`Filed November 9, 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.
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`Petitioners
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`v.
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`ABRAXIS BIOSCIENCE, LLC
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`Patent Owner
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`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
`————————————————
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`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
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
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`II.
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`STATEMENT OF MATERIAL FACTS ........................................................ 2
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 3
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`A.
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`Joinder Is Appropriate Because It Will Expedite Resolution of the
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`Proceeding ............................................................................................. 5
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`1.
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`2.
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`Substantively Identical Petitions ................................................. 5
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`Consolidated Filings and Discovery ........................................... 6
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`B. No New Grounds of Unpatentability .................................................... 6
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`C. No Impact on IPR Trial Schedule ......................................................... 7
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`D.
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`E.
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`F.
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`Briefing and Discovery Will Be Streamlined ....................................... 7
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`Joinder Will Not Prejudice Abraxis or Actavis..................................... 7
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`Expedited Briefing will Ensure Efficient Administration of the Joint
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`Proceeding ............................................................................................. 8
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`IV. PROPOSED ORDER ...................................................................................... 8
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`V.
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`CONCLUSION ............................................................................................... 9
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`TABLE OF AUTHORITIES
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` Page(s)
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`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
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`35 U.S.C. § 315(c) ................................................................................................. 1, 3
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`35 U.S.C. § 316(b) ..................................................................................................... 4
`Other Authorities
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`37 C.F.R. § 42.1(b) ................................................................................................ 5, 8
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`37 C.F.R. § 42.22 ............................................................................................... 1, 2, 3
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`37 C.F.R. § 42.122(b) ........................................................................................ 1, 2, 3
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`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011)
`(statement of Sen. Kyl) ......................................................................................... 5
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`ii
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22 & 42.122(b), Petitioners
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`Apotex Inc. and Apotex Corp. (“Apotex”) request institution of an inter partes review
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`concerning U.S. Patent No. 7,820,788 (“the ’788 patent”) and move for joinder with
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`the inter partes review concerning the same p atent, Actavis LLC v. Abraxis
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`BioScience, LLC, IPR2017-01101 (the “Actavis IPR”) that was instituted on October
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`10, 2017.
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`In view of the Board’s Representative Order outlining issues to be addressed in a
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`motion for joi nder (Kyocera Corp. et al. v. Softview LLC, Paper No. 15,
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`IPR2013-00004, Apr. 24, 2013), Petitioners submit that: (1) joinder is appropriate
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`because it will promote efficient resolution of the proceedings without prejudice to
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`the prior petitioner and patent owne r, Actavis LLC (“Actavis”) and
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`Abraxis
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`BioScience, LLC (“Abraxis”), respectivel y; (2) Petitioners’ IPR petition (“Apote x
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`Petition”) does not raise new grounds of unpatentability over those instituted by the
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`Board in the Actavis IPR; (3) joinder wo uld not affect the pending schedule in the
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`Actavis IPR; and (4) Pe titioners and Actavis agree to su bmit consolidated filings to
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`minimize the burde n and the impact on t he schedule. See, e.g., Advanced Micro
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`Devices Inc. v. Zond LLC, Paper No. 12, IPR2014-01042 (Nov. 7, 2014) and Amneal
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`Pharm., LLC v. Yeda Res. & Dev. Co., Ltd., Paper No. 9, IPR2015-01976 (Dec. 28,
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`2015) (granting motions for joinder under si milar circumstances). Petitioners have
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`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.
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`This Motion for J oinder is timely under 37 C. F.R. §§ 42 .22 & § 42.122(b)
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`because it is submitted within one month from the October 10, 2017 date the Board
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`instituted the Actavis IPR. Actavis IPR, Paper No. 7.
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`II.
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`STATEMENT OF MATERIAL FACTS
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`1.
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`On April 6, 2016, Abraxis filed a complaint against Actavis asserting
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`infringement of the ’788 patent and related U.S. Patent Nos. 8,138,229 and
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`7,923,536. Abraxis BioScience, LLC et al., v. Actavis LLC, No. 2:16-cv-01925
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`(D.N.J).
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`2.
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`On April 4, 2017, Actavis filed a petition for inter partes review of the
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`’788 patent, alleging unpatentability of all claims on anticipation and obviousness
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`grounds. Actavis IPR, Paper No. 2.
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`3.
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`On July 12, 2017, Abraxis filed a Preliminary Patent Owner’s response.
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`Id., Paper No. 6.
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`4.
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`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.
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`7.
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`5.
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`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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`6.
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`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
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`same expert.
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`7.
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`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
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`declaration he submitted in the Actavis IPR.
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
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`Petitioners respectfully request that the Board exercise its discretion and grant
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`joinder of the Apotex Petition and the Ac tavis IPR pursuant to 35 U.S.C. § 315(c)
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`and 37 C.F.R. §§ 42.22 & 42.122(b).
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` In support of this m otion, Petitioners and
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`Actavis have agreed to consolidated
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`filings and to additional procedural
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`accommodations designed to streamline the proceedings. Petitioners a nd Actavis
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`have also agreed to rely on the same expert and expert declarations in support of
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`their Petitions.
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`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
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`review proceedings. The statutory provision governing joinder of inter partes
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`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
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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.
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`In exercising its discretion to grant joinder, the Board considers the impact of
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`substantive and procedural issues on
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`the proceedings, as well as other
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`considerations, while being “mindful that patent trial regulations, including the rules
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`for joinder, must be construed to secure the just, speedy, and inexpensive resolution
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`of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions, Inc.,
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`IPR2013-00385, Paper No. 17, Slip Op. at 3 (July 29, 2013). The Board should
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`consider “the policy preference for joining a party that does not present new issues
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`that might co mplicate or del ay an existing proceeding.”
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`Id. at 10. Under t his
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`framework, joinder of the Apotex Petition with the Actavis IPR is appropriate.
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`“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.
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`Joinder Is Appropriate Because It Will Expedite Resolution of the
`Proceeding
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`Joinder is appropriate here because it is the most expedient way to secure the
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`just, speedy, and inexpensive resolution of the two related proceedings. See 35
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`U.S.C. § 316(b); 37 C.F.R. § 42.1(b). The Apotex Petition is substantively identical
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`to the petition submitted in the Actavis IPR and is supported by a substantively
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`identical expert declaration. Petitioners and Actavis have agreed to consolidated
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`filings and discovery in addition to other procedural concessions so that Petitioners
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`will be bound by the schedule set forth in the Actavis IPR.
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`1.
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`Substantively Identical Petitions
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`The Apotex Petition challenges the same patent claims, contains the same
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`grounds of unpatentability, and is identical in all substantive aspects to the petition
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`in the instituted Actavis IPR. Both petitions contain the same analysis and exhibits,
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`and Petitioners rely upon the
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` same expert and substant
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`ively identical expert
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`declarations. The Board has already instituted trial in the Actavis IPR (Paper No. 7)
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`and will not need to expe
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`nd additional resources to decide institution on the
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`substantively identical Apotex Petition. See 157 CONG. REC. S1376 (daily ed. Mar.
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`8, 2011) (statement of Sen. Kyl) (“The Office anticipates that joinder will be allowed
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`as of right —if an inter partes review is instituted on the basis of a petition, for
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`example, a party that files an identical petition will be joined to that proceeding, and
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`thus allowed to file its own briefs and make its own arguments.”).
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`2.
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`Consolidated Filings and Discovery
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`Petitioners and Actavis have agreed to submit consolidated filings for all
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`substantive papers in the proceeding. Neither Petitioners nor Actavis will request
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`any increase in the ordinary li mit on length for the se consolidated filings. These
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`agreed-to consolidated filings will avoid lengthy and duplicative briefing.
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`Consolidated discovery is also appropriate given that Petitioners and Actavis
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`will rely on the same expert and substantia lly identical expert declarations in the
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`joint proceedings. Neither Petitioners nor Actavis will request any increase in time
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`allotted for discovery. Petitioners agree to coordinate discovery with Actavis so
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`that a single attorney will conduct cross-examination of any given witness produced
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`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.
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`The consolidated filings and coordinated discovery described above will
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`streamline the proceeding, reduce the costs and burdens on the parties, and conserve
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`the Board’s resources.
`B. No New Grounds of Unpatentability
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`Petitioners’ IPR petition contains the same grounds of unpatentability and
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`raises no new grounds of unpatentability from those of the petition in the instituted
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`Actavis IPR. In fact, the grounds of unpatentability are identical in all substantive
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`respects.
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`C. No Impact on IPR Trial Schedule
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`The trial schedule for the Actavis IPR will not be delayed because Petitioners
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`have agreed to adhere to the Actavis IPR schedule. Because the Apotex Petition
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`asserts the same grounds of unpatentability as instituted in the Actavis IPR, Abraxis
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`should be able to expedite filing its preliminary response if not waive it entirely. The
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`joint proceeding would allow the Board and parties to timely focus on the merits of
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`the case.
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`D. Briefing and Discovery Will Be Streamlined
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`Petitioners and Actavis have agreed to consolidat ed filings and discovery to
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`simplify the briefing and discovery process. Because Petitioners and Actavis rely
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`on the same unpatentability grounds, expert, and expert declaration, there should be
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`no delay t o the joint proceeding even if Actavis s ettles and withdraws from the
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`Actavis IPR. If Actavis were to withdraw from the join proceeding, Petitioners
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`agree to work with the Boar d and remain ing parties to the joint proceeding to
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`expeditiously complete the proceeding.
`E.
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`Joinder Will Not Prejudice Abraxis or Actavis
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`Permitting joinder will not prejudice Abraxis or Actavis. Actavis consents to
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`joinder. Joinder will not affect the schedule of the Actavis IPR because Petitioners
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`raise no new issues before the Board. Going forward, Abraxis only needs to file one
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`set of briefing because Petitioners’ and Actavis’ petitions and evidence are
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`substantively identical, and both Actavis and Apotex have agreed to file
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`consolidated briefings. No additional burdens or costs will be incurred if joinder is
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`granted.
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`Petitioners agree to join the Actavis IPR as an understudy and will rely on
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`identical grounds for unpatentability and the same expert as in the Actavis IPR.
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`Petitioners will only actively participate in the proceeding if Actavis settles or
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`terminates the Actavis IPR.
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`F.
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`Expedited Briefing will Ensure Efficient Administration of the
`Joint Proceeding
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`Petitioners respectfully request an expedited briefing schedule that requires
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`the patent owner to file its preliminary response within one month. An expedited
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`briefing schedule will not prejudice Abraxis because the petition, unpatentability
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`grounds, references and expert declaration are substantially identical to those in the
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`Actavis IPR. In such circumstances, an expedited briefing schedule will assist in
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`administering this proceeding in a just, speedy, and efficient manner pursuant to 37
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`C.F.R. § 42.1(b).
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`IV. PROPOSED ORDER
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`Petitioners propose a joinder order for consideration by the Board as follows:
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`• The Apotex Petition will be instituted and joined with the Actavis IPR
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`on the same grounds as those for wh ich review was instituted in the
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`Actavis IPR.
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`• The scheduling order entered in the Actavis IPR will apply to the joint
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`proceeding.
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`• Petitioners are bound by the procedur
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`al concessions set forth in
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`Petitioners’ Motion for Joinde r to th e Actavis IPR, or as otherwise
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`agreed between the parties to the joined proceedings or ordered by the
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`Board.
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`• An expedited briefing schedule,
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`requiring
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`the p atent owner’s
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`preliminary response to be filed within one month.
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`V. CONCLUSION
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`For the foregoing reasons, Petitioners respectfully request that their Petition
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`for inter partes review of U.S. Patent No. 7,820 ,788 be instituted and that the
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`proceeding be joined with Actavis LLC v. Abraxis BioScience, LLC, IPR2017-01101.
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`Although no additi onal fee is believed
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`to be required for this Mot
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`ion, the
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`Commissioner is he reby authorized to ch arge any additional fees which may be
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`required for this Motion to Deposit Acct. No. 19-4293.
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`Dated: Novem ber 9, 2017
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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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`9
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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-10615778 v.2
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`CERTIFICATE OF SERVICE
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`I hereby certify that a copy of the foregoing PETITIONERS’ MOTION
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`FOR JOINDER PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 &
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`42.122(b), was served in its entirety on November 9, 2017 by filing this document
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`through the Patent Trial Appeal Board End to End System as well as by delivering a
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`copy via 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/
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`Siew Yen Chong
`Counsel for Apotex Inc. and Apotex Corp.
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`Date: November 9, 2017
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