`
`
`
`Paper No. ____
`Filed: May 9, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ICOS CORPORATION,
`Patent Owner.
`
`_____________________________
`
`Case No. IPR2017-00323
`Patent No. 6,943,166
`
`_____________________________
`
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S
` UPDATED LIST OF EXHIBITS
`
`
`
`
`Exhibit
`No.
`
`1001
`
`LIST OF EXHIBITS
`
`Description
`
`Pullman, W. E.., et al., Compositions Comprising Phosphodiesterase
`[Inhibitors] for the Treatment of Sexual Dysfunction, U.S. Patent No.
`6,943,166 (filed on April 26, 2000; issued September 13, 2005)
`
`1002 Declaration of Dr. George Grass, Pharm.D., Ph.D.
`
`1003
`
`Curriculum vitae of Dr. George Grass
`
`1004 Declaration of Dr. Muta Issa, M.D.
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`Curriculum vitae of Dr. Muta Issa
`
`File History for U.S. Patent No. 6,943,166
`
`Daugan, A.C-M., Use of cGMP-Phosphodiesterase Inhibitors to Treat
`Impotence, Int'l Pub. No. WO 97/03675 (filed on July 11, 1996;
`published February 6, 1997)
`
`Center for Drug Evaluation and Research, Approval Package for
`VIAGRA, Approval Date March 27, 1998
`
`Dose-Response Information to Support Drug Registration, 59 FEDERAL
`REGISTER, (November 9, 1994) 55972-55976
`
`CIALIS® Approved Label, Reference ID: 3820620, Revised
`September 2015, downloaded from the Food and Drug Administration
`website
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021368s
`026lbl.pdf, last accessed November 1, 2016
`
`Eardley, I., New Oral Therapies for the Treatment of Erectile
`Dysfunction, 81 BR. J. UROL. (1998) 122-127.
`
`Laumann, E.O., et al., Sexual Dysfunction in the United States, 281
`JAMA, (1999) 537-544
`
`-1-
`
`
`
`
`
`1013
`
`1014
`
`1015
`
`Terrett, N.K., et al., Sildenafil (VIAGRATM), A Potent and Selective
`Inhibitor of Type 5 cGMP Phosphodiesterase with Utility for the
`Treatment of Male Erectile Dysfunction, 6 BIOORG. MED. CHEM. LETT.,
`(1996) 1819-1824
`
`VIAGRA® Approved Label, 69-5485-00-2, Revised November 1998,
`downloaded from the Food and Drug Administration website
`http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/viagrala
`bel2.pdf, last accessed November 1, 2016
`
`Boolell, M., et al., Sildenafil: an orally active type 5 cyclic GMP-
`specific phosphodiesterase inhibitor for the treatment of penile erectile
`dysfunction, 8 INT. J. IMPOT. RES., (1996) 47-52
`
`1016
`
`Licht, M.R., Sildenafil (Viagra) for treating male erectile dysfunction, 65
`65 CLEVE. CLIN. J. MED., (1998) 301-304
`
`1017
`
`1018
`
`Gingell, C. J. C., et al., A New Oral Treatment for Erectile Dysfunction:
`A Double-Blind, Placebo-Controlled, Once Daily Dose Response
`Study, 155 Suppl 5 J. UROL. (1996) Abstract No. 738
`
`Morales, A., et al., Clinical safety of oral sildenafil citrate (VIAGRATM)
`in the treatment of erectile dysfunction, 10 INT. J. IMPOT. RES., (1998)
`69-74
`
`1019
`
`Cheitlin, M.D., et al, Use of Sildenafil (Viagra) in Patients with
`Cardiovascular Disease, 33 J. AM. COLL. CARDIOL. (1999) 273-282
`
`1020
`
`Lilly and ICOS Establish a Joint Venture to Develop and Market PDE5
`Compounds to Treat Sexual Dysfunction Eli Lilly and Company PRESS
`RELEASE 1998 October 1
`
`1021
`
`Norman, P., IC-351 ICOS Corp, 1 CURR. OPIN. CPNS INVEST. DRUGS
`(1999) 268-271
`
`1022
`
`Reserved
`
`1023
`
`Nies, A.S., Principles of Therapeutics, GOODMAN AND GILMAN’S THE
`PHARMACOLOGICAL BASIS OF THERAPEUTICS (Gilman, A. G., et al.,
`eds., 8th Ed. 1990) 62-83
`
`
`
`
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`Oates, J. A. and Wilkinson, G. R., Principles of Drug Therapy,
`HARRISON’S PRINCIPLES OF INTERNAL MEDICINE (Isselbacher, K. J., et
`al., eds., 13th Ed. 1994)
`
`Bourne, H. R., and Roberts, J. M., Drug Receptors &
`Pharmacodynamics, BASIC & CLINICAL PHARMACOLOGY (Katzung, B.
`G. ed., 6th Ed. 1995) 9-32
`
`Halvorsen, J.G., and Metz, M.E., Sexual Dysfunction, Part I:
`Classification, Etiology, And Pathogenesis, 5 J. AM. BOARD FAM.
`PRACT., (1992) 51-61
`
`COLOR ATLAS OF PHARMACOLOGY, (Lüllmann, H., et al., eds., 1993)
`44-57
`
`Goldstein, I., et al., Oral Sildenafil in the Treatment of Erectile
`Dysfunction, 338 N. ENGL. J. MED., (1998) 1397-1404
`
`de Mey, C., Opportunities for the Treatment of Erectile Dysfunction by
`Modulation of the NO Axis-Alternatives to Sildenafil Citrate, 14 CURR.
`MED. RES. OPIN., (1998) 187-202
`
`1030
`
`Eli Lilly and Company et al v. Mylan Pharmaceuticals Inc., No. 1:16-
`cv-01122 (AJT-MSN)
`
`1031
`
`Drug Approval Package: Viagra (Sildenafil) NDA 020895, Date
`Created March 27, 1998, downloaded from the Food and Drug
`Administration website
`http://www.accessdata.fda.gov/drugsatfda_docs/NDA/98/viagra/viagra
`_toc.cfm, last accessed November 4, 2016
`
`1032 Approval Letter Viagra (Sildenafil) NDA 020895, March 27, 1998.
`
`1033
`
`Drug company’s shares rise on FDA approval of pill to treat
`impotence, CNNMoney.com, March 27, 1998, downloaded from
`http://money.cnn.com/1998/03/27/companies/impotence/, last accessed
`November 17, 2016
`
`1034
`
`Pfizer’s Eagerly Anticipated Impotence Drug Viagra Wins FDA
`Approval, Dow Jones Online News, March 27, 1998
`
`
`
`
`
`1035
`
`1036
`
`1037
`
`ICOS Announces Clinical Results and Initiation of Trials ICOS
`Corporation PRESS RELEASE 1998 September 17
`
`U.S. Provisional Patent Application No. 60/123,244, filed March 8,
`1999
`
`Transcript of April 27, 2017 Telephonic Hearing in IPR2017-00323
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Updated List of Exhibits and
`
`Exhibit 1037, on this 9th day of May, 2017, on the Patent Owner at the
`
`correspondence address of the Patent Owner as follows:
`
`Mark J. Feldstein
`Joshua L. Goldberg
`Yieyie Yang
`Maureen D. Queler
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Email: mark.feldstein@finnegan.com
`Email: joshua.goldberg@finnegan.com
`Email: yieyie.yang@finnegan.com
`Email: maureen.queler@finnegan.com
`
`Mark J. Stewart
`Dan L. Wood
`Gerald P. Keleher
`Eli Lilly and Company
`Lilly Corporate Center
`Indianapoliz, IN 46285
`Email: stewart_mark@lilly.com
`Email: wood_dan_l@lilly.com
`Email: keleher_gerald@lilly.com
`
`
`
`
`
`
`Dated: May 9, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`/ Steven W. Parmelee /
`Steven W. Parmelee,
`Reg. No. 31,990
`
`
`
`
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