Filed on behalf of: Abraxis Bioscience, LLC
`
`Filed: December 11, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`CIPLA LTD.
`Petitioner
`v.
`ABRAXIS BIOSCIENCE, LLC
`Patent Owner
`_____________________
`Case IPR2018-00163
`U.S. Patent No. 7,923,536
`————————————————
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION FOR
`JOINDER PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 &
`42.122(b)
`
`
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`
`2.
`
`3.
`
`4.
`
`
`
`V.
`
`TABLE OF CONTENTS
`TABLE OF AUTHORITIES ................................................................................... ii
`EXHIBIT LIST ........................................................................................................ iv 
`I.
`INTRODUCTION .......................................................................................... 1 
`II.
`BACKGROUND ............................................................................................ 2 
`III. LEGAL STANDARD .................................................................................... 4 
`IV. ARGUMENT .................................................................................................. 6 
`A.
`Joinder Should be Denied Because it Would Complicate and
`Delay, not Simplify or Expedite, the Actavis IPR ............................... 6 
`1.
`A Discovery Extension Would Be Required to
`Accommodate Discovery from Cipla ........................................ 6 
`The Direct-Competitor Relationship Between Actavis
`and Cipla Would Complicate the Actavis IPR .......................... 7 
`The Cipla Petition Presents Real-Party-in-Interest Issues
`that Would Complicate and Delay the Actavis IPR ................ 10 
`Joinder Would Prejudice Abraxis and the Public, But
`There is No Prejudice to Cipla if Joinder is Denied ................ 11 
`B. Alternatively, a Six-Month Extension is Needed if Cipla is
`Joined .................................................................................................. 12 
`CONCLUSION ............................................................................................. 13 
`
`
`
`i
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`
`TABLE OF AUTHORITIES
`
`Page
`
`
`
`CASES
`
`Abraxis Bioscience, LLC v. Actavis LLC,
`C.A. No. 16-cv-1925 (D.N.J.) .................................................................... 2, 8, 10
`
`Actavis LLC v. Abraxis BioScience, LLC,
`IPR2017-01103 ............................................................................................passim
`
`Apotex Corp. v. VIIV Healthcare Co.,
`IPR2014-00876, Paper No. 24 (PTAB Apr. 2, 2015) ....................................... 6, 9
`
`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`IPR2013-00385, Paper No. 17 (PTAB July 29, 2013) ......................................... 5
`
`Samsung Elecs. Co., Ltd. et al. v. Arendi S.A.R.L.,
`IPR2014-01142, Paper No. 11 (PTAB Oct. 2, 2014) ........................................... 8
`
`Samsung Elecs. Co., Ltd. et al. v. Arendi S.A.R.L.,
`IPR2014-01143, Paper No. 11 (PTAB Oct. 2, 2014) ........................................... 8
`
`Sony Corp. of Am. v. Network-I Security Solutions, Inc.,
`IPR2013-00386, Paper No. 16 (PTAB July 29, 2013) ..................................... 4, 5
`
`Telit Wireless Solutions Inc. v. M2M Solutions LLC,
`IPR2016-01081, Paper No. 11 (PTAB Sept. 29, 2016) ...................................... 12
`
`Unified Patents Inc. v. Personalized Media Comm., LLC,
`IPR2015-00520, Paper No. 16 (PTAB June 8, 2015) ........................................ 11
`
`Unified Patents, Inc. v. PersonalWeb Tech., LLC,
`IPR2014-00702, Paper No. 12 (PTAB July 24, 2014) ......................................... 5
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.1(b) .................................................................................................... 5
`
`
`
`
`
`ii
`
`
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`37 C.F.R. § 42.20(c) ................................................................................................... 4
`
`37 C.F.R. § 42.51(b)(1)(iii) ........................................................................................ 7
`
`37 C.F.R. § 42.122(b) ............................................................................................ 3, 4
`
`35 U.S.C. § 315(c) ..................................................................................................... 4
`
`35 U.S.C. § 316(b) ..................................................................................................... 5
`
`
`
`
`
`
`
`
`
`iii
`
`
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`
`
`EXHIBIT LIST
`Email from Frank Calvosa, Associate, Quinn Emanuel Urquhart &
`Sullivan, LLP to Michael Freno et al., K&L Gates, LLP (Dec. 6, 2017)
`Email from Eimeric Reig, Winston & Strawn LLP to Andrew Chalson et
`al., Quinn Emanuel Urquhart & Sullivan, LLP (Nov. 28, 2017)
`Cipla To Acquire 100% Of Generic Businesses In US for $550M,
`CISION PR NEWSWIRE, available at https://www.prnewswire.com/news-
`releases/cipla-to-acquire-100-of-generic-businesses-in-us-for-550m-
`300138118.html
`
`Ex. 1
`
`Ex. 2
`
`Ex. 3
`
`
`
`
`
`iv
`
`
`
`

`

`
`I.
`
`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`
`INTRODUCTION
`Patent Owner Abraxis Bioscience, LLC (“Abraxis”) submits this Opposition
`
`to Petitioner Cipla Ltd.’s (“Cipla”) Motion for Joinder (Paper 3) (“Motion for
`
`Joinder”). Cipla seeks to join the inter partes review (“IPR”) that was requested
`
`by third-party Actavis LLC (“Actavis”) and instituted on October 10, 2017:
`
`Actavis LLC v. Abraxis BioScience, LLC, IPR2017-01103 (“the Actavis IPR”).
`
`Cipla has failed, however, to demonstrate that joinder, which is a determination in
`
`the Board’s discretion, would be efficient.
`
`Instead of increasing efficiency, joining Cipla to the Actavis IPR, which is
`
`well underway, would present several new substantive and procedural issues,
`
`including discovery issues, confidentiality concerns, and real-party-in-interest
`
`issues. Those new issues would complicate and delay the Actavis IPR—to the
`
`prejudice of Abraxis, and contrary to the public interest, in confirming the validity
`
`of Abraxis’s patent in a just, efficient, and speedy manner. Meanwhile, nothing
`
`would be gained by joinder, since Cipla’s Petition presents only the same asserted
`
`grounds of unpatentability that were already instituted for trial in the Actavis IPR.
`
`Joinder should, therefore, be denied. If the Board nonetheless grants joinder,
`
`Abraxis respectfully submits that a six-month extension of the Actavis IPR
`
`schedule is warranted.
`
`
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`
`II. BACKGROUND
`The Actavis IPR that Cipla seeks to join concerns Abraxis’s U.S. Patent No.
`
`U.S. Patent No. 7,923,536 (the “’536 patent”). The Actavis IPR relates to a co-
`
`pending litigation in which Abraxis has asserted the ’536 patent as well as three
`
`other patents against Actavis: U.S. Patent Nos. 8,138,229 (the “’229 patent”),
`
`7,820,788 (the “’788 patent”), and 8,853,260 (the “’260 patent”) (collectively, the
`
`“asserted patents”). See Abraxis Bioscience, LLC v. Actavis LLC, C.A. No. 16-cv-
`
`1925 (D.N.J.) (the “co-pending litigation”). In the co-pending litigation, Actavis
`
`has stipulated to infringement of all four asserted patents.
`
`On April 4, 2017—the eve of its statutory deadline—Actavis filed for IPR of
`
`the asserted patents. See IPR2017-01100; IPR2017-01101; IPR2017-01103;
`
`IPR2017-01104. On October 10, 2017, the Board instituted IPR of the ’229 patent,
`
`the ’788 patent, and the ’536 patent. The Board denied IPR of the ’260 patent.
`
`The three instituted Actavis IPRs are proceeding on the same schedule,
`
`which is well underway. Multiple initial deadlines have passed, the parties are far
`
`along into Actavis’s discovery period, and on November 30, 2017, Abraxis
`
`deposed Actavis’s expert witness Dr. Cory Berkland, Ph.D. Abraxis’s briefing
`
`period has also advanced; its deadline for filing the Patent Owner Responses is
`
`January 10, 2018—less than a month away. See, e.g., Actavis IPR, Paper 8.
`
`
`
`2
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`To join any of Actavis’s instituted IPRs, a motion was due no later than
`
`November 10, 2017 (or the next business day given the holiday). See 37 C.F.R.
`
`§ 42.122(b). Cipla waited until November 9, 2017, to file Petitions for IPR that are
`
`substantively identical to Actavis’s Petitions, and moved for joinder with the
`
`Actavis IPRs.1 That same day, Apotex Inc. and Apotex Corp. (collectively,
`
`“Apotex”) also filed their own Petitions for IPR that are substantively identical to
`
`Actavis’s Petitions, and likewise moved for joinder with the Actavis IPRs.2
`
`Actavis, Apotex, and Cipla are all generic drug manufacturers that directly
`
`compete with each other in the field related to the asserted patents.
`
`Cipla’s and Apotex’s Joinder Motions are not identical. They are organized
`
`differently, cite different case law, and propose different joinder procedures. For
`
`
`1 See IPR2018-00162 (Cipla Petition and Joinder Motion regarding the ‘788
`
`patent); IPR2018-00163 (Cipla Petition and Joinder Motion regarding the ‘536
`
`patent); IPR2018-00164 (Cipla Petition and Joinder Motion regarding the ‘229
`
`patent).
`
`2 See IPR2018-00151 (Apotex Petition and Joinder Motion regarding the
`
`‘229 patent); IPR2018-00152 (Apotex Petition and Joinder Motion regarding the
`
`‘788 patent); IPR2018-00153 (Apotex Petition and Joinder Motion regarding the
`
`‘536 patent).
`
`
`
`3
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`instance, although Apotex proposes to serve as an understudy if Actavis remains in
`
`the IPRs (IPR2018-00153, Paper 3 at 8), Cipla states only that it “will agree, if
`
`joinder is granted and as long as Actavis remains a party to the proceeding, to
`
`coordinate discovery with Actavis and to coordinate filings with Actavis for all
`
`substantive papers except motions that do not involve Actavis.” (Paper 3 at 7.)
`
`Additionally, there is a pending lawsuit between Abraxis and Cipla, which
`
`Abraxis timely filed over a year ago on December 7, 2016, once Cipla filed its
`
`ANDA regarding the asserted patents and provided notice of that filing to Abraxis.
`
`There is no pending infringement lawsuit between Abraxis and Apotex regarding
`
`any of the asserted patents.
`
`III. LEGAL STANDARD
`The decision whether to join separately-filed IPR Petitions is in the Board’s
`
`discretion. See 35 U.S.C. § 315(c); see also Sony Corp. of Am. v. Network-I
`
`Security Solutions, Inc., IPR2013-00386, Paper No. 16 at 3 (PTAB July 29, 2013)
`
`(“[T]he decision to grant joinder is discretionary.”). As the moving party, Cipla
`
`bears the burden of establishing that the Board’s exercise of its discretion would be
`
`warranted. See 37 C.F.R. § 42.20(c) & § 42.122(b).
`
`The Board has identified four requirements for joinder motions. The movant
`
`“should: (1) set forth the reasons why joinder is appropriate; (2) identify any new
`
`grounds of unpatentability asserted in the petition; (3) explain what impact (if any)
`
`
`
`4
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`joinder would have on the trial schedule for the existing review; and (4) address
`
`specifically how briefing and discovery may be simplified.” Sony, IPR2013-
`
`00386, Paper No. 16 at 4.
`
`Assertion of the same grounds of unpatentability, or even submission of a
`
`substantively identical petition, is not enough to warrant joinder. See Unified
`
`Patents, Inc. v. PersonalWeb Tech., LLC, IPR2014-00702, Paper No. 12 at 3-4
`
`(PTAB July 24, 2014) (citing 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b); 157 Cong.
`
`Rec. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl)) (Even if the petitions
`
`are “nearly identical,” “joinder is not automatic.”). Rather, the overall concern is
`
`whether joinder would promote an efficient and speedy determination, or if joinder
`
`would impose additional time and costs or affect the trial schedule of the already-
`
`pending IPR. See id. at 4 (noting the “need to complete proceedings in a just,
`
`speedy and inexpensive manner” and focusing on “(1) time and cost
`
`considerations, including the impact joinder would have on the trial schedule; and
`
`(2) how briefing and discovery may be simplified”); Dell, Inc. v. Network-1
`
`Security Solutions, Inc., IPR2013-00385, Paper No. 17 at 3 (PTAB July 29, 2013)
`
`(explaining that the “patent trial regulations, including the rules for joinder, must
`
`be construed to secure the just, speedy, and inexpensive resolution of every
`
`proceeding”).
`
`
`
`5
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`
`IV. ARGUMENT
`A.
`Joinder Should be Denied Because it Would Complicate and
`Delay, not Simplify or Expedite, the Actavis IPR
`Joining Cipla to the Actavis IPR would introduce complications and
`
`additional proceedings, which would preclude trial of that IPR on its current
`
`schedule. These complications would also require separate briefing and
`
`representation from Actavis and Cipla, notwithstanding Cipla’s assertion
`
`(unsubstantiated from Actavis) that Cipla would coordinate discovery and briefing
`
`with Actavis. Indeed, as its similarly situated movant Apotex has recognized in
`
`opposing joinder in another IPR, joinder is inappropriate where it would result in
`
`“a more complicated schedule, delay in deadlines, and increased costs in dealing
`
`with the complexity.” Apotex Corp. v. VIIV Healthcare Co., IPR2014-00876,
`
`Paper No. 24 at 4 (PTAB Apr. 2, 2015). As set forth further below, that is the case
`
`here.
`
`1.
`
`A Discovery Extension Would Be Required to
`Accommodate Discovery from Cipla
`If Cipla were joined to the Actavis IPR, discovery with respect to Cipla
`
`could not be completed on the current schedule in the Actavis IPRs. In the Actavis
`
`IPRs, Abraxis’s discovery period closes soon, on January 3, 2018. Even assuming
`
`the Board ordered joinder immediately, that would allow barely three weeks for
`
`Abraxis to obtain discovery from Cipla. That is not sufficient time for Abraxis to
`
`take meaningful discovery from Cipla.
`
`
`
`6
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`In instituting the Actavis IPRs, the Board noted that Abraxis may wish to
`
`present evidence of “loss of paclitaxel during commercial synthesis of the
`
`nanoparticles.” E.g., Actavis IPR at 18 n.7. As such, Abraxis has already asked
`
`Cipla whether it will oppose a request for “all documents and things relating to loss
`
`of paclitaxel during processing or development of any albumin-bound paclitaxel
`
`nanoparticle formulation.” (Ex. 1.) But Cipla has not yet provided a substantive
`
`response. Abraxis, therefore, does not know whether Cipla will properly produce
`
`such information as routine discovery under 37 C.F.R. § 42.51(b)(1)(iii), or force
`
`Abraxis to move the Board for the information as additional discovery. In either
`
`case, Abraxis can only conduct meaningful discovery of Cipla after Cipla provides
`
`this threshold information. It would, therefore, be all but impossible to complete
`
`discovery by the January 3, 2018 deadline in the Actavis IPRs if Cipla were joined.
`
`Moreover, only after Cipla provides the discovery sought would Abraxis be
`
`able to assess whether it needs to re-depose Dr. Berkland. An additional
`
`deposition would require a further extension of the schedule. The necessary
`
`extension of the Actavis IPR schedule if Cipla were joined weighs against joinder.
`
`2.
`
`The Direct-Competitor Relationship Between Actavis and
`Cipla Would Complicate the Actavis IPR
`Cipla and Actavis are direct competitors of each other, presenting another
`
`complication if Cipla were joined to the Actavis IPR. Cipla does not address this
`
`fact, though its restraint from proposing to serve as an understudy suggests that it
`
`
`
`7
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`recognizes confidentiality concerns. Instead, Cipla vaguely proposes to coordinate
`
`discovery and consolidate briefing with Actavis. (Paper 3 at 7.) But difficulties
`
`due to the proprietary and confidential nature of discovery and attorney work
`
`product will inevitably arise. Notably, although Actavis does not oppose joinder,
`
`there is no evidence that Actavis agrees to Cipla’s proposed consolidated filings.
`
`On similar facts, the Board has denied joinder. See Samsung Elecs. Co., Ltd. et al.
`
`v. Arendi S.A.R.L., IPR2014-01143, Paper No. 11 at 6 (PTAB Oct. 2, 2014)
`
`(denying joinder in part because petitioner’s statements concerning simplified
`
`briefing through coordination with earlier petitioner were not substantiated by
`
`evidence of such an agreement); Samsung Elecs. Co., Ltd. et al. v. Arendi S.A.R.L.,
`
`IPR2014-01142, Paper No. 11 at 5 (PTAB Oct. 2, 2014) (noting that Samsung
`
`“submit[ted] no evidence that the petitioner in [the original petition] has agreed to,
`
`or will, ‘work together’ with [Samsung] to ‘manage the questioning at depositions,
`
`and presentations at the hearing, to manage within the time normally allotted, and
`
`to avoid redundancy’”).
`
`Moreover, if joinder were granted, Abraxis may be forced to proceed in the
`
`Actavis IPR without being able to rely on confidential discovery from either
`
`Actavis or Cipla, to the substantial prejudice of Abraxis. Indeed, a current dispute
`
`in the co-pending litigation provides direct insight into the complexities and
`
`prejudice to Abraxis that would be imposed by the requested joinder.
`
`
`
`8
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`Specifically, after Actavis previously produced certain confidential Actavis
`
`information to Abraxis for use in the Actavis IPR, Actavis did an about-face once
`
`the possibility of joinder by Cipla or Apotex arose. According to Actavis’s
`
`communication with Abraxis on November 28, 2017, now that “Apotex and Cipla
`
`have moved to join the IPRs,” Actavis “would be severely prejudiced if its highly
`
`confidential information were disclosed to its competitors,” and it claims Abraxis
`
`is no longer entitled to use the already-produced information. (Ex. 2.) Moreover,
`
`this confidentiality concern relates not only to the documents that Actavis is now
`
`seeking to claw back from the IPRs, but much more broadly to any documents that
`
`are confidential and proprietary to either Actavis or Cipla.
`
`Notably, Apotex, Cipla’s similarly situated movant, has previously opposed
`
`joinder on the ground that the petitioners were direct competitors with each other
`
`and thus could not effectively coordinate efforts and briefing, given confidentiality
`
`concerns. See Apotex Corp., IPR2014-00876, Paper No. 24 at 5 (PTAB Apr. 2,
`
`2015). As Apotex argued, the petitioner seeking joinder (Teva) was “a direct
`
`competitor of Apotex’s,” which prevented Apotex from being willing to share its
`
`draft briefs with Teva. Id. at 5. The same considerations apply here. Indeed, Teva
`
`is Actavis’s parent company, and multiple Teva entities are listed as real parties-in-
`
`interest in the Actavis IPR. Moreover, there is no agreement between Actavis and
`
`Cipla regarding the logistics of each one’s confidential information and there has
`
`
`
`9
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`already been a dispute about this issue in the co-pending litigation. The
`
`confirmed divergent interests among these direct competitors further renders
`
`joinder inappropriate.3
`
`3.
`
`The Cipla Petition Presents Real-Party-in-Interest Issues
`that Would Complicate and Delay the Actavis IPR
`The Cipla Petition presents real-party-in-interest issues not present in the
`
`Actavis IPR. In addition to identifying itself as “the real party-in-interest,” Cipla
`
`“additionally discloses” other Cipla entities and InvaGen Pharmaceuticals, Inc.
`
`(“InvaGen”). (Paper 2 at 4.) The disclosure of InvaGen raises questions as to
`
`whether all of the real parties-in-interest have been disclosed. For instance, public
`
`sources state that, at the same time Cipla acquired InvaGen, a pharmaceutical
`
`company, it acquired another pharmaceutical company, Exelan Pharmaceuticals,
`
`Inc. (“Exelan”). (Ex. 3 at 1.) Public sources further state that Exelan “sells
`
`products manufactured by InvaGen to government buyers.” (Id. at 3.)
`
`Notwithstanding this apparent drug-manufacturer/drug-sales relationship between
`
`InvaGen and Exelan, however, Cipla did not identify Exelan as a real party-in-
`
`
`3 Joinder of Cipla would only further complicate the proceedings. With
`
`three direct competitors as Petitioners, each of the three would have their own
`
`confidential material.
`
`
`
`10
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`interest. Also, it is not clear whether InvaGen or Exelan have any related
`
`companies that should also have been disclosed as real parties-in-interest.
`
`Addressing these threshold issues before IPR can be instituted will require
`
`additional discovery and time that would complicate and delay the Actavis IPR if
`
`Cipla were joined. Thus, the Board should deny joinder, as it has done in similar
`
`situations. See, e.g., Unified Patents Inc. v. Personalized Media Comm., LLC,
`
`IPR2015-00520, Paper No. 16 at 4-5 (PTAB June 8, 2015) (The “potential for
`
`additional discovery” regarding whether Petitioner identified all real parties-in-
`
`interest “presents a new substantive issue” that “weighs in favor of denying
`
`Petitioner’s Motion for Joinder”).
`
`4.
`
`Joinder Would Prejudice Abraxis and the Public, But There
`is No Prejudice to Cipla if Joinder is Denied
`Unlike the prejudice to Abraxis from these delays and complications, which
`
`would postpone its ability to resolve the unmeritorious challenges to its patent,
`
`there is no prejudice to Cipla if joinder is denied. Cipla’s delay in seeking joinder
`
`until the last possible moment makes clear that Cipla’s Petition is not time-
`
`sensitive. This is true notwithstanding the pending lawsuit against Cipla. Cipla
`
`could have filed for IPR before or as soon as that litigation began in December
`
`2016, but it did not. Instead, it waited almost a year to file for IPR, and did so at
`
`the near-end of its period for seeking to join the Actavis IPR. As such, Cipla
`
`elected to be on a significantly later track than the Actavis IPR. Cipla has not
`
`
`
`11
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`offered any justification for the delay. These facts, too, weigh against joinder. The
`
`Board should not reward Cipla for its self-created delay, as the Board has
`
`previously found that petitioners’ delays in filing petitions and moving for joinder
`
`weighed against joinder. See Telit Wireless Solutions Inc. v. M2M Solutions LLC,
`
`IPR2016-01081, Paper No. 11 at 8 n.3 (PTAB Sept. 29, 2016) (“We note that the
`
`delay in deciding the issue of joinder is largely attributable to Petitioner having
`
`filed the instant Petition a full month after the Decision on Institution in the -55
`
`Case, and a month and a half before the original deadline for Patent Owner’s
`
`Response in the -55 Case.”).
`
`Moreover, because Cipla’s Petition is substantively identical to the Actavis
`
`Petition, denial of joinder would not prejudice Cipla. The Board has already
`
`considered all of the grounds raised in Cipla’s Petition and has instituted trial on
`
`those grounds in the Actavis IPR. There is nothing to be gained, but much
`
`efficiency to be lost, by instituting IPR on Cipla’s Petition and joining Cipla to the
`
`Actavis IPR.
`
`B. Alternatively, a Six-Month Extension is Needed if Cipla is Joined
`If the Board, notwithstanding the delay, complications, and prejudice to
`
`Abraxis noted above, joins Cipla to the Actavis IPR, the trial schedule should be
`
`extended. While Abraxis would be prejudiced by an extended schedule, an
`
`extension would be necessary for Abraxis to have a fair opportunity to respond to
`
`
`
`12
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`the Cipla Petition and address the new issues arising from it addressed herein.
`
`Although Cipla asserts that no extensions would be needed, it fails to acknowledge
`
`that joinder under the current schedule would substantially curtail, if not
`
`effectively preclude, Abraxis’s ability to obtain discovery from Cipla.
`
`Accordingly, if joinder is granted, Abraxis respectfully submits that a six-month
`
`extension of all dates in the Actavis IPR is warranted.
`
`V. CONCLUSION
`For the reasons stated above, Abraxis requests that the Board deny Cipla’s
`
`Motion for Joinder. If the Board nonetheless grants joinder, Abraxis respectfully
`
`submits that a six-month extension of the Actavis IPR schedule is needed.
`
`Respectfully submitted,
`
`
`
`Dated: December 11, 2017
`
`
`
`
`
`
`
`/s/ Christopher J. Harnett
`Christopher J. Harnett (Reg. No. 35,538)
`Anthony M. Insogna (Reg. No. 35,203)
`Cary Miller, Ph.D. (Reg. No. 54,708)
`Lisamarie LoGiudice, Ph.D. (Reg. No. 71,047)
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`Tel: (212) 326-3939
`Fax: (212) 755-7306
`charnett@jonesday.com
`aminsogna@jonesday.com
`cmiller@jonesday.com
`llogiudice@jonesday.com
`
`F. Dominic Cerrito (Reg. No. 38,100)
`13
`
`

`

`Opposition to Motion for Joinder in IPR2018-00163
`U.S. Patent 7,923,536
`Andrew S. Chalson (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7450
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`andrewchalson@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`Counsel for Patent Holder
`Abraxis BioScience, LLC
`
`
`
`14
`
`

`

`EXHIBIT 1
`
`EXHIBIT 1
`
`

`

`Corr, Steven J.
`
`From:
`Sent:
`To:
`
`Cc:
`
`Subject:
`
`Frank Calvosa <frankcalvosa@quinnemanuel.com>
`Wednesday, December 6, 2017 9:04 AM
`michael.freno@klgates.com; anil.patel@klgates.com; jason.engel.ptab@klgates.com;
`peter.giunta@klgates.com; elizabeth.weiskopf@klgates.com
`Harnett, Christopher J.; Insogna, Anthony M.; Miller, Cary; Corr, Steven J.; Nick Cerrito;
`Andrew Chalson; Daniel Wiesner
`IPR2018-00162, -163, -164
`
`Counsel, 
` 
`We have received Cipla’s petitions for inter partes review (“IPR”) and accompanying motions for joinder.  Based on the 
`arguments made in your petitions (which mirror those made in the Actavis’s IPRs addressing the same patents) and in 
`view of the Board’s institution decisions in the Actavis IPRs, we intend to seek limited discovery from Cipla in the 
`IPRs.  Specifically, we plan to request:  All documents and things relating to loss of paclitaxel during processing or 
`development of any albumin‐bound paclitaxel nanoparticle formulation.   
` 
`Please let us know by close of business on Friday, December 8 if Cipla opposes this request. 
` 
`Best, 
` 
`Frank Calvosa
`Associate
`Quinn Emanuel Urquhart & Sullivan, LLP
`
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`212-849-7569 Direct
`212-849-7000 Main Office Number
`212-849-7100 FAX
`frankcalvosa@quinnemanuel.com
`www.quinnemanuel.com
`
`NOTICE: The information contained in this e-mail message is intended only for the personal and confidential use of the recipient(s) named above. This message
`may be an attorney-client communication and/or work product and as such is privileged and confidential. If the reader of this message is not the intended
`recipient or agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this document in error and that any
`review, dissemination, distribution, or copying of this message is strictly prohibited. If you have received this communication in error, please notify us immediately
`by e-mail, and delete the original message.  
`
`1
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`

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`EXHIBIT 2
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`EXHIBIT 2
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`

`

`Corr, Steven J.
`
`From:
`Sent:
`To:
`
`Cc:
`
`Subject:
`Attachments:
`
`Reig, Eimeric <EReigPlessis@winston.com>
`Tuesday, November 28, 2017 1:10 PM
`Andrew Chalson; Daniel Wiesner; Joseph Linares; Ross Misskelley; Insogna, Anthony M.;
`Miller, Cary; Elsevier, J. Patrick; LoGiudice, Lisamarie; Corr, Steven J.; clizza@saul.com;
`Moses, David L. <dmoses@saul.com>; ssullivan@saul.com; WBaton@saul.com; Nick
`Cerrito; Eric Stops; Robert Wilson; Catherine Mattes; Jeffrey Matthews; Harnett,
`Christopher J.; Frank Calvosa
`Klein, Chuck; Park, Sam; Warner, Kevin E.; Lin, Sharon; lwalsh@walsh.law; Hector D. Ruiz
`(hruiz@walsh.law); Joseph Linares (jlinares@walsh.law)
`RE: Abraxis BioScience, LLC, et al. v. Actavis LLC, C.A. No. 16-1925 (D.N.J.)
`2017-07-03 Letter from Reig to Cerrito.pdf
`
`Andrew, 
` 
`Celgene is mistaken.  As we made clear in our letter of July 3, 2017 (re‐attached here), “Actavis has neither ‘produced’ 
`anything in the IPR nor consented to any unauthorized use of its Highly Confidential information.”  Moreover, “using 
`Actavis’s Highly Confidential information for purposes other than the district court litigation (e.g., in the IPRs) without 
`Actavis’s express consent would be a violation of the Court’s [Discovery Confidentiality] Order.” 
` 
`Following our letter, the parties met and conferred, and Celgene agreed that it would not violate the DCO by using 
`Actavis’s confidential information in the IPRs.  Consistent with that agreement, Celgene did not seek to rely on the “Pilot 
`Studies” in its Patent Owner Preliminary Responses.  We understood that this was the end of the matter, and we are 
`surprised by Celgene’s renewed request and incorrect characterization of the parties’ discussions. 
` 
`Moreover, since our discussions last summer, circumstances have materially changed.  Apotex and Cipla have moved to 
`join the IPRs, and the law governing claim amendments in IPRs has changed.  See Aqua Prods., Inc. v. Matal, 872 F.3d 
`1290 (Fed. Cir. 2017) (en banc).  Actavis would be severely prejudiced if its highly confidential information were 
`disclosed to its competitors and could be used by Celgene in prosecuting new claims.  In any event, any attempt to use 
`Actavis’s confidential documents in the IPRs would be futile, as they would be inadmissible at least as unauthenticated 
`hearsay. 
` 
`Even apart from these additional issues, as before, we do not understand how Celgene’s unilateral belief that Actavis’s 
`confidential information is relevant to issues in the IPRs provides any basis to bypass the DCO’s explicit 
`prohibitions.  Please provide the authority that Celgene relies on for its position and we would be happy to discuss 
`further.  In the meantime, we trust that Celgene will continue to comply with the DCO. 
` 
`For clarity, we note that any use of or reliance on Actavis’s confidential information (including the “Pilot Studies”) at Dr. 
`Berkland’s deposition this Thursday would be an outright violation of the DCO, and Actavis reserves all rights to seek 
`appropriate relief for any such violation. 
` 
`Thanks, 
`Eimeric 
` 
`Eimeric Reig
`Winston & Strawn LLP
`D: +1 202-282-5508
`winston.com
`
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`EXHIBIT 3
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`EXHIBIT 3
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`Cipla to acquire 100% of generic businesses in US for $550M
`~ Through the acquisition of InvaGen, Cipla gains scale in the US generics market with a strong manufacturing and R&D base,
`access to broad product portfolio and a strong customer base consisting of top wholesalers/retailers
`
`~ Through the acquisition of Exelan, Cipla gains access to the government and institutional market in the US
`Sep 03, 2015, 23:38 ET from Cipla Limited
`
`Cipla Logo    
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`
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`
`MUMBAI, India, Sept. 3, 2015 /PRNewswire/ -- Cipla, a global pharmaceutical company which uses technology and innovation to meet the
`everyday needs of all patients, today announced that its UK arm, Cipla EU has entered into denitive agreements to acquire two US-based
`companies, InvaGen Pharmaceuticals Inc., and Exelan Pharmaceuticals Inc. The transaction being subject to certain closing conditions, is
`valued at $550 million and will be an all cash transaction. The combined revenue from these transactions is over $200 million for the year ended
`Dec 2014 and over $225 million in LTM June 2015. This acquisition, which is the second landmark acquisition in Cipla's 80 years of history, will give
`the company scale in the US generics market throu