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Paper No. __
`Filed November 9, 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
`
`
`U.S. Patent No. 7,820,788
`Filed:
`October 26, 2006
`Issued:
`October 26, 2010
`Inventor: Neil P. Desai, et al.
`
`TITLE: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`
`Inter Partes Review No.: IPR2018-00152
`————————————————
`
`PETITIONERS’ MOTION FOR JOINDER PURSUANT
`TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 & 42.122(b)
`
`
`
`
`
`
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`
`
`

`

`TABLE OF CONTENTS
`
`I. 
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1 
`
`II. 
`
`STATEMENT OF MATERIAL FACTS ........................................................ 2 
`
`III.  STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 3 
`
`A. 
`
`Joinder Is Appropriate Because It Will Expedite Resolution of the
`
`Proceeding ............................................................................................. 5 
`
`1. 
`
`2. 
`
`Substantively Identical Petitions ................................................. 5 
`
`Consolidated Filings and Discovery ........................................... 6 
`
`B.  No New Grounds of Unpatentability .................................................... 6 
`
`C.  No Impact on IPR Trial Schedule ......................................................... 7 
`
`D. 
`
`E. 
`
`F. 
`
`Briefing and Discovery Will Be Streamlined ....................................... 7 
`
`Joinder Will Not Prejudice Abraxis or Actavis..................................... 7 
`
`Expedited Briefing will Ensure Efficient Administration of the Joint
`
`Proceeding ............................................................................................. 8 
`
`IV.  PROPOSED ORDER ...................................................................................... 8 
`
`V. 
`
`CONCLUSION ............................................................................................... 9 
`
`
`
`
`
`
`
`i
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`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Abraxis BioScience, LLC et al., v. Actavis LLC,
`No. 2:16-cv-01925 (D.N.J) ................................................................................... 2
`Advanced Micro Devices Inc. v. Zond LLC, Paper No. 12,
`IPR2014-01042 (November 7, 2014) ................................................................... 1
`Amneal Pharm., LLC v. Yeda Res. & Dev. Co., Ltd., Paper No. 9,
`IPR2015-01976 (Dec. 28, 2015) ........................................................................... 1
`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`IPR2013-00385, Paper No. 17, Slip Op. (July 29, 2013) ..................................... 4
`Kyocera Corp. et al. v. Softview LLC, Paper No. 15, IPR2013-00004,
`Apr. 24, 2013 ........................................................................................................ 1
`Statutes
`
`35 U.S.C. § 315(c) ................................................................................................. 1, 3
`
`35 U.S.C. § 316(b) ..................................................................................................... 4
`Other Authorities
`
`37 C.F.R. § 42.1(b) ................................................................................................ 5, 8
`
`37 C.F.R. § 42.22 ............................................................................................... 1, 2, 3
`
`37 C.F.R. § 42.122(b) ........................................................................................ 1, 2, 3
`
`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011)
`(statement of Sen. Kyl) ......................................................................................... 5
`
`
`
`
`
`
`
`
`
`
`
`
`ii
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`

`

`I.
`
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22 & 42.122(b), Petitioners
`
`Apotex Inc. and Apotex Corp. (“Apotex”) request institution of an inter partes review
`
`concerning U.S. Patent No. 7,820,788 (“the ’788 patent”) and move for joinder with
`
`the inter partes review concerning the same p atent, Actavis LLC v. Abraxis
`
`BioScience, LLC, IPR2017-01101 (the “Actavis IPR”) that was instituted on October
`
`10, 2017.
`
`In view of the Board’s Representative Order outlining issues to be addressed in a
`
`motion for joi nder (Kyocera Corp. et al. v. Softview LLC, Paper No. 15,
`
`IPR2013-00004, Apr. 24, 2013), Petitioners submit that: (1) joinder is appropriate
`
`because it will promote efficient resolution of the proceedings without prejudice to
`
`the prior petitioner and patent owne r, Actavis LLC (“Actavis”) and
`
`Abraxis
`
`BioScience, LLC (“Abraxis”), respectivel y; (2) Petitioners’ IPR petition (“Apote x
`
`Petition”) does not raise new grounds of unpatentability over those instituted by the
`
`Board in the Actavis IPR; (3) joinder wo uld not affect the pending schedule in the
`
`Actavis IPR; and (4) Pe titioners and Actavis agree to su bmit consolidated filings to
`
`minimize the burde n and the impact on t he schedule. See, e.g., Advanced Micro
`
`Devices Inc. v. Zond LLC, Paper No. 12, IPR2014-01042 (Nov. 7, 2014) and Amneal
`
`Pharm., LLC v. Yeda Res. & Dev. Co., Ltd., Paper No. 9, IPR2015-01976 (Dec. 28,
`
`2015) (granting motions for joinder under si milar circumstances). Petitioners have
`
`
`
`
`
`
`
`

`

`also agreed to work with Actavis and take an “understudy” role in the joint IPR so
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`long as Actavis does not settle and/or dismiss the Actavis IPR.
`
`This Motion for J oinder is timely under 37 C. F.R. §§ 42 .22 & § 42.122(b)
`
`because it is submitted within one month from the October 10, 2017 date the Board
`
`instituted the Actavis IPR. Actavis IPR, Paper No. 7.
`
`II.
`
`
`STATEMENT OF MATERIAL FACTS
`
`1.
`
`On April 6, 2016, Abraxis filed a complaint against Actavis asserting
`
`infringement of the ’788 patent and related U.S. Patent Nos. 8,138,229 and
`
`7,923,536. Abraxis BioScience, LLC et al., v. Actavis LLC, No. 2:16-cv-01925
`
`(D.N.J).
`
`2.
`
`On April 4, 2017, Actavis filed a petition for inter partes review of the
`
`’788 patent, alleging unpatentability of all claims on anticipation and obviousness
`
`grounds. Actavis IPR, Paper No. 2.
`
`3.
`
`On July 12, 2017, Abraxis filed a Preliminary Patent Owner’s response.
`
`Id., Paper No. 6.
`
`4.
`
`On October 10, 2017, the Board instituted trial on the grounds of
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`unpatentability raised by Actavis for Claims 1-12 of the ’788 patent. Id., Paper No.
`
`7.
`
`5.
`
`On November 9, 2017, Petitioners filed the Apotex Petition and Motion
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`for Joinder within one month of the Actavis IPR October 10, 2017 institution date.
`
`
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`2
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`

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`6.
`
`The Apotex Petition challenges the same patent claims using the same
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`instituted grounds of unpatentability as the petition in the Actavis IPR. Both
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`petitions contain the same substantive analysis, identical exhibits, and rely upon the
`
`same expert.
`
`7.
`
`Actavis consents to joinder with Petitioners. And Petitioners have
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`jointly-retained Actavis’ expert, Dr. Cory J. Berkland, who submits an expert
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`declaration on behalf of Petitioners that is substantively identical to the expert
`
`declaration he submitted in the Actavis IPR.
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`Petitioners respectfully request that the Board exercise its discretion and grant
`
`joinder of the Apotex Petition and the Ac tavis IPR pursuant to 35 U.S.C. § 315(c)
`
`and 37 C.F.R. §§ 42.22 & 42.122(b).
`
` In support of this m otion, Petitioners and
`
`Actavis have agreed to consolidated
`
`filings and to additional procedural
`
`accommodations designed to streamline the proceedings. Petitioners a nd Actavis
`
`have also agreed to rely on the same expert and expert declarations in support of
`
`their Petitions.
`
`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review proceedings. The statutory provision governing joinder of inter partes
`
`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
`
`
`
`3
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`
`

`

`(c) JOINDER.—If the Director instit utes an inter partes review, th e
`Director, in his or her discretion, may join as a party to that inter partes
`review any person who properly files a petition under section 311 that
`the Director, after receiving a pre liminary response under section 313
`or the expiration of the tim e for filing such a response, determ ines
`warrants the institution of an inter partes review under section 314.
`
`In exercising its discretion to grant joinder, the Board considers the impact of
`
`substantive and procedural issues on
`
`
`
`the proceedings, as well as other
`
`considerations, while being “mindful that patent trial regulations, including the rules
`
`for joinder, must be construed to secure the just, speedy, and inexpensive resolution
`
`of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions, Inc.,
`
`IPR2013-00385, Paper No. 17, Slip Op. at 3 (July 29, 2013). The Board should
`
`consider “the policy preference for joining a party that does not present new issues
`
`that might co mplicate or del ay an existing proceeding.”
`
`Id. at 10. Under t his
`
`framework, joinder of the Apotex Petition with the Actavis IPR is appropriate.
`
`“A motion for joinder shoul d: (1) se t forth t he reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the petition;
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`(3) explain what i mpact (if any) joinder would have on the trial schedule for the
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`existing review; and (4) address specifica lly how briefing a nd discovery may be
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`simplified.” Id. at 4. Each of these factors is addressed in detail below.
`
`
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`4
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`

`

`A.
`
`Joinder Is Appropriate Because It Will Expedite Resolution of the
`Proceeding
`
`Joinder is appropriate here because it is the most expedient way to secure the
`
`
`
`
`just, speedy, and inexpensive resolution of the two related proceedings. See 35
`
`U.S.C. § 316(b); 37 C.F.R. § 42.1(b). The Apotex Petition is substantively identical
`
`to the petition submitted in the Actavis IPR and is supported by a substantively
`
`identical expert declaration. Petitioners and Actavis have agreed to consolidated
`
`filings and discovery in addition to other procedural concessions so that Petitioners
`
`will be bound by the schedule set forth in the Actavis IPR.
`
`1.
`
`Substantively Identical Petitions
`
`The Apotex Petition challenges the same patent claims, contains the same
`
`grounds of unpatentability, and is identical in all substantive aspects to the petition
`
`in the instituted Actavis IPR. Both petitions contain the same analysis and exhibits,
`
`and Petitioners rely upon the
`
` same expert and substant
`
`ively identical expert
`
`declarations. The Board has already instituted trial in the Actavis IPR (Paper No. 7)
`
`and will not need to expe
`
`nd additional resources to decide institution on the
`
`substantively identical Apotex Petition. See 157 CONG. REC. S1376 (daily ed. Mar.
`
`8, 2011) (statement of Sen. Kyl) (“The Office anticipates that joinder will be allowed
`
`as of right —if an inter partes review is instituted on the basis of a petition, for
`
`example, a party that files an identical petition will be joined to that proceeding, and
`
`thus allowed to file its own briefs and make its own arguments.”).
`
`
`
`5
`
`
`
`
`

`

`2.
`
`Consolidated Filings and Discovery
`
`Petitioners and Actavis have agreed to submit consolidated filings for all
`
`substantive papers in the proceeding. Neither Petitioners nor Actavis will request
`
`any increase in the ordinary li mit on length for the se consolidated filings. These
`
`agreed-to consolidated filings will avoid lengthy and duplicative briefing.
`
`Consolidated discovery is also appropriate given that Petitioners and Actavis
`
`will rely on the same expert and substantia lly identical expert declarations in the
`
`joint proceedings. Neither Petitioners nor Actavis will request any increase in time
`
`allotted for discovery. Petitioners agree to coordinate discovery with Actavis so
`
`that a single attorney will conduct cross-examination of any given witness produced
`
`by Abraxis. The redirect of any given witness produced by Petitioners and Actavis
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`will also be conducted by a single attorney designated by Actavis and Petitioners.
`
`The consolidated filings and coordinated discovery described above will
`
`streamline the proceeding, reduce the costs and burdens on the parties, and conserve
`
`the Board’s resources.
`B. No New Grounds of Unpatentability
`
`Petitioners’ IPR petition contains the same grounds of unpatentability and
`
`raises no new grounds of unpatentability from those of the petition in the instituted
`
`Actavis IPR. In fact, the grounds of unpatentability are identical in all substantive
`
`respects.
`
`
`
`
`
`6
`
`
`
`
`

`

`C. No Impact on IPR Trial Schedule
`
`The trial schedule for the Actavis IPR will not be delayed because Petitioners
`
`have agreed to adhere to the Actavis IPR schedule. Because the Apotex Petition
`
`asserts the same grounds of unpatentability as instituted in the Actavis IPR, Abraxis
`
`should be able to expedite filing its preliminary response if not waive it entirely. The
`
`joint proceeding would allow the Board and parties to timely focus on the merits of
`
`the case.
`
`D. Briefing and Discovery Will Be Streamlined
`
`Petitioners and Actavis have agreed to consolidat ed filings and discovery to
`
`simplify the briefing and discovery process. Because Petitioners and Actavis rely
`
`on the same unpatentability grounds, expert, and expert declaration, there should be
`
`no delay t o the joint proceeding even if Actavis s ettles and withdraws from the
`
`Actavis IPR. If Actavis were to withdraw from the join proceeding, Petitioners
`
`agree to work with the Boar d and remain ing parties to the joint proceeding to
`
`expeditiously complete the proceeding.
`E.
`
`Joinder Will Not Prejudice Abraxis or Actavis
`
`
`
`Permitting joinder will not prejudice Abraxis or Actavis. Actavis consents to
`
`joinder. Joinder will not affect the schedule of the Actavis IPR because Petitioners
`
`raise no new issues before the Board. Going forward, Abraxis only needs to file one
`
`set of briefing because Petitioners’ and Actavis’ petitions and evidence are
`
`substantively identical, and both Actavis and Apotex have agreed to file
`
`
`
`
`
`
`
`
`

`

`consolidated briefings. No additional burdens or costs will be incurred if joinder is
`
`granted.
`
`Petitioners agree to join the Actavis IPR as an understudy and will rely on
`
`identical grounds for unpatentability and the same expert as in the Actavis IPR.
`
`
`
`Petitioners will only actively participate in the proceeding if Actavis settles or
`
`terminates the Actavis IPR.
`
`F.
`
`Expedited Briefing will Ensure Efficient Administration of the
`Joint Proceeding
`
`Petitioners respectfully request an expedited briefing schedule that requires
`
`
`
`the patent owner to file its preliminary response within one month. An expedited
`
`briefing schedule will not prejudice Abraxis because the petition, unpatentability
`
`grounds, references and expert declaration are substantially identical to those in the
`
`Actavis IPR. In such circumstances, an expedited briefing schedule will assist in
`
`administering this proceeding in a just, speedy, and efficient manner pursuant to 37
`
`C.F.R. § 42.1(b).
`
`IV. PROPOSED ORDER
`
`
`Petitioners propose a joinder order for consideration by the Board as follows:
`
`
`• The Apotex Petition will be instituted and joined with the Actavis IPR
`
`on the same grounds as those for wh ich review was instituted in the
`
`Actavis IPR.
`
`
`
`8
`
`
`
`
`

`

`• The scheduling order entered in the Actavis IPR will apply to the joint
`
`proceeding.
`
`• Petitioners are bound by the procedur
`
`al concessions set forth in
`
`Petitioners’ Motion for Joinde r to th e Actavis IPR, or as otherwise
`
`agreed between the parties to the joined proceedings or ordered by the
`
`Board.
`
`• An expedited briefing schedule,
`
`requiring
`
`the p atent owner’s
`
`preliminary response to be filed within one month.
`
`V. CONCLUSION
`
`For the foregoing reasons, Petitioners respectfully request that their Petition
`
`for inter partes review of U.S. Patent No. 7,820 ,788 be instituted and that the
`
`proceeding be joined with Actavis LLC v. Abraxis BioScience, LLC, IPR2017-01101.
`
`Although no additi onal fee is believed
`
`to be required for this Mot
`
`ion, the
`
`Commissioner is he reby authorized to ch arge any additional fees which may be
`
`required for this Motion to Deposit Acct. No. 19-4293.
`
`
`Dated: Novem ber 9, 2017
`
`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
`
`
`
`9
`
`
`Respectfully submitted,
`
`/John Josef Molenda/
`John Josef Molenda
`Reg. No. 47,804
`
`Lead Counsel for Petitioners
`
`Doc. # DC-10615778 v.2
`
`
`
`

`

`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that a copy of the foregoing PETITIONERS’ MOTION
`
`FOR JOINDER PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 &
`
`42.122(b), was served in its entirety on November 9, 2017 by filing this document
`
`through the Patent Trial Appeal Board End to End System as well as by delivering a
`
`copy via electronic mail, with Patent Owner’s consent, to the following attorneys for
`
`Petitioner and Patent Owner in the Actavis IPR:
`
`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.
`
`Date: November 9, 2017
`
`
`
`
`
`
`
`

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