`
`Case: IPR2015-01836
`Patent No. 7,932,268
`
`Doc. No.
`Paper 1
`
`Paper 7
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`Ex. 1001
`Ex. 10011
`Ex. 1002
`Ex. 1003
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`Ex. 1006
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`Ex. 1013
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`Ex. 1014
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`Ex. 1015
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`Ex. 1018
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`Ex. 1031
`
`Nickname
`CFAD Pet.
`
`U.S. Provisional Patent Application No. 60/550,915
`
`Description
`Petition for Inter Partes Review of U.S. Patent No.
`8,618,135, dated August, 28, 2015.
`Institution of Inter Partes Review, IPR2015-01835,
`Institution
`dated March 7, 2016.
`Decision
`’268 Patent U.S. Patent No. 7,932,268
`’135 Patent U.S. Patent No. 8,618,135
`Zusman Dec. Declaration of Randall J. Zusman, M.D.
`Mayersohn
`Declaration of Michael Mayersohn, Ph.D.
`Dec.
`’915
`Provisional
`Pink Sheet
`2004
`
`“Bayer/PPD Implitapide Development Follows
`Zetia Model”, THE PINK SHEET, Vol. 66, No. 7, p. 17
`(2004)
`Evan Stein, “Microsomal Triglyceride Transfer
`Protein (MTP) Inhibitor (implitapide) program”,
`Presentation Given at PPD’s Analyst Day (February
`5, 2004)
`Chang, et al., “Microsomal triglyceride transfer
`protein (MTP) inhibitors: Discovery of clinically
`active inhibitors using high-throughput screening
`and parallel synthesis paradigms”, CURRENT
`OPINION IN DRUG DISCOVERY & DEV., Vol. 5, No. 4,
`pp. 562-570 (2002)
`Wetterau Wetterau, et. al, “An MTP Inhibitor That
`Normalizes Atherogenic Lipoprotien Levels in
`WHHL Rabbits,” SCIENCE, Vol. 282, pp. 751-754
`(1998)
`Shiomi & Ito, “MTP inhibitor decreases plasma
`cholesterol levels in LDL receptor-deficient WHHL
`
`Stein
`
`Chang
`
`Shiomi
`
`
`1 This exhibit appears in the docket for related case IPR2015-01835.
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`1
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`PENN EX. 2032
`CFAD v. PENN
`IPR2015-01836
`
`
`
`Doc. No.
`
`Nickname
`
`Ex. 2002
`
`Ex. 2007
`
`Lomitapide
`NDA
`Cutchel
`
`Ex. 2011
`
`Ex. 2020
`
`Pink Sheet
`2000
`Robl
`
`Ex. 2028
`
`n/a
`
`Ex. 2034
`
`Rowland
`
`Ex. 2035
`
`Huang
`
`Ex. 2036
`
`Lüllmann
`
`Ex. 2037
`
`Ploemen
`
`Ex. 2038
`
`Cavalli
`
`
`
`
`
`
`
`Description
`rabbits by lowering the VLDL secretion,” European
`Journal of Pharmacology, Vol. 431, pp. 127-131
`(2001)
`NDA No. 203858, Sponsor’s Background Package
`(October 17, 2012)
`Cuchel, et. al, “Efficacy and safety of a microsomal
`triglyceride transfer protein inhibitor in patients with
`homozygous familial hypercholesterolaemia: a
`single-arm, open-label, phase 3 study,” THE
`LANCET, Vol. 381, pp. 40-46 (2013)
`“MTP inhibitor research discontinued”, THE PINK
`SHEET (2000)
`Robl, et. al, “A Novel Series of Highly Potent
`Benzimidazole-Based Microsomal Triglyceride
`Transfer Protein Inhibitors,” JOURNAL OF
`MEDICINAL CHEMISTRY, Vol. 44, pp. 851-56 (2001)
`(Penn Ex. 2020, “Robl”)
`Curriculum Vitae for Thomas A. Baillie, Ph.D.,
`D.Sc.
`Rowland & Tozer, Clinical Pharmacokinetics:
`Concepts and Applications, William and Wilkins
`(1995)
`Huang & Lie, “Phosphodiesterase-5 (PDE5)
`Inhibitors in the Management of Erectile
`Dysfunction”, PHARMACY AND THERAPEUTICS, Vol.
`38, No. 7, pp. 407-419 (2013)
`Lüllmann, et. al, “Lipidosis Induced by
`Amphiphillic Cationic Drugs”, Biochemical
`Pharmacology, Vol. 27, pp. 1103-08 (1978)
`Ploemen, et. al, “Use of physiochemical calculation
`of pKa and CLogP to predict phospholipidosis-
`inducing potential: A case study with structurally
`related piperazines,” EXPERIMENTAL AND TOXIC
`PATHOLOGY, Vol. 55, pp. 347-55 (2004)
`Cavalli, et. al, “Toward a pharmacophore for drugs
`inducing the long QT syndrome: insights from a
`CoMFA study of HERG K(+) channel blockers,”
`2
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`PENN EX. 2032
`CFAD v. PENN
`IPR2015-01836
`
`
`
`Doc. No.
`
`Nickname
`
`Ex. 2039
`
`Walsh
`
`Ex. 2040
`
`Le Bigot
`
`Ex. 2041
`
`Aegerion
`Press Release
`
`Ex. 2042
`
`PPD 10-K
`
`Ex. 2054
`
`Adams
`
`Description
`JOURNAL OF MEDICINAL CHEMISTRY, Vol. 45, pp.
`3844-53 (2002) (Penn Ex. 2038, “Cavalli”)
`Walsh, et. al, “The Metabolic Activation of
`Abacavir by Human Liver Cytosol and Expressed
`Human Alcohol Dehydrogenase
`Isozymes," CHEMICO-BIOLOGICAL INTERACTIONS,
`Vol. 142, pp. 135-54 (2002)
`Le Bigot, et. al, “Metabolism of Ketotifen by
`Human Liver Microsomes,” DRUG METABOLISM
`AND DISPOSITION, Vol. 11, pp. 585-89 (1983)
`Aegerion Pharmaceuticals, Press Release: “FDA
`Advisory Committee Recommends Approval of
`Lomitapide for Treatment of Homozygous Familial
`Hypercholesterolemia (HoFH)” (October 17, 2012)
`Pharmaceutical Product Development, Inc., Annual
`Report for the Fiscal Year Ending December 31,
`2005, SEC Form 10-K (2006)
`Adams, et al., "Studies on the biotransformation of
`ketamine. I - Identification of metabolites produced
`in vitro from rat liver microsomal preparations,”
`BIOMEDICAL MASS SPECTROMETRY, Vol. 8, pp. 527-
`38 (1981)
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`PENN EX. 2032
`CFAD v. PENN
`IPR2015-01836
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