UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SANDOZ INC.,
`Petitioner,
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`v .
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`PHARMACYCLICS LLC,
`Patent Owner.
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`U.S. Patent No. 9,795,604 to Byrd et al.
`Issue Date: October 24, 2017
`Title: Methods of Treating and Preventing Graft Versus Host Disease
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`Inter Partes Review No. IPR2019-00865
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO STRIKE
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SANDOZ INC.,
`Petitioner,
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`v .
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`PHARMACYCLICS LLC,
`Patent Owner.
`
`U.S. Patent No. 9,795,604 to Byrd et al.
`Issue Date: October 24, 2017
`Title: Methods of Treating and Preventing Graft Versus Host Disease
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`
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`Inter Partes Review No. IPR2019-00865
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO STRIKE
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Petitioner’s Opposition to Patent Owner’s Motion to Strike
` IPR2019-00865
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` Striking a portion of a brief is “an exceptional remedy that the Board expects
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`will be granted rarely.” Trial Practice Guide at 80. The Board should deny Patent
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`Owner’s belated (see id. at 81) Motion to Strike §§ III.B and III.C.1 of Petitioner’s
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`Reply (Paper 17) because those sections permissibly respond to arguments raised in
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`the Patent Owner Response (“POR,” Paper 13). Moreover, unlike in In re NuVasive,
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`Inc., 841 F.3d 966, 971 (Fed. Cir. 2016), cited by Patent Owner, here there is no
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`prejudice because Patent Owner has already addressed the sections in its Surreply
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`(Paper 24, at 7–9 and 9–10, respectively) and may do so again at oral argument.
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`I.
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`The Board Should Not Strike Section III.B of the Reply.
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`In the Petition, Petitioner argued that the ’085 Publication anticipated
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`dependent claims 4, 13, and 15. Pet., Paper 2, at 38–39. In the Institution Decision,
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`the Board preliminarily found these claims not anticipated. Dec., Paper 8, at 20.
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`During trial, Patent Owner cross-examined Petitioner’s expert (Dr. Ferrara), and he
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`provided testimony supporting anticipation of these claims. See Reply, § III.B.
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`Despite that testimony, and without even addressing it, Patent Owner argued in the
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`POR that “[i]t is undisputed that the steroid-resistant/refractory limitations are not
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`disclosed in the ’085 Publication.” POR at 20. In Section III.B of the Reply,
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`Petitioner explained that Patent Owner is wrong—the ’085 Publication anticipates
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`because, among other reasons, and consistent with Dr. Ferrara’s testimony, the ’085
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`Publication explicitly discloses the limitations of dependent claims 4, 13, and 15.
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`Petitioner’s Opposition to Patent Owner’s Motion to Strike
` IPR2019-00865
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`Petitioner’s Reply permissibly responded to the POR arguments. “Replies are
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`a vehicle for responding to arguments raised in a corresponding patent owner
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`response.” Unified Patents v. Intellectual Ventures, IPR2016-01643, Paper 51 at 50
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`(PTAB Mar. 26, 2018). The Board has permitted, and relied on, Reply arguments
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`that respond to a POR argument, even if the Petition had not addressed them. See,
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`e.g., Juniper Networks v. Chrimar Sys., IPR2016-01391, Paper 66 at 77 (PTAB Dec.
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`20, 2017) (denying motion to strike where Reply arguments, while not raised in the
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`Petition, responded to POR arguments); Idemitsu Kosan Co. v. SFC Co., 870 F.3d
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`1376 (Fed. Cir. 2017) (“To the extent [Patent Owner] suggests that the Board could
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`not reach a counterargument because it was not preemptively addressed by the
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`petition or institution decision, [Patent Owner] is plainly mistaken.”).
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`Patent Owner’s cases are inapposite. In Arista Networks, Inc. v. Cisco
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`Systems, Inc., the Board found that the “explanations in the Reply . . . [were] not
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`responsive to Patent Owner’s arguments.” IPR2016-00308, Paper 42 at 14 (PTAB
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`May 25, 2017). In Henny Penny Corp. v. Frymaster LLC, there was no suggestion
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`or argument that Petitioner’s “new theory first raised in reply” was responsive to
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`Patent Owner’s arguments. 938 F.3d 1324, 1331 (Fed. Cir. 2019). Finally, in Ariosa
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`Diagnostics v. Verinata Health, Inc., the court stated that the applicable regulation
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`“limit[s] Reply submissions to matter responsive to the Patent Owner’s Response,”
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`invoking “efficiency and fairness interests.” 805 F.3d 1359, 1368 (Fed. Cir. 2015).
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`2
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`Petitioner’s Opposition to Patent Owner’s Motion to Strike
` IPR2019-00865
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`Here, the Reply section sought to be struck directly responds to the POR.
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`Moreover, Patent Owner itself elicited the testimony cited in the Reply (see EX2056,
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`207:11–213:22) and has already addressed the testimony in its Surreply (at 7–9). See
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`SK Hynix v. Netlist, IPR2017-00577, Paper 26 at 30 (PTAB July 5, 2018) (“[T]he
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`alleged new theory relies on the same references detailed in the Petition and the
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`Institution Decision and, because the alleged new theory occurred in a deposition
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`held prior to filing the Patent Owner Response, Patent Owner had an opportunity to
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`address the alleged new theory before the hearing and Final Written Decision.”).
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`II. The Board Should Not Strike Section III.C.1 of the Reply.
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`In the Petition, Petitioner argued that the ’085 Publication anticipated certain
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`dependent claims. Pet. at 39–41. Addressing the base claims, Petitioner argued that
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`“the ’085 Publication discloses administering ibrutinib to treat GVHD.” Id. at 39
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`(emphasis added). The POR argued that the ’085 Publication is “completely silent
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`as to partial or complete response rates for any drug.” POR at 17. The Reply then
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`repeated what Petitioner earlier said in the Petition—the Reply argued that “[t]he
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`’085 Publication discloses a ‘method of treating’ certain diseases by ‘administering’
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`ibrutinib, including treating ‘[GVHD].’” Reply at 10–11 (citation omitted). In
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`response to the POR, the Reply emphasized that “treating” encompasses the claimed
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`patient outcomes. Id. at 11. The argument was not new, responded to the POR, has
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`been addressed by Patent Owner in the Surreply (at 9–10), and should not be struck.
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`3
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`Date: June 9, 2020
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`Petitioner’s Opposition to Patent Owner’s Motion to Strike
` IPR2019-00865
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`RESPECTFULLY SUBMITTED,
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`ALSTON & BIRD LLP
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`/Kirk T. Bradley/
`Kirk T. Bradley
`Registration No. 46,571
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`Counsel for Petitioner
`Sandoz Inc.
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`Petitioner’s Opposition to Patent Owner’s Motion to Strike
` IPR2019-00865
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`CERTIFICATION OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e), the undersigned certifies that on June 9,
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`2020, a complete copy of the foregoing Petitioner’s Opposition to Patent Owner’s
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`Motion to Strike was served via electronic mail to the Patent Owner by serving their
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`attorneys of record:
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`William B. Raich
`Erin M. Sommers
`Cora R. Holt
`Stefan O. Ochiana
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Telephone: (202) 408-4210
`Facsimile: (202) 408-4400
`Email: william.raich@finnegan.com
`erin.sommers@finnegan.com
`cora.holt@finnegan.com
`stefan.ochiana@finnegan.com
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`Respectfully submitted,
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`ALSTON & BIRD LLP
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`By: /Kirk T. Bradley/
`Kirk T. Bradley
`Reg. No. 46,571
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