Paper No. ____
`Patent 9,187,405
`
`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 NOVARTIS’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.
`
`
`Patent 9,187,405
`
`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 NOVARTIS’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.
`
`
`
`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 testimony and exhibits submitted by
`
`Petitioners in Petitioners’ Sur-Reply Regarding Patent Owner’s Motion to Amend
`
`(Paper 85).
`
`Novartis’s objections to the admissibility of the testimony and 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 1061
`Novartis objects to the admissibility of Exhibit 1061, the transcript of the
`
`April 5, 2018, deposition of Dr. Lawrence Steinman, for all the reasons Novartis
`
`stated on the record at the deposition. 37 C.F.R. § 42.64(a). Novartis further
`
`objects to Petitioners’ use of that deposition in Paper 85, where petitioners assert
`
`that the deposition is relevant to certain issues. (Paper 85 at 3-6.) Novartis objects
`
`to the testimony as irrelevant for that purpose and because any probative value is
`
`outweighed by the dangers of unfair prejudice to Novartis and confusion of the
`
`issues. F.R.E. 402-403. Novartis further objects to this testimony under F.R.E.
`
`106 insofar as other parts of the testimony provided or exhibits used in the
`
`
`
`
`
`
`
`deposition should “in fairness” be considered alongside the cited testimony.
`
`Novartis further objects to this testimony and related argument as untimely
`
`presented.
`
`B.
`Exhibit 1062
`Novartis objects to the admissibility of Exhibit 1062, the transcript of the
`
`April 6, 2018, deposition of Dr. Fred Lublin, for all the reasons Novartis stated on
`
`the record at the deposition. 37 C.F.R. § 42.64(a). Novartis further objects to
`
`Petitioners’ use of that deposition in Paper 85, where petitioners assert that the
`
`deposition is relevant to certain issues. (Paper 85 at 8-9.) Novartis objects to the
`
`testimony as irrelevant for that purpose and because any probative value is
`
`outweighed by the dangers of unfair prejudice to Novartis and confusion of the
`
`issues. F.R.E. 402-403. Novartis further objects to this testimony under F.R.E.
`
`106 insofar as other parts of the testimony provided or exhibits used in the
`
`deposition should “in fairness” be considered alongside the cited testimony.
`
`Novartis further objects to this testimony and related argument as untimely
`
`presented.
`
`C. Exhibit 1064
`Novartis objects to the admissibility of Exhibit 1064, the transcript of the
`
`April 10, 2018, deposition of Dr. William Jusko, for all the reasons Novartis stated
`
`on the record at the deposition. 37 C.F.R. § 42.64(a). Novartis further objects to
`
`
`
`Petitioners’ use of that deposition in Paper 85, where petitioners assert that the
`
`deposition is relevant to certain issues. (Paper 85 at 4-5.) Novartis objects to the
`
`testimony as irrelevant for that purpose and because any probative value is
`
`outweighed by the dangers of unfair prejudice to Novartis and confusion of the
`
`issues. F.R.E. 402-403. Novartis further objects to this testimony under F.R.E.
`
`106 insofar as other parts of the testimony provided or exhibits used in the
`
`deposition should “in fairness” be considered alongside the cited testimony.
`
`Novartis further objects to this testimony and related argument as untimely
`
`presented.
`
`D. Exhibit 1065
`Novartis objects to the admissibility of Exhibit 1065, U.S. Pat. No.
`
`6,770,628, “Hematopoietic Stimulation” (filed June 11, 2001) (issued August 3,
`
`2004), as irrelevant and because any probative value is outweighed by the dangers
`
`of unfair prejudice to Novartis and confusion of the issues. F.R.E. 401-403.
`
`Novartis further objects to this exhibit as untimely submitted, and lacking proper
`
`foundation, to the extent it is offered to prove any material fact at issue. Novartis
`
`further objects to this exhibit as hearsay to the extent it is offered to prove the truth
`
`of the matter asserted. F.R.E 801-802.
`
`E.
`Exhibit 1066
`Novartis objects to the admissibility of Exhibit 1066, U.S. Pat. Application
`
`
`
`Publication No. 2005/0031585, “Method for Treating Hepatitis C Virus Infection
`
`in Treatment Failure Patients” (published February 10, 2005), as irrelevant and
`
`because any probative value is outweighed by the dangers of unfair prejudice to
`
`Novartis and confusion of the issues. F.R.E. 401-403. Novartis further objects to
`
`this exhibit as untimely submitted, and lacking proper foundation, to the extent it is
`
`offered to prove any material fact at issue. Novartis further objects to this exhibit
`
`as hearsay to the extent it is offered to prove the truth of the matter asserted. F.R.E
`
`801-802.
`
`F.
`Exhibit 1067
`Novartis objects to the admissibility of Exhibit 1067, Lawrence M. Blatt and
`
`Henry H. Hsu: International Publication No. WO 2004/078194 (published
`
`September 16, 2004), as irrelevant and because any probative value is outweighed
`
`by the dangers of unfair prejudice to Novartis and confusion of the issues. F.R.E.
`
`402-403. Novartis further objects to this exhibit as untimely submitted, and
`
`lacking proper foundation, to the extent it is offered to prove any material fact at
`
`issue. Novartis further objects to this exhibit as hearsay to the extent it is offered
`
`to prove the truth of the matter asserted. F.R.E 801-802.
`
`G. Exhibit 1068
`Novartis objects to the admissibility of Exhibit 1068, Edward Paul Bowman
`
`et al.: International Publication No. WO 2008/156865 (published December 24,
`
`
`
`2008), as irrelevant and because any probative value is outweighed by the dangers
`
`of unfair prejudice to Novartis and confusion of the issues. F.R.E. 401-403.
`
`Novartis further objects to this exhibit as untimely submitted, and lacking proper
`
`foundation, to the extent it is offered to prove any material fact at issue. Novartis
`
`further objects to this exhibit as hearsay to the extent it is offered to prove the truth
`
`of the matter asserted. F.R.E 801-802.
`
`H. Exhibit 1069
`Novartis objects to the admissibility of Exhibit 1069, Hazel Hunt:
`
`International Publication No. WO 2017/151613 (published September 8, 2017), as
`
`irrelevant and because any probative value is outweighed by the dangers of unfair
`
`prejudice to Novartis and confusion of the issues. F.R.E. 401-403. Novartis
`
`further objects to this exhibit as untimely submitted, and lacking proper
`
`foundation, to the extent it is offered to prove any material fact at issue. Novartis
`
`further objects to this exhibit as hearsay to the extent it is offered to prove the truth
`
`of the matter asserted. F.R.E 801-802.
`
`Dated: April 23, 2018
`
`/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
`
`
`
`IPR2017-00854
`Patent 9,187,405
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on April 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
`
`Winston & Strawn LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`
`
`
`
`
`For Teva:
`
`
`
`Dated: April 23, 2018
`
`Amanda Hollis: amanda.hollis@kirkland.com
`Eugene Goryunov: egoryunov@kirkland.com
`Gregory Springsted: greg.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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