Paper No. ___
`Filed: July 7, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
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`MYLAN PHARMACEUTICALS INC,
`Petitioner
`
`v.
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`ICOS CORPORATION,
`Patent Owner
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`
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`
`
`_____________________________
`
`Case IPR2017-00323
`Patent No. 6,943,166
`_____________________________
`
`
`JOINT MOTION TO TERMINATE PROCEEDING
`PURSUANT TO 35 U.S.C. § 317 AND 37 C.F.R. § 42.74
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`
`Filed: July 7, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`MYLAN PHARMACEUTICALS INC,
`Petitioner
`
`v.
`
`ICOS CORPORATION,
`Patent Owner
`
`
`
`
`
`_____________________________
`
`Case IPR2017-00323
`Patent No. 6,943,166
`_____________________________
`
`
`JOINT MOTION TO TERMINATE PROCEEDING
`PURSUANT TO 35 U.S.C. § 317 AND 37 C.F.R. § 42.74
`
`
`
`Patent No. 6,943,166
`Case No. IPR2017-00323
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`I. INTRODUCTION
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`Pursuant to 35 U.S.C. § 317(a), Petitioner Mylan Pharmaceuticals Inc.
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`(“Petitioner”) and Patent Owner ICOS Corporation (“Patent Owner”) (together,
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`“the Parties”) jointly request termination of the inter partes review of U.S. Patent
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`No. 6,943,166 (ʼ166 patent), Case No. IPR2017-00323 in light of the Parties’
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`resolution of their dispute relating to this IPR. In accordance with 37 C.F.R. §
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`42.20(b), the Parties sought, and received, authorization via email from the Board
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`to file this motion on July 6, 2017.
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`The Parties have settled their disputes regarding the ʼ166 patent. The
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`Parties’ settlement is memorialized in agreements (collectively referred to herein
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`as “Settlement Agreements”), true and correct copies of which are filed as Exhibit
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`1038, as required by 35 U.S.C. § 317(b).
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`II. TERMINATION IS APPROPRIATE
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`The Parties have reached agreement regarding their disputes relating to the
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`ʼ166 patent. Pursuant to Section III.A of the Binding Term Sheet, Patent Owner
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`and Petitioner jointly agreed to terminate this proceeding. (Ex. 1038 at 1.)
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`Accordingly, the parties jointly request that this proceeding be terminated under 35
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`U.S.C. § 317(a) and 37 C.F.R. § 42.74.
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`1
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`Patent No. 6,943,166
`Case No. IPR2017-00323
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`The litigation between the Parties related to this proceeding has also been
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`settled and the parties have agreed to stipulate to dismiss the related litigation. (Ex.
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`1038 at 5.)
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`The Parties are unaware of any other matter before the USPTO that would
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`be affected by the settlement and termination of this proceeding. Institution of
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`IPR2017-00412 (Monosol Rx, LLC v. ICOS Corporation), which also involved the
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`ʼ166 Patent, was denied on July 3, 2017 (Paper No. 11).
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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 of
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`the petitioner and the patent owner, unless the Office has decided the merits of the
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`proceeding before the request for termination is filed.” This proceeding has been
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`instituted but the Patent Owner has not yet filed a Patent Owner Response and the
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`Board has not decided on the merits of the proceeding.
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`Strong public policy considerations favor settlement between the parties to
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`an inter partes review proceeding. See Office Trial Practice Guide, Fed. Reg., Vol.
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`77, No. 157 at 48768 (Aug. 14, 2012). No public interest or other factors weigh
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`against termination of this proceeding.
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`Because the underlying disputes have been resolved between the parties and
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`because full termination would encourage settlement of Patent Office proceedings,
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`consistent with federal judicial preference and the management of limited judicial
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`2
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`Patent No. 6,943,166
`Case No. IPR2017-00323
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`and Patent Office resources, the Parties submit that termination of this proceeding
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`is appropriate.
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`III. SUBMISSION OF THE SETTLEMENT AGREEMENTS
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`Submitted concurrently with this Motion are the Settlement Agreements
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`between the Parties (EX1038), as required by 35 U.S.C. § 317(b) and 37 C.F.R. §
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`42.74(b). The Parties jointly request that these Settlement Agreements be treated
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`as business confidential and be kept separate from the file of the involved patent
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`and be made available only to Federal Government agencies on written request or
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`to any person only on a showing of good cause pursuant to 35 U.S.C. § 317(b) and
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`37 C.F.R. § 42.74(c). The Parties are filing, concurrently herewith, a Joint Request
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`to File the Settlement Agreements as Business Confidential Information.
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`IV. CONCLUSION
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`For the reasons stated above, the Parties respectfully request the Board
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`terminate this proceeding, Case No. IPR2017-00323.
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`3
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`Patent No. 6,943,166
`Case No. IPR2017-00323
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`Dated: July 7, 2017
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`Respectfully submitted,
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`
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`
`
`/ Steven W. Parmelee /
`Steven W. Parmelee
`Registration No. 31,990
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Tel.: 206-883-2542
`Email: sparmelee@wsgr.com
`
`Attorneys for Petitioner
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`/ Mark J. Feldstein /
`Mark J. Feldstein
`Registration No. 46,693
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Tel.: 202-408-4092
`Email: mark.feldstein@finnegan.com
`
`Attorneys for Patent Owner
`
`
`4
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`
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`Patent No. 6,943,166
`Case No. IPR2017-00323
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`Exhibit
`No.
`
`1001
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
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`1008
`
`1009
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`1010
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`1011
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`1012
`
`1013
`
`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)
`
`Declaration of Dr. George Grass, Pharm.D., Ph.D.
`
`Curriculum vitae of Dr. George Grass
`
`Declaration of Dr. Muta Issa, M.D.
`
`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
`
`5
`
`
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`Patent No. 6,943,166
`Case No. IPR2017-00323
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`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`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
`
`Licht, M.R., Sildenafil (Viagra) for treating male erectile
`dysfunction, 65 65 CLEVE. CLIN. J. MED., (1998) 301-304
`
`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
`
`Cheitlin, M.D., et al, Use of Sildenafil (Viagra) in Patients with
`Cardiovascular Disease, 33 J. AM. COLL. CARDIOL. (1999) 273-282
`
`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
`
`Norman, P., IC-351 ICOS Corp, 1 CURR. OPIN. CPNS INVEST. DRUGS
`(1999) 268-271
`
`Reserved
`
`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
`
`6
`
`
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`Patent No. 6,943,166
`Case No. IPR2017-00323
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`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`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
`
`Eli Lilly and Company et al v. Mylan Pharmaceuticals Inc., No.
`1:16-cv-01122 (AJT-MSN)
`
`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/via
`gra_toc.cfm, last accessed November 4, 2016
`
`Approval Letter Viagra (Sildenafil) NDA 020895, March 27, 1998.
`
`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
`
`1035
`
`Pfizer’s Eagerly Anticipated Impotence Drug Viagra Wins FDA
`Approval, Dow Jones Online News, March 27, 1998
`
`7
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`Patent No. 6,943,166
`Case No. IPR2017-00323
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`1036
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`1037
`
`1038
`
`ICOS Announces Clinical Results and Initiation of Trials ICOS
`Corporation PRESS RELEASE 1998 September 17
`
`Transcript of April 27, 2017 Telephonic Hearing in IPR2017-00323
`
`Confidential Settlement Agreements
`
`
`
`8
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`
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`Patent No. 6,943,166
`Case No. IPR2017-00323
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`CERTIFICATE OF SERVICE
`
`
`
`Pursuant to 37 C.F.R. § 42.6(e), this is to certify that I caused to be served a
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`true and correct copy of the foregoing Joint Motion to Terminate and Exhibit 1038,
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`by electronic service, on this 7th day of July 2017, on the Patent Owners at the
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`correspondence address of the Patent Owners 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
`Indianapolis, IN 46285
`Email: stewart_mark@lilly.com
`Email: wood_dan_l@lilly.com
`Email: keleher_gerald@lilly.com
`
`
`
`
`Dated: July 7, 2017
`
`
`
`Respectfully submitted,
`
`
`
`/ Steven W. Parmelee /
`Steven W. Parmelee, Lead Counsel
`Reg. No. 31,990
`
`
`
`
`9
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`
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