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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`SAWAI USA, INC. and SAWAI PHARMACEUTICAL CO., LTD.
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`Petitioners,
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`v.
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`BIOGEN MA INC.,
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`Patent Owner.
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`____________
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`Case IPR2019-00789
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`Patent 8,399,514
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`____________
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`PATENT OWNER’S OPPOSITION TO
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`PETITIONER’S MOTION FOR JOINDER
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`Table of Contents
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`I.
`II.
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`III.
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`Introduction ...................................................................................................... 1
`Legal Standard: Joinder Should Be Denied Where It Would Cause
`Inconvenience or Delay ................................................................................... 1
`Joinder with Sawai Would Inconvenience and Delay the Mylan IPR ............ 3
`A.
`Sawai’s New Declarants Introduce New Issues .................................... 4
`B.
`The Sawai RPI Issue Will Require Additional Briefing and
`Discovery ............................................................................................... 9
`Joining Sawai Would Frustrate the Mylan IPR and Not Provide
`an Efficient Alternative to the Litigation ............................................ 12
`IV. Conclusion ..................................................................................................... 15
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`C.
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`I.
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`Introduction
`Time-barred Petitioner Sawai1 filed its motion for joinder with IPR2018-
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`01493 (“Mylan IPR”) on the next to last possible day. Instead of relying on the
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`Mylan IPR declarants, however, Sawai introduces new declarants and further
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`creates a new real party in interest (“RPI”) problem. The need to address the new
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`declarants and new RPI issues will interfere with and delay the Mylan IPR. Sawai
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`also fails to justify joinder where Sawai’s district court trial has been scheduled for
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`December 9, 2019, several weeks before the February 6, 2020, date for a final
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`decision in the Mylan IPR.
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`Sawai’s motion should be denied.
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`II. Legal Standard: Joinder Should Be Denied Where It Would Cause
`Inconvenience or Delay
`In deciding whether to permit joinder of one inter partes review with
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`another under 35 U.S.C. § 315, the Board “take[s] into account the particular facts
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`of each case, substantive and procedural issues, and other considerations.”
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`1 See Paper 1 at 2, identifying as a related litigation involving U.S. Patent No.
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`8,399,514, Biogen Int’l GmbH v. Sawai USA, Inc., C.A. No. 17-cv-00875 (D.
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`Del.), in which Biogen served the complaint on Sawai more than a year before
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`Sawai’s petition in this IPR.
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`1
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`Macronix Int’l Co. v. Spansion, IPR2014-00898, Paper 15 at 4 (PTAB Aug. 13,
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`2014 (citing 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen.
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`Kyl)). The burden to prove that joinder is appropriate rests solely on the movant
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`and the Board’s decision to grant joinder is discretionary. 35 U.S.C. § 315(c); 37
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`C.F.R. §§ 42.20(c), 42.122; Medtronic, Inc. v. Norred, Troy, IPR2014-00823,
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`Paper 12 at (Dec. 8, 2014) (denying joinder where “Petitioner’s stated reasons for
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`allowing joinder do not outweigh meaningful reasons not to allow joinder”).
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`Considerations relevant to the Board’s discretion include (1) impact on the
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`trial schedule for the existing review, (2) complication of briefing and discovery,
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`and (3) adverse effects on potential settlements. See, e.g., Hyundai Motor Co. v.
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`Am. Vehicular Scis. LLC, IPR2014-01543, Paper 11 at 3 (PTAB Oct. 24, 2014);
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`Macronix, IPR2014-00898, Paper 15 at 4 (quoting Kyocera Corp. v. Softview LLC,
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`IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013)); Global Foundries U.S. Inc.
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`v. Godo Kaisha IP Bridge 1, IPR2017-00926, Paper 12 at 10 (PTAB Jun. 9, 2017).
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`For example, the Board recognizes that additional discovery, at least cross-
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`examination of the new declarants, will be required where the joining petitioner
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`relies on new declarants and denies “Motion[s] for Joinder [that do] not offer a
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`practical way to accommodate the additional discovery without inconveniencing
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`all involved or delaying the due dates in the [earlier] IPR.” Mylan Pharma., v
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`Janssen Oncology, Inc., IPR2016-01332, Paper 21 at 11 (PTAB Jan. 10, 2017); see
`2
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`also 37 C.F.R. § 42.51(b)(1)(ii). Similarly, the “potential for additional discovery
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`[to address Petitioner’s failure to identify all RPIs] presents a new substantive
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`issue. . . and, as a result, weighs in favor of denying Petitioner’s Motion for
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`Joinder.” Unified Patents Inc. v. Personalized Media Commc’ns, LLC, IPR2015-
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`00521, Paper 14 at 5 (PTAB Jun. 8, 2015).
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`III. Joinder with Sawai Would Inconvenience and Delay the Mylan IPR
`The Board should deny Sawai’s motion because joinder would obstruct the
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`“just, speedy, and inexpensive resolution” of the Mylan IPR. Dell Inc. v. Network-
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`1 Solutions, Inc., IPR2013-00385, Paper 17 at 3 (PTAB Jul. 29, 2013) (“When
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`exercising its discretion, the Board is mindful that patent trial regulations,
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`including the rules for joinder, must be construed to secure the just, speedy, and
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`inexpensive resolution of every proceeding. See 35 U.S.C. § 316(b); 37 C.F.R.
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`§ 42.1(b).”). First, Sawai’s petition adds new declarants, each of whom will need
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`to be cross-examined. Yet, Sawai offers no proposal to accommodate this
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`additional discovery without prejudicing Biogen and delaying the Mylan IPR.
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`Second, Sawai’s petition adds new substantive issues concerning its identification
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`of all RPIs as required under 35 U.S.C. § 312(a)(2). This new issue, coupled with
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`Sawai’s failure to coordinate with Mylan regarding declarants, indicates that Sawai
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`will have an active role in, and interfere with, the Mylan IPR. Sawai points to no
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`case granting joinder under such circumstances. Finally, Sawai provides no valid
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`3
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`reason that joinder is appropriate where (i) the trial in the Sawai district court
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`litigation will finish several weeks before a decision is due in the Mylan IPR and
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`(ii) institution of Sawai’s petition necessarily requires deciding the pending motion
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`for joinder because the time bar under 35 U.S.C. § 315(b) otherwise bars Sawai’s
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`petition.
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`A.
`Sawai’s New Declarants Introduce New Issues
`Sawai’s petition continues to rely on declarations from declarants different
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`than those in the Mylan IPR. Mot. at 4-5. In each of the cases granting joinder that
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`Sawai cites (id.), however, the joined petitioners committed to rely on the same
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`declarants as the original petitioner. Hyundai, IPR2014-01543, Paper 11 at 3
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`(joinder petitioner “relies on the same declaration testimony of [the prior expert],
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`albeit submitted in a separate declaration”); Dell, IPR2013-00385, Paper 17 at 7
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`(“Dell submitted a declaration from the same declarant as Avaya . . . .”); Sony
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`Corp. of Am. v. Network-1 Sec. Solutions, Inc., IPR2013-00495, Paper 13 at 5
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`(PTAB Sep. 16, 2013) (“Petitioners submit the same declaration . . . that Dell
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`submitted . . . .”); Motorola Mobility LLC v. Softview LLC, IPR2013-00256, Paper
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`10 at 4-10 (PTAB June 20, 2013) (the second petition copied the exhibits from the
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`earlier petition). Using different declarants is reason enough to deny joinder, as
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`cross-examination of Sawai’s witnesses would necessarily complicate and delay
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`the Mylan IPR. See e.g., Unified Patents, IPR2015-00521, Paper 14 at 4-5.
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`4
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`Sawai’s two purported justifications for joinder with new declarants are
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`without merit. First, Sawai seeks to rely on SAP America Inc. v. Clouding IP, LLC,
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`IPR2014-00306, but conditions withdrawing its new declarations on whether
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`“Mylan allows Sawai to use” Mylan declarants Corboy, Benet, Rock, and
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`McKeague. Id. at 4-5. Unlike here, however, the joining petitioner in SAP America
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`unconditionally withdrew its new testimony to “eliminate the need to alter the trial
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`schedule to accommodate the deposition of the [new expert].” SAP Am., IPR2014-
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`00306, Paper 13 at 4. Sawai has not withdrawn its new declarations, and concedes
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`that it may never do so “if Mylan does not permit Sawai to rely directly on”
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`Mylan’s declarants. Mot. at 5. Not only does SAP America not support joinder
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`under the present facts, but Sawai also does not identify even one case granting
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`joinder where discovery from new declarants would be required. Id. at 8.
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`Second, Sawai contends that joinder would be proper even “if Mylan does
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`not permit Sawai to rely directly on” Mylan’s declarants because Sawai’s
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`declarants “present substantively identical testimony” to Mylan’s declarants. Id. at
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`5. Not only does Sawai fail to cite any case that supports joinder with different
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`declarants merely because their direct testimony is substantively identical, but
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`Sawai completely ignores that cross-examination of each new declarant would still
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`be required, necessarily complicating and delaying the Mylan IPR. See 37 C.F.R.
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`§ 42.51(b)(1)(ii); Kyocera Corp. v. Softview LLC, IPR2013-00007, Paper 18 at 4
`5
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`(May 3, 2013) (declarants must be made “available for cross examination on all
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`direct testimony”). And any reply declarations from Sawai’s declarants could
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`require yet additional cross-examination.
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`Joinder under these circumstances would inevitably interfere with and delay
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`the Mylan IPR. As the chart below shows, Biogen’s patent owner response in the
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`Mylan IPR is due two days after Sawai’s reply to this opposition. Moreover, all
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`substantive briefing in the Mylan IPR will be finished before the Board’s statutory
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`deadline to issue an institution decision on Sawai’s petition. There is thus no way
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`to accommodate cross-examination of Sawai’s declarants before Biogen’s patent
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`owner response or, indeed, before substantive briefing ends in the Mylan IPR.
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`6
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`Sawai IPR
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`5/5/2019: Sawai Reply ISO Joinder
`Motion
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`Mylan IPR
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`5/7/2019: Biogen Patent Owner
`Response
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`6/14/2019: Biogen's Preliminary
`Response
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`8/7/2019: Petitioner Reply
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`9/9/2019: Biogen Sur-Reply
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`9/14/2019: Statutory Date for
`Institution and Joinder Decisions
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`11/19/19: Oral Argument
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`Cross-examination of Sawai’s new declarants also cannot be reasonably
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`deferred until after Biogen’s patent owner response in the Mylan IPR. This would
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`be inequitable and prejudicial to Biogen because Sawai and its declarants will
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`have already had the benefit of Biogen’s patent owner response, including any
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`declaratory evidence. See General Plastic Indus. v. Canon Kabushiki Kaisha,
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`IPR2016-01357, Paper 19 at 17-28. (PTAB Sept. 6, 2017) (Precedential) (“Our
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`intent in formulating the factors [for follow-on petitions] was to take undue
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`inequities and prejudices to Patent Owner into account. Thus, factor 3 [(whether at
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`the time of filing of the second petition the petitioner already received the patent
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`owner’s preliminary response to the first petition or received the Board’s decision
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`on whether to institute review in the first petition)] is directed to Petitioner’s
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`potential benefit from receiving and having the opportunity to study Patent
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`Owner’s Preliminary Response, as well as our institution decisions on the first-
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`filed petitions, prior to its filing of follow-on petitions.”). Later cross-examination
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`would also require supplemental briefs to address the resulting testimony, which
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`wastes the Board’s and the parties’ resources.
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`Yet, notwithstanding its recognized obligation to have addressed “what
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`impact, if any, joinder will have on the trial schedule” and “how briefing and
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`discovery may be simplified” (Mot. at 3-4 (citations omitted)), Sawai offers no
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`practical means to accommodate cross-examination of its new declarants without
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`inconveniencing all involved and delaying the Mylan IPR. See Mylan, IPR2016-
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`01332, Paper 21 at 11. The motion’s “Trial Schedule” and “New Grounds”
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`sections, for example, rely on either entirely conclusory assertions (see, e.g., Mot.
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`at 6: “Sawai does not believe that any extension of the trial schedule will be
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`required as a result of joinder”)) or irrelevant cases involving identical declarants
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`(supra at pp. 3-4 (addressing each cited case in the “New Grounds” section of
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`Sawai’s motion for joinder)). Instead, Sawai appears to concede that depositions of
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`its declarants would interfere with the Mylan IPR as Sawai only argues that “no
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`additional depositions will be needed prior to Due Date 1 of the Mylan IPR” if
`8
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`Mylan authorizes use of its declarants. Mot. at 8.
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`Sawai fails to show joinder is appropriate given that its new declarants will
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`necessarily complicate and delay the Mylan IPR and prejudice Biogen. The Board
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`should deny joinder for this reason alone.
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`B.
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`The Sawai RPI Issue Will Require Additional Briefing and
`Discovery
`Joinder should be denied because the additional briefing and discovery
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`required to address the RPI issue Sawai creates will necessarily interfere with the
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`Mylan IPR.
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`Sawai’s petition lists a number of additional RPIs, including Upsher-Smith
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`Laboratories LLC (“Upsher-Smith”), but omits at least one other RPI—Sumitomo
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`Corporation. Paper 1 at 1. Based on press releases from Petitioner and Upsher-
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`Smith, unnamed Sumitomo Corporation meets the criteria of an RPI as it has
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`“management participation” in Upsher-Smith (Ex. 2001). 77 Fed. Reg. 157, Trial
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`Practice Guide, 48759 (Aug. 14, 2012) (describing the “common consideration” in
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`determining RPI status as “whether the non-party exercised or could have
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`exercised control over a party’s participation in a proceeding”). Sumitomo’s
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`website goes even further, demonstrating that Sumitomo has control over Upsher-
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`Smith and is “a clear beneficiary that has a preexisting, established relationship
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`with the petitioner.” Applications in Internet Time, LLC v. RPX Corp., 897 F.3d
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`9
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`1336, 1351 (Fed. Cir. 2018) (“Determining whether a non-party is a ‘real party in
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`interest’ demands a flexible approach that takes into account both equitable and
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`practical considerations, with an eye toward determining whether the non-party is a
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`clear beneficiary that has a preexisting, established relationship with the
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`petitioner.”). For example, Sumitomo represents:
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`In addition to helping Sawai Pharmaceutical in operating USL’s
`business, Sumitomo Corporation will endeavor to enhance USL’s
`corporate value by employing the Sumitomo Corporation Group’s
`global network and expertise to put new products on the market.
`Sumitomo Corporation and SCOA also seek to contribute to
`promoting physical and mental human health by widely supplying
`high-quality generic medications in the United States.
`Ex. 2002.
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`The requirement for Sawai to attempt to establish that it named the proper
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`RPIs will require active participation by Sawai with additional briefing and
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`discovery. As the Board has explained, “[i]f a patent owner alleges that the
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`petitioner omitted a real party in interest and produces some evidence to support its
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`argument, the petitioner bears the ultimate burden of persuasion to show patent
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`owner’s allegations are incorrect.” Toshiba Memory Corporation et al v. Anza
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`Technology, Inc., IPR2018-01597, Paper 12 at 7 (PTAB Mar. 12, 2018) (citing
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`Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1242, 1246-47 (Fed. Cir. 2018)
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`10
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`(holding that the Board should “weigh the [RPI] evidence in a manner that places
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`the ultimate burden of persuasion on” the IPR petitioner).
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`For example, in Unified Patents, the Board denied joinder where patent
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`owner intended to seek discovery regarding the funding and control of petitioner
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`by its founders, who had not been identified as RPIs in the petition. IPR2015-
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`00521, Paper 14 at 4-5. In light of statements from petitioner implicating its
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`founders, the Board found that it was “not unreasonable for Patent Owner to seek
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`authorization for additional discovery.” Id. As the Board further explained, “[t]his
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`potential for additional discovery presents a new substantive issue beyond what is
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`already before us in [the instituted IPR] and, as a result, weighs in favor of denying
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`Petitioner’s Motion for Joinder.” Id.
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`Moreover, even in the short history of this proceeding, Sawai has shown that
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`it will cause unnecessary interference and complication. Rather than coordinate in
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`advance, Sawai did not obtain agreement to use Mylan’s declarants. Nor did Sawai
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`“contact the Board in advance of filing to arrange a conference call with the parties
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`and Board to discuss the joinder request.”2 Instead, it filed is motion for joinder
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`with conditional positions that needlessly multiply the issues. Sawai’s inability to
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`2 www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/ptab-
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`e2e-frequently-asked-questions#H.%20Joinder%20and%20Consolidation, H5.
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`11
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`coordinate with Mylan and willingness to complicate the proceedings suggests that
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`Sawai’s “unless it disagrees with Mylan” exception to an “understudy” role will
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`swallow the rule. Mot. at 7.
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`None of the cases cited in Sawai’s motion granted joinder where, as here,
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`active participation by the joined petitioner was anticipated. Mot. at 7; Mylan,
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`IPR2018-01358, Paper 11 at 4; Hyundai, IPR2014-01543, Paper 11 at 4; Dell,
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`IPR2013-00385, Paper 17 at 8; Motorola, IPR2013-00256, Paper 10 at 8. To the
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`contrary, in cases where additional briefing or discovery is likely, such as here
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`where evidence supports an RPI challenge, joinder has been denied. See, e.g.,
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`Unified Patents, IPR2015-00521, Paper 14 at 4-5.
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`C.
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`Joining Sawai Would Frustrate the Mylan IPR and Not Provide
`an Efficient Alternative to the Litigation
`Congress intended inter partes reviews to “provid[e] quick and cost
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`effective alternatives to litigation.” H.R.REP. NO. 112-98, at 48 (2011), reprinted
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`in 2011 U.S.C.C.A.N. 67, 78 (emphasis added). Joinder of the Sawai and Mylan
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`IPRs would undermine this principle because the Sawai district court trial will
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`finish weeks before the statutory deadline for the Mylan IPR final written decision.
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`Thus, joinder does not avoid duplication; it would only impede any potential pre-
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`decision resolution of the Mylan IPR.
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`Sawai’s right to seek an IPR on its own expired on July 5, 2018. Ex. 2003;
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`12
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`35 U.S.C. § 315(b). Sawai served invalidity contentions in the district court action
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`before this date and could have filed a timely IPR to the extent it was interested in
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`such a proceeding. But Sawai did not. Sawai’s intentional delay has resulted in the
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`Sawai district court trial being ahead of an IPR decision from the PTAB, thereby
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`frustrating the concept of a “just, speedy, and inexpensive resolution”: fact
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`discovery is already closed, expert discovery will be complete by September 13,
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`2019, and trial is set for December 9, 2019. Ex. 2004. Sawai’s unsupported, pro
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`forma assertions that “[j]oinder is appropriate because it will promote an efficient
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`and consistent resolution of a single patent” and “because it will promote the just,
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`speedy, and inexpensive resolution of patentability issues” (Mot. at 2, 6) are not
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`applicable given the relative timing of the district court and PTAB proceedings.
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`Instead, at best, Sawai’s joinder could only delay the Mylan IPR, where a final
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`written decision is not due until weeks after the Sawai district court trial.
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`Under these circumstances, instituting Sawai’s IPR via its joinder motion
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`“would be an inefficient use of Board resources.” NHK Spring Co. Ltd. v Intri-plex
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`Technologies, IPR2018-00752, Paper 8 at 20 (PTAB Sept. 12, 2018). As the Board
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`has explained, where the Board’s final written decision would follow a district
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`court trial, institution “would not be consistent with an objective of the AIA to
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`provide an effective and efficient alternative to district court litigation.” Id.
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`(internal quotations omitted).
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`13
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`Regarding the “possible chilling effect of joinder on settlement” factor
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`(Global Foundries U.S., IPR2017-00926, Paper 12 at 10), Sawai implies that the
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`Board’s decision in Global Foundries supports Sawai’s motion. Mot. at 8-9, n. 1.
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`In fact, the decision supports denial of joinder. Unlike Sawai, the petitioner in
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`Global was not time-barred without joinder. Global Foundries U.S., IPR2017-
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`00925, Paper 3 at § III(B). Thus, in Global, unlike in this case, without joinder
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`there was a risk of “separate concurrent proceedings [that] would duplicate efforts,
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`and create a risk of inconsistent results and piecemeal review.” Id. Furthermore,
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`unlike in this case, joinder of Global’s petition did not impact the existing trial
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`schedule. Global Foundries U.S., IPR2017-00926, Paper 12 at 8. It was in light of
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`these and other distinguishing factors that the Board concluded that the benefits of
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`joinder “outweigh[ed] any potential effect on settlement.” Id.
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`Sawai points to no case granting joinder where there is no potential for
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`added efficiency or potential prejudice to the later petitioner. Creating barriers to
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`resolution in such a context would be wholly contrary to promoting the just,
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`speedy, and inexpensive resolution of the earlier IPR. Indeed, it is a factor clearly
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`weighing against joinder, Global Foundries U.S., IPR2017-00926, Paper 12 at 10,
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`particularly when petitioner is already going to get its day in court before the IPR
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`is complete. NHK Spring Co. Ltd. v Intri-plex Technologies, IPR2018-00752,
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`Paper 8 at 20.
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`14
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`Case IPR2019-00789
`Opposition to Motion for Joinder
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`
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`
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`IV. Conclusion
`Joinder would require additional briefing and discovery caused by issues
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`unique to Sawai’s petition and would impede the just, speedy, and inexpensive
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`resolution of the Mylan IPR. Joinder, therefore, should be denied.
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`Dated: April 5, 2019
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`Respectfully submitted,
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`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4047
`Counsel for Patent Owner
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`15
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Opposition to Petitioner’s Motion for Joinder was served electronically
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`via e-mail on April 5, 2019, in their entirety on the following:
`
`Brian Sodikoff
`Katten Muchin Rosenman LLP
`525 West Monroe Street
`Chicago, IL 60661-3693
`Telephone: (312) 902-5462
`E-mail: brian.sodikoff@kattenlaw.com
`
`Christopher B. Ferenc
`Katten Muchin Rosenman LLP
`2900 K Street NW
`North Tower - Suite 200
`Washington, DC 20007
`Telephone: (202) 625-3647
`E-mail: Christopher.ferenc@kattenlaw.com
`Petitioner has agreed to electronic service.
`
`Dated: April 5, 2019
`
`By: / Catherine A. Sadler /
`Catherine A. Sadler
`Case Manager
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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