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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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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 SUR-REPLY IN OPPOSITION TO
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`PETITIONER’S MOTION FOR JOINDER
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`IPR2019-00789
`Patent 8,399,514
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`Contents
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`I.
`Sawai Established Even More Reason to Deny Joinder .................................. 1
`Sawai’s New Declarant Must Be Produced for Cross-Examination ............... 2
`II.
`III. Conclusion ....................................................................................................... 3
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`IPR2019-00789
`Patent 8,399,514
`Biogen’s Opposition to Sawai’s Motion for Joinder presented three reasons
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`to deny joinder: (1) Sawai’s declarants introduce new issues, (2) the Sawai RPI
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`issue will require additional briefing and discovery, and (3) joining Sawai would
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`frustrate the Mylan IPR and not provide an efficient alternative to the litigation.
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`Sawai’s response on the RPI issues included a new declaration of Tatsufumi
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`Hiramatsu (Ex. 1060) that raises more RPI questions than it answers. Moreover, it
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`establishes that joinder is unwarranted because availability of this declarant for
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`cross-examination is required as routine discovery under 37 CFR § 42.51(b)(1)
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`and merely the “potential for additional discovery [to address Petitioner’s failure to
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`identify all RPIs] presents a new substantive issue… [that] weighs in favor of
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`denying Petitioner’s Motion for Joinder.” Unified Patents Inc. v. Personalized
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`Media Commc’ns, LLC, IPR2015-00521, Paper 14 at 5 (PTAB Jun. 8, 2015)
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`(emphasis added). Moreover, Sawai reinforces Biogen’s first basis for opposition
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`to joinder: Sawai’s introduces new declarations to be cross-examined without
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`“offer[ing] a practical way to accommodate the additional discovery without
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`inconveniencing all involved or delaying the due dates in the [earlier] IPR.” Mylan
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`Pharma., v. Janssen Oncology, Inc., IPR2016-01332, Paper 21 at 11 (PTAB Jan.
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`10, 2017); see, e.g., Opp. at 1-3. Joinder should be denied.
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`Sawai Established Even More Reason to Deny Joinder
`There is even more reason to deny joinder here than in Unified Patents,
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`1
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`I.
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`IPR2019-00789
`Patent 8,399,514
`where the Board found that it was “not unreasonable for Patent Owner to seek
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`authorization for additional discovery” relating to the appropriate RPIs and held
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`that “[t]his potential for additional discovery… weighs in favor of denying
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`Petitioner’s Motion for Joinder.” IPR2015-00521, Paper 14 at 4-5 (emphasis
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`added). Here, there is not just the “potential” for additional RPI discovery: The
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`Board’s self-executing, routine discovery rules specifically authorize the cross-
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`examination of declarants like Sawai’s Mr. Hiramatsu. See § II, below.
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`While the ultimate resolution of the RPI issue is outside the scope of this
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`motion, and Patent Owner anticipates addressing it further in the POPR, Sawai’s
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`new declaration confirms an RPI issue. It admits a pre-existing relationship
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`between Petitioner Sawai Japan and Sumitomo as co-owners (via wholly owned
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`intermediates) of an intended beneficiary of the IPR and fails to dispute the
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`evidence of Sumitomo’s role in running Upsher-Smith. Resp. at 3, 5 n.1; Ex. 1060
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`at ¶ 10; Opp. at 9-11; Exs. 2001, 2002.
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`II.
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`Sawai’s New Declarant Must Be Produced for Cross-Examination
`The Opposition explained that a new Sawai declarant is reason enough to
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`deny joinder, as cross-examination would necessarily complicate and delay the
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`Mylan IPR. Opp. at 4 (citing Unified Patents, IPR2015-00521, Paper 14 at 4-5).
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`Sawai responded that it “does not intend to produce its own testifying witnesses or
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`file substantive papers in the Mylan IPR so long as Mylan remains a party to the
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`2
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`IPR2019-00789
`Patent 8,399,514
`case.” Resp. at 1. While the parties dispute Sawai’s contention that it can pull its
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`expert declarants off the field (see id.), Sawai does not dispute that Biogen is
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`entitled to the cross-examination of Sawai’s Mr. Hiramatsu based on his
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`declaration. 37 CFR § 42.51(b)(1); see also BlackBerry Corp. v. Wi-Lan USA Inc.,
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`IPR2013-00126, Paper 15 at 2 (PTAB Aug. 19, 2013) (noting that “routine
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`discovery under 37 C.F.R. § 42.51(b)(1) is self-executing and self-enforcing”).
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`Notwithstanding its introduction of another new declarant, Sawai ignores its
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`obligation to provide practical means to accommodate the discovery, at least cross-
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`examination, without inconveniencing all involved and delaying the Mylan IPR.
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`Mylan, IPR2016-01332, Paper 21 at 11; see, e.g., Opp. at 1-3, 8. Indeed, there is no
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`reasonable way to accommodate the cross-examination of Mr. Hiramatsu and
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`briefing on Sawai’s RPI issue given that an institution decision in the Sawai IPR is
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`not due until late in the Mylan IPR schedule and only shortly before Sawai’s
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`district court trial.
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`III. Conclusion
`For the reasons above and in the Opposition, Joinder should be denied.
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`Dated: May 21, 2019
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`Respectfully submitted,
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`By: /Barbara C. McCurdy/
`Barbara C. McCurdy
`Reg. No. 32,120
`Counsel for Patent Owner
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`3
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S SUR-REPLY IN OPPOSITION TO PETITIONER’S MOTION
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`FOR JOINDER was filed and served electronically via the PTAB
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`electronic filing on May 21, 2019, in its entirety on the following:
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`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
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`Petitioner has agreed to electronic service.
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`Dated: May 21, 2019
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`By: / Catherine A. Sadler /
`Catherine A. Sadler
`Case Manager
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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