`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`APOTEX INC., APOTEX CORP., and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
` v.
`NOVARTIS AG,
`Patent Owner.
`______________________
`Case IPR2017-008541
`U.S. Patent No. 9,187,405
`______________________
`PATENT OWNER’S EXHIBIT LIST
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
` 1 Case IPR2017-01550 has been joined with this proceeding.
`
` 1
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`
`
`Exhibit
`2001
`
`2002
`
`2003
`
`2004
`2005
`
`2006
`2007
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`2014
`
`2015
`
`2016
`
`List of Patent Owner’s Evidence and Exhibits
`Reference
`Declaration of Robert W. Trenchard in Support of Motion for
`Admission Pro Hac Vice
`Order Admitting Robert W. Trenchard Pro Hac Vice, Torrent
`Pharm. Ltd. v. Novartis AG, IPR2014-00784, Paper 8
`Declaration of Fred D. Lublin, M.D. in support of Patent Owner’s
`Preliminary Response
`Curriculum Vitae of Fred D. Lublin, M.D.
`Declaration of William J. Jusko, Ph.D. in support of Patent
`Owner’s Preliminary Response
`Curriculum Vitae of William J. Jusko, Ph.D.
`United States Patent 5,604,229 to Fujita et al.
`Brinkmann et al., The Immune Modulator FTY720 Targets
`Sphingosine 1-Phosphate Receptors, 277 J. Bio. Chem. 24,
`21453–57 (2002)
`Forrest et al., Immune Cell Regulation and Cardiovascular Effects
`of Sphingosine 1-Phosphate Receptor Agonists in Rodents Are
`Mediated via Distinct Receptor Subtypes, 309 J. Pharm. And
`Experimental Therapeutics 2, 758–68 (2004)
`Lublin et al., Defining the clinical course of multiple sclerosis:
`Results of an international survey, 46 Neurology 907–11 (1996)
`Miller et al., How Modeling and Simulation Have Enhanced
`Decision Making in New Drug Development, 32 J.
`Pharmacokinetics and Pharmacodynamics 2, 185–97 (2005)
`Sanna et al., Sphingosine 1-Phosphate (S1P) Receptor Subtypes
`S1P1 and S1P3, Respectively, Regulate Lymphocyte Recirculation
`and Heart Rate, 279 J. Bio. Chem. 14, 13839–48 (2004)
`Public LinkedIn Profile of Tadimeti S. Rao, Ph.D.
`Webb et al., Sphingosine 1-phosphate receptor agonists attenuate
`relapsing-remitting experimental autoimmune encephalitis in SJL
`mice, 153 J. Neuroimmunology 108–21 (2004)
`U.S. Food and Drug Administration Guidance – “Guidance for
`Industry End-of-Phase 2A Meetings,” accessed on March 30, 2009
`at https://www.fda.gov/Error/index.htm.
`U.S. Food and Drug Administration Guidance – “Clinical
`Pharmacology Section of Labeling for Human Prescription Drug
`and Biological Products – Content and Format,” (December 2016)
`
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`Exhibit
`2017
`
`2018
`2019
`
`2020
`
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`
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`Reference
`Bloomberg Profile of Klemens Budde, M.D., accessed on April
`27, 2017 at http://www.bloomberg.com
`Public LinkedIn Profile of Janet Karlix
`Bibliographic Data of Application No. 06/633,481, accessed on
`May 1, 2017 at portal.uspto.gov/pair/PublicPair
`Transcript of August 25, 2017, conference call between the parties
`and the Board regarding Patent Owner’s List of Proposed
`Motions.
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 4.26, I hereby certify that on August 30, 2017, a true
`
`and accurate copy of PATENT OWNER’S EXHIBIT LIST was served via electronic
`
`mail, by agreement of the parties, on the following counsel of record for Petitioners:
`
`For Apotex:
`
`For Argentum:
`
`
`
`Dated: August 30, 2017
`
`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: dyelling@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
`
`/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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