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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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`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., and AKORN INC.,
`Petitioners
`
`v.
`
`SAINT REGIS MOHAWK TRIBE.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`_____________
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`ALLERGAN INC.’S MOTION TO WITHDRAW
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` 1
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` Cases IPR2017-00578 and IPR2017-00596 have been joined with this proceeding.
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`
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
`
`EXHIBIT LIST
`
`EX. 2002
`EX. 2003
`
`EX. 2004
`EX. 2005
`EX. 2006
`EX. 2007
`EX. 2008
`EX. 2009
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`EX. 2010
`EX. 2011
`
`Exhibit No. Description
`EX. 2001
`NDA 21-023 Cyclosporine Ophthalmic Emulsion 0.05%, Original
`NDA Filing, Vol. 1 (Feb. 24, 1999)
`U.S. Pat. No. 4,839,342
`Said et al., Investigative Ophthalmology & Visual Science, vol. 48,
`No. 11 (Nov. 2007):5000-5006
`Alba et al., Folia Ophthalmol. Jpn. 40:902-908 (1989)
`Stedman’s Medical Dictionary, definition of therapeutic
`Dorland’s Illustrated Medical Dictionary, definition of therapeutic
`Stedman’s Medical Dictionary, definition of palliative
`RESTASIS® label
`Murphy, R., “The Once and Future Treatment of Dry Eye,” Review
`of Optometry, pp. 73-75 (Feb. 15, 2000)
`RESERVED
`Agarwal, Priyanka and Ilva D. Rupenthal, “Modern Approaches to
`the Ocular Delivery of Cyclosporine A,” Drug Discovery Today, vol.
`21, no. 6 (June 2016)
`Damato et al., “Senile Atrophy of the Human Lacrimal Gland: The
`Contribution of Chronic Inflammatory Disease,” British Journal of
`Ophthalmology (1984)
`Higuchi, “Physical Chemical Analysis of Percutaneous Absorption
`Process From Creams and Ointments,” Seminar, New York City
`(1959)
`Lallemand et al., “Cyclosporine a Delivery to the Eye: A
`Pharmaceutical Challenge,” European Journal of Pharmaceutics and
`Biopharmaceutics (2003)
`
`EX. 2012
`
`EX. 2013
`
`EX. 2014
`
`i
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`das Neves et al., “ Mucosal Delivery of Biopharmaceuticals: Biology,
`Challenges and Strategies,” Springer Science (2014)
`Power et al., “Effect of Topical Cyclosporin A on Conjunctival T
`Cells in Patients with Secondary Sjögren’s Syndrome,” Cornea 12(6):
`507-511 (1993)
`Schaefer et al., “Skin Permeability,” Springer-Verlag (1982)
`Stern et al., “The Pathology of Dry Eye: The Interaction Between the
`Ocular Surface and Lacrimal Glands,” Cornea 17(6): 584-589 (1998)
`Wepierre, Jacques and Jean-Paul Marty, “Percutaneous Absorption of
`Drugs,” Elsvier/North-Holland Biomedical Press (1970)
`Williamson et al., “Histology f the Lacrimal Gland in
`Keratoconjunctivitis Sicca,” Brit. F. Ophthal /91973)
`“Approved Drug Products with Therapeutic Equivalence
`Evaluations,” U.S. Department of Health and Huma Services, 37th
`Edition (2017)
`Lemp, Michael A., “ Report of the National Eye Institute/Industry
`Workshop on Clinical Trials in Dry Eyes,” CLAO Journal, vol. 21,
`no. 4 (October 1995)
`Deposition transcript of Mansoor Amiji, Ph.D
`Declaration of John D. Sheppard, M.D., M.M.Sc.
`Declaration of Dr. Thorsteinn Loftsson, Ph.D.
`Declaration of Eric Rubinson
`Allergan PK-98-074 Report
`Declaration of Robert S. Maness, Ph.D.
`DiMasi, “Risks in New Drug Development: Approval Success Rates
`for Investigational Drugs,” Clinical Pharmacology and Therapeutics,
`May 2001
`FDA Review, “The Drug Development and Approval Process”
`
`ii
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`
`
`EX. 2015
`
`EX. 2016
`
`EX. 2017
`EX. 2018
`
`EX. 2019
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`EX. 2020
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`EX. 2021
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`EX. 2022
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`EX. 2023
`EX. 2024
`EX. 2025
`EX. 2026
`EX. 2027
`EX. 2028
`EX. 2029
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`EX. 2030
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`
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`Allergan – NYSE: AGN – Company Profile
`Drugs@FDA: FDA Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=021023
`Drugs@FDA: FDA Approved Drug Products, Restasis Approved,
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-
`023_Restasis_Approv.PDF
`Drugs@FDA: FDA Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=050790
`Facts About Dry Eye, https://nei.nih.gov/health/dryeye/dryeye
`Christopher Glenn, “New Thinking Spurs New Products,” Review of
`Ophthalmology, February 15, 2003
`Mark B. Abelson, MD and Jason Casavant, “Give Dry Eye a One-
`two Punch,” Review of Ophthalmology, March 15, 2003
`Deposition of David LeCause, February 17, 2017
`Joan-Marie Stiglich ELS, “Restasis: the road to approval,” Ocular
`Surgery News, March 1, 2003
`Lynda Charters, “Increased Tear Production,” Ophthalmology Times,
`February 1, 2003
`RESERVED
`Jonathan R. Pirnazar, MD, “Taking a Custom Approach to Dry Eye
`Treatment,” Ophthalmology Management, February 1, 2004
`RESERVED
`FDA label for Xiidra®
`RESERVED
`Restasis Strategic Plan Forecast 2009-2013
`
`iii
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`
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`EX. 2031
`EX. 2032
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`EX. 2033
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`EX. 2034
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`EX. 2035
`EX. 2036
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`EX. 2037
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`EX. 2038
`EX. 2039
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`EX. 2040
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`EX. 2041
`EX. 2042
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`EX. 2043
`EX. 2044
`EX. 2045
`EX. 2046
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`Allergan Inc., Credit Suisse First Boston Equity Research Report, Jan
`30, 2003
`Allergan Inc., Buckingham Research Group Equity Research Report,
`Feb 5, 2003
`Allergan Inc., SalomonSmithBarney Equity Research Report, Feb 12,
`2003
`Allergan Inc., Morgan Stanley Equity Research Report, Jan 30, 2003
`Restasis P&L (US Only excl. Canada and Puerto Rico)
`Allergan Inc., Morgan Stanley Equity Research Report, Apr 30, 2004
`Allergan Inc., JP Morgan Equity Research Report, Nov 1, 2005
`RESERVED
`“commercial Restasis Formulary June 2006.xls”
`“NOVEMBER 2006 input MHC Report Restasis Playbook data.ppt”
`Restasis® 2013 Managed Markets Tactics & Preliminary Budget,
`August 8, 2012
`RESERVED
`RESERVED
`“Allergan Inc. (AGN) - Q4 2002 Financial Release Conference Call
`Wednesday, January 29, 2003 11:00 am” Fair Disclosure Financial
`Network
`Restasis Launch Marketing Plan, dated February 12-13, 2003
`Allergan Dry Eye, “Dry Eye Franchise 2014 Business Plan,” 2014
`U.S. Eye Care Sales & Marketing Plan, September 9, 2013
`Allergan Eye Care, “US Dry Eye Strat Plan Narrative: Summary
`Version,” April 16, 2011
`Kline, Kate, “Restasis Professional Critical Issues,” Allergan Dry
`Eye, 2010
`
`iv
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`
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`EX. 2047
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`EX. 2048
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`EX. 2049
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`EX. 2050
`EX. 2051
`EX. 2052
`EX. 2053
`EX. 2054
`EX. 2055
`EX. 2056
`EX. 2057
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`EX. 2058
`EX. 2059
`EX. 2060
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`EX. 2061
`EX. 2062
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`EX. 2063
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`EX. 2064
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`Allergan Dry Eye, “Restasis Business Update,” August 16, 2010
`“Sales-Units_2011-2016_AllData_NSP_Feb-19-
`2017_RESTASIS.xlsx”
`RESERVED
`Iazuka and Jin, “The Effect of Prescription Drug Advertising on
`Doctor Visits,” Journal of Economics and Management Strategy,
`2007
`Bradford, Kleit, Nietert, et al, “How Direct-to-Consumer Television
`Advertising for Osteoarthritis Drugs Affect Physicians’ Prescribing
`Behavior,” Health Affairs, 2006
`Calfee, Winston, and Stempski, “Direct-to-Consumer Advertising
`and the Demand for Cholesterol Reducing Drugs,” Journal of Law
`and Economics, 2002
`Bradford, Kleit, Nietert, et al, “Effects of Direct-to-Consumer
`Advertising of Hydroxymethylglutaryl Coenzyme A Reductase
`Inhibitors or Attainment of LDL-C Goals,” Clinical Therapeutics,
`2006
`Restasis NPA Monthly
`Restasis Projects, Global R&D Cost
`Refresh Endura Lubricant Eye Drops (Allergan), Theodora
`Declaration of Jonathan Singer in support of Petitioner’s Motion for
`Pro Hac Vice Admission
`Memorandum Opinion and Order, Allergan, Inc. v. Teva
`Pharmaceuticals USA, Inc., et al., Case No. 2:15-cv-1455-WCB
`Nussenblatt, R. et al. Local Cyclosporine Therapy for Experimental
`Autoimmune Uveitis in Rats. Arch Ophthalmology, Volume 103,
`October 1985.
`Medical Officer’s Review of NDA 21-023
`
`v
`
`
`
`EX. 2065
`EX. 2066
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`EX. 2067
`EX. 2068
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`EX. 2069
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`EX. 2070
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`EX. 2071
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`EX. 2072
`EX. 2073
`EX. 2074
`EX. 2075
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`EX. 2076
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`EX. 2077
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`EX. 2078
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`Correction to Sall article (Ex. 1007), Opthalmology, Vol. 107, No. 7,
`July 2000.
`GraphPad Calculation of Bloch Table 2 – 3 mo. B vs A.
`GraphPad Calculation of Bloch Table 2 – 3 mo. C vs A.
`Deposition transcript of Andrew F. Calman, M.D., Ph.D.
`Deposition transcript of Daniel A. Bloch, Ph.D.
`Deposition transcript of Ivan T. Hofmann
`Assignment
`Patent Assignment Agreement
`REDACTED Exhibit 2087 Patent License Agreement
`Declaration of Christopher Evans in support of Motion for pro hac
`vice Admission
`Declaration of Michael Shore in support of Motion for pro hac vice
`Admission
`09/11/17 Transcript of Telephone Hearing before PTAB
`Federal Register, Vol. 82, No. 10, January 17, 2017
`Treaty with the Seven Nations of Canada, 1796
`Executive Order 13647
`TCR-2017-36
`Covidien LP v. Univ. of Fla. Research Found. Inc., Case IPR 2016-
`01274, Paper 21 (Jan. 25, 2017)
`Neochord, Inc. v. Univ. of Md., et al, Case IPR2016-00208, Paper 28
`(May 23, 2017)
`Reactive Surfaces Ltd., LLP v. Toyota Motor Corp., Case IPR2016-
`01914, Paper 36 (July 13, 2017)
`
`vi
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`
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`EX. 2079
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`EX. 2080
`EX. 2081
`EX. 2082
`EX. 2083
`EX. 2084
`EX. 2085
`EX. 2086
`EX. 2087
`EX. 2088
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`EX. 2089
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`EX. 2090
`EX. 2091
`EX. 2092
`EX. 2093
`EX. 2094
`EX. 2095
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`EX. 2096
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`EX. 2097
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`Order, Allergan, Inc. v. Teva Pharmas USA, Inc. et al, No. 2:15-cv-
`1455 (E.D. Tex.), Docket No. 478 (September 8, 2017)
`Joint Pre-Trial Order in Allergan, Inc. v. Teva Pharmaceuticals USA,
`Inc., et al., No. 2:15-cv-1455 (E.D. Tex.), Docket No. 379 (July 25,
`2017)
`National Congress of American Indians, Current Tax Needs in Indian
`Country
`National Congress of American Indians, Securing Our Futures
`National Congress of American Indians, Taxation
`Patent Assignment from Allergan, Inc. to Saint Regis Mohawk Tribe
`dated 09/08/17
`Declaration of Marsha K. Schmidt In Support of Motion for Pro Hac
`Vice Admission
`IP and the U.S. Economy 2016 Update
`Guest Post - America Invents Act Cost the US Economy over $1
`Trillion, Patently-O
`GIPC IP Index 2017 Report
`PTAB's 'Death Squad' Label Not Totally Off-Base, Chief Says,
`Law360
`2017 SRMT Ltr to Grassley & Feinstein (Judiciary)
`'Reverse" Patent Trolling, Westlaw
`Imprimis Pharmaceuticals to Offer Compounded Cyclosporine
`Alternative to Restasis
`Declaration of Dale White In Support of Patent Owner's Motion to
`Seal
`Excerpts of Chief Judge David Rushke at 11-09-17 PPAC Quarterly
`Meeting
`
`vii
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`
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`EX. 2098
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`EX. 2099
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`EX. 2100
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`EX. 2101
`EX. 2102
`EX. 2103
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`EX. 2104
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`EX. 2105
`EX. 2106
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`EX. 2107
`EX. 2108
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`EX. 2109
`EX. 2110
`EX. 2111
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`EX. 2112
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`EX. 2113
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`Michelle Stephenson, The Latest Uses of Restatis, Review of
`Ophthalmology (Dec. 30, 2005)
`Eric Donnenfeld MD and Stephen Pflugfelder MD, Topical
`Ophthalmic Cyclosporine: Pharmacology and Clinical Uses, Survey
`of Ophthalmology, Vol 54, Number 3, May-June 2009
`Emails concerning Discovery
`
`
`
`EX. 2114
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`EX. 2115
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`EX. 2116
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`
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`viii
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`
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`
`I. INTRODUCTION
`
`
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`Pursuant to 37 C.F.R 42.20(b), Allergan, Inc. moves to withdraw from
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`pending IPR proceedings IPR2016-01127; -01128; -01129; -01130, -01131; and -
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`01132 on the ground that as of September 8, 2017, Allergan ceased to be an owner
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`of the six patents involved in these IPR proceedings. In an e-mail to the parties
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`dated January 2, 2018, the Board authorized Allergan to file its motion to
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`withdraw.
`
`
`II. STATEMENT OF FACTS
`
`
`1. On June 3, 2016, Mylan Pharmaceuticals Inc. (“Mylan”) filed six IPR
`
`petitions against six patents owned by Allergan, Inc.: U.S. 8,685,930 (IPR2016-
`
`01127); U.S. 8,629,111 (IPR2016-01128); U.S. 8,642,556 (IPR2016-01129); U.S.
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`8,633,162 (IPR2016-01130); U.S. 8,648,048 (IPR2016-01131); and U.S.
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`9,248,191 (IPR2016-01132). The Board granted the six petitions on December 8,
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`2016. See, e.g., IPR2016-01127, Paper No. 8.
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`2. On January 6, 2017, Teva Pharmaceuticals USA, Inc. (“Teva”) filed six
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`IPR petitions against the same six patents. See IPR2017-00576; IPR2017-00578;
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`IPR2017-00579; IPR2017-00583; IPR2017-00585; and IPR2017-00586.
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`3. On January 6, 2017, Akorn Inc. (“Akorn”) filed six IPR petitions
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`1
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`
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`against the same six patents. See IPR2017-00594; IPR2017-00596; IPR2017-
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`00598; IPR2017-00599; IPR2017-00600; and IPR2017-00601.
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`4. On March 31, 2017, the Board joined the Teva and Akorn IPR petitions
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`with the corresponding Mylan IPR proceedings. See, e.g., IPR2016-01127, Paper
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`Nos. 18 and 19.
`
`5. On September 8, 2017, Allergan, Inc. assigned all six patents
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`to the Saint Regis Mohawk Indian Tribe (“Tribe”). EX. 2086; EX. 2103. The
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`Tribe concurrently granted back an exclusive limited field-of-use license to
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`Allergan, Inc. EX. 2087.
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`6. On September 8, 2017, the Tribe filed updated Mandatory Notices to
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`reflect that the Tribe was the Patent Owner in each proceeding. See, e.g.,
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`IPR2016-01127, Paper No. 63. The updated Mandatory Notices listed Allergan,
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`Inc. as a real party in interest. Id.
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`7. On September 22, 2017, the Tribe filed a motion to dismiss in each IPR
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`proceeding on the basis of tribal sovereign immunity. See, e.g., IPR2016-01127,
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`Paper No. 81. The motion to dismiss is pending.
`
`
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`8. On September 26, 2017, during a teleconference with the Board, Allergan
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`sought leave to file a motion to withdraw from the six IPR proceedings on the
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`ground that Allergan was no longer the owner of the six patents at issue. EX.
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`1143. On October 4, 2017, the Board denied Allergan’s request without prejudice,
`2
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`stating that Allergan could renew its request once briefing on the Tribe’s motion to
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`dismiss had been completed. See, e.g., IPR2016-01127, Paper No. 85.
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`
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`9. On October 31, 2017, in an e-mail to the Board after briefing on the
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`Tribe’s motion to dismiss had been completed, Allergan renewed its request for
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`leave to file a motion to withdraw from the six IPR proceedings. On November 3,
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`2017, the Board granted requests for leave to file amicus briefs and denied without
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`prejudice Allergan’s request for leave to file a motion to withdraw, stating that
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`Allergan could renew its request once amicus briefing had been completed. See,
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`e.g., IPR2016-01127, Paper No. 96.
`
`
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`10. On December 21, 2017, in an e-mail to the Board after amicus briefing
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`had been completed, Allergan renewed its request for leave to file a motion to
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`withdraw from the six IPR proceedings. On January 2, 2018 in an e-mail to the
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`parties, the Board granted Allergan’s request.
`
`III. ARGUMENT
`
`Unlike constitutional standing in the federal courts, administrative standing
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`is determined solely by the language of the statutes and regulations authorizing the
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`administrative hearing, and not by Article III. See Coach Servs., Inc. v. Triumph
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`Learning LLC, 668 F.3d 1356, 1376 (Fed. Cir. 2012) (“[F]or an agency such as the
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`PTO, standing is conferred by statute.”); Ritchie v. Simpson, 170 F.3d 1092, 1095
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`(Fed. Cir. 1999) (“[T]he starting point for a standing determination for a litigant
`3
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`
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`before an administrative agency is not Article III, but is the statute that confers
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`standing before that agency.”). In an IPR proceeding, the applicable statutes and
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`regulations identify only two classes of allowable participants: patent owners and
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`petitioners. See 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.8, 42.9, 42.101,
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`42.107, and 42.120 (petitioners and patent owners only parties authorized to take
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`any actions).
`
`Allergan is not a member of either class of authorized participants. By
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`virtue of the assignment executed on September 8, 2017, Allergan transferred to
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`the Tribe all “right, title, prerogatives, benefits and interest in” the six patents at
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`issue in the IPR proceedings, and “any ownership claims or beneficial rights, of
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`any kind whatsoever of [Allergan] that have accrued, or that may accrue now or in
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`the future.” EX. 2086 at 1. The Tribe, in a separate agreement, provided Allergan
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`an exclusive license for “all FDA-approved uses in the United States” and an
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`exclusive right to commercialize “Licensed Product[s].” EX. 2087 at §§ 2.1, 3.1,
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`1.33. The Tribe retained for itself all rights under the patents “not expressly
`
`granted” to Allergan, which included rights to utilize the patents to develop uses
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`that are not currently FDA-approved, and then commercially exploit those
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`developments, provided they do not qualify as or compete with “Licensed
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`Products.” Id. at § 2.4. The Tribe also reserved the right to use and practice the
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`patents for “research, scholarly use, teaching, education, patient care incidental to
`4
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`the foregoing [and] sponsored research” in connection with the FDA-approved use
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`of Restasis, as well as off-label uses. Id.
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`As a result of the assignment and license agreement, Allergan, as of
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`September 8, 2017, is no more than an exclusive field-of-use licensee. Therefore,
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`Allergan lacks authority to continue to participate in these proceedings under the
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`applicable statutes and regulations. Accordingly, Allergan requests that the Board
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`permit it to withdraw from the six pending IPR proceedings..
`
`
`
`
`
`Respectfully submitted,
`
`/Dorothy P. Whelan/
`Dorothy P. Whelan
`Reg. No. 33,814
`
`
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`
`
`Dated: January 9, 2018
`
`
`
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`Customer Number 26191
`Fish & Richardson P.C.
`Telephone: (612) 337-2502
`Facsimile: (612) 288-9696
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
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`that on January 9, 2018, a complete and entire copy of this Allergan Inc.’s Motion
`
`to Withdraw was provided via electronic service, to the Petitioner by serving the
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`correspondence address of record as follows:
`
`Steven W. Parmelee, Michael T. Rosato, Jad A. Mills,
`Wendy L. Devine, Douglas H. Carsten, Richard Torczon
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`wdevine@wsgr.com
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`
`Brandon M. White, Crystal Canterbury, Charles G. Curtis, Jr.
`Jennifer MacLean, Benjamin S. Sharp, Shannon M. Bloodworth, Eric D. Miller
`PERKINS COIE LLP
`700 13th Street NW
`Washington DC 20005
`bmwhite@perkinscoie.com
`ccanterbury@perkinscoie.com
`ccurtis@perkinscoie.com
`jmaclean@perkinscoie.com
`bsharp@perkinscoie.com
`sbloodworth@perkinscoie.com
`emiller@perkinscoie.com
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`6
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`Michael R. Dzwonczyk, Azy S. Kokabi, Travis B. Ribar
`Sughrue Mion, PLLC
`2100 Pennsylvania Ave., NW, Suite 800
`Washington, DC 20037
`mdzwonczyk@sughrue.com
`akokabi@sughrue.com
`tribar@sughrue.com
`
`Gary J. Speier, Mark D. Schuman
`Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, Minnesota 55402
`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
`IPRCyclosporine@carlsoncaspers.com
`
`
`
`
`
`
`
`/Diana Bradley/
`
`Diana Bradley
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(858) 678-5667
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