits
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`cc:
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`The Honorable Madeline C. Arleo, U.S.M.J.
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`All counsel (via e—mail)
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`CFAD VI 1044 - 0005
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`CFAD VI 1044 - 0005
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`Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 6 of 23 PageID: 11126
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`Exhibit A
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`Confidential Material Redacted Pursuant to the
`Court’s March 12, 2013 Order (D.I. 198)
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`
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`CFAD VI 1044 - 0006
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`Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 7 of 23 PageID: 11127
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`Exhibit B
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`Confidential Material Redacted Pursuant to the
`Court’s March 12, 2013 Order (D.I. 198)
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`CFAD VI 1044 - 0007
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`Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 8 of 23 PageID: 11128
`Case 2:lO—cv—05197—SDW—SCM Document 344 Filed 09/03/14 Page 8 of 23 Page|D: 11128
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`EXHIBIT C
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`EXHIBIT C
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`CFAD VI 1044 - 0008
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`CFAD VI 1044 - 0008
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`Case 2:10-cv-06108-ES-MAH Document 316 Filed 03/24/14 Page 1 of 2 PageID: 10556Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 9 of 23 PageID: 11129
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`CFAD VI 1044 - 0009
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`Case 2:10-cv-06108-ES-MAH Document 316 Filed 03/24/14 Page 2 of 2 PageID: 10557Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 10 of 23 PageID: 11130
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`CFAD VI 1044 - 0010
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 1 of 12 PageID: 9895Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 11 of 23 PageID: 11131
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`CFAD VI 1044 - 0011
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 2 of 12 PageID: 9896Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 12 of 23 PageID: 11132
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`CFAD VI 1044 - 0012
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 3 of 12 PageID: 9897Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 13 of 23 PageID: 11133
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`CFAD VI 1044 - 0013
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 4 of 12 PageID: 9898Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 14 of 23 PageID: 11134
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`CFAD VI 1044 - 0014
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 5 of 12 PageID: 9899Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 15 of 23 PageID: 11135
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`CFAD VI 1044 - 0015
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 6 of 12 PageID: 9900Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 16 of 23 PageID: 11136
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`CFAD VI 1044 - 0016
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 7 of 12 PageID: 9901Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 17 of 23 PageID: 11137
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`CFAD VI 1044 - 0017
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 8 of 12 PageID: 9902Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 18 of 23 PageID: 11138
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`CFAD VI 1044 - 0018
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 9 of 12 PageID: 9903Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 19 of 23 PageID: 11139
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`CFAD VI 1044 - 0019
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 10 of 12 PageID: 9904Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 20 of 23 PageID: 11140
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`CFAD VI 1044 - 0020
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 11 of 12 PageID: 9905Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 21 of 23 PageID: 11141
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`CFAD VI 1044 - 0021
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`Case 2:10-cv-06108-ES-JAD Document 270 Filed 12/05/13 Page 12 of 12 PageID: 9906Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 22 of 23 PageID: 11142
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`CFAD VI 1044 - 0022
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`Case 2:10-cv-05197-SDW-SCM Document 344 Filed 09/03/14 Page 23 of 23 PageID: 11143
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`Exhibit D
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`Confidential Material Redacted Pursuant to the
`Court’s March 12, 2013 Order (D.I. 198)
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`CFAD VI 1044 - 0023