.
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC., and AKORN INC.1
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`_______________________
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)
`__________________________
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-00596,
`IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-00599,
`IPR2017-00585 and IPR2017-00600, and IPR2017-00601., have respectively been
`joined with the captioned proceedings. The word-for-word identical page is filed
`in each proceeding identified in the caption pursuant to the Board’s Scheduling
`Order (Paper 10).
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC., and AKORN INC.1
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`_______________________
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)
`__________________________
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-00596,
`IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-00599,
`IPR2017-00585 and IPR2017-00600, and IPR2017-00601., have respectively been
`joined with the captioned proceedings. The word-for-word identical page is filed
`in each proceeding identified in the caption pursuant to the Board’s Scheduling
`Order (Paper 10).
`
`
`
`
`
`Exhibit No.
`
`EX. 2001
`
`EX. 2003
`
`Description
`NDA 21-023 Cyclosporine Ophthalmic Emulsion 0.05%, Original
`NDA Filing, Vol. 1 (Feb. 24, 1999)
`EX. 2002 U.S. Pat. No. 4,839,342
`Said et al., Investigative Ophthalmology & Visual Science, vol. 48,
`No. 11 (Nov. 2007):5000-5006
`EX. 2004 Alba et al., Folia Ophthalmol. Jpn. 40:902-908 (1989)
`Stedman’s Medical Dictionary, definition of therapeutic
`EX. 2005
`EX. 2006 Dorland’s Illustrated Medical Dictionary, definition of therapeutic
`Stedman’s Medical Dictionary, definition of palliative
`EX. 2007
`EX. 2008 RESTASIS® label
`Murphy, R., “The Once and Future Treatment of Dry Eye,” Review
`of Optometry, pp. 73-75 (Feb. 15, 2000)
`EX. 2010 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)
`
`EX. 2009
`
`EX. 2011
`
`EX. 2012
`
`EX. 2013
`
`EX. 2014
`
`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. 2015
`
`das Neves et al., “ Mucosal Delivery of Biopharmaceuticals: Biology,
`Challenges and Strategies,” Springer Science (2014)
`
`EX. 2016
`
`EX. 2017
`
`EX. 2018
`
`EX. 2019
`
`EX. 2020
`
`EX. 2021
`
`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)
`
`EX. 2022
`
`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)
`EX. 2023 Deposition transcript of Mansoor Amiji, Ph.D
`EX. 2024 Declaration of John D. Sheppard, M.D., M.M.Sc.
`EX. 2025 Declaration of Dr. Thorsteinn Loftsson, Ph.D.
`EX. 2026 Declaration of Eric Rubinson
`EX. 2027 Allergan PK-98-074 Report
`EX. 2028 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
`
`EX. 2029
`
`
`
`FDA Review, “The Drug Development and Approval Process”
`EX. 2030
`EX. 2031 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
`
`EX. 2032
`
`EX. 2033
`
`EX. 2034
`
`EX. 2035
`
`EX. 2036
`
`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
`
`EX. 2037
`
`Mark B. Abelson, MD and Jason Casavant, “Give Dry Eye a One-
`two Punch,” Review of Ophthalmology, March 15, 2003
`EX. 2038 Deposition of David LeCause, February 17, 2017
`Joan-Marie Stiglich ELS, “Restasis: the road to approval,” Ocular
`Surgery News, March 1, 2003
`
`EX. 2039
`
`EX. 2040
`
`EX. 2042
`
`Lynda Charters, “Increased Tear Production,” Ophthalmology Times,
`February 1, 2003
`EX. 2041 RESERVED
`Jonathan R. Pirnazar, MD, “Taking a Custom Approach to Dry Eye
`Treatment,” Ophthalmology Management, February 1, 2004
`EX. 2043 RESERVED
`FDA label for Xiidra®
`EX. 2044
`EX. 2045 RESERVED
`
`
`
`EX. 2046 Restasis Strategic Plan Forecast 2009-2013
`Allergan Inc., Credit Suisse First Boston Equity Research Report, Jan
`30, 2003
`
`EX. 2047
`
`EX. 2048
`
`Allergan Inc., Buckingham Research Group Equity Research Report,
`Feb 5, 2003
`
`EX. 2049
`
`Allergan Inc., SalomonSmithBarney Equity Research Report, Feb 12,
`2003
`EX. 2050 Allergan Inc., Morgan Stanley Equity Research Report, Jan 30, 2003
`EX. 2051 Restasis P&L (US Only excl. Canada and Puerto Rico)
`EX. 2052 Allergan Inc., Morgan Stanley Equity Research Report, Apr 30, 2004
`EX. 2053 Allergan Inc., JP Morgan Equity Research Report, Nov 1, 2005
`EX. 2054 RESERVED
`“commercial Restasis Formulary June 2006.xls”
`EX. 2055
`
`EX. 2056
`
`“NOVEMBER 2006 input MHC Report Restasis Playbook data.ppt”
`
`EX. 2057
`
`Restasis® 2013 Managed Markets Tactics & Preliminary Budget,
`August 8, 2012
`EX. 2058 RESERVED
`EX. 2059 RESERVED
`“Allergan Inc. (AGN) - Q4 2002 Financial Release Conference Call
`Wednesday, January 29, 2003 11:00 am” Fair Disclosure Financial
`Network
`EX. 2061 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
`
`EX. 2060
`
`EX. 2062
`
`
`
`EX. 2063
`
`Allergan Eye Care, “US Dry Eye Strat Plan Narrative: Summary
`Version,” April 16, 2011
`
`EX. 2064
`
`EX. 2066
`
`Kline, Kate, “Restasis Professional Critical Issues,” Allergan Dry
`Eye, 2010
`EX. 2065 Allergan Dry Eye, “Restasis Business Update,” August 16, 2010
`“Sales-Units_2011-2016_AllData_NSP_Feb-19-
`2017_RESTASIS.xlsx”
`EX. 2067 RESERVED
`Iazuka and Jin, “The Effect of Prescription Drug Advertising on
`Doctor Visits,” Journal of Economics and Management Strategy,
`2007
`
`EX. 2068
`
`EX. 2069
`
`EX. 2070
`
`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
`
`EX. 2071
`
`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
`EX. 2072 Restasis NPA Monthly
`EX. 2073 Restasis Projects, Global R&D Cost
`EX. 2074 Refresh Endura Lubricant Eye Drops (Allergan), Theodora
`Declaration of Jonathan Singer in support of Petitioner’s Motion for
`Pro Hac Vice Admission
`
`EX. 2075
`
`EX. 2076
`
`Memorandum Opinion and Order, Allergan, Inc. v. Teva
`Pharmaceuticals USA, Inc., et al., Case No. 2:15-cv-1455-WCB
`
`
`
`EX. 2079
`
`EX. 2077
`
`Nussenblatt, R. et al. Local Cyclosporine Therapy for Experimental
`Autoimmune Uveitis in Rats. Arch Ophthalmology, Volume 103,
`October 1985.
`EX. 2078 Medical Officer’s Review of NDA 21-023
`Correction to Sall article (Ex. 1007), Opthalmology, Vol. 107, No. 7,
`July 2000.
`EX. 2080 GraphPad Calculation of Bloch Table 2 – 3 mo. B vs A.
`EX. 2081 GraphPad Calculation of Bloch Table 2 – 3 mo. C vs A.
`EX. 2082 Deposition transcript of Andrew F. Calman, M.D., Ph.D.
`EX. 2083 Deposition transcript of Daniel A. Bloch, Ph.D.
`EX. 2084 Deposition transcript of Ivan T. Hofmann
`EX. 2085 Assignment (Short form)
`EX. 2086 Assignment Agreement (Long form)
`Patent License Agreement
`EX. 2087
`
`EX. 2088
`
`EX. 2089
`
`EX. 2090
`
`EX. 2091
`
`EX. 2092
`
`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
`
`Transcript of Conference Call held on 09/11/17
`
`Federal Register, Vol. 82, No. 10, January 17, 2017
`
`Treaty with the Seven Nations of Canada, 1776
`
`Executive Order 13647
`
`EX. 2093
`TCR-2017-36
`EX. 2094
`EX. 2095 Covidien LP v. Univ. of Fla. Research Found. Inc., Case IPR 2016-
`01274, Paper 21 (Jan. 25, 2017)
`
`
`
`EX. 2096 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-
`EX. 2097
`01914, Paper 36 (July 13, 2017)
`EX. 2098 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 Pharmas USA, Inc. et
`EX. 2099
`al, No. 2:15-cv-1455 (E.D. Tex.), Docket No. 379 (July 25, 2017)
`EX. 2100 National Congress of American Indians, Current Tax Needs in Indian
`Country
`EX. 2101 National Congress of American Indians, Securing Our Futures
`EX. 2102 National Congress of American Indians, Taxation
`EX. 2103 Recorded Assignment
`EX. 2104 Declaration of Marsha K. Schmidt in Support of Motion for Pro Hac
`Vice Admission
`EX. 2105
`Intellectual Property and the U.S. Economy: 2016 Update
`Richard Baker, American Invents Act Cost the U.S. Economy over $1
`Trillion, PatentlyO (June 8, 2015),
`https://patentlyo.com/patent/2015/06/america-invents-trillion.html
`The Roots of Innovation, U.S. Chamber International IP Index (Fifth
`EX. 2107
`Ed. February 2017)
`EX. 2108 Ryan Davis, PTAB’s ‘Death Squad’ Label Not Totally Off-Base Chief
`Says, Law360 (Aug. 14, 2014)
`Letter from Saint Regis Mohawk Tribal Counsel to Senator Charles
`Grassley sent on Oct. 12, 2017`
`Adam Perlman et al, ‘Reverse’ Patent Trolling: Nontraditional
`Participants in the Inter Partes Review Process, 33 Westlaw Journal
`Pharmaceutical 9 (2017).
`Imprimis Pharmaceuticals to Offer Compounded Cyclosporine
`EX. 2111
`Alternative to Restasis®, Cision PR Newswire (Oct. 19, 2017)
`EX. 2112 Declaration of Dale White in Support of Patent Owner’s Motion to
`Seal
`
`EX. 2109
`
`EX. 2106
`
`EX. 2110
`
`
`
`EX. 2113
`
`EX. 2114
`
`
`Ex. 2115
`
`Ex. 2116
`
`Excerpts of Chief Judge David Rushke’s Testimony at 11/09/17
`PPAC Quarterly Meeting
`Michelle Stephenson; The Latest Use for 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)
`12/27/17 email string regarding discovery
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies that on January
`2, 2018, a complete and entire copy of PATENT OWNER’S UPDATED EXHIBIT LIST was
`provided, via electronic service, to the Petitioners by serving the correspondence addresses of
`record as follows:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`Wendy L. Devine
`WILSON SONSINI GOODRICH & ROSATI
`One Market Street, Spear Tower Floor 33
`San Francisco, CA 94105-1126
`wdevine@wsgr.com
`
`Douglas H. Carsten
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`dcarsten@wsgr.com
`
`Richard Torczon
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`
`
`
`
`Brandon M. White
`Crystal Canterbury
`Charles G. Curtis, Jr.
`Jennifer MacLean
`Benjamin S. Sharp
`Shannon M. Bloodworth
`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
`
`Eric D. Miller
`PERKINS COIE LLP
`1201 Third Avenue, Suite 4900
`Seattle, WA 98101-3099
`emiller@perkinscoie.com
`Counsel for Mylan Pharmaceuticals, Inc.
`
`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
`Attorneys for Akorn Inc.
`
`
`And upon the remaining Petitioners as follows:
`
`
`
`
`
`Gary J. Speier
`Mark D. Schuman
`CARLSON, CASPERS, VANDENBURGH, LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
`IPRCyclosporine@carlsoncaspers.com
`Attorneys for Teva Pharmaceuticals
`
`
`
`
`
`
`
`
`
`
`
`/Alfonso G. Chan/
`Alfonso G. Chan
`
`SHORE CHAN DEPUMPO LLP
`
`901 Main Street, Suite 3300
`Dallas, Texas 75202
`(214) 593-9110
`
`
`
`
`
`
`
`
`
`
`
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