Paper No. ____
`Date Filed: June 3, 2016
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`Case IPR2016-00084
`Patent No. 5,665,772
`
`PATENT OWNER’S EXHIBIT LIST 2
`
`
`Date Filed: June 3, 2016
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`Case IPR2016-00084
`Patent No. 5,665,772
`
`PATENT OWNER’S EXHIBIT LIST 2
`
`
`
`Description
`
`Abbreviation
`
`Exhibit
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`2025
`
`Iino, Y. et al., “Improvement of Renal
`Function in Transplanted Kidneys with a
`New Immunosuppressive Drug, 15-
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`Aulton
`
`Silverman
`
`4
`
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`
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`
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`
`2034
`
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`2038
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`2039
`
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`
`2040
`
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`
`2041
`
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`
`2042
`
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`
`2043
`
`Brookhaven Protein Databank Entry 1FKB
`(produced by Par in the related litigation)
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`
`5
`
`Takada
`
`’138 patent
`
`’726 patent
`
`’876 patent
`
`’051 patent
`
`’389 patent
`
`’399 patent
`
`PDB Entry
`
`
`
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`
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`
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`
`2044
`
`Pauling, L., “7-4 Aromatic Hydrocarbons,
`Benzene,” General Chemistry Dover Edition
`(1988)
`
`Pauling
`
`Lemke
`
`2045
`
`Lemke, T., Chapters 10, 11, 12, Review of
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`
`2046
`
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`2047
`
`Franz, D. et al., “Efficacy and Safety of
`Everolimus for Subependymal Giant Cell
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`32 (2013)
`
`Franz
`
`2048
`
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`(Revised: 01/2015)
`
`Afinitor®
`Package Insert
`
`2049
`
`2050
`
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`
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`
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`
`Marsoni
`
`6
`
`
`
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`
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`
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`
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`Detector Diffractometer as a National
`Resource for Protein Crystallography,” Acta
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`
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`
`2051
`
`2052
`
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`
`2053
`
`Rapamune® Package Insert
`(Revised 05/2015)
`
`2054
`
`Kahan, B. et al., “A Phase I Study of a 4-
`week Course of SDZ-RAD (RAD) in
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`
`Merck Index
`
`Rapamune®
`Package Insert
`
`Kahan
`
`2055
`
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`(Revised 11/2015)
`
`Zortress®
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`
`2056
`
`2057
`
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`
`GB Application 9221220 (October 9, 1992)
`from certified file history of U.S. Patent
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`
`Podder
`
`GB 220
`
`7
`
`
`
`Exhibit
`
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`
`Abbreviation
`
`2058
`
`Reserved
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
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`
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`
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`
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`
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`
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`
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`
`
`
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`
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`
`2065
`
`2066
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`
`
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`
`2071
`
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`
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`
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`
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`
`Excerpts from Novartis’ 2009-2015 Form
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`
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`
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`
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`
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`
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`
`
`
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`
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`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`Description
`
`Abbreviation
`
`Haliburton Energy Servs., Inc. v. Dynamic
`3D Geosolutions LLC, IPR2014-1186, Paper
`18 (P.T.A.B. Feb. 18, 2015)
`
`Apotex Inc. v. Merck Sharp & Dohme Corp.,
`IPR2015-00419, Paper 14 (P.T.A.B. June 25,
`2015)
`
`Pfizer Inc. v. Teva Pharms. USA, Inc., 555 F.
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`
`Mylan Pharms. Inc. v. AstraZeneca AB,
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`2015)
`
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`
`Pfizer Inc. v. Mylan Pharms. Inc., 71 F.
`Supp. 3d 458 (D. Del. 2014), aff’d, No.
`2015-1131, 2016 WL 147840 (Fed. Cir., Jan.
`13, 2016)
`
`AstraZeneca Pharms. LP v. Anchen Pharms.,
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`App’x 999 (Fed. Cir. 2013)
`
`11
`
`
`
`Exhibit
`
`Description
`
`Abbreviation
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`Lupin Ltd. v. Vertex Pharms. Inc., IPR2015-
`00405, Paper 13 (P.T.A.B. July 9, 2015)
`
`Neupak Inc. v. Ideal Mfg. & Sales Corp., 41
`Fed. App’x 435, 440 (Fed. Cir. 2002)
`
`Janssen Pharm. N.V. v. Mylan Pharms., Inc.,
`223 Fed. App’x 999 (Fed. Cir. 2007)
`affirming 456 F. Supp. 2d 644 (D.N.J. 2006)
`
`Pfizer Inc. v. Mylan Pharms. Inc., No. 2015-
`1131, 2016 WL 147840 (Fed. Cir., Jan. 13,
`2016) affirming 71 F. Supp. 3d 458 (D. Del.
`2014)
`
`Declaration in Support of Patent Owner
`Novartis’s Motion for Pro Hac Vice
`Admission of Christina Schwarz Under 37
`C.F.R. § 42.10
`
`12
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Exhibit List 2 was
`
`served on June 3, 2016 by causing it to be sent by email to counsel for Petitioner at
`
`the following email addresses:
`
`Daniel G. Brown (daniel.brown@lw.com)
`
`Robert Steinberg (bob.steinberg@lw.com)
`
`Dated: June 3, 2016
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 32,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`13
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