`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 SAINT REGIS MOHAWK TRIBE’S
`UNOPPOSED MOTION FOR PRO HAC VICE ADMISSION OF
`MICHAEL W. SHORE UNDER 37 C.F.R. § 42.10(c)
`
`
`
`
`
`
` 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 IPR2017-00586 and IPR2017-00601, have
`respectively been joined with the captioned proceedings. The word-for-word
`identical paper is filed in each proceeding identified in the caption pursuant to the
`Board’s Scheduling Order (Paper 10).
`
`
`
`EXHIBIT LIST
`
`EX. 2002
`EX. 2003
`
`EX. 2010
`EX. 2011
`
`EX. 2012
`
`EX. 2013
`
`EX. 2004
`EX. 2005
`EX. 2006
`EX. 2007
`EX. 2008
`EX. 2009
`
`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)
`das Neves et al., “ Mucosal Delivery of Biopharmaceuticals: Biology,
`Challenges and Strategies,” Springer Science (2014)
`
`EX. 2014
`
`EX. 2015
`
`i
`
`
`
`EX. 2016
`
`EX. 2017
`EX. 2018
`
`EX. 2019
`
`EX. 2020
`
`EX. 2021
`
`EX. 2022
`
`EX. 2023
`EX. 2024
`EX. 2025
`EX. 2026
`EX. 2027
`EX. 2028
`EX. 2029
`
`EX. 2030
`EX. 2031
`
`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”
`Allergan – NYSE: AGN – Company Profile
`
`ii
`
`
`
`EX. 2032
`
`EX. 2033
`
`EX. 2034
`
`EX. 2035
`EX. 2036
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`EX. 2037
`
`EX. 2038
`EX. 2039
`
`EX. 2040
`
`EX. 2041
`EX. 2042
`
`EX. 2043
`EX. 2044
`EX. 2045
`EX. 2046
`EX. 2047
`
`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
`Allergan Inc., Credit Suisse First Boston Equity Research Report, Jan
`30, 2003
`
`iii
`
`
`
`EX. 2048
`
`EX. 2049
`
`EX. 2050
`EX. 2051
`EX. 2052
`EX. 2053
`EX. 2054
`EX. 2055
`EX. 2056
`EX. 2057
`
`EX. 2058
`EX. 2059
`EX. 2060
`
`EX. 2061
`EX. 2062
`
`EX. 2063
`
`EX. 2064
`
`EX. 2065
`EX. 2066
`
`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
`Allergan Dry Eye, “Restasis Business Update,” August 16, 2010
`“Sales-Units_2011-2016_AllData_NSP_Feb-19-
`2017_RESTASIS.xlsx”
`
`iv
`
`
`
`EX. 2067
`EX. 2068
`
`EX. 2069
`
`EX. 2070
`
`EX. 2071
`
`EX. 2072
`EX. 2073
`EX. 2074
`EX. 2075
`
`EX. 2076
`
`EX. 2077
`
`EX. 2078
`EX. 2079
`
`EX. 2080
`EX. 2081
`
`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
`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.
`
`v
`
`
`
`EX. 2082
`EX. 2083
`EX. 2084
`EX. 2085
`EX. 2086
`EX. 2087
`EX. 2088
`
`EX. 2089
`
`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
`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
`
`vi
`
`
`
`
`I. RELIEF REQUESTED
`Under 37 C.F.R. § 42.10(c), Patent Owner, Saint Regis Mohawk Tribe,
`
`respectfully request the pro hac vice admission of Michael W. Shore in this
`
`proceeding. This motion is unopposed.
`
`II. GOVERNING LAWS, RULES, AND PRECEDENT
`Section 42.10(c) states as follows:
`
`The Board may recognize counsel pro hac vice during
`a proceeding upon a showing of good cause, subject to
`the condition that lead counsel be a registered
`practitioner and to any other conditions as the Board may
`impose. For example, where the lead counsel is a
`registered practitioner, a motion to appear pro hac
`vice by counsel who is not a registered practitioner may
`be granted upon showing that counsel is an experienced
`litigating attorney and has an established familiarity with
`the subject matter at issue in the proceeding.
`As stated in the "Order Authorizing Motion for Pro Hac Vice Admission"
`
`entered in Case IPR2013-00010 (MPT) (Paper 6) ("Motorola Order"), any motion
`
`for pro hac vice admission under 37 C.F.R. § 42.10(c) must be filed “no sooner
`
`than (21) days after service of the petition.
`
`III. STATEMENT OF FACTS
`Based on the following facts, and supported by the Declaration of Michael W.
`
`Shore (“Shore Decl.”) submitted herewith, Saint Regis Mohawk Tribe requests the
`
`pro hac vice admission of Michael W. Shore in this proceeding.
`
`1
`
`
`
`1. Patent Owner Saint Regis Mohawk Tribe’s lead counsel, Alfonso Chan, is a
`
`registered practitioner (Reg. No. 45,964).
`
`2. In addition, Allergan, Inc.’s lead counsel, Dorothy Whelan, is a registered
`
`practitioner (Reg. No. 33,814).
`
`3. Mr. Shore is a partner at the law firm of Shore Chan DePumpo LLP. Shore
`
`Decl. at ¶ 3.
`
`4. Mr. Shore is an experienced litigation attorney who has been litigating patent
`
`cases for nineteen years. Id.at ¶ 5.
`
`5. Mr. Shore has been practicing law since 1990 and has extensive experience
`
`litigating patent infringement cases in many different district courts across the United
`
`States. Id. at ¶ 4.
`
`6. Mr. Shore has been lead counsel in multiple trials and argued multiple
`
`Markman hearings and many other patent-related hearings. Id. at ¶ 6.
`
`7. Mr. Shore has an established familiarity with tribal sovereign immunity which
`
`is a subject matter at issue in this proceeding because he represents the Saint Regis
`
`Mohawk Tribe and has represented other sovereign entities, such as the University of
`
`Florida Research Foundation, Inc. Id. at ¶¶ 13-14.
`
`8. Mr. Shore has unique and specialized knowledge concerning the application of
`
`tribal sovereign immunity in inter partes review. Id.
`
`9. Mr. Shore is a member in good standing of the State Bar of Texas. Id. at ¶ 6.
`
`2
`
`
`
`10. Mr. Shore has never been suspended or disbarred from practice before any
`
`court or administrative body. Id. at ¶ 7.
`
`11. No application of Mr. Shore for admission to practice before any court or
`
`administrative body has ever been denied. Id. at ¶ 8.
`
`12. Mr. Shore has not had a court or administrative body impose sanctions or
`
`contempt citations against him related to his conduct in his 26-year legal career
`
`except for one instance when he was instructed not to send opposing counsel emails
`
`for a limited period during a hotly contested trial. Mr. Shore does not believe this
`
`instruction qualifies as a “sanction” but include its disclosure out of an abundance of
`
`caution. Id. at ¶ 9.
`
`13. Mr. Shore has read and will comply with the Office Patent Trial Practice
`
`Guide and the Board’s Rules of Practice for Trials set forth in 37 C.F.R. § 42. Id. at ¶
`
`10.Mr. Shore understands that he will be subject to the USPTO Code of Professional
`
`Responsibility set forth in 37 C.F.R. §§ 10.20 et seq. and disciplinary jurisdiction
`
`under 37 C.F.R. § 11.19(a). Id. at ¶ 11.
`
`14. Mr. Shore has not applied to appear pro hac vice in any other proceedings
`
`before the Office in the last three years. Id. at ¶ 12.
`
`15. This motion was filed more than 21 days after service of the Petition in this
`
`proceeding.
`
`3
`
`
`
`IV. GOOD CAUSE EXISTS FOR THE PRO HAC VICE ADMISSION OF
`MR. SHORE IN THIS PROCEEDING
`The Board may recognize counsel pro hac vice during a proceeding upon a
`
`showing of good cause, subject to the condition that lead counsel be a registered
`
`practitioner and to any other conditions as the Board may impose. 37 C.F.R. §
`
`42.10(c). Patent Owner’s lead counsel, Alfonso Chan, is a registered practitioner.
`
`Based on the facts contained herein, as supported by Mr. Shore's Declaration, good
`
`cause exists to admit Mr. Shore pro hac vice in this proceeding.
`
`Mr. Shore is an experience patent litigator with unique knowledge of the
`
`application of the Saint Regis Mohawk Tribe’s tribal sovereign immunity to these
`
`proceedings. And tribal sovereign immunity is a jurisdictional issue that must be
`
`decided before this case may proceed. In view of Mr. Shore's extensive knowledge
`
`of this subject matter Patent Owner, Saint Regis Mohawk Tribe, has a substantial
`
`need for Mr. Shore's pro hac vice admission and his involvement in the briefing
`
`and oral arguments concerning that issue.
`
`V. CONCLUSION
`For the foregoing reasons as well as the reasons contained in the attached
`
`affidavit, Patent Owner Saint Regis Mohawk Tribe respectfully requests admission
`
`of Michael W. Shore as counsel pro hac vice in this proceeding.
`
`
`
`
`
`4
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`
`
`Dated: September 8, 2017
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`/Alfonso Chan/
`Alfonso Chan, Reg. No. 45,964
`achan@shorechan.com
`
`
`Shore Chan DePumpo LLP
`901 Main Street, Suite 3300
`Dallas, TX 75201
`214-593-9110
`
`
`
`
`
`5
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies that
`
`on September 11, 2017, a complete and entire copy of this Patent Owner’s Motion
`
`for pro hac vice Admission of Michael Shore and supporting declaration was
`
`provided via electronic service, to the Petitioner by serving the 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
`
`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
`
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`6
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`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
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` /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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`7
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