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`Paper No. 7
`Filed January 10, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
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`APOTEX INC. and APOTEX CORP.
`
`Petitioners
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`v.
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`ABRAXIS BIOSCIENCE, LLC
`
`
`Patent Owner
`
`
`U.S. Patent No. 7,923,536
`Filed:
`April 12, 2010
`Issued:
`April 12, 2011
`Inventor: Neil P. Desai, et al.
`
`TITLE: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`
`Inter Partes Review No.: IPR2018-00153
`————————————————
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`REPLY TO PATENT OWNER’S OPPOSITION
`TO PETITIONER’S MOTION FOR JOINDER
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II.
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`JOINDER WILL NOT DELAY THE ACTAVIS IPR ................................... 1
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`A. Abraxis Is the Only Party Seeking to Delay the Proceedings By
`Seeking Additional Discovery that Has No Valid Basis ....................... 1
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`B.
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`That Actavis and Apotex Are Competitors Will Not Complicate
`Discovery ............................................................................................... 3
`C. Apotex’s IPR Correctly Named the Real-Parties-in-Interest ................ 4
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`D. Denial of Joinder Will Prejudice Apotex and the PTAB, as It Will
`Cause Needless Re-Litigation of the Same Issues ................................ 5
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`III. CONCLUSION ................................................................................................ 5
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`i
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper 25 (PTAB Mar. 5, 2013) ................................................. 3
`
`Intell. Ventures Mgmt., LLC. v. Xilinx, Inc.,
`IPR2012-00018, Paper 12 ( PTAB Jan. 24, 2013) ............................................... 5
`
`Samsung Elecs., Co., Ltd. v. Raytheon Co.,
`IPR2016-00962, Paper 12 (PTAB Aug. 24, 2016) ............................................... 1
`
`Statutes
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`25 U.S.C. § 316(a)(5) ................................................................................................. 2
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`35 U.S.C. §312(a)(2) .................................................................................................. 4
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`35 U.S.C. § 316(b) ..................................................................................................... 5
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`Other Authorities
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`77 Fed. Reg. 48,759-60 (Aug. 14, 2012) ................................................................... 4
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`ii
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`I.
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`INTRODUCTION
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`Apotex has submitted a substantively identical petition and declaration as in
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`the Actavis IPR, has agreed to an understudy role, and has made discovery and
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`procedural concessions to minimize delay. The Board routinely grants joinder
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`motions under such circumstances and should do so here. See, e.g., Samsung Elecs.,
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`Co., Ltd. v. Raytheon Co., IPR2016-00962, Paper 12 at 9 (PTAB Aug. 24, 2016).
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`Facing these dispositive facts, Abraxis argues that joinder will cause undue delay
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`and complexity in discovery, and asserts that all real-parties-in-interest have not
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`been named. As explained in detail below, each of these arguments is without
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`merit. Apotex has agreed to adhere to the procedural and discovery constraints in
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`the Actavis IPR; to the extent there are any discovery delays, they are attributable
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`solely to Abraxis. And while Abraxis contends that confidentiality issues will add
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`to the complexity of the proceedings, this argument will be mooted by a two-tiered
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`protective order in the Actavis IPR. As for its real-party-in-interest challenge,
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`Abraxis’ arguments fail, because Apotex named all the real-parties-in-interest. The
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`Board should thus grant Apotex’s joinder motion.
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`II.
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`JOINDER WILL NOT DELAY THE ACTAVIS IPR
`A. Abraxis Is the Only Party Seeking to Delay the Proceedings
`By Seeking Additional Discovery that Has No Valid Basis
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`Abraxis first argues that if joinder were ordered, it would require an extension
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`of the discovery schedule in order for Abraxis to obtain discovery from Apotex
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`related to the loss of paclitaxel during commercial production of nanoparticles.
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`Opp. Br. 6-7. This argument fails for several reasons. First, Abraxis will be
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`unable to satisfy its burden of showing that such additional discovery is “necessary
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`in
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`the
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`interest of
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`justice.” 25 U.S.C. § 316(a)(5).
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` Despite extensive
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`correspondence, Ex. 1027, Abraxis never explained, nor will it be able to explain,
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`how the paclitaxel loss in Apotex’s large-scale commercial process informs the
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`amount of paclitaxel loss (if any) in the bench-scale Example 1 of WO 99/00133
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`(“Desai”), the lead prior art in the Actavis IPR.
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`Second, Abraxis over-reads the Board’s Institution Decision with respect to
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`what evidence Abraxis may seek concerning paclitaxel loss. The Board was clear
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`that Abraxis could provide evidence concerning actual paclitaxel loss in Example 1
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`of Desai, as well as Abraxis’ Capxol and Abraxane commercial production. Actavis
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`IPR, Paper 7 at 17-18 & nn. 6-7 (PTAB Oct. 10, 2017). The Board’s instruction
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`follows from that the fact that this evidence is already under Abraxis’ custody and
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`control. The Board did not invite Abraxis to undertake a fishing expedition into
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`Apotex’s post-date processes for making albumin/paclitaxel nanoparticles. Such
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`evidence is not relevant to the issue of paclitaxel loss in the prior art Desai reference.
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`Lastly, even if the Board were to allow for additional discovery, it would not
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`impact the Actavis IPR schedule given that oral argument is not until July 11, 2018,
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`and the scope of potential production would necessarily be limited pursuant to the
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`2
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`Board’s rules and precedent. Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
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`IPR2012-00001, Paper 25 at 5-6 (PTAB Mar. 5, 2013). This belies Abraxis’
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`exaggerated claims of delay should the Board order production by Apotex.1 For this
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`reason, the Board should also reject Abraxis’ unwarranted request for a six-month
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`delay in the event that joinder is ordered. Opp. Br. 12-13.
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`B.
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`That Actavis and Apotex Are Competitors Will Not
`Complicate Discovery
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`Abraxis next asserts that the Actavis IPR will be complicated by the fact that
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`Actavis, Apotex, and Cipla are competitors, pointing to purported difficulties in
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`coordination and confidentiality. Opp. Br. 7-9. This argument is baseless.
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`Coordination is not an issue, because Apotex agreed to be bound by the discovery
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`and procedural constraints set forth in the Actavis IPR, and Actavis consented to
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`Apotex’s joinder motion. Apotex IPR, Paper 3 at 6-9 (PTAB Nov. 9, 2017).2 As
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`1 Abraxis contends that it may need to redepose Dr. Berkland concerning any new
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`Apotex documents. Opp. Br. 7. This argument is moot as Abraxis will depose Dr.
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`Berkland again anyway on his declaration in support of Petitioner’s Reply Brief.
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`2 Citing no authority, Abraxis argues that Actavis and Apotex must submit
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`affirmations as to Apotex’s understudy role. Opp. Br. 6. Even if this were the law,
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`which it is not, Apotex made such an affirmation in its joinder motion, and Actavis
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`consented to Apotex’s motion. Apotex IPR, Paper 3 at 7-8 (PTAB Nov. 9, 2017).
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`3
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`for confidentiality issues, this argument will be moot given that Petitioners are in the
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`process of agreeing to be governed by a two-tiered protective order, which provides
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`for an “outside counsel eyes only” designation.
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`C. Apotex’s IPR Correctly Named the Real-Parties-in-Interest
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`Abraxis next makes the puzzling assertion that the naming of Panacea Biotec
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`Ltd. “presents questions” as to whether all the correct real-parties-in-interest have
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`been named. Opp. Br. 10. Abraxis points to a U.S. subsidiary of Panacea Biotec
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`Ltd., Panacea Biotec, Inc. (“Panacea-US”), arguing that Apotex failed to name the
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`subsidiary or explain the relationship of it to the parent, and also did not explain why
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`it did not name other Panacea entities. Id. at 10. In view of these purported issues,
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`Abraxis argues that discovery will be necessary to resolve them. Id. at 11. These
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`arguments are likewise without merit. In complying with 35 U.S.C. §312(a)(2),
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`Apotex identified the real-parties-in-interest in its petition, namely those parties who
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`control and finance the proceedings. 77 Fed. Reg. 48,759-60 (Aug. 14, 2012).
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`Apotex was not required to explain why it did not name other parties, or explain
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`Panacea Biotec Ltd.’s relationship to its subsidiaries, and Abraxis provides no
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`support for such obligations. And underscoring the baselessness of Celgene’s
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`argument, Panacea-US was dissolved in 2011, and Panacea Biotec Ltd. no longer
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`has any U.S. subsidiaries in any event. See e.g., Exs. 1028, 1029 at p. 115. Lastly,
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`because Abraxis did not assert that any other parties financed the proceedings or
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`4
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`asserted control over the proceedings, its request for real-party-in-interest discovery
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`is nothing more than speculative and should be denied. Intell. Ventures Mgmt.,
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`LLC. v. Xilinx, Inc., IPR2012-00018, Paper 12 at 4 ( PTAB Jan. 24, 2013).
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`D. Denial of Joinder Will Prejudice Apotex and the PTAB, as It
`Will Cause Needless Re-Litigation of the Same Issues
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`Despite admitting that Apotex’s petition is substantively identical to the
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`Actavis petition, Abraxis alleges that denial of joinder will not prejudice Apotex or
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`the public, contending that Apotex can merely re-file its petition. Opp. Br. 11.
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`Abraxis asserts that Apotex is under no time pressure because it delayed filing its
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`petition and is not in litigation. Id. These arguments are without merit.
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`Denial of joinder will prejudice Apotex and the Board because both will have
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`to re-litigate the same issues currently raised in the Actavis IPR. And given the
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`near identity of the petitions, denial of joinder would be a waste of resources and
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`would be contrary to timely and economically completing the proceedings. See 35
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`U.S.C. § 316(b). As for Abraxis’ remaining arguments, Apotex timely filed its
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`petition without delay, and the fact that it is not in litigation is simply irrelevant.
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`III. CONCLUSION
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`For the foregoing reasons and those set forth in its opening brief, Apotex
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`respectfully request that their motion for joinder be granted.
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`5
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`Dated: January 10, 2018
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`STEPTOE & JOHNSON LLP
`1114 Avenue of the Americas, 35th Floor
`New York, NY 10036
`Phone: 212-506-3900
`Fax: 212-506-3950
`Email: Abraxane@Steptoe.com
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`Respectfully submitted,
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`/John Josef Molenda/
`John Josef Molenda
`Reg. No. 47,804
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`Lead Counsel for Petitioners
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`Doc. # DC-10816899 v.1
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`6
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that a copy of the foregoing REPLY TO PATENT
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`OWNER’S OPPOSITION TO PETITIONER’S MOTION FOR JOINDER
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`was served in its entirety on January 10, 2017 by filing this document through the
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`Patent Trial Appeal Board End to End System as well as by delivering a copy via
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`electronic mail, with Patent Owner’s consent, to the following attorneys for
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`Petitioner and Patent Owner in the Actavis IPR:
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`Counsel for Petitioner Actavis Counsel for Patent Owner Abraxis
`Samuel S. Park (lead counsel)
`J. Patrick Elsevier (lead counsel)
`George C. Lombardi
`Anthony M. Insogna
`Charles B. Klein
`Cary Miller
`Kevin E. Warner
`Christopher J. Harnett
`Eimeric Reig-Plessis
`Lisamarie LoGiudice
`WINSTON & STRAWN LLP
`JONES DAY
`AbraxaneIPR@winston.com
`jpelsevier@jonesday.com
`
`aminsogna@jonesday.com
`cmiller@jonesday.com
`llogiudice@jonesday.com
`charnett@jonesday.com
`
`F. Dominic Cerrito
`Andrew S. Chalson
`Daniel C. Wiesner
`Frank C. Calvosa
`QUINN EMANUEL URQUHART & SULLIVAN
`nickcerrito@quinnemanuel.com
`andrewchalson@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`/Siew Yen Chong/
`Siew Yen Chong
`Counsel for Apotex Inc. and Apotex Corp.
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`Date: January 10, 2018
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