UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`INTELGENX CORP.
`Petitioner
`
`v.
`
`ICOS CORP.
`Patent Owner
`
`_____________________
`
`Case IPR: Unassigned
`
`U.S. Patent No. 6,943,166 B2
`_____________________
`
`
`
`INTELGENX CORP’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
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`INTELGENX CORP.
`Petitioner
`
`v.
`
`ICOS CORP.
`Patent Owner
`
`_____________________
`
`Case IPR: Unassigned
`
`U.S. Patent No. 6,943,166 B2
`_____________________
`
`
`
`INTELGENX CORP’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
`
`
`
`IntelGenX Corp’s Exhibit List for
`Inter Partes Review of U.S. Patent No. 6,943,166
`
`
`IntelGenX
`Exhibit #
`
`Description
`
`Pullman, W.E., et al., "Compositions Comprising Phosphodiesterase
`[Inhibitors] for the Treatment of Sexual Disfunction," U.S. Patent
`No. 6,943,166 (filed on April 26, 2000; issued September 13, 2005)
`
`Daugan, A.C-M.,, "Use of cGMP-Phosphodiesterase Inhibitors to
`Treat Impotence," Int'l Pub. No. WO 97/03675 (filed July 11, 1996;
`published February 6, 1997)
`
`"Center for Drug Evaluation and Research," Approval Package for
`VIAGRA, Approval Date March 27, 1998 ("SNDA")
`
`"Center for Drug Evaluation and Research," Approval Package for
`VIAGRA, Approval Date March 27, 1998, pp. i-xxx, 99-103, 183-
`188 ("SNDA Condensed")
`
`Declaration of Wayne J.G. Hellstrom, M.D., FACS
`
`Dr. Wayne J.G. Hellstrom's Curriculum Vitae
`
`Declaration of Douglas Reid Patterson, D.V.M, PH.D
`
`Dr. Douglas Reid Patterson's Curriculum Vitae
`
`Boolell, M., et al., "Sildenafil: an orally active type 5 cyclic GMP-
`specific phosphodiesterase inhibitor for the treatment of penile
`erectile dysfunction," Int'l J. Impot. Res., 8:47-52 (1996)
`
`Rosen, R.C., et al., "The International Index of Erectile Function
`(IIEF): A Multidimensional Scale for Assessment of Erectile
`Dysfunction," Urology, 49:822-830 (1997)
`
`Laumann, E.O., et al., "Sexual Dysfunction in the United States,"
`JAMA, 281:537-544 (1999)
`
`Halvorsen, J.G., and Metz, M.E., "Sexual Dysfunction, Part I:
`Classification, Etiology, And Pathogenesis," JABFP, 5:51-61 (1992)
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`
`
`- 1 -
`
`
`
`IntelGenX Corp’s Exhibit List for
`Inter Partes Review of U.S. Patent No. 6,943,166
`
`IntelGenX
`Exhibit #
`
`Description
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`Goldstein, I., et al., "Oral Sildenafil in the Treatment of Erectile
`Dysfunction," N. Engl. J. Med., 338:1397-1404 (1998)
`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," Bioorg. Med.
`Chem. Lett., 6:1819-1824 (1996)
`
`Daugan, A.C-M.,, "Tetracyclic Derivatives, Process of Preparation
`and Use," Int'l Pub. No. WO 95/19978 (filed Jan. 19, 1995;
`published July 27, 1995)
`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/viagralabel2.pdf,
`last accessed February 18, 2016
`
`Licht, M.R., "Sildenafil (Viagra) for treating male erectile
`dysfunction," Curr. Drug Ther., 65:301-304 (1998)
`
`Gingell, C.J.C., et al., "A New Oral Treatment for Erectile
`Dysfunction: A Double-Blind, Placebo-Controlled, Once Daily
`Dose Response Study," J. Urology, 155(Suppl 5):495A, Abstract
`No. 738 (1996)
`
`de Mey, C., "Opportunities for the Treatment of Erectile
`Dysfunction by Modulation of the NO Axis-Alternatives to
`Sildenafil Citrate," Curr. Med. Res. Opin., 14:187-202 (1998)
`
`"Lilly/ICOS Joint Venture's PDE5 to Treat Sexual Dysfunction,"
`Worldwide Biotech, 11(10), pp. 1-2, November 1998
`
`Michaels, P., "Biotech's Drug Pipeline Ready To Rupture," The
`New America, Investor's Business Daily, p. A7, April 23, 1999
`
`- 2 -
`
`
`
`
`
`
`
`IntelGenX Corp’s Exhibit List for
`Inter Partes Review of U.S. Patent No. 6,943,166
`
`IntelGenX
`Exhibit #
`
`Description
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`Edelhart, C., "Lilly venture to create impotency pill, Firm will team
`up with drugmaker in Seattle to create drug to rival Viagra.," The
`Indianapolis Star, pp. D1-D2, October 2, 1998
`
`COLOR ATLAS OF PHARMACOLOGY, pp. 44-57 (Lüllmann, H., et al.,
`eds., 1993)
`File History for U.S. Patent No. 6,943,166
`
`Viagra Approval Letter, Department of Health & Human Services,
`NDA 20-895, March 27, 1998
`
`Sybertz, E., and Czarniecki, M., "Inhibitors of PDE1 and PDE5
`cGMP phosphodiesterases: patents and therapeutic potential,"
`Expert Opin. Ther. Pat., 7:631-639 (1997)
`
`File History for U.S. Patent No. 7,182,958
`
`Padma-Nathan, H., "Efficacy and Tolerability of Tadalafil, a Novel
`Phosphodiesterase 5 Inhibitor, in Treatment of Erectile
`Dysfunction," Am. J. Cardiol., 92:19M-25M (2003)
`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 February 18, 2016
`
`Nies, A.S., "Principles of Therapeutics" in GOODMAN AND GILMAN'S
`THE PHARMACOLOGICAL BASIS OF THERAPEUTICS, Ch. 4, pp. 62-83
`(Gilman, A.G., et al., eds., 8th Ed. 1990)
`
`Babb, J., et al., "Cancer Phase I Clinical Trials: Efficient Dose
`Escalation with Overdose Control," Statist. Med., 17:1103-1120
`(1998)
`
`- 3 -
`
`
`
`
`
`
`
`IntelGenX Corp’s Exhibit List for
`Inter Partes Review of U.S. Patent No. 6,943,166
`
`IntelGenX
`Exhibit #
`
`Description
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`Oates, J.A. and Wilkinson, G.R., "Principles of Drug Therapy," in
`HARRISON'S PRINCIPLES OF INTERNAL MEDICINE, Ch. 66, pp. 393-
`412 (Isselbacher, K.J., et al.,Eds., 13th Ed. 1994)
`
`THE MERCK MANUAL OF MEDICAL INFORMATION, Ch. 5, pp. 23-27
`(Berkow, R., et al., Eds., Home Edition 1997)
`Bourne, H.R.
`and Roberts,
`J.M.,
`"Drug Receptors &
`Pharmacodynamics," in BASIC & CLINICAL PHARMACOLOGY, Ch. 2,
`pp. 9-32 (Katzung, B.G., ed., 6th Ed. 1995)
`
`of
`impact
`"The
`and Workman, P.,
`Graham, M.A.,
`pharmacokinetically guided dose escalation strategies in phase I
`clinical trials: Critical evaluation and recommendations for future
`studies," Ann. Oncol., 3:339-347 (1992)
`
`Piantadosi, S., and Liu, G., "Improved Designs for Dose Escalation
`Studies Using Pharmacokinetic Measurements," Stat. Med.,
`15:1605-1618 (1996)
`
`Rinaldi, D.A., et al., "Initial Phase I Evaluation of the Novel
`Thymidylate Synthase Inhibitor, LY231514, Using the Modified
`Continual Reassessment Method for Dose Escalation," J. Clin.
`Oncol., 13:2842-2850 (1995)
`
`"What's hot Impotency drugs," Discount Store News, p. 35, June 22,
`1998
`
`Cialis Approval Letter- Department of Health & Human Services,
`NDA 21-368, November 21, 2003, downloaded from the Food and
`Drug Administration website
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/2136
`8ltr.pdf, last accessed February 18, 2016
`
`- 4 -
`
`
`
`
`
`
`
`IntelGenX Corp’s Exhibit List for
`Inter Partes Review of U.S. Patent No. 6,943,166
`
`IntelGenX
`Exhibit #
`
`Description
`
`"Guideline for Industry Dose-Response Information to Support
`Drug Registration," ICH-E4, November 1994, downloaded from the
`Food and Drug Administration website
`http://www.fda.gov/downloads/drugs/guidancecomplianceregulator
`yinformation/guidances/ucm073115.pdf, last accessed February 18,
`2016
`
`Morales, A., et al., "Clinical safety of oral sildenafil citrate
`(VIAGRATM) in the treatment of erectile dysfunction," Int'l J.
`Impot. Res., 10:69-74 (1998)
`
`Zippe, C.D., et al., "Treatment of Erectile Dysfunction After
`Radical Prostatectomy with Sildenafil Citrate (Viagra)," Urology,
`52:963-966 (1998)
`
`Svejgaard, E., "Double-Blind Trial of Miconazole in
`Dermatomycosis," Acta Dermatovener, 53:497-500 (1973)
`
`1040
`
`1041
`
`1042
`
`1043
`
`Respectfully Submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
` f
`
`
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
`Attorney for Petitioner
`
`
`
`
`
`
`
`
`
`
`
`Date: February 26, 2016
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202)371-2600
`
`
`
`- 5 -
`
`
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`The undersigned hereby certifies that the above-captioned “IntelGenX
`
`
`
`Corp's Exhibit List” and Exhibits 1001 - 1043, were served in their entirety on
`
`February 26, 2016, upon the following party via FEDEX®:
`
`MARSHALL, GERSTEIN & BORUN LLP
`233 South Wacker Drive
`6300 Willis Tower
`Chicago IL 60606-6357
`
`Patent owner’s correspondence address of
`record for U.S. Patent No. 6,943,166
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
` f
`
`
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
`Attorney for Petitioner
`
`
`
`
`
`Date: February 26, 2016
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202)371-2600
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