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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`CIPLA LTD.,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`
`
`Case IPR2018-00163
`Patent 7,923,536 B2
`Issued: April 12, 2011
`
`Title: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`
`
`MOTION FOR JOINDER
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b)
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`
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`IPR2018-00163 (7,923,536 B2)
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`TABLE OF CONTENTS
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`Page
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
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`STATEMENT OF MATERIAL FACTS ........................................................ 2
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`
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`I.
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`II.
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`III. DISCUSSION .................................................................................................. 3
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`A.
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`B.
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`Cipla’s Motion for Joinder is Timely .................................................... 4
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`The Four Factors Weigh in Favor of Joinder ........................................ 4
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`1.
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`2.
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`3.
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`4.
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`Joinder is Appropriate Because it Will Promote an
`Efficient Determination of the Validity of the ’536
`Patent Without Prejudice to any Party. ....................................... 4
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`The Cipla Petition Does Not Raise Any New Grounds
`of Unpatentability and Therefore Does Not Add
`Additional Complexity to the Grounds in the Actavis
`Petition ........................................................................................ 5
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`Joinder Would Not Affect the Schedule of the Actavis
`IPR ............................................................................................... 6
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`Joinder Will Simplify Briefing and Discovery Because
`Cipla Will Agree to Consolidate Filings and Coordinate
`Discovery .................................................................................... 7
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`IV. CONCLUSION ................................................................................................ 8
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`IPR2018-00163 (7,923,536 B2)
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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,
`C.A. No. 2:16-cv-01925 ....................................................................................... 2
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`Abraxis BioScience, LLC, et al., v. Cipla Ltd.,
`C.A. No. 2:16-cv 0974-JMV-MF ......................................................................... 2
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`Actavis LLC v. Abraxis Bioscience, LLC,
`IPR2017-01103, Paper 7 (PTAB Oct. 10, 2017) .......................................... 1, 2, 3
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`Amerigen Pharm. Ltd., v. UCB Pharma GmbH,
`IPR2016-01665, Paper 8 (PTAB Dec. 7, 2016) ................................................... 7
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`Dell Inc. v. Network-1 Sec. Sols., Inc.,
`IPR2013-00385, Paper 17 (PTAB July 29, 2013) ................................................ 6
`
`Hyundai Motor Co. v. Am. Vehicular Scis. LLC,
`IPR2014-01543, Paper 11 (PTAB Oct. 24, 2014) ................................................ 6
`
`Lupin Ltd. v. Horizon Therapeutics, Inc.,
`IPR2016-00284, Paper 11 (PTAB June 8, 2016) ................................................. 6
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`Samsung Bioepis Co., Ltd. v. Genentech, Inc.,
`IPR2017-01960, Paper 1 (PTAB Aug. 25, 2017) ............................................. 3, 4
`
`Samsung Elecs., Co., Lt.d v. Raytheon Co.,
`IPR2016-00962, Paper 12 (PTAB Aug. 24, 2016) ............................................... 5
`
`Sony Corp. of Am. v. Network-1 Sec. Sols., Inc.,
`IPR2013-00495, Paper 13 (PTAB Sept. 16, 2013) ............................................... 6
`
` Sony Corp. v. Memory Integrity, LLC,
`IPR2015-01353, Paper 11 (PTAB Oct. 15, 2015) ................................................ 6
`
`Torrent Pharm. Ltd., v. UCB Pharma GmbH,
`IPR2016-01636, Paper 10 (PTAB Dec. 7, 2016) ................................................. 7
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`ii
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`IPR2018-00163 (7,923,536 B2)
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`Statutes
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`35 U.S.C. § 102 .......................................................................................................... 2
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`35 U.S.C. § 102(b) ..................................................................................................... 3
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`35 U.S.C. § 103 .......................................................................................................... 2
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`35 U.S.C. § 103(a) ..................................................................................................... 3
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`35 U.S.C. § 315(c) ................................................................................................. 1, 3
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`Other Authorities
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`37 C.F.R. § 42.22 ....................................................................................................... 1
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`37 C.F.R. § 42.122(b) ........................................................................................ 1, 3, 4
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`
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`iii
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`IPR2018-00163 (7,923,536 B2)
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Petitioner Cipla Ltd. respectfully requests its petition for Inter Partes
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`Review of claims 1–16 of U.S. Patent No. 7,923,536 (the “’536 patent”) (the
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`“Cipla Petition”), be granted and joined pursuant to 35 U.S.C. § 315(c) and 37
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`C.F.R. §§ 42.22 and 42.122(b) with the petition for inter partes review filed by
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`Actavis LLC concerning the ’536 patent: Actavis LLC v. Abraxis Bioscience, LLC,
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`IPR2017-01103 (the “Actavis Petition”). Cipla timely submits this request for
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`joinder less than one month after the institution of the Actavis Petition by the
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`Patent Trial and Appeal Board (the “Board”). See 37 C.F.R. § 42.122(b).
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`The Board instituted review of the Actavis Petition on October 10, 2017.
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`The Cipla Petition is identical to the Actavis Petition in all substantive respects,
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`includes identical exhibits to the Actavis Petition, and relies upon the same expert
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`declarant as the Actavis Petition.1 Actavis does not oppose this motion. As such,
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`institution and joinder will not create an additional burden for the Board and will
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`lead to efficient resolution of the inter partes review proceeding.
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`1 Cipla relies on an expert declaration that is substantively identical to the Actavis
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`expert declaration, except for a single sentence that indicates that Cipla has
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`retained Cory J. Berkland, Ph.D. See EX1002 ¶ 1.
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`
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`1
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`IPR2018-00163 (7,923,536 B2)
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`II.
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`1.
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`STATEMENT OF MATERIAL FACTS
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`The Cipla Petition and the Actavis Petition are related to patents that are
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`being asserted by Abraxis BioScience, LLC and Celgene Corp. in the District of
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`New Jersey in at least Abraxis BioScience, LLC, et al., v. Cipla Ltd., C.A. No.
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`2:16-cv 0974-JMV-MF and Abraxis BioScience, LLC, et al. v. Actavis LLC, C.A.
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`No. 2:16-cv-01925. Abraxis BioScience, LLC and Celgene Corp. have asserted
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`U.S. Patent Nos. 7,820,788; 7,923,536; 8,138,229; and 8,853,260 (“the Abraxis
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`patents”) in the district court litigation.
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`2.
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`The Board has already issued its decision instituting inter partes review
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`(“Decision”) on all challenged claims of the ’536 patent on the same grounds
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`raised in the concurrently filed Petition for Inter Partes Review.2 See IPR2017-
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`1103 (Paper 7). In its October 10, 2017 Decision, the Board found that Petitioner
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`Actavis has demonstrated a reasonable likelihood that claims 1–16 of the ’536
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`patent are unpatentable for failing to satisfy the novelty requirement of 35 U.S.C.
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`§ 102 and the nonobviousness requirement of 35 U.S.C. § 103. Id.
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`3.
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`The Board instituted inter partes review of the challenged claims on the
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`following separate grounds:
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`2 The Board has instituted review in IPR2017-01101, IPR 2017-01103, and
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`IPR2017-01104 (collectively, “the Actavis IPRs” and individually, “the Actavis
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`IPR”).
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`2
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`IPR2018-00163 (7,923,536 B2)
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`Ground 1: Claims 1–16 of the ’536 patent under 35 U.S.C. § 102(b) as
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`anticipated by Desai.
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`Ground 2.A: Claims 1–16 of the ’536 patent under 35 U.S.C. § 103(a) as
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`obvious over Desai.
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`Ground 2.B: Claims 1–16 of the ’536 patent under 35 U.S.C. § 103(a) as
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`obvious over Desai, Kadima, and Liversidge.
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`See IPR2017-1103 (Paper 7).
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`The Cipla Petition is based on the same grounds and seeks to join the
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`instituted inter partes review on these challenged claims.
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`III. DISCUSSION
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`Under 35 U.S.C. § 315(c), the Board may join any person who properly files
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`a petition for inter partes review to an existing inter partes review. A request for
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`joinder must be filed “no later than one month after the institution date of any inter
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`partes review for which joinder is requested.” 37 C.F.R. § 42.122(b).
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`A motion for joinder should “(1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the
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`petition; (3) explain what impact (if any) joinder would have on the trial schedule
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`for the existing review; and (4) address specifically how briefing and discovery
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`may be simplified.” Samsung Bioepis Co., Ltd. v. Genentech, Inc., IPR2017-
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`3
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`IPR2018-00163 (7,923,536 B2)
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`01960, Paper 1 at 2 (PTAB Aug. 25, 2017) (quoting Macronix Int’l Co., Ltd. v.
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`Spansion LLC, IPR2014-00898, Paper 15 at 4 (PTAB Aug. 13, 2014)).
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`Cipla’s motion is timely, and the Board should grant joinder because
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`consideration of the foregoing factors weighs in favor of joinder.
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`A. Cipla’s Motion for Joinder is Timely
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`Joinder may be requested “no later than one month after the institution date
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`of any inter partes review for which joinder is requested.” 37 C.F.R. § 42.122(b).
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`Here, the Board instituted review of the Actavis Petition on October 10, 2017, and
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`Cipla files this motion for joinder less than one month after this institution date.
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`B.
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`The Four Factors Weigh in Favor of Joinder
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`Each of the four factors that the Board considers in motions for joinder
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`favors granting of Cipla’s motion. Joinder will not add further complication to the
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`proceedings or cause prejudice to the parties. Joinder will significantly simplify
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`briefing, discovery, and trial associated with review of the ’536 patent.
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`1.
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`Joinder is Appropriate Because it Will Promote an Efficient
`Determination of the Validity of the ’536 Patent Without
`Prejudice to any Party
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`Joinder is appropriate because it will promote efficiency by determining
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`validity of the same patent claims in a single proceeding. The Cipla Petition and
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`Actavis Petition are substantively the same, challenging the validity of the same
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`claims of the ’536 patent on identical grounds. Cipla also relies on the same
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`IPR2018-00163 (7,923,536 B2)
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`supporting evidence in its petition as Actavis, and even submits a supporting
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`declaration from the same expert, including the same discussion of the prior art and
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`the same analysis as the declaration Actavis submitted. A consolidated proceeding
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`will also be more efficient, less wasteful, and avoid duplication because all the
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`issues raised in both the Actavis Petition and the Cipla Petition can be resolved in a
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`single trial.
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`Joining Cipla as a party to the Actavis IPR also would not cause prejudice to
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`any party. Joinder will instead streamline the proceedings and reduce the costs and
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`burdens on the parties. For example, joinder will decrease the number of papers
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`the parties must file and the time and expense for depositions and other discovery
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`required by duplicative proceedings. In addition, the Cipla Petition has been filed
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`early enough that it will not affect the schedule of the inter partes review or the
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`costs associated with a full trial.
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`This factor favors joinder.
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`2.
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`The Cipla Petition Does Not Raise Any New Grounds of
`Unpatentability and Therefore Does Not Add Additional
`Complexity to the Grounds in the Actavis Petition
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`The Board “routinely grants motions for joinder where the party seeking
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`joinder introduces identical arguments and the same grounds raised in the existing
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`proceeding.” Samsung Elecs., Co., Ltd. v. Raytheon Co., IPR2016-00962, Paper
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`12 at 9 (PTAB Aug. 24, 2016) (emphasis in original) (citations omitted). Joinder
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`IPR2018-00163 (7,923,536 B2)
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`of this proceeding with the Actavis IPR will not raise any new issues of
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`patentability and will not add complexity to the case. The Cipla Petition does not
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`add any grounds for unpatentability that are not already present in the Actavis IPR.
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`As explained above, the Cipla Petition is substantially identical to the Actavis
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`Petition and relies upon the same expert declarant, the same prior art, and the same
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`analysis. The Board has granted motions for joinder in similar factual scenarios.
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`See Lupin Ltd. v. Horizon Therapeutics, Inc., IPR2016-00284, Paper 11 at 6
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`(PTAB June 8, 2016); Hyundai Motor Co. v. Am. Vehicular Scis. LLC, IPR2014-
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`01543, Paper 11 at 2–4 (PTAB Oct. 24, 2014); Sony Corp. of Am. v. Network-1
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`Sec. Sols., Inc., IPR2013-00495, Paper 13 at 5–9 (PTAB Sept. 16, 2013); Dell Inc.
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`v. Network-1 Sec. Sols., Inc., IPR2013-00385, Paper 17 at 6–10 (PTAB July 29,
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`2013).
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`This factor favors joinder.
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`Joinder Would Not Affect the Schedule of the Actavis IPR
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`3.
`The Board has granted motions for joinder when “joinder should not
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`necessitate any additional briefing or discovery from Patent Owner beyond that
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`already required in [the original IPR].” See Sony Corp. v. Memory Integrity, LLC,
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`IPR2015-01353, Paper 11 at 6 (PTAB Oct. 15, 2015). Because the substantial
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`similarity between the Cipla IPR and the Actavis IPR, joinder should not have a
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`substantial impact on the parties or the trial schedule. To the extent joinder would
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`IPR2018-00163 (7,923,536 B2)
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`cause any delay, Cipla agrees to coordinate with Actavis such that Cipla’s
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`participation would result in no changes to the schedule.
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`This factor favors joinder.
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`4.
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`Joinder Will Simplify Briefing and Discovery Because Cipla Will
`Agree to Consolidate Filings and Coordinate Discovery
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`To prevent joinder from imposing any additional burden and to further
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`ensure that there are no changes in the potential trial schedule, Cipla will agree, if
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`joinder is granted and as long as Actavis remains a party to the proceeding, to
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`coordinate discovery with Actavis and to consolidate filings with Actavis for all
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`substantive papers except motions that do not involve Actavis. Furthermore if
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`joinder is granted and as long as Actavis remains a party to the proceeding, Cipla
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`agrees that cross-examinations will occur within the timeframe normally allotted
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`by the rules to one party and will not need to be extended in light of the joinder.
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`Thus, no further time to address additional arguments or discovery will be
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`required by any party, and the consolidated trial can proceed at the same pace as if
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`Cipla were not joined. Joinder is appropriate under these circumstances. See
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`Torrent Pharm. Ltd, v. UCB Pharma GmbH, IPR2016-01636, Paper 10 at 5–6
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`(PTAB Dec. 7, 2016); Amerigen Pharm. Ltd., v. UCB Pharma GmbH, IPR2016-
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`01665, Paper 8 at 6 (PTAB Dec. 7, 2016).
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`This factor favors joinder.
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`7
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`IPR2018-00163 (7,923,536 B2)
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`IV. CONCLUSION
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`For the foregoing reasons, Cipla respectfully requests that the Board grant its
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`concurrently filed Petition for inter partes review of the ’536 patent and join the
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`grounds of invalidity therein raised with the Actavis IPR.
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`Dated: November 9, 2017
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`Respectfully submitted,
`
`
`/s/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Lead Counsel for Petitioner
`
`Anil Patel (pro hac vice to be filed)
`K&L GATES LLP
`1000 Main Street, Suite 2550
`Houston, TX 77002
`T: 713.815.7304
`F: 713.583.9417
`anil.patel@klgates.com
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`Jason A. Engel (Reg. No. 51,654)
`K&L GATES LLP
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`T: 312.807.4236
`F: 312.827.8145
`jason.engel.ptab@klgates.com
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`Peter L. Giunta (Reg. No. 55,207)
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`IPR2018-00163 (7,923,536 B2)
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`K&L GATES LLP
`599 Lexington Avenue
`New York, NY 10022
`T: 212.536.3910
`F: 212.536.3901
`peter.giunta@klgates.com
`
`Elizabeth Weiskopf (pro hac vice to
`be filed)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7964
`F: 206.623.7022
`elizabeth.weiskopf@klgates.com
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`Back-Up Counsel for Petitioner
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`CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATION
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`IPR2018-00163 (7,923,536 B2)
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`Pursuant to 37 C.F.R. § 42.24, I certify that the foregoing MOTION FOR
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`JOINDER contains less than 15 pages, pursuant to 37 C.F.R. § 42.24(a)(1).
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`
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`Respectfully submitted,
`
`
`/s/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Lead Counsel for Petitioner
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`Dated: November 9, 2017
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`500840582 v4
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`IPR2018-00163 (7,923,536 B2)
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e) , I certify that, on November 9, 2017, true
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`and correct copies of the foregoing MOTION FOR JOINDER, were served by
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`FedEx overnight delivery on Patent Owner at the correspondence address of record
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`for U.S. Patent No. 7,923,536 B2, and other addresses known as likely to effect
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`service, as follows:
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`MORRISON & FOERSTER LLP
`755 Page Mill Rd.
`Palo Alto, CA 94304-1018
`Customer Number: 25226
`
`F. Dominic Cerrito
`Eric C. Stops
`Evangeline Shih
`Andrew S. Chalson
`Catherine T. Mattes
`Ross C. Misskelley
`Robert B. Wilson
`Daniel C. Wiesner
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
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`Anthony M. Insogna
`J. Patrick Elsevier, Ph.D.
`Cary Miller, Ph.D.
`Steven J. Corr
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
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`500840582 v4
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`IPR2018-00163 (7,923,536 B2)
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`Respectfully submitted,
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`/s/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
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`Lead Counsel for Petitioner
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`Dated: November 9, 2017
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