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 IPR2016-011321
`Patent 9,248,191
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`PATENT OWNER ALLERGAN’S MOTION
`FOR OBSERVATIONS ON THE CROSS-EXAMINATION
`TESTIMONY OF ANDREW F. CALMAN, M.D., PH.D.
`
`
`1 Cases IPR2017-00586 and IPR2017-00601 have been joined with this
`proceeding.
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
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`ALLERGAN, INC.
`Patent Owner
`
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`
`
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`
`
`Case IPR2016-011321
`Patent 9,248,191
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`
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`
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`PATENT OWNER ALLERGAN’S MOTION
`FOR OBSERVATIONS ON THE CROSS-EXAMINATION
`TESTIMONY OF ANDREW F. CALMAN, M.D., PH.D.
`
`
`1 Cases IPR2017-00586 and IPR2017-00601 have been joined with this
`proceeding.
`
`
`
`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`
`EXHIBIT LIST
`
`EX. 2002
`EX. 2003
`
`EX. 2004
`EX. 2005
`EX. 2006
`EX. 2007
`EX. 2008
`EX. 2009
`
`EX. 2010
`EX. 2011
`
`EX. 2012
`
`EX. 2013
`
`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:
`
`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
`
`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`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”
`Allergan – NYSE: AGN – Company Profile
`
`ii
`
`
`
`EX. 2032
`
`EX. 2033
`
`EX. 2034
`
`EX. 2035
`EX. 2036
`
`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
`
`EX. 2048
`
`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`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
`Allergan Inc., Buckingham Research Group Equity Research
`
`iii
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`
`
`EX. 2049
`
`EX. 2050
`
`EX. 2051
`EX. 2052
`
`EX. 2053
`EX. 2054
`EX. 2055
`EX. 2056
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`EX. 2057
`
`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
`
`EX. 2065
`
`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`
`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 IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`“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 IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`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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`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`Patent Owner Allergan hereby submits observations on the deposition
`
`testimony of Petitioner’s Declarant Dr. Andrew Calman given on July 12, 2017
`
`(Ex. 2082).
`
`Dr. Calman Offers No Opinions to Contradict Dr. Loftsson’s Testimony
`Regarding Thermodynamic Principles
`
`In Ex. 2082 at p. 157, line 12 to p. 158, line 22, Dr. Calman testified that he
`
`is not offering any opinions related to the thermodynamic principles associated
`
`with the interaction between CsA and the oil in water emulsion, but rather defers to
`
`Dr. Amiji for any opinions related to that topic.
`
`Dr. Calman’s deposition testimony is relevant to his statements at ¶ 76 of his
`
`declaration (Ex. 1039) in which he discusses Dr. Loftsson’s opinions regarding
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`“Allergan’s confidential, internal pharmacokinetic studies […] allegedly confirm
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`that a person of ordinary skill in the art would have expected decreased
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`bioavailability and decreased efficacy from a formulation that increased the castor
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`oil concentration relative to the amount of cyclosporin” and Dr. Calman’s opinion
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`that Dr. Loftsson’s opinions regarding unexpected results are “not support[ed]” by
`
`data presented in PK-00-163, PK-98-074, Schiffman Exhibit B, or Schiffman
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`Exhibit C. Id.
`
`The deposition testimony is relevant because Dr. Amiji provided no opinions
`
`regarding thermodynamic principles in his declaration or deposition testimony.
`
`See e.g., Ex. 1002; Ex. 2023 at p. 161, line 9 to p. 162, line 13. This deposition
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`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`testimony demonstrates Dr. Loftsson’s opinion regarding the expectation of a
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`person of skill in the art regarding the decreased bioavailability and decreased
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`efficacy of a formulation that increased the castor oil concentration relative to the
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`amount of cyclosporin is unrefuted by Dr. Amiji and Dr. Calman.
`
`Dr. Calman’s Opinions Regarding Sall Figure 2 are Inconsistent with Facts
`Presented in Sall, Statements in Mylan’s Petition and the Opinions of Dr.
`Amiji
`
`In Ex. 2082 at p. 65, lines 11 to 21, Dr. Calman admitted data in Sall Fig. 2,
`
`reporting on increased tear production, demonstrated that at six months the 0.05%
`
`CsA formulation was numerically superior to the 0.1% CsA formulation.
`
`Additionally, at p. 61, line 7 to 18, Dr. Calman acknowledges that in Sall Fig. 2 the
`
`data shows that at three months the 0.05% CsA formulation was statistically
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`significant compared to the vehicle. See also Ex. 2082 at p. 63, lines 8-25.
`
`Dr. Calman’s deposition testimony is relevant to his statements at ¶ 63 of his
`
`declaration (Ex. 1039) where he states Sall Fig. 2 does not “suggest that the 0.10%
`
`CsA treatment group failed to achieve the same improvement in STT as the 0.05%
`
`CsA treatment group” and Sall Fig. 2 does not teach “that the Restasis® 0.05%
`
`CsA formulation increased tearing more than the 0.1% CsA formulation.”
`
`Dr. Calman’s deposition testimony is relevant because it is consistent with
`
`statements in Dr. Amiji’s declaration and the conclusions of Sall itself, but
`
`inconsistent with the conclusions presented in Dr. Calman’s declaration.
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`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`For example, Sall Figure 2 demonstrates the 0.05% CsA group increased
`
`tear production at month 3 as compared to vehicle, while the 0.1% CsA
`
`formulation decreased tear production. Ex. 1007 at p. 635.
`
`Similarly, Dr. Amiji’s declaration states “[a]t six months of treatment,
`
`Figure 2 in Sall depicts a negative change in Schirmer value (indicating worsening
`
`dry eye disease/KCS) for the vehicle, and positive changes (indicating
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`improvement) for both CsA treatments, with the CsA 0.05% treatment having an
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`average change in Schirmer score more than one standard deviation higher (better)
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`than the CsA 0.10% treatment." Ex. 1002 at ¶ 77.
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`The deposition testimony is relevant because it demonstrates that the
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`statements in Dr. Calman’s declaration are inconsistent with the facts and
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`statements set forth in Sall (Ex. 1007) and Dr. Amiji’s declaration (Ex. 1002).
`
`
`Dr. Calman is Not Qualified to Offer Opinions on the Design of Clinical Trials
`to Evaluate Formulations for Treating Dry Eye
`
`In Ex. 2082 at p. 30, line 2 to p. 31, line 17, Dr. Calman admitted all of the
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`clinical trials he has been involved in all relate to glaucoma drugs and not the
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`treatment of dry eye. Additionally, Dr. Calman admitted that he has not published
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`any papers related to the treatment of dry eye or making ophthalmic formulations.
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`Ex. 2082 at p. 22, lines 2-13.
`
` Dr. Calman’s deposition testimony is relevant to:
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`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`his statements at ¶ 60 of his declaration (Ex. 1039) in
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`(1)
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`which he states “based on the amount of times each clinical measure was
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`conducted, STT with anesthesia seems to be the least prioritized measure
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`in the Phase 3 clinical trials” and “[s]urely if STT with anesthesia was
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`such a singularly important test, the clinical trial would have
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`implemented it at each study visit.”
`
`(2)
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`his statements at ¶ 61 of his declaration (Ex. 1039) in
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`which he states “[a]s the anesthetized STT results are only given for two
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`time points, the data presented in Figure 2 of Sall is […] not as
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`meaningful as that for STT without anesthesia, which, like almost every
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`other clinical measure, was conducted ‘at baseline and at each study
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`visit.’”
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`The deposition testimony is relevant because it demonstrates that Dr.
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`Calman is not qualified to provide expert testimony regarding the design of clinical
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`trials involving ophthalmic formulations that increase tear production to treat dry
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`eye.
`
`Dr. Calman’s Analysis of the Data in Sall Figure 2
`is Unsupported
`
`In Ex. 2082 at p. 89, line 8 to p. 107, line 21, Dr. Calman admitted he cites
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`no document or reference to support the type of analysis he conducted in his
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`declaration (Ex. 1039) regarding the data in Sall Figure 2, and conceded that he
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`would be “deeply apologetic” if he had to present his analysis of the data in Sall
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`Figure 2 at a medical conference. Dr. Calman’s deposition testimony is relevant to
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`his statements at ¶¶ 67-71 of his declaration (Ex. 1039) regarding his “putative
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`conversions” and subsequent analysis of the Schirmer Tear Test data in Sall Figure
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`2. The deposition testimony is relevant because it demonstrates that Dr. Calman’s
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`analysis from which he bases his conclusion that a person of skill in the art would
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`conclude there was “no material clinical difference” between the 0.05% CsA and
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`0.1% CsA formulations was not based on an accepted scientific practice. Ex. 1039
`
`at ¶ 71.
`
`Dr. Calman Failed to Review Clinical Evidence Demonstrating the 0.05%
`CsA Formulation Works Differently than the 0.1% CsA Formulation
`
`In Ex. 2082 at p. 124, line 15 to line 20, Dr. Calman admitted that he did not
`
`review any of the public FDA files related to the approval of RESTASIS® in
`
`preparing his declaration. Dr. Calman’s deposition testimony is relevant to his
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`statements at ¶ 73 of his declaration (Ex. 1039) where he states he has “seen no
`
`clinical evidence that the 0.05% formulation ‘works better’ or ‘works differently’
`
`than the 0.1% CsA formulation evaluated in Sall.” The deposition testimony is
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`relevant because it demonstrates that Dr. Calman’s analysis from which he bases
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`his conclusion that the 0.05% and 0.1% formulations did not work differently did
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`not include review of publicly available FDA documents, including Ex. 2078,
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`which demonstrates the FDA concluded the 0.05% formulation works differently
`
`than the 0.1% CsA formulation.
`
`The Kaswan Article on Which Dr. Calman Relied Fails to Prove that CsA
`Was Known to be Therapeutically Effective Between 50 to 300 ng/g in
`Increasing Tear Production
`
`In Ex. 2082 at p. 131, line 18 to 132 line 22, p. 135 lines 2 to 10, and p. 153
`
`
`
`line 19 to p. 154 line 24, Dr. Calman testified as follows:
`
`(1) the Kaswan article (Ex. 1011) cites the Nussenblatt article (Ex. 2077) for
`
`the proposition that the intraocular level of CsA speculated to be needed for control
`
`of uveitis is 50 to 300 nanograms per gram (131:18 to 132:22); but
`
`(2) the Nussenblatt article (Ex. 2077), reports on therapeutic levels of
`
`cyclosporin of 50 to 300 nanograms per mL in serum (blood) (135:2-10); and
`
`(3) neither the Kaswan article (Ex. 1011), the Nussenblatt article (Ex. 2077),
`
`or the Oellerich article (Ex. 1058) identify the concentration of CsA necessary in
`
`the ocular tissues to increase tear production in dry eye patients (153:19-154:24).
`
`Dr. Calman’s deposition testimony is relevant to:
`
`(1) statements at ¶ 75 of his declaration (Ex. 1039) where he opined “that
`
`substantially equal performance of the 0.05% CsA formulation and 0.1% CsA
`
`formulation in increasing basal tear production would not have been remotely
`
`surprising to a person of ordinary skill in the art”;
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`(2) statements at ¶¶ 78-79 of his declaration (Ex. 1039) where he opined that
`
`(a) based upon his review of Dr. Attar’s pharmacokinetic data, both the 0.05% and
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`0.1% CsA formulations were “well above the threshold required for therapeutic
`
`efficacy” (¶ 78, emphasis in original); (b) the values reported for the amount of
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`CsA delivered to the cornea and conjunctiva “are much higher than those identified
`
`in the literature prior to September 15, 2003 as therapeutically effective” (¶ 79);
`
`and (c) “CsA has long been known to achieve therapeutic efficacy in a variety of
`
`target tissues when concentrations are in the range of 100-400 ng/g.” (¶ 79).
`
`Dr. Calman’s deposition testimony is relevant because it proves that
`
`Kaswan’s teachings regarding whether ocular doses of 50 to 300 ng/g are
`
`therapeutically effective is inaccurate. Accordingly, Dr. Calman’s deposition
`
`testimony demonstrates that the therapeutically effective amount of CsA in the
`
`ocular tissues necessary to increase tear production was not known prior to
`
`September 15, 2003. Dr. Calman’s deposition testimony is further relevant
`
`because it demonstrates, in contradiction to the opinions set forth in his
`
`declaration, that persons of ordinary skill in the art would not have expected the
`
`0.05% CsA formulation and 0.1% CsA formulation to be equally effective in
`
`increasing tear production.
`
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`Dr. Calman Agrees the Only Data Relevant to Demonstrating Increased Tear
`Production in Sall is Figure 2
`
`In Ex. 2082 at p. 45, line 6 to p. 47, line 9, p. 53, line 13 to page 55, line 21
`
`
`
`and p. 78, line 7 to p. 86, line 21, Dr. Calman testified as follows:
`
`(1) the Schirmer Tear Test without anesthesia reports on both basal and
`
`reflexive tearing (45:6-25), whereas the Schirmer Tear Test with anesthesia only
`
`reports on basal tearing (46:12-47:9); and
`
`(2) the only data presented in Sall that reports on increased basal tear
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`production is Figure 2 (53:13-55:21; 78:7-19; 79:13-16; 80:22-86:21).
`
`Dr. Calman’s deposition testimony is relevant to:
`
`(1)
`
`statements at ¶ 59 of his declaration (Ex. 1039) where he
`
`opined “[i]n light of the totality of the results, Sall reports that treatment
`
`with both the 0.05% and 0.1% CsA formulations resulted in
`
`improvements in both objective and subjective measures and that there
`
`was no dose-response effect: i.e., there was no material difference
`
`between the 0.05% CsA formulation and the 0.1% CsA formulation. This
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`data supports the conclusion that both of the CsA formulations were
`
`therapeutically effective in treating dry eye, including by increasing
`
`aqueous tear production from the lacrimal glands”; and
`
`(2)
`
`statements at ¶ 60 of his declaration (Ex. 1039) where he
`
`opined that “the person of ordinary skill would not have selectively
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`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`limited an analysis of comparative efficacy to solely data reported for the
`
`STT with anesthesia.”
`
`Dr. Calman’s deposition testimony is relevant because it proves that the only
`
`data in Sall reporting on tear basal tear production was Sall Figure 2. Dr. Calman’s
`
`deposition testimony is further relevant because it demonstrates, in contradiction to
`
`the opinions set forth in his declaration (Ex. 1039), that persons of ordinary skill in
`
`would have focused their analysis on Sall Figure 2 when comparing the efficacy of
`
`the 0.05% CsA formulation and 0.1% CsA formulation in increasing basal tear
`
`production.
`
`
`
`
`
`
`
`Date:/July 20, 2017/
`
`
`
`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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`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
`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 For Observations On The Cross-Examination Testimony Of Andrew
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`F. Calman, M.D., Ph.D. was provided via electronic service, to the Petitioner by
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`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
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`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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`10
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`Case IPR2016-01132
`Attorney Docket No: 13351-0008IP6
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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/
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`Jessica K. Detko
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(612) 337-2516
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`11
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