Filed on behalf of: Abraxis Bioscience, LLC
`
`Filed: December 11, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`APOTEX INC. and APOTEX CORP.
`Petitioners
`v.
`ABRAXIS BIOSCIENCE, LLC
`Patent Owner
`_____________________
`Case IPR2018-00153
`U.S. Patent No. 7,923,536
`————————————————
`PATENT OWNER’S OPPOSITION TO PETITIONERS’ 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 IPR2018-00153
`U.S. Patent 7,923,536
`
`TABLE OF CONTENTS
`TABLE OF AUTHORITIES ................................................................................... ii
`EXHIBIT LIST ........................................................................................................ iv 
`I.
`INTRODUCTION .......................................................................................... 1 
`II.
`BACKGROUND ............................................................................................ 2 
`III. LEGAL STANDARD .................................................................................... 4 
`IV. ARGUMENT .................................................................................................. 5 
`A.
`Joinder Should be Denied Because it Would Complicate and
`Delay, not Simplify or Expedite, the Actavis IPR ............................... 5 
`1.
`A Discovery Extension Would Be Required to
`Accommodate Discovery from Apotex ..................................... 6 
`The Direct-Competitor Relationship Between Actavis
`and Apotex Would Complicate the Actavis IPR ....................... 7 
`The Apotex 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 Apotex if Joinder is Denied ............. 11 
`B. Alternatively, a Six-Month Extension is Needed if Apotex is
`Joined .................................................................................................. 12 
`CONCLUSION ............................................................................................. 13 
`
`V.
`
`
`
`
`
`i
`
`2.
`
`3.
`
`4.
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`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, 9
`
`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
`
`Telit Wireless Solutions Inc. v. M2M Solutions LLC,
`IPR2016-01081, Paper No. 11 (PTAB Sept. 29, 2016) ...................................... 12
`
`Unified Patents Inc. v. Personalized Media Communications, 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 IPR2018-00153
`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
`
`

`

`Ex. 2
`
`Ex. 3
`
`Ex. 4
`
`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`
`Ex. 1
`
`EXHIBIT LIST
`Email from Frank Calvosa, Quinn Emanuel Urquhart & Sullivan, LLP to
`Counsel for Apotex (Dec. 6, 2017)
`Email from Eimeric Reig, Winston & Strawn LLP to Andrew Chalson et
`al., Quinn Emanuel Urquhart & Sullivan, LLP (Nov. 28, 2017)
`S&P Capital IQ Filtered Corporate Tree Aggregates for Pancea Biotec
`Limited
`Panacea Biotech Ltd, PHARMABIZ.COM, available at
`http://saffron.pharmabiz.com/red.asp?fn=/services/comprof/Panacea.asp
`6/
`Panacea Biotec, Inc., B-400776 (Comp. Gen. Jan. 21, 2009)
`Ex. 5
`Ex. 6 Department of State: Division of Corporations, Entity Details, Panacea
`Biotec, Inc., DELAWARE.GOV, available at
`https://icis.corp.delaware.gov/Ecorp/EntitySearch/NameSearch.aspx
`
`
`
`iv
`
`

`

`
`I.
`
`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`
`INTRODUCTION
`Patent Owner Abraxis Bioscience, LLC (“Abraxis”) submits this Opposition
`
`to Petitioners Apotex Inc. and Apotex Corp.’s (collectively, “Apotex”) Motion for
`
`Joinder (Paper 3) (“Motion for Joinder”). Apotex 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”). Apotex has failed, however, to demonstrate
`
`that joinder, which is a determination in the Board’s discretion, would be efficient.
`
`Instead of increasing efficiency, joining Apotex 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 Apotex’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 IPR2018-00153
`U.S. Patent 7,923,536
`
`II. BACKGROUND
`The Actavis IPR that Apotex seeks to join concerns Abraxis’s 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 IPR2018-00153
`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). Apotex 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, Cipla Ltd. (“Cipla”) also filed its 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.
`
`Apotex’s and Cipla’s Joinder Motions are not identical. They are organized
`
`differently, cite different case law, and propose different joinder procedures. For
`
`
`1 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).
`
`2 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).
`
`
`
`3
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`instance, Apotex proposes to serve as an “understudy” if Actavis remains in the
`
`IPRs (Paper 3 at 8), whereas Cipla does not. See IPR2018-00153, Paper 3 at 8.
`
`Additionally, there is no pending infringement lawsuit between Abraxis and
`
`Apotex regarding any of the asserted patents. There is, however, a pending lawsuit
`
`between Abraxis and Cipla. Abraxis timely filed that lawsuit on December 7,
`
`2016, once Cipla filed its ANDA regarding the asserted patents and provided
`
`notice of that filing to Abraxis.
`
`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, Apotex
`
`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)
`
`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.
`
`
`
`4
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`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”).
`
`IV. ARGUMENT
`A.
`Joinder Should be Denied Because it Would Complicate and
`Delay, not Simplify or Expedite, the Actavis IPR
`Joining Apotex to the Actavis IPR would introduce complications and
`
`additional proceedings, which would preclude trial of that IPR on its current
`
`
`
`5
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`schedule. These complications would also require separate briefing and
`
`representation from Actavis and Apotex, notwithstanding Apotex’s assertion
`
`(unsubstantiated from Actavis) that Apotex would serve as an understudy and
`
`would file consolidated briefs with Actavis. In opposing joinder in another IPR,
`
`Apotex has recognized that 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 Apotex
`If Apotex were joined to the Actavis IPR, discovery with respect to Apotex
`
`would require an extension of 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 Apotex. That is not sufficient time for
`
`Abraxis to take meaningful discovery from Apotex.
`
`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
`
`Apotex whether it will oppose a request for “all documents and things relating to
`
`loss of paclitaxel during processing or development of any albumin-bound
`
`
`
`6
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`paclitaxel nanoparticle formulation.” (Ex. 1.) But Apotex has not yet provided a
`
`substantive response. Abraxis, therefore, does not know whether Apotex 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 Apotex after Apotex 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 Apotex were joined.
`
`Moreover, only after Apotex 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 Apotex were joined weighs against
`
`joinder.
`
`2.
`
`The Direct-Competitor Relationship Between Actavis and
`Apotex Would Complicate the Actavis IPR
`Apotex and Actavis are direct competitors of each other, presenting another
`
`complication if Apotex were joined to the Actavis IPR. Apotex does not address
`
`this fact. Instead, it merely asserts that it will serve in an understudy role and file
`
`consolidated briefs with Actavis. (Paper 3 at 6-8.) 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
`
`
`
`7
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`evidence that Actavis agrees to Apotex’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 Apotex, to the substantial prejudice of Abraxis. Indeed, a current
`
`dispute in the co-pending litigation provides direct insight into the complexities
`
`and potential prejudice to Abraxis that would be imposed by the requested joinder.
`
`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 Apotex or Cipla arose. According to Actavis’s
`
`communication with Abraxis on November 28, 2017, now that “Apotex and Cipla
`
`
`
`8
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`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 Apotex.
`
`Notably, Apotex 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 Apotex regarding the
`
`logistics of each one’s confidential information, and there has 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 Joinder of Cipla would only further complicate the proceedings. With
`
`
`
`9
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`The Apotex Petition Presents Real-Party-in-Interest Issues
`that Would Complicate and Delay the Actavis IPR
`The Apotex Petition presents real-party-in-interest issues not present in the
`
`3.
`
`Actavis IPR. In addition to identifying itself as “the real parties-in-interest,”
`
`Apotex also identifies “[a]dditional real parties-in-interest,” including additional
`
`Apotex entities as well as Panacea Biotec Ltd. (“Panacea”). (Paper 2 at 4.) The
`
`disclosure of Panacea presents questions as to whether all of the real parties-in-
`
`interest have been disclosed. For instance, public sources indicate that Panacea is
`
`an Indian company that has several subsidiaries and related companies. (Ex. 3.)
`
`Public sources further indicate that one of Panacea’s wholly-owned subsidiaries is
`
`Panacea Biotec, Inc. (“Panacea-US”), an entity incorporated in Delaware “with its
`
`main objects to established [sic] its presence in US.” (Ex. 4 at 5; Ex. 5 at 1 n.1;
`
`Ex. 6.) Notwithstanding this U.S. corporate subsidiary, Apotex did not identify
`
`Panacea-US as a real party-in-interest. Nor has Apotex explained its relationship
`
`with Panacea (or any other Panacea entities), or explained why it did not name
`
`additional Panacea entities (like the additional Apotex entities) as real parties-in-
`
`interest.
`
`Addressing these threshold issues before IPR can be instituted will require
`
`
`three direct competitors as Petitioners, each of the three would have their own
`
`confidential material.
`
`
`
`10
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`additional discovery and time that would complicate and delay the Actavis IPR if
`
`Apotex 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 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 Apotex 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 Apotex if joinder is denied. Apotex’s delay in seeking
`
`joinder until the last possible moment makes clear that Apotex’s Petition is not
`
`time-sensitive. Indeed, unlike Actavis, Apotex’s stake in the ’536 patent is entirely
`
`unclear. Notably, Apotex has not been served with a complaint for patent
`
`infringement of the ’536 patent. Thus, Apotex faces no deadline for filing its
`
`Petition and can re-file at any later date, including if Actavis were to withdraw its
`
`IPR before a merits determination, which further weighs against joinder. See Id.,
`
`at 7 (denying joinder where, “should the [earlier] proceedings be terminated,
`
`Petitioner will be free to refile its Petition”).
`
`
`
`11
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`Also, in waiting to seek joinder until the last possible moment, Apotex
`
`elected to be on a significantly later track than the Actavis IPR. Apotex has not
`
`offered any justification for the delay. This fact, too, weighs 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 Apotex’s Petition is substantively identical to the Actavis
`
`Petition, denial of joinder would not prejudice Apotex. The Board has already
`
`considered all of the grounds raised by Apotex’s Petition and has instituted trial on
`
`those grounds in the Actavis IPR. Thus, there is nothing to be gained, but much
`
`efficiency to be lost, by instituting IPR on Apotex’s Petition and joining Apotex to
`
`the Actavis IPR.
`
`B. Alternatively, a Six-Month Extension is Needed if Apotex is
`Joined
`If the Board, notwithstanding the delay, complications, and prejudice to
`
`Abraxis noted above, joins Apotex 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
`
`the Apotex Petition and address the new issues arising from it addressed herein.
`
`
`
`12
`
`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`Although Apotex 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 Apotex.
`
`Accordingly, if joinder is granted, Abraxis respectfully submits that a six-month
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`extension of all dates in the Actavis IPR is warranted.
`
`V. CONCLUSION
`For the reasons stated above, Abraxis requests that the Board deny Apotex’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)
`Andrew S. Chalson (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`
`13
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`

`

`Opposition to Motion for Joinder in IPR2018-00153
`U.S. Patent 7,923,536
`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
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`

`

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`EXHIBIT 1
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`EXHIBIT 1
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`

`

`Corr, Steven J.
`
`From:
`Sent:
`To:
`Cc:
`
`Subject:
`
`Frank Calvosa <frankcalvosa@quinnemanuel.com>
`Wednesday, December 6, 2017 9:01 AM
`Abraxane@Steptoe.com
`Harnett, Christopher J.; Insogna, Anthony M.; Miller, Cary; Corr, Steven J.; Nick Cerrito;
`Andrew Chalson; Daniel Wiesner
`IPR2018-00151, -152, -153
`
`Counsel, 
` 
`We have received Apotex’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 Apotex 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 Apotex 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
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`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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`Panacea Biotec Limited (BSE:531349) > Corporate Tree
`
`Report Criteria
`Relationship Types
`
`Company Name
`
`Panacea Biotec Limited (BSE:531349)
`
`Adveta Power Pvt. Ltd
`Best On Health Ltd
`Chiron Panacea Vaccines Private Limited
`
`Panacea Biotec Germany GmbH
`Panacea Biotec, Inc.
`Panera Biotec Pvt. Ltd
`Panheber Biotec Pvt. Ltd.
`Radhika Heights Limited
`Radicura & Co. Ltd.
`Rees Investments Limited
`Panacea Biotec (international) Sa
`Trinidhi Finance Pvt. Ltd.
`*denotes proprietary relationship information
`
`Current Subsidiaries/Operating Units
`
`CIQ Company ID
`
`Parent Company
`
`8954199 -
`
`247300025 Panacea Biotec Limited (BSE:531349)
`31250842 Panacea Biotec Limited (BSE:531349)
`29455213 Panacea Biotec Limited (BSE:531349), Novartis Vaccines & Diagnostics s.r.l.
`
`223161188 Panacea Biotec Limited (BSE:531349)
`108406946 Panacea Biotec Limited (BSE:531349)
`247300036 Panacea Biotec Limited (BSE:531349)
`30823523 Panacea Biotec Limited (BSE:531349)
`536073641 Panacea Biotec Limited (BSE:531349)
`31271033 Panacea Biotec Limited (BSE:531349)
`65309287 Panacea Biotec Limited (BSE:531349)
`225702264 Rees Investments Limited
`223160298 Panacea Biotec Limited (BSE:531349)
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