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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`v.
`
`ICOS CORPORATION,
`Patent Owner
`
`U.S. Patent No. 6,943,166 B1
`Inter Partes Review No. IPR2017-01762
`
`JOINT MOTION TO TERMINATE
`UNDER 35 U.S.C. § 317(a)
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`I.
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`INTRODUCTION
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`Pursuant to 35 U.S.C. § 317(a), the Petitioner and Patent Owner jointly
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`request termination of this inter partes review, which is directed at U.S. Patent No.
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`6,943,166 and in which a decision has not yet been entered regarding institution.
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`II. TERMINATION IS APPROPRIATE
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`Termination of this review is appropriate because the parties have settled
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`their dispute and have reached an agreement to terminate this review. See EX1039
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`(Settlement Agreement (concurrently filed as business confidential information
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`pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c)). “Generally, the Board
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`expects that a proceeding will terminate after the filing of a settlement agreement.”
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`Oracle Corp. v. Cmty. United IP, LLC, CBM2013-00015, Paper 13 (July 25, 2013)
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`(citing Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48765-66 (Aug. 14,
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`2012)).
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`On August 21, 2017, the Parties informed the Board of the settlement
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`via e-mail and requested authorization to file a joint motion to terminate the
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`proceeding with respect to both the Patent Owner and the Petitioner. As set
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`forth in an e-mail dated August 25, 2017, the Board authorized the filing of
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`the requested joint motion to terminate this proceeding as to both parties.
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`Accordingly, Petitioner and Patent Owner jointly request termination of the
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`-1-
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`present proceeding.
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`Public policy favors
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`terminating
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`the present
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`inter partes review
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`proceeding. Congress and federal courts have expressed a strong interest in
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`encouraging settlement in litigation. See, e.g., Delta Air Lines. Inc. v. August,
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`450 U.S. 346, 352 (1981) (“The purpose of [Fed. R. Civ. P.] 68 is to encourage
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`the settlement of litigation.”) Bergh v. Dept. of Transp., 794 F.2d 1575, 1577
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`(Fed. Cir. 1986) (“The law favors settlement of cases.”), cert. denied, 479 U.S.
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`950 (1986). The Federal Circuit places a particularly strong emphasis on
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`settlement. See Cheyenne River Sioux Tribe v. U.S., 806 F.2d 1046, 1050 (Fed.
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`Cir. 1986) (noting that the law favors settlement to reduce antagonism and
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`hostility between parties). And, the Board’s Trial Practice Guide stresses that
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`“[t]here are strong public policy reasons to favor settlement between the parties
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`to a proceeding.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
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`46,768 (Aug. 14, 2012).
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`Ending this IPR early promotes the Congressional goal of establishing a
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`more efficient patent system by limiting unnecessary and counterproductive
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`costs. See Changes to Implement Inter Partes Review Proceedings, Post-Grant
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`Review Proceedings, and Transitional Program for Covered Business Method
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`-2-
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`Patents, 77 Fed. Reg. 48,680 (Aug. 14, 2012). Permitting termination as to all
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`parties provides certainty and fosters an environment that promotes settlements,
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`creating a timely, cost-effective alternative to litigation.
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`Under 35 U.S.C. § 317(a), “[a]n inter partes review instituted under this
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`chapter shall be terminated with respect to any petitioner upon the joint request
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`of the petitioner and the patent owner, unless the Office has decided the merits of
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`the proceeding before the request for termination is filed.” Termination of this
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`IPR is appropriate as the Board has not reached a decision on institution, thus it
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`has yet “decided the merits of the proceeding.” See, e.g., Office Patent Trial
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`Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14, 2012). Argentum filed its
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`petition for inter partes review on July 12, 2017. The parties have now settled
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`their dispute, and have reached agreement to terminate this inter partes review.
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`The USPTO can conserve its resources through terminating the proceedings
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`now, removing the need for the Board to further consider the arguments, to issue
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`an Institution Decision and to render a Final Decision. Furthermore, no other
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`party’s rights will be prejudiced by the termination of this proceeding.
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`The following matters regarding the ’166 patent remain pending before the
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`USPTO. The parties assert, however, that these matters will not be affected by
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`-3-
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`the settlement and termination of this proceeding.
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`•
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`IPR2017-00412
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`(Monosol Rx, LLC v.
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`ICOS Corporation).
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`Institution was denied on July 3, 2017. A request for rehearing was filed on July
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`21, 2017. Patent Owner filed an opposition to the request for rehearing on
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`August 9, 2017. Petitioner filed a reply to Patent Owner’s opposition on August
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`16, 2017.
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`•
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`IPR2017-017557 ( Dr. Reddy’s Laboratories,
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`Inc v.
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`ICOS
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`Corporation). A petition was filed on July 10, 2017. A motion for joinder to now
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`terminated IPR2017-00323 was also filed on July 10, 2017, Patent Owner filed
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`an opposition to the motion for joinder on August 10, 2017. On August 14, 2017,
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`the parties to this IPR requested authorization from the Board to file a joint
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`motion to terminate the proceedings.
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`III. SUBMISSION OF THE SETTLEMENT AGREEMENT
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`As required by 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(b), a true copy of
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`the parties’ written settlement agreement between the Petitioner and the Patent
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`Owner is being filed as an exhibit contemporaneously with this joint motion to
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`terminate. The settlement agreement has been filed for access by the “Parties and
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`Board Only.” The Parties request that the settlement agreement be treated as
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`business confidential and be kept separate from the file of the involved patent and
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`-4-
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`be made available only to Federal Government agencies on written request or to
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`any person only on a showing of good cause pursuant to 35 U.S.C. § 317(b) and 37
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`C.F.R. § 42.74(c). The Parties are filing, concurrently herewith, a Joint Request to
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`File the Settlement Agreements as Business Confidential Information.
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`IV. CONCLUSION
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`Therefore, Petitioner and the Patent Owner respectfully request termination
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`of this inter partes review of U.S. Patent No. 6,943,166.
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`Respectfully submitted,
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`Date: Aug. 28, 2017
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`
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`/Kevin B. Laurence/
`
`Kevin B. Laurence
`Lead Counsel for Petitioner
`Registration No. 38,219
`klaurence@lpiplaw.com
`
`Laurence & Phillips IP Law LLP
`1940 Duke St., Ste. 200
`Alexandria, Virginia 22314
`Telephone: 703-448-8787
`
`/Mark J. Feldstein/
`
`Mark J. Feldstein
`Lead Counsel for Patent Owner
`Registration No. 46,693
`mark.feldstein@finnegan.com
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Telephone: 202-408-4092
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`-5-
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`APPENDIX – LIST OF EXHIBITS
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`Exhibit
`No.
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`1001
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`Description
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`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)
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`1002 Declaration of Dr. George Grass, Pharm.D., Ph.D.
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`1003
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`Curriculum vitae of Dr. George Grass
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`1004 Declaration of Dr. Muta Issa, M.D.
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`Curriculum vitae of Dr. Muta Issa
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`File History for U.S. Patent No. 6,943,166
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`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
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`Dose-Response Information to Support Drug Registration, 59 FEDERAL
`REGISTER, (November 9, 1994) 55972-55976
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`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
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`Eardley, I., New Oral Therapies for the Treatment of Erectile
`Dysfunction, 81 BR. J. UROL. (1998) 122-127.
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`Laumann, E.O., et al., Sexual Dysfunction in the United States, 281
`JAMA, (1999) 537-544
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`-6-
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`1013
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`1014
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`1015
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`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
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`Licht, M.R., Sildenafil (Viagra) for treating male erectile dysfunction, 65
`65 CLEVE. CLIN. J. MED., (1998) 301-304
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`1017
`
`1018
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`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
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`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
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`1019
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`Cheitlin, M.D., et al, Use of Sildenafil (Viagra) in Patients with
`Cardiovascular Disease, 33 J. AM. COLL. CARDIOL. (1999) 273-282
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`1020
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`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
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`1021
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`Norman, P., IC-351 ICOS Corp, 1 CURR. OPIN. CPNS INVEST. DRUGS
`(1999) 268-271
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`1022
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`Reserved
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`1023
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`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
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`-7-
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
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`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
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`Halvorsen, J.G., and Metz, M.E., Sexual Dysfunction, Part I:
`Classification, Etiology, And Pathogenesis, 5 J. AM. BOARD FAM.
`PRACT., (1992) 51-61
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`COLOR ATLAS OF PHARMACOLOGY, (Lüllmann, H., et al., eds.,
`1993) 44-57
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`Goldstein, I., et al., Oral Sildenafil in the Treatment of Erectile
`Dysfunction, 338 N. ENGL. J. MED., (1998) 1397-1404
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`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
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`1030
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`Eli Lilly and Company et al v. Mylan Pharmaceuticals Inc., No. 1:16-
`cv-01122 (AJT-MSN)
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`1031
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`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
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`1032 Approval Letter Viagra (Sildenafil) NDA 020895, March 27, 1998.
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`1033
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`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
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`Pfizer’s Eagerly Anticipated Impotence Drug Viagra Wins FDA
`Approval, Dow Jones Online News, March 27, 1998
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`-8-
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`ICOS Announces Clinical Results and Initiation of Trials ICOS
`Corporation PRESS RELEASE 1998 September 17
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`U.S. Provisional Patent Application No. 60/123,244, filed March 8,
`1999
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`Declaration of Dr. Culley C. Carson III, M.D.
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`Declaration of Dr. Jackie Corbin, Ph.D.
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`Confidential Settlement Agreement
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`-9-
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`1035
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`1036
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`1037
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`1038
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`1039
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`Joint Motion to Terminate, IPR2017-01762
`U.S. Patent No. 6,943,166
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, the undersigned certifies that
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`on Aug. 26, 2017, a complete copy of the foregoing Joint Motion to Terminate
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`Inter Partes Review and Exhibit 1039 was served on patent owner’s counsel of
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`record via e-mail, as agreed to by counsel, as follows:
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`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
`Indianapolis, IN 46285
`Email: stewart_mark@lilly.com
`Email: wood_dan_l@lilly.com
`Email: keleher_gerald@lilly.com
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`Dated: August 26, 2017
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`Respectfully submitted,
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`/Kevin B. Laurence/
`Kevin B. Laurence, Lead Counsel for Petitioner
`Registration No. 38,219
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`-10-
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