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 IPR2016-011291
`Patent 8,642,556
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`PATENT OWNER ALLERGAN, INC.’S
`MOTION FOR PRO HAC VICE ADMISSION
`UNDER 37 C.F.R. § 42.10(c)
`
`
`
`
`
`1 Cases IPR2017-00579 and IPR2017-00598 have been joined with this
`proceeding.
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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 IPR2016-011291
`Patent 8,642,556
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`
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`PATENT OWNER ALLERGAN, INC.’S
`MOTION FOR PRO HAC VICE ADMISSION
`UNDER 37 C.F.R. § 42.10(c)
`
`
`
`
`
`1 Cases IPR2017-00579 and IPR2017-00598 have been joined with this
`proceeding.
`
`
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`
`
`
`Exhibit No. Description
`
`EXHIBITS
`
`EX. 2001
`
`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
`
`EX. 2003
`
`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)
`
`EX. 2005
`
`Stedman’s Medical Dictionary, definition of therapeutic
`
`EX. 2006
`
`Dorland’s Illustrated Medical Dictionary, definition of therapeutic
`
`EX. 2007
`
`Stedman’s Medical Dictionary, definition of palliative
`
`EX. 2008
`
`RESTASIS® label
`
`EX. 2009
`
`Murphy, R., “The Once and Future Treatment of Dry Eye,” Review
`of Optometry, pp. 73-75 (Feb. 15, 2000)
`
`EX. 2010
`
`RESERVED
`
`EX. 2011
`
`EX. 2012
`
`EX. 2013
`
`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)
`
`ii
`
`
`
`EX. 2014
`
`EX. 2015
`
`EX. 2016
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`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)
`
`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)
`
`EX. 2017
`
`Schaefer et al., “Skin Permeability,” Springer-Verlag (1982)
`
`EX. 2018
`
`EX. 2019
`
`EX. 2020
`
`EX. 2021
`
`EX. 2022
`
`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)
`
`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
`
`iii
`
`
`
`EX. 2028
`
`EX. 2029
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`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. 2030
`
`FDA Review, “The Drug Development and Approval Process”
`
`EX. 2031
`
`Allergan – NYSE: AGN – Company Profile
`
`EX. 2032
`
`EX. 2033
`
`EX. 2034
`
`Drugs@FDA: FDA Approved Drug Products,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ov
`erview.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=ov
`erview.process&ApplNo=050790
`
`EX. 2035
`
`Facts About Dry Eye, https://nei.nih.gov/health/dryeye/dryeye
`
`EX. 2036
`
`EX. 2037
`
`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
`
`EX. 2038
`
`Deposition of David LeCause, February 17, 2017
`
`EX. 2039
`
`EX. 2040
`
`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
`
`EX. 2041
`
`RESERVED
`
`iv
`
`
`
`EX. 2042
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`Jonathan R. Pirnazar, MD, “Taking a Custom Approach to Dry Eye
`Treatment,” Ophthalmology Management, February 1, 2004
`
`EX. 2043
`
`RESERVED
`
`EX. 2044
`
`FDA label for Xiidra®
`
`EX. 2045
`
`RESERVED
`
`EX. 2046
`
`Restasis Strategic Plan Forecast 2009-2013
`
`EX. 2047
`
`EX. 2048
`
`EX. 2049
`
`EX. 2050
`
`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
`
`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
`
`EX. 2055
`
`“commercial Restasis Formulary June 2006.xls”
`
`EX. 2056
`
`EX. 2057
`
`“NOVEMBER 2006 input MHC Report Restasis Playbook
`data.ppt”
`
`Restasis® 2013 Managed Markets Tactics & Preliminary Budget,
`August 8, 2012
`
`EX. 2058
`
`RESERVED
`
`v
`
`
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`
`EX. 2059
`
`RESERVED
`
`EX. 2060
`
`“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
`
`EX. 2062
`
`EX. 2063
`
`EX. 2064
`
`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
`
`EX. 2065
`
`Allergan Dry Eye, “Restasis Business Update,” August 16, 2010
`
`EX. 2066
`
`“Sales-Units_2011-2016_AllData_NSP_Feb-19-
`2017_RESTASIS.xlsx”
`
`EX. 2067
`
`RESERVED
`
`EX. 2068
`
`EX. 2069
`
`EX. 2070
`
`EX. 2071
`
`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,
`
`vi
`
`
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`
`2006
`
`EX. 2072
`
`Restasis NPA Monthly
`
`EX. 2073
`
`Restasis Projects, Global R&D Cost
`
`EX. 2074
`
`Refresh Endura Lubricant Eye Drops (Allergan), Theodora
`
`EX. 2075
`
`Declaration of Jonathan Singer in support of Patent Owner’s
`Motion for Pro Hac Vice Admission
`
`
`
`
`
`vii
`
`
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`Pursuant to 37 C.F.R. § 42.10(c), the Patent Owner (“Allergan”) respectfully
`
`requests that the Board recognize Jonathan Singer as counsel pro hac vice in this
`
`proceeding. Patent Owner seeks the counsel of Jonathan Singer due to his
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`experience in life sciences-related patent matters and particularly due to his
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`familiarity with the substantive and technical issues involved in this proceeding.
`
`This motion is authorized by the Notice of Filing Date Accorded to Petition and
`
`Time for Filing Patent Owner Preliminary Response that was mailed on June 9,
`
`2016.
`
`1.
`
`Statement of Facts
`
`Mr. Singer is a patent litigation attorney with significant experience
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`representing clients in more than a dozen United States District Courts, the Federal
`
`Circuit Court of Appeals, and the United States Supreme Court. Mr. Singer has
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`experience in all stages of litigation, from preliminary injunction through trial and
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`appeal, and across a wide range of technologies, including pharmaceutical drugs
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`and formulations, dosages, and molecular biology. Allergan provides Exhibit A, as
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`evidence, Jonathan Singer’s biography.
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`Mr. Singer also has particular experience and familiarity with the substantive
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`and technical issues involved in this inter partes review proceeding. In a related
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`matter involving the ‘556 patent, Mr. Singer represents Allergan in consolidated
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`litigation currently pending in the Eastern District of Texas. See Allergan, Inc. v.
`
`1
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`
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`Teva Pharmaceuticals USA, Inc. et al., No. 2:15-cv-01455 (Lead Case). In
`
`addition, Mr. Singer has tried numerous patent cases in United States District
`
`Courts involving pharmaceutical patents. Included in the cases Mr. Singer has
`
`tried are Gilead Sciences, Inc. v. Merck & Co., Inc., 5:13-cv-04057 (N.D. Cal.)
`
`(SOVALDI®); Allergan, Inc. v. Sandoz, Inc., 2:09-cv-00097 (E.D. Tex.)
`
`(LUMIGAN®); Aptalis Pharmatech, Inc. v. Apotex, Inc., 1:14-cv-01038 (D. Del.)
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`(AMRIX®); Cephalon, Inc. v. Watson Pharm., Inc., 1:09-cv-00724 (D. Del.)
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`(FENTORA®); and Prometheus Laboratories v. Mayo Collaborative Services,
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`(S.D. Cal.). Through these representations, Mr. Singer has gained a significant
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`understanding of the technology at issue in this proceeding.
`
`Mr. Singer has also performed a detailed review of the ‘556 Patent, the
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`parties’ submissions in the present Inter Partes Review proceeding, and the
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`Board’s Decision instituting Inter Partes Review of the ‘556 Patent. Additionally,
`
`Mr. Singer has served an essential role in this Inter Partes Review proceeding,
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`including working with the present Lead and Backup Counsel to prepare the Patent
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`Owner’s response. Mr. Singer thus has a detailed understanding of the ’556 Patent
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`and the substantive and technical issues involved in this proceeding.
`
`Allergan has invested significant financial resources in these proceedings.
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`Moreover, through his representation in these and related matters, Allergan has
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`developed a particular relationship with Mr. Singer, which Allergan desires to
`
`2
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`
`
`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`continue with Mr. Singer for the purpose of this proceeding. Accordingly, Patent
`
`Owner respectfully requests that the Board grant this Motion.
`
`
`
`2.
`
`
`
`Declaration of Individual Seeking to Appear
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`This Motion for Pro Hac Vice Admission is accompanied by a Declaration
`
`of Jonathan Singer (Ex. 2075) as required by the Order Authorizing Motion for
`
`Pro Hac Vice mailed June 9, 2016.
`
`Accordingly, Allergan submits that there is good cause under 37 C.F.R. §
`
`42.10(c) for the Board to recognize Jonathan Singer as counsel Pro Hac Vice
`
`during this proceeding.
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`
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`Respectfully submitted,
`
`
`
`/Dorothy P. Whelan/
`Dorothy P. Whelan, Reg. No. 33,814
`Fish & Richardson P.C.
`P.O. Box 1022
`Minneapolis, MN 55440-1022
`T: 612-337-2509
`F: 612-288-9696
`
`3
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`
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`Date: May 2, 2017
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`
`
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`Proceeding No.: IPR2016-01129
`Attorney Docket: 13351-0008IP3
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
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`that on May 2, 2017, a complete and entire copy of this Patent Owner Allergan,
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`Inc.’s Motion for Pro Hac Vice Admission was provided via electronic service, to
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`the Petitioner by serving the correspondence address 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
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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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`4
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