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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`SAWAI USA, INC. and SAWAI PHARMACEUTICAL CO., LTD.
`
`Petitioners,
`
`v.
`
`BIOGEN MA INC.,
`
`Patent Owner.
`
`____________
`
`Case IPR2019-00789
`
`Patent 8,399,514
`
`____________
`
`PATENT OWNER’S SUR-REPLY IN OPPOSITION TO
`
`PETITIONER’S MOTION FOR JOINDER
`
`
`
`

`

`IPR2019-00789
`Patent 8,399,514
`
`Contents
`
`
`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
`
`
`
`
`
`
`

`

`IPR2019-00789
`Patent 8,399,514
`Biogen’s Opposition to Sawai’s Motion for Joinder presented three reasons
`
`to deny joinder: (1) Sawai’s declarants introduce new issues, (2) the Sawai RPI
`
`issue will require additional briefing and discovery, and (3) joining Sawai would
`
`frustrate the Mylan IPR and not provide an efficient alternative to the litigation.
`
`Sawai’s response on the RPI issues included a new declaration of Tatsufumi
`
`Hiramatsu (Ex. 1060) that raises more RPI questions than it answers. Moreover, it
`
`establishes that joinder is unwarranted because availability of this declarant for
`
`cross-examination is required as routine discovery under 37 CFR § 42.51(b)(1)
`
`and merely the “potential for additional discovery [to address Petitioner’s failure to
`
`identify all RPIs] presents a new substantive issue… [that] weighs in favor of
`
`denying Petitioner’s Motion for Joinder.” Unified Patents Inc. v. Personalized
`
`Media Commc’ns, LLC, IPR2015-00521, Paper 14 at 5 (PTAB Jun. 8, 2015)
`
`(emphasis added). Moreover, Sawai reinforces Biogen’s first basis for opposition
`
`to joinder: Sawai’s introduces new declarations to be cross-examined without
`
`“offer[ing] a practical way to accommodate the additional discovery without
`
`inconveniencing all involved or delaying the due dates in the [earlier] IPR.” Mylan
`
`Pharma., v. Janssen Oncology, Inc., IPR2016-01332, Paper 21 at 11 (PTAB Jan.
`
`10, 2017); see, e.g., Opp. at 1-3. Joinder should be denied.
`
`Sawai Established Even More Reason to Deny Joinder
`There is even more reason to deny joinder here than in Unified Patents,
`
`1
`
`I.
`
`
`
`

`

`IPR2019-00789
`Patent 8,399,514
`where the Board found that it was “not unreasonable for Patent Owner to seek
`
`authorization for additional discovery” relating to the appropriate RPIs and held
`
`that “[t]his potential for additional discovery… weighs in favor of denying
`
`Petitioner’s Motion for Joinder.” IPR2015-00521, Paper 14 at 4-5 (emphasis
`
`added). Here, there is not just the “potential” for additional RPI discovery: The
`
`Board’s self-executing, routine discovery rules specifically authorize the cross-
`
`examination of declarants like Sawai’s Mr. Hiramatsu. See § II, below.
`
`While the ultimate resolution of the RPI issue is outside the scope of this
`
`motion, and Patent Owner anticipates addressing it further in the POPR, Sawai’s
`
`new declaration confirms an RPI issue. It admits a pre-existing relationship
`
`between Petitioner Sawai Japan and Sumitomo as co-owners (via wholly owned
`
`intermediates) of an intended beneficiary of the IPR and fails to dispute the
`
`evidence of Sumitomo’s role in running Upsher-Smith. Resp. at 3, 5 n.1; Ex. 1060
`
`at ¶ 10; Opp. at 9-11; Exs. 2001, 2002.
`
`II.
`
`Sawai’s New Declarant Must Be Produced for Cross-Examination
`The Opposition explained that a new Sawai declarant is reason enough to
`
`deny joinder, as cross-examination would necessarily complicate and delay the
`
`Mylan IPR. Opp. at 4 (citing Unified Patents, IPR2015-00521, Paper 14 at 4-5).
`
`Sawai responded that it “does not intend to produce its own testifying witnesses or
`
`file substantive papers in the Mylan IPR so long as Mylan remains a party to the
`
`
`
`2
`
`

`

`IPR2019-00789
`Patent 8,399,514
`case.” Resp. at 1. While the parties dispute Sawai’s contention that it can pull its
`
`expert declarants off the field (see id.), Sawai does not dispute that Biogen is
`
`entitled to the cross-examination of Sawai’s Mr. Hiramatsu based on his
`
`declaration. 37 CFR § 42.51(b)(1); see also BlackBerry Corp. v. Wi-Lan USA Inc.,
`
`IPR2013-00126, Paper 15 at 2 (PTAB Aug. 19, 2013) (noting that “routine
`
`discovery under 37 C.F.R. § 42.51(b)(1) is self-executing and self-enforcing”).
`
`Notwithstanding its introduction of another new declarant, Sawai ignores its
`
`obligation to provide practical means to accommodate the discovery, at least cross-
`
`examination, without inconveniencing all involved and delaying the Mylan IPR.
`
`Mylan, IPR2016-01332, Paper 21 at 11; see, e.g., Opp. at 1-3, 8. Indeed, there is no
`
`reasonable way to accommodate the cross-examination of Mr. Hiramatsu and
`
`briefing on Sawai’s RPI issue given that an institution decision in the Sawai IPR is
`
`not due until late in the Mylan IPR schedule and only shortly before Sawai’s
`
`district court trial.
`
`III. Conclusion
`For the reasons above and in the Opposition, Joinder should be denied.
`
`Dated: May 21, 2019
`
`Respectfully submitted,
`
`By: /Barbara C. McCurdy/
`Barbara C. McCurdy
`Reg. No. 32,120
`Counsel for Patent Owner
`
`
`
`
`
`3
`
`

`

`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing PATENT
`
`OWNER’S SUR-REPLY IN OPPOSITION TO PETITIONER’S MOTION
`
`FOR JOINDER was filed and served electronically via the PTAB
`
`electronic filing on May 21, 2019, in its 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: May 21, 2019
`
`By: / Catherine A. Sadler /
`Catherine A. Sadler
`Case Manager
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
`
`
`
`

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