IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`Mylan Pharmaceuticals Inc., Petitioner
`
`v.
`
`Nissan Chemical Industries Ltd.
`Patent Owner
`
`U.S. Patent No. 5,856,336 to Fujikawa et al.
`Issue Date: January 5, 1999
`Title: Quinoline Type Mevalonolactones
`
`_____________________
`
`Inter Partes Review No.: IPR2015-01069
`
`Petitioners Exhibit List
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`Mylan Pharmaceuticals Inc., Petitioner
`
`v.
`
`Nissan Chemical Industries Ltd.
`Patent Owner
`
`U.S. Patent No. 5,856,336 to Fujikawa et al.
`Issue Date: January 5, 1999
`Title: Quinoline Type Mevalonolactones
`
`_____________________
`
`Inter Partes Review No.: IPR2015-01069
`
`Petitioners Exhibit List
`
`
`
`Exhibit
`#
`
`Petitioner’s Exhibit List
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`U.S. Patent No. 5,856,336 (“the ’336 patent”)
`
`U.S. Patent No. 5,872,130
`
`U.S. Application Ser. No. 233,752
`
`Japanese Patent Application No. JP 62-207224 with English
`translation provided by the ’336 patentee from U.S. Application Ser.
`07/233,752,
`related family member of
`the ’336 patent, with
`accompanying sworn declaration provided by the patentee to the
`USPTO attesting to the accuracy of the translation.
`
`JP 63-15585 with English
`Japanese Patent Application No.
`translation provided by the ’336 patentee from U.S. Application Ser.
`07/233,752,
`related family member of
`the ’336 patent, with
`accompanying sworn declaration provided by the patentee to the
`USPTO attesting to the accuracy of the translation.
`
`Japanese Patent Application No. JP 63-193606 with English
`translation provided by the ’336 patentee from U.S. Application Ser.
`07/233,752,
`related family member of
`the ’336 patent, with
`accompanying sworn declaration provided by the patentee to the
`USPTO attesting to the accuracy of the translation.
`
`Curriculum Vitae of Roger Frank Newton, Ph.D.
`
`Declaration of Roger Frank Newton, Ph.D.
`
`Faizulla G. Kathawala, et al., XU 62-320, An HMG-CoA Reductase
`Inhibitor, More Potent Than Compactin, Abstract for American
`Chemical Society library stamp July 29, 1987
`
`1010
`
`U.S. Patent No. 4,739,073
`
`Alston & Bird LLP
`
`
`
`Exhibit
`#
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`Description
`
`R. G. Engstrom et al., Hypolipoproteinemic Effects of a Potent
`HMG-CoA Reductase Inhibitor, IX International Symposium on
`Drugs Affecting Lipid Metabolism, Florence (Italy), Oct. 22-25,
`1986
`
`Jonathan A. Tobert, New Developments in Lipid-Lowering Therapy:
`The Role of
`Inhibitors of Hydroxymethylglutaryl-Coenzyme A
`Reductase, 76 CIRCULATION 534 (1987)
`
`Ta-Jyh Lee, Synthesis, SARs and Therapeutic Potential of HMG-
`CoA Reductase Inhibitors, 8 TRENDS PHARMACOL. SCI. 442 (1987)
`
`Akira Endo et al., ML-236A, ML-236B, and ML-236C, New
`Inhibitors of Cholesterogenesis Produced by Penicillium Citrinium,
`29 J. ANTIBIOTICS 1346 (1976)
`
`Declaration of David Gortler, Pharm.D.
`
`U.S. Patent No. 4,647,576
`
`Approved Drug Products with Therapeutic Equivalence Evaluations
`(“Orange Book”), FOOD AND DRUG ADMINISTRATION,
`available
`at
`listing
`for
`active
`ingredient
`“lovastatin,”
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?A
`ppl_No=019643&TABLE1= OB_Disc (last visited April 13, 2015)
`
`U.S. Patent No. 4,613,610
`
`U.S. Patent No. 4,681,893
`
`U.S. Patent No. 4,751,235
`
`U.S. Patent No. 4,761,419
`
`Alfred W. Alberts, Mevinolin: A Highly Potent Competitive
`Inhibitor of Hydroxymethylglutaryl-Coenzyme a Reductase and a
`Cholesterol-Lowering Agent, 77 PROC. NAT’L. ACAD. SCI. U.S.A.
`3957 (1980)
`
`Alston & Bird LLP
`
`2
`
`
`
`Exhibit
`#
`
`Description
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`J.B. Taylor & P.D. Kennewell, Introductory Medicinal Chemistry
`94 (1981)
`
`Corwin Hansch et al., “Aromatic” Substituent Constants for
`Structure-Activity Correlations, 16 J. MED. CHEM. 1207 (1973)
`(“Hansch II”)
`
`European Patent No. 0114027
`
`U.S. Patent No. 4,537,859
`
`Stephen M. Berge, Pharmaceutical Salts, 66 J. PHARM. SCI. 1
`(1977)
`
`Philip L. Gould, Salt Selection for Basic Drugs, 33 INT. J. PHARM.
`201 (1986)
`
`John T. Suh et al., Angiotensin-Converting Enzyme Inhibitors New
`Orally
`Active
`Antihypertensive
`(Mercaptoalkanoyl)-
`and
`[(Acylthio)alkanoyl]glycine Derivatives, 28 J. MED. CHEM. 57
`(1985)
`
`Michael S. Brown, M.D. et al., Lowering Plasma Cholesterol by
`Raising LDL Receptors, 305 NEW ENG. J. MED. 515 (1981)
`
`Fujikawa Reply to the Opposition to Fujikawa et al.’s Motion to
`Add Counts 3 and 4, received July 21, 1992. U.S. Interference No.
`102,608 (“Paper No. 32”)
`
`Declaration of Masaki Kitahara, submitted in the ’336 patent, dated
`May 25, 1992
`
`O. E. Schultz et al., Schätzung des Verteilungfkoeffizienten mit Hilfe
`Quantenchemischer Molekülgroen,
`25
`ZEITSCHRIFT
`FÜR
`NATURFORSCHUNG B 1024 (1970), certified English translation
`included
`
`Alston & Bird LLP
`
`3
`
`
`
`Exhibit
`#
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`Description
`
`Corwin Hansch et al., The Effect of Intramolecular Hydrophobic
`Bonding on Partition Coefficients, 32 J. ORG. CHEM. 2583 (1967)
`(“Hansch I”)
`
`European Patent Publication 179,559
`
`I. T. Scoular et al., Human Studies on the Bioavailability of a
`Quaternary Ammonium Compound, Tiemonium Iodide
`and
`Tiemonium Methosulphate, 4 CURR. MED. RES. OPIN. 732 (1977)
`
`Curriculum Vitae of David Gortler, Pharm.D.
`
`David J. Shapiro & Victor W. Rodwell, Regulation of Hepatic 3-
`Hydroxy-3-Methylglutaryl Coenzyme A Reductase and Cholesterol
`Synthesis, 246 J. BIOL. CHEM. 3210 (1971)
`
`Yoshio Tsujita et al., CS-514, A Competitive Inhibitor of 3-Hydroxy-
`3-Methylglutaryl Coenzyme
`A
`Reductase:
`Tissue-Selective
`Inhibition of Sterol Synthesis and Hypolipidemic Effect on Various
`Animal Species, 877 BIOCHIMICA ET BIOPHYSICA ACTA 50 (1986)
`
`G.E. Stokker et al., 3-Hydroxy-3-Methylglutaryl-Coenzyme A
`Reductase Inhibitors. 1. Structural Modification of 5-Substituted
`3,5-Dihydroxypentanoic Acids and Their Lactone Derivatives, 28 J.
`MED. CHEM. 347 (1985) (“Stokker I”)
`
`G.E. Stokker et al., 3-Hydroxy-3-Methylglutaryl-Coenzyme A
`Reductase Inhibitors 3. 7-(3,5-Disubstituted [1,1’-biphenyl]-2-yl)-
`3,5-Dihydroxy-6-Heptenoic Acids and Their Lactone Derivatives,
`29 J. MED. CHEM. 170, 175 (1986) (“Stokker II”)
`
`Final Hearing, November 22, 1994. U.S. Interference No. 102,608
`(“Paper No. 122”)
`
`Alston & Bird LLP
`
`4
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