Paper No. ____
`Filed: February 23, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`INDUSTRIES, INC., and SUN PHARMA GLOBAL FZE,
`
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`
`______________________
`
`Case IPR2017-008541
`U.S. Patent No. 9,187,405
`______________________
`
`PATENT OWNER’S NOTICE OF OBJECTIONS TO EVIDENCE
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
` 1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
`with this proceeding.
`
`
`
`
`
`Filed: February 23, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`INDUSTRIES, INC., and SUN PHARMA GLOBAL FZE,
`
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`
`______________________
`
`Case IPR2017-008541
`U.S. Patent No. 9,187,405
`______________________
`
`PATENT OWNER’S NOTICE OF OBJECTIONS TO EVIDENCE
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
` 1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
`with this proceeding.
`
`
`
`
`
`
`Case IPR2017-00854
`Patent 9,187,405
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Novartis objects to the
`
`admissibility of the below-referenced exhibits submitted by Petitioners in
`
`Petitioners’ Reply (Paper 49).
`
`Novartis’s objections to the admissibility of exhibits submitted with the
`
`Petition are made in accordance with the Federal Rules of Evidence (“FRE”).
`
`Novartis’s objections are also made pursuant to the Code of Federal Regulations
`
`(“C.F.R.”) governing this proceeding, including without limitation 37 C.F.R. §§
`
`42.61-42.65 and § 42.6(a)(3).
`
`I.
`
`OBJECTIONS TO PETITIONERS’ EXHIBITS
`A. Exhibit 1046
`Novartis objects to the admissibility of Exhibit 1046, the transcript of the
`
`January 29, 2018 deposition of Fred D. Lublin, M.D., to the extent that the
`
`citations to this transcript in Petitioners’ Reply and/or the reply declaration of
`
`Leslie Z. Benet, Ph.D. (Exhibit 1047) are incomplete with respect to the addressed
`
`topics. FRE 106. Novartis also maintains each of its specific objections as stated
`
`in the deposition record. 37 C.F.R. § 42.64(a).
`
`B.
`Exhibit 1047
`Novartis objects to the admissibility of Exhibit 1047, the declaration of
`
`Leslie Z. Benet, Ph.D., to the extent that it raises new arguments and presents new
`
`evidence that are essential to Petitioners’ prima facie case and thus are improper
`
`reply material. Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1081–82 (Fed. Cir.
`
`
`
`
`
`Case IPR2017-00854
`Patent 9,187,405
`
`2015); 37 C.F.R. § 42.23(b); 77 Fed.Reg. at 48,767.
`
`Novartis also objects to the to the admissibility of Exhibit 1047 to the extent
`
`that arguments made by Dr. Benet in Exhibit 1047 are impermissibly incorporated
`
`by reference into Petitioners’ Reply. 37 C.F.R. § 42.6(a)(3)
`
`Novartis also objects to the admissibility of Exhibit 1047 to the extent that
`
`Dr. Benet purports to testify to matters beyond his expertise, such as opining on
`
`matters specific to multiple sclerosis and/or EAE models and on how matters
`
`would be viewed from the perspective of a physician with experience in treating
`
`multiple sclerosis. FRE 702.
`
`Novartis also objects to the admissibility of Exhibit 1047 to the extent that
`
`Dr. Benet’s citations to deposition transcripts are incomplete with respect to the
`
`addressed topics. FRE 106.
`
`Novartis also objects to the admissibility of Exhibit 1047 to the extent that
`
`Dr. Benet relies on Exhibit 1049. Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064,
`
`1081–82 (Fed. Cir. 2015); 37 C.F.R. § 42.23(b); 77 Fed.Reg. at 48,767; FRE 901;
`
`FRE 402; FRE 403.
`
`C. Exhibit 1048
`Novartis objects to the admissibility of Exhibit 1048 because it contains
`
`inadmissible hearsay to the extent its contents are offered for the truth of any
`
`matter asserted therein. FRE 802.
`
`
`
`
`
`Case IPR2017-00854
`Patent 9,187,405
`
`
`Novartis also objects to the admissibility of Exhibit 1048 because it lacks
`
`relevance to any issue in this case. FRE 402.
`
`D. Exhibit 1049
`Novartis objects to the admissibility of Exhibit 1049 to the extent that it
`
`raises new arguments and presents new evidence that are essential to Petitioners’
`
`prima facie case and thus are improper reply material. Belden Inc. v. Berk-Tek
`
`LLC, 805 F.3d 1064, 1081–82 (Fed. Cir. 2015); 37 C.F.R. § 42.23(b); 77 Fed.Reg.
`
`at 48,767.
`
`To the extent that Petitioners cite Exhibit 1049 for the purpose of
`
`demonstrating how a person of skill would scale effective doses of FTY720 in
`
`animals to doses that have equivalent efficacy in humans, Novartis also objects to
`
`the admissibility of Exhibit 1049 because Petitioners have failed to produce
`
`evidence or lay a foundation sufficient to support a finding that Exhibit 1049 may
`
`be used for such a purpose. FRE 901.
`
`Novartis also objects to the admissibility of Exhibit 1049 because it lacks
`
`relevance to any issue in this case. FRE 402. Furthermore, any probative value of
`
`Exhibit 1049 is outweighed by the dangers of unfair prejudice to Novartis and
`
`confusing the issues. FRE 403.
`
`E.
`Exhibit 1050
`Novartis objects to the admissibility of Exhibit 1050, the transcript of the
`
`
`
`
`
`Case IPR2017-00854
`Patent 9,187,405
`
`December 13, 2017 deposition of Christian Schnell, to the extent that the citations
`
`to this transcript in Petitioners’ Reply and/or the reply declaration of Leslie Z.
`
`Benet, Ph.D. (Exhibit 1047) are incomplete with respect to the addressed topics.
`
`FRE 106. Novartis also maintains each of its specific objections as stated in the
`
`deposition record. 37 C.F.R. § 42.64(a).
`
`F.
`Exhibit 1051
`Novartis objects to the admissibility of Exhibit 1051 as irrelevant to the
`
`extent cited as prior art, because Exhibit 1051 was not publicly available as of the
`
`priority date and therefore is not prior art. Rule 402. Furthermore, any probative
`
`value of Exhibit 1051 is outweighed by the dangers of unfair prejudice to Novartis
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owners
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`and confusing the issues. FRE 403.
`
`
`
`Dated: February 23, 2018
`
`
`
`
`
`
`
`
`
`Case IPR2017-00854
`Patent 9,187,405
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on February 23, 2018, a
`
`true and accurate copy of PATENT OWNER’S NOTICE OF OBJECTIONS TO
`
`EVIDENCE was served via electronic mail on the following counsel of record for
`
`Petitioners:
`
`For Apotex:
`
`For Argentum:
`
`
`For Sun:
`
`
`
`Steven W. Parmelee: sparmelee@wsgr.com
`Michael T. Rosato: mrosato@wsgr.com
`Jad A. Mills: jmills@wsgr.com
`
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Telephone: 206-883-2542
`
`
`Teresa Stanek Rea: trea@crowell.com
`Deborah H. Yellin: dyellin@crowell.com
`Shannon M. Lentz: slentz@crowell.com
`Tyler C. Liu: TLiu@agpharm.com
`
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`(202) 624-2620
`
`Samuel Park: SPark@winston.com
`Charles B. Klein: CKlein@winston.com
`Sharick Naqi: SNaqi@winston.com
`
`Winston & Strawn LLP
`
`
`
`
`
`Case IPR2017-00854
`Patent 9,187,405
`
`
`
`For Teva:
`
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`
`
`
`Dated: February 23, 2018
`
`Amanda Hollis: amanda.hollis@kirkland.com
`Eugene Goryunov: egoryunov@kirkland.com
`Gregory Springsted: gregory.springsted@kirkland.com
`
`Kirkland & Ellis LLP
`300 North LaSalle
`Chicago, IL 60654
`Telephone: (312) 862-2000
`(202) 624-2620
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owners
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`
`
`
`
`
`
`
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