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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.
`
`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`_____________
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`PATENT OWNER’S UPDATED MANDATORY NOTICES PURSUANT TO
`37 C.F.R. § 42.8(a)(3)
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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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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`EXHIBIT LIST
`
`EX. 2002
`EX. 2003
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`EX. 2004
`EX. 2005
`EX. 2006
`EX. 2007
`EX. 2008
`EX. 2009
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`EX. 2010
`EX. 2011
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`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
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`EX. 2013
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`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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`
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`EX. 2015
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`EX. 2016
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`EX. 2017
`EX. 2018
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`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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`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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`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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`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
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`
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`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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`
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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
`
`
`
`EX. 2079
`
`EX. 2080
`EX. 2081
`EX. 2082
`EX. 2083
`EX. 2084
`EX. 2085
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`
`
`vi
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`Under 37 C.F.R. § 42.8(a)(3), Patent Owner Saint Regis Mohawk Tribe and
`
`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`Allergan, Inc. hereby submit the following mandatory change-of-information
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`notice in connection with consolidated cases listed in the caption above.
`
`A. Real Party-In-Interest – 37 CFR § 42.8(b)(1)
`Saint Regis Mohawk Tribe (the “Tribe”) hereby makes a special appearance2
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`before this Board to respectfully request that the Board immediately enter an order
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`staying all proceedings in this and all related IPRs set forth on the cover page of
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`this Motion pending resolution of its motion to dismiss based on sovereign
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`immunity. The Tribe has taken assignment of all six patents involved in this
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`consolidated proceeding. EX. 2085 (Assignment). The Tribe does not consent to
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`this proceeding.
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`B. Related Matters – 37 C.F.R. § 42.8(b)(2)
`Unchanged.
`
`C. Lead and Back-up Counsel – 37 C.F.R. § 42.8(b)(3)
`Allergan is exclusively represented in this proceeding by the following Lead
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`and Back-Up Counsel:
`
`
`
` 2
`
` See Friends of Amador County v. Salazar, 554 Fed.Appx. 562, 564 (9th Cir. 2014)
`(tribe made special appearance before district court so as not to waive immunity to
`present Rule 19 motion); Saginaw Chippewa Indian Tribe of Michigan v. NLRB, 838
`F.Supp.2d 598, 601 (E.D. Mich. 2011)(tribe made special appearance before NLRB
`to challenge jurisdiction on immunity grounds).
`1
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`LEAD COUNSEL
`Dorothy P. Whelan, Reg. No. 33,814
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Tel: (612) 337-2509
`Email: IPR13351-0008IP2@fr.com
`Fax: (612) 288-9696
`
`
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`
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`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
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`BACK-UP COUNSEL
`Michael Kane, Reg. No. 39,722
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Tel: (612) 337-2502
`Email: PTABInbound@fr.com
`Fax: (612) 288-9696
`
`Susan Morrison Colletti, Reg. No.
`56,332
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Tel: (302) 778-8434
`Email: PTABInbound@fr.com
`Fax: (612) 288-9696
`
`Robert M. Oakes, Reg. No. 62,189
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Tel: (302) 778-8477
`Email: PTABInbound@fr.com
`Fax: (612) 288-9696
`
`2
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`
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`The Tribe is exclusively represented in this proceeding by the following Back-Up
`Counsel:
`
`Case No.: IPR2016-01128
`Attorney Docket No.: 13351-0008IP2
`
`BACK-UP COUNSEL
`Alfonso Chan, Reg. No. 45,964
`Shore Chan DePumpo LLP
`901 Main Street, Suite 3300
`Dallas, TX 75201
`Telephone: (214) 593-9110
`Email: achan@shorechan.com
`Fax: (214) 593-9111
`
`Joseph DePumpo, Reg. No. 38,124
`Shore Chan DePumpo LLP
`901 Main Street, Suite 3300
`Dallas, TX 75201
`Telephone: (214) 593-9110
`Email: jdepumpo@shorechan.com
`Fax: (214) 593-9111
`
`
`D. Electronic Service
`Please address all correspondence and service to counsel as listed above.
`
`Allergan consents to service by email at IPR13351-0008IP2@fr.com (ref.: Docket
`
`No. IPR13351-0008IP2). The Tribe consents to service by email at
`
`IPR01227@shorechan.com.
`
`Dated: September 8, 2017
`
`
`
`
`Customer Number 26191
`Fish & Richardson P.C.
`Telephone: (612) 337-2502
`Facsimile: (612) 288-9696
`
`
`
`
`Respectfully submitted,
`
`/Michael Kane/
`
`Michael Kane
`Reg. No. 39,722
`
`
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`3
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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 September 8, 2017, a complete and entire copy of this Patent Owner
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`Allergan, Inc.’s Updated Mandatory Notices, Power of Attorney, and supporting
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`exhibit were 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
`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
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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
`Shelia Blackston
`Sughrue Mion, PLLC
`2100 Pennsylvania Ave., NW, Suite 800
`Washington, DC 20037
`mdzwonczyk@sughrue.com
`akokabi@sughrue.com
`tribar@sughrue.com
`sblackston@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
`
`
`
`
`
` /Jessica K. Detko/
`
`Jessica K. Detko
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(612) 337-2516
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