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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`DR. REDDY’S LABORATORIES, INC.
`Petitioner
`
`v.
`
`ICOS CORPORATION
`Patent Owner
`______________________
`
`IPR2017-01757
`Patent No. 6,943,166
`______________________
`
`
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`
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`JOINT MOTION TO TERMINATE PROCEEDING
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`
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`IPR2017-01757
`Patent No. 6,943,166
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`I. INTRODUCTION
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`Pursuant to 35 U.S.C. § 317(a), Petitioner Dr. Reddy’s Laboratories, Inc
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`(“DRL” or “Petitioner”) and Patent Owner ICOS Corporation’s ( collectively “the
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`Parties”) request termination of the inter partes review of U.S. Patent No. 6,943,166
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`(ʼ166 patent), Case No. IPR2017-01757, in light of the Parties’ resolution of their
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`dispute relating to this IPR. In accordance with 37 C.F.R. § 42.20(b), Petitioner
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`sought, and received, authorization via email from the Board to file this motion on
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`September 11, 2017.
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`The Parties have settled their disputes regarding the ʼ166 patent. The settlement
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`is memorialized in an agreement (referred to herein as “Settlement Agreement”), a
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`true and correct copy of which is filed as Exhibit 1037, as required by 35 U.S.C. §
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`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 ʼ166
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`patent. Pursuant to Section VIII.A of the Binding Term Sheet, the Parties agreed to
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`terminate this proceeding. (Ex. 1037 at 8.) Accordingly, the Parties request that the
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`this proceeding be terminated under 35 U.S.C. § 317(a) and 37 C.F.R. § 42.74 .
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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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`1037 at 8.)
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`1
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`IPR2017-01757
`Patent No. 6,943,166
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`The following matters regarding the ’166 patent remain pending before the
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`USPTO. Petitioner asserts, however, that these matters would not be affected by the
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`settlement and termination of this proceeding.
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` IPR2017-00412 (Monosol Rx, LLC v. ICOS Corporation). Institution was
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`denied on July 3, 2017. A request for rehearing was filed on July 21, 2017.
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`Patent Owner filed an opposition to the request for rehearing on August 9,
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`2017. Petitioner filed a reply to Patent Owner’s opposition on August 16, 2017.
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` IPR2017-01762 (Argentum Pharmaceuticals LLC v. ICOS Corporation). A
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`petition and motion for joinder was filed on July 12, 2017. Patent Owner filed
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`an opposition to the motion for joinder on August 14, 2017. The parties to that
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`IPR filed a joint motion to terminate on August 28, 2017. The motion is
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`currently pending before the Board.
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`Under 35 U.S.C. § 317(a), “[a]n inter partes review instituted under this chapter
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`shall be terminated with respect to any petitioner upon the joint request of the
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`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.” Patent Owner has not yet filed
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`a preliminary response, the proceeding has not been instituted, and the Board has not
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`decided on the merits of the proceeding.
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`Strong public policy considerations favor settlement between the parties to an
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`inter partes review proceeding. See Office Trial Practice Guide, Fed. Reg., Vol. 77,
`2
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`
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`IPR2017-01757
`Patent No. 6,943,166
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`No. 157 at 48768 (Aug. 14, 2012). No public interest or other factors weigh against
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`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 and
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`Patent Office resources, Petitioner submits that termination of this proceeding is
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`appropriate.
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`III. SUBMISSION OF THE SETTLEMENT AGREEMENT
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`Submitted concurrently with this Motion is the Settlement Agreement between
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`the Parties (Ex. 1037), as required by 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(b).
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`The Parties request that this Settlement Agreement be treated as business confidential
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`and be kept separate from the file of the involved patent and be made available only to
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`Federal Government agencies on written request or to any person only on a showing
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`of good cause pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c). The Parties
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`are filing, concurrently herewith, a Joint Request to File the Settlement Agreement as
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`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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`withdraw the Petition and Motion for Joinder and terminate this proceeding, Case No.
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`IPR2017-01757.
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`3
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`IPR2017-01757
`Patent No. 6,943,166
`
`Dated: September 13, 2017
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`Respectfully submitted,
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`/
`
`/ Louis H. Weinstein
`
`
`Louis H. Weinstein (Reg. 45,205) \
`Alan H. Pollack (Reg. No. 39,802)
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`
`Attorneys for Petitioner
`
`
`
`/ Maureen D. Queler/
`
`
`
`
`
`Mark J. Feldstein (Reg. No. 46,693)
`Maureen D. Queler (Reg. No. 61, 879)
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`
`Attorneys for Patent Owner
`
`4
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`
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`IPR2017-01757
`Patent No. 6,943,166
`
`
`
`Exhibit
`No.
`
`LIST OF EXHIBITS
`
`Description
`
`1001
`
`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. Fatemeh Akhlaghi, Pharm.D., Ph.D.
`Curriculum vitae of Dr. Fatemeh Akhlaghi
`1003
`1004 Declaration of Dr. Anthony Sliwinski, M.D.
`Curriculum vitae of Dr. Anthony Sliwinski
`1005
`
`
`
`
`
`
`
`
`
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`
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`
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`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/2015/021368s0
`26lbl.pdf, last accessed July 5, 2017
`
`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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`IPR2017-01757
`Patent No. 6,943,166
`
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`
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`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/viagralab
`el2.pdf, last accessed July 5, 2017
`
`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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`
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`IPR2017-01757
`Patent No. 6,943,166
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`1024
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`1025
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`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
`
`Complaint - Eli Lilly and Company et al v. Dr. Reddy’s Laboratories,
`Inc. et al., No. 2:17- cv-02541-KM-MAH
`
`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_to
`c.cfm, last accessed July 5, 2017
`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
`July 5, 2017
`
`1034
`
`Pfizer’s Eagerly Anticipated Impotence Drug Viagra Wins FDA
`Approval, Dow Jones Online News, March 27, 1998
`
`7
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`IPR2017-01757
`Patent No. 6,943,166
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`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
`
`Confidential Settlement Agreement
`
`
`
`
`
`1035
`
`1036
`
`
`1037
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`
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`
`
`8
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`IPR2017-01757
`Patent No. 6,943,166
`
`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 1037, by
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`electronic service, on September 13, 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: September 13, 2017
`
`
`1147476
`
`Respectfully submitted,
`
`
`
`/ Louis H. Weinstein
` Louis H. Weinstein
`
` /
`
`
`
`
`
`
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