UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`1 Cases IPR2017-00578 and IPR2017-00596 have been joined with this
`proceeding.
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`1 Cases IPR2017-00578 and IPR2017-00596 have been joined with this
`proceeding.
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`EXHIBIT LIST
`
`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`
`EX. 2002
`EX. 2003
`
`EX. 2004
`EX. 2005
`EX. 2006
`EX. 2007
`EX. 2008
`EX. 2009
`
`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
`
`
`
`EX. 2015
`
`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
`
`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`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
`
`
`
`EX. 2031
`EX. 2032
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`EX. 2033
`
`EX. 2034
`
`EX. 2035
`EX. 2036
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`EX. 2037
`
`EX. 2038
`EX. 2039
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`EX. 2040
`
`EX. 2041
`EX. 2042
`
`EX. 2043
`EX. 2044
`EX. 2045
`EX. 2046
`EX. 2047
`
`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`Allergan – NYSE: AGN – Company Profile
`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
`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
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`
`
`EX. 2048
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`EX. 2049
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`EX. 2050
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`EX. 2051
`EX. 2052
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`EX. 2053
`EX. 2054
`EX. 2055
`EX. 2056
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`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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`EX. 2065
`
`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`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
`
`iv
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`
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`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
`EX. 2079
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`EX. 2080
`
`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`“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
`Correction to Sall article (Ex. 1007), Opthalmology, Vol. 107, No.
`7, July 2000.
`GraphPad Calculation of Bloch Table 2 – 3 mo. B vs A.
`
`v
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`
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`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
`
`EX. 2081
`EX. 2082
`EX. 2083
`EX. 2084
`
`vi
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`
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`I. INTRODUCTION
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`
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`Allergan requests the Board to exclude the testimony of Mylan’s declarants,
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`Drs. Calman (EX. 1039) and Bloch (EX. 1040), under F.R.E. 402, 403, and 702.
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`Both Drs. Calman and Bloch used unreliable methods to support their opinions that
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`the claimed emulsion having 0.05% CsA and 1.25% castor oil vehicle was not
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`unexpectedly more effective at increasing tear production than the closest prior art
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`emulsion having 0.1% CsA and 1.25% castor oil vehicle. The use of unreliable
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`methods renders both declarations inadmissible under F.R.E. 702. In addition,
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`Mylan introduced both declarations for the first time in its reply. In spite of the
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`surreply that the Board authorized Allergan to file, Mylan’s action deprived
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`Allergan of the opportunity to respond meaningfully to the new arguments that
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`Drs. Calman and Bloch raised with declarations of its own. Allowing Mylan to
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`rely on the Calman and Bloch declarations unfairly prejudices Allergan, rendering
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`both declarations inadmissible under F.R.E. 402 and 403.
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`
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`Allergan further requests the Board to exclude the testimony of Mylan’s
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`third new declarant, Mr. Hofmann (EX. 1041), under F.R.E. 402 and 403. Mr.
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`Hofmann’s declaration relates to commercial success. As in the case of Drs.
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`Calman and Bloch, Mylan introduced Mr. Hofmann’s declaration for the first time
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`in its reply. Mr. Hofmann’s declaration properly belonged in Mylan’s original
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`petition as part of Mylan’s prima facie case. By waiting until its reply, Mylan
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`forced Allergan to define positions that Mylan could then rebut, knowing that
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`Allergan would lack any meaningful opportunity to respond. Allowing Mylan to
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`rely on Mr. Hofmann’s declaration unfairly prejudices Allergan, rendering the
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`declaration inadmissible under F.R.E. 402 and 403.
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`
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`Allergan timely objected to all three declarations in its Objections to
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`Evidence filed July 10, 2017 (Paper No. 40).
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`II. MYLAN’S THREE NEW DECLARATIONS ARE INADMISSIBLE
`UNDER F.R.E. 402 AND 403
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`
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`In an inter partes review, the APA “imposes particular requirements on the
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`PTO.” Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1301 (Fed. Cir. 2016). These
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`requirements include “allow[ing] ‘a party . . . to submit rebuttal evidence . . . as
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`may be required for a full and true disclosure of the facts.’” Id. (citing 5 U.S.C. §
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`556(d)) (emphasis added). Under the APA’s standards, [a patent owner is] entitled
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`to an adequate opportunity to respond to [newly asserted facts].” In re NuVasive,
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`Inc., 841 F.3d 966, 972 (Fed. Cir. 2016). In this regard, “[o]bservations are not a
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`vehicle for submitting new evidence, including new expert declarations, by the
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`patent owner.” Id. at 973. In Nuvasive, the Court explicitly held that “the
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`opportunity to file observations was not enough” because they are not “a substitute
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`for the opportunity to present arguments and evidence.” Id. (emphasis added).
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`Here, while the Board did authorize Allergan to file a surreply, any reliance
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`by the Board on these untimely declarations would violate Allergan’s due process
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`rights because Allergan lacks the opportunity to present responsive declaration
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`evidence.
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`A. The Calman and Bloch Declarations Propose New Theories of
`Unpatentability
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`Mylan’s Reply relies upon the Calman and Bloch declarations (EXs. 1039
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`and 1040) in its reply. These declarations are entirely different from, and in certain
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`cases even contradict, the statements made in its original Petition. For example, in
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`its Petition, Mylan and its expert, Dr. Amiji, relied heavily on Sall (EX. 1007),
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`stating that “Sall teaches either concentration of CsA is ‘therapeutically effective’
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`in increasing tear production and treating dry eye disease/KCS,” and that based on
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`Sall, “it would have been a routine matter for a skilled artisan to make and then
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`confirm the efficacy of the emulsion comprising 1.25% castor oil and 0.05% CsA.”
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`Petition at 39, 41. In its Reply, with support from Drs. Calman and Bloch, Mylan,
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`for the first time, criticizes the tear production data shown in Sall rather than
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`embracing it.
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`
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`Dr. Calman criticizes the Schirmer Tear Test (“STT”) with anesthesia data
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`reported in Sall’s Figure 2, including Sall’s use of categorized STT measurements.
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`See, e.g., EX. 1039, ¶¶ 45-47, 56, 60-61, and 65-71. Dr. Calman argues that based
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`upon the data in Sall’s Figure 2, there is no statistical difference in tear production
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`between the 0.05% and 0.1% CsA formulations tested in Sall. Id. at ¶ 56. This is
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`the first time Mylan has presented arguments or evidence based upon an alleged
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`statistical analysis.
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`
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`Dr. Calman also includes a series of “conversions” that allegedly correlate
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`Sall’s categorized STT values with individual Schirmer scores (which Dr.
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`Calman’s “infers” from Sall) to support his theory that there is no meaningful
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`difference in tear production between the 0.05% and 0.1% CsA formulations. Id.
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`at ¶¶ 65-71. While Dr. Calman’s methodology is scientifically unsound for the
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`reasons discussed below, this is the first time Mylan has criticized Sall’s use of
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`categorized STT values to evaluate tear production and attempted to rely on
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`individual Schirmer values. It represents a new theory of unpatentability and thus
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`is untimely. As a result, Allergan has been deprived of a meaningful opportunity
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`to rebut Dr. Calman’s testimony with a declaration from its own clinician.
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`Mylan also includes the declaration of Dr. Bloch (EX. 1040), a
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`biostatistician, in its reply. Dr. Bloch’s declaration attempts, for the first time, a
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`statistical analysis of Sall’s STT tear production data based upon values he
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`eyeballed from Sall’s Figure 2 (¶¶ 28-47), as well as Allergan’s bioavailability data
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`(¶¶ 48-68). While Dr. Bloch’s methodology is scientifically unsound for the
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`reasons discussed below, Allergan lacks a meaningful opportunity to rebut Dr.
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`Bloch’s testimony with a declaration from its own biostatistician.
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`The declarations of Drs. Calman and Bloch introduce new theories and
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`arguments at the reply stage of the proceeding. There is no reason why Mylan
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`could not have included these declarations, and the underlying theories, in its
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`original Petition. Although the Board authorized Allergan to file a surreply,
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`Allergan remained unable to submit declarations from its clinician and a
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`biostatistician to rebut Mylan’s new theories based upon a purported statistical
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`analysis of the Sall tear production data—data that Mylan relied upon in its
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`Petition.
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`Through its reliance on the Calman and Bloch declarations, Mylan has
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`changed its theory of unpatentability at the reply stage. In effect, Mylan has filed a
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`new Petition. While Mylan’s actions underscore the weaknesses of Mylan’s
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`original theory, it is manifestly unfair to allow Mylan to introduce the new
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`declarations at this stage of the proceeding. See Nuvasive, 841 F.3d at 971-72 (due
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`process requires that patent owner have an opportunity present arguments and
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`evidence). Accordingly, Allergan requests that the Board exclude the Calman and
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`Bloch declarations because each is inadmissible under F.R.E. 402 and 403.
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`B. The Hofmann Declaration Is Untimely
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`Mr. Hofmann (EX. 1041) provides analyses of “certain claimed objective
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`indicia of nonobviousness, specifically commercial success and nexus.” EX. 1041,
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`¶ 9. Mylan had the opportunity and obligation to present these analyses in its
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`Petition as part of its prima facie case, but did not. Instead, Mylan waited until
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`Allergan had staked out its positions and then responded to those positions. In
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`doing so, Mylan unfairly gained a strategic advantage, particularly given that
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`Allergan, at this stage, has only a limited ability to address the evidence and
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`arguments that Mr. Hofmann presents. See Nuvasive, 841 F.3d at 973 (“the
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`opportunity to file observations was not enough” because observations are not “a
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`substitute for the opportunity to present arguments and evidence.”) Accordingly,
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`Allergan requests the Board to exclude the Hofmann declaration because it is
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`inadmissible under F.R.E. 402 and 403.
`
`III. THE CALMAN AND BLOCH DECLARATIONS ARE
`INADMISSABLE UNDER F.R.E. 702 BECAUSE EACH RELIES UPON
`UNRELIABLE METHODS TO REACH HIS OPINION
`
`
`Courts have a duty to ensure “that an expert’s testimony both rests on a
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`reliable foundation and is relevant to the task at hand.” Daubert v. Merrell Dow
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`Pharm., Inc., 509 U.S. 579, 597 (1993). The primary inquiry “entails a
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`preliminary assessment of whether the reasoning or methodology underlying the
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`testimony is scientifically valid and of whether that reasoning or methodology
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`properly can be applied to the facts in issue.” Id. at 592–93. Indeed, Federal Rule
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`of Evidence 702, as applied in Daubert and later in Kumho Tire Co. v. Carmichael,
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`526 U.S. 137 (1999), provides that an expert may give opinion testimony only if:
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`(1) the opinion is based on sufficient facts or data; (2) the testimony is the product
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`of reliable principles and methods; and (3) the witness has applied the principles
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`and methods reliably to the facts of the case. In applying the foregoing test, the
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`trial court must act as a “gatekeeper” to exclude expert testimony that “is irrelevant
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`or does not result from the application of reliable methodologies or theories to the
`
`facts of the case.” Micro Chem., Inc. v. Lextron, Inc., 317 F.3d 1387, 1391 (Fed.
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`Cir. 2003). The Supreme Court has also clarified that the trial court’s gatekeeper
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`role is not limited to an evaluation of the reliability of the methods used by an
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`expert, but also extends to a review of the strength of the connection between an
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`expert’s conclusions and the facts on which those conclusions are based. Gen.
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`Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). The expert’s testimony is unreliable
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`and should be excluded where “there is simply too great an analytical gap between
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`the data and the opinion proffered.” Id.
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`Both Drs. Calman (EX. 1039) and Bloch (EX. 1040) rely on scientifically
`
`unsound methodologies to support their opinions, rendering each declaration
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`inadmissible under F.R.E. 702.
`
`Dr. Calman provides “putative conversions” to the Schirmer Tear Test (with
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`anesthesia) scores reported in Figure 2 of Sall to generate “inferred raw STT
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`scores” and uses these scores to conclude “no material clinical difference would be
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`expected between the two CsA groups, as again the estimated raw values for the
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`0.05% and 0.1% CsA treatment groups at 6 months are only roughly half a
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`Case IPR2016-01128
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`millimeter apart.” See EX. 1039, ¶¶ 68-71. Dr. Calman’s analyses are
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`inadmissible as they are not based on sufficient facts or data, are not the product of
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`reliable principles and methods, and do not apply reliable principles and methods
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`to the facts of the case.
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`Dr. Calman admits his conversions are inferences and not “literal
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`conversions” to actual raw Schirmer scores. See EX. 1039, ¶ 68. Instead, Dr.
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`Calman conducts his analysis by estimating raw Schirmer Tear Test values (mm)
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`from the categorized Schirmer scores reported in Sall Figure 2. Id. For example,
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`Dr. Calman infers a Schirmer score of 3 corresponds to an estimated raw value of 7
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`mm; a score of 3.25 corresponds to an estimated raw value of 8 mm; a score of 3.5
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`corresponds to an estimated raw value of 9 mm; and a score of 3.75 corresponds to
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`an estimated raw value of 10 mm. See EX. 1039, ¶ 68. But Sall specifically states
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`that the mean categorized Schirmer value of 3 relates to all patients with raw
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`values of ranging from 7 to 10 mm. See EX. 1007, at page 635. Dr. Calman’s
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`“opinions” as to whether a person of skill in the art viewing Sall Figure 2 would
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`conclude there is no clinically meaningful difference between the 0.05% and 0.1%
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`CsA formulations should be excluded as inadmissible under F.R.E. 702.
`
`
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`In addition to relying on his own improper analysis, Dr. Calman also relies
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`on Dr. Bloch’s dubious analysis derived from “gleaning” the mean change from
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`baseline values for each composition in Sall Figure 2 to the nearest hundredth
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`decimal place. As discussed in more detail below, Dr. Bloch’s analysis on
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`unsubstantiated values is improper and unreliable, as it is not based on sufficient
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`facts or data, is not the product of reliable principles and methods, and does not
`
`apply reliable principles and methods to the facts of the case. Thus, Dr. Calman’s
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`“opinions” which rely on Dr. Bloch’s improper analysis to conclude that Sall does
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`not disclose any statistically significantly different results between the 0.05% and
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`0.1% CsA formulations (EX. 1039, ¶¶ 67-71) should be excluded as inadmissible
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`under F.R.E. 702.
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`Dr. Bloch provides “statistical analyses for certain data reported in
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`Stevenson, Sall Figures 1-2” and “Allergan’s animal PK [pharmacokinetic] studies
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`testing cyclosporine ophthalmic emulsions as used by Dr. Attar in her Exhibit B to
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`her Declaration presented to the USPTO.” See EX. 1040, ¶ 10. Dr. Bloch’s
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`analyses are inadmissible as they are not based on sufficient facts or data, are not
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`the product of reliable principles and methods, and do not apply reliable principles
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`and methods to the facts of the case. Dr. Bloch conducts his analysis by allegedly
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`“glean[ing] through precise measurements of the y-axis and bars within each bar
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`graph.” Id. For example, from Figure 1 of Sall, which contains a y-axis that
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`measures change in baseline in corneal staining to the tenth decimal place, Dr.
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`Bloch “gleans” the mean change from baseline values for each composition tested
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`to the hundredth decimal place, and conducts his analysis on these unsubstantiated
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`9
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`values and improper analysis. See EX. 1040, ¶¶ 33, 35-38. But Dr. Bloch admits
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`that using his “gleaned” values to calculate p-values gives different results than the
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`actual p-values reported in Sall. Ex. 2083 at 88:20-89:25.
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`Dr. Bloch’s analysis of Exhibit B of Dr. Attar’s Declaration is equally
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`suspect. Despite Dr. Attar’s testimony that she combined the upper and lower
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`conjunctiva data from the 98-074 study to compare against the same data from the
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`00-163 study, Dr. Bloch nevertheless bases his analysis on the data from the lower
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`conjunctiva in the 98-074 study. See EX. 1038, 167:8-169:24; EX. 1040, ¶¶ 65-68.
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`After “simply magnifying the scale of Dr. Attar’s exhibit,” and drawing a set of
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`rudimentary lines across the figure (which has a y axis with intervals of 0.5), Dr.
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`Bloch goes on to conclude that Dr. Attar “did the wrong ‘thing’ (analysis) when
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`she created her Exhibit B,” because of a purported three-hundredth point
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`difference in values (0.29 compared to 0.32) that he states is “clear” evidence that
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`she used the incorrect data. EX. 1040, ¶ 68.
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`Dr. Bloch’s methods are unreliable and unsubstantiated in light of Dr.
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`Attar’s testimony. Therefore, his “opinions” as to whether Stevenson, Sall or
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`Exhibit B of Dr. Attar’s Declaration disclose any statistically significantly different
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`results between the 0.05% and 0.1% CsA formulations should be excluded as
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`inadmissible under F.R.E. 702.
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`IV. CONCLUSION
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`
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`Allergan requests that the Board exclude the Calman, Bloch, and Hofmann
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`declarations (EX. 1039, 1040, and 1041) that Mylan submitted for the first time
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`with its reply. For at least the foregoing reasons, the declarations are inadmissible
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`under F.R.E. 402, 403, and 702.
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`Date:/July 20, 2017/
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`
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`Customer Number 26191
`Fish & Richardson P.C.
`Telephone: (612) 337-2509
`Facsimile: (612) 288-9696
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`Respectfully submitted,
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`/Dorothy P. Whelan/
`Dorothy P. Whelan, Reg. No. 33,814
`Michael J. Kane, Reg. No. 39,722
`Attorneys for Allergan, Inc.
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
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`that on July 20, 2017, a complete and entire copy of this Patent Owner Allergan,
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`Inc.’s Motion to Exclude Evidence was provided via electronic service, to the
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`Petitioner by serving the correspondence address of record as follows:
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`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`Wendy L. Devine
`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
`
`
`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
`sblackston@sughrue.com
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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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
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`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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`13
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