`
`Paper No. ___
`Filed: August 3, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`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 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,642,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132 (US 9,248,191 B2)
`_____________________________
`
`PETITIONERS’ REPLY IN SUPPORT OF
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`
`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).
`
`
`
`
`
`
`
`
`
`I.
`
`Petitioners’ Motion Did Not Violate the Board’s Order
`
`Allergan contends that Petitioners’ motion to exclude violated a Board e-
`
`mail denying Mylan’s request to file a response to Allergan’s surreply (Paper 51,
`
`2-3, 7-8), but the motion was filed the day before the Board’s e-mail issued.
`
`EX1136 (July 21, 2017 email). Petitioners could not have violated an e-mail that
`
`did not exist. In contrast, Allergan’s belated Sur-reply arguments and evidence
`
`violate an existing Board order. Paper 10, 3 (“[A]ny arguments for patentability
`
`not raised in the response will be deemed waived.”). Further, the Board did not
`
`foreclose Petitioners from seeking to exclude EX2077-2079 and has confirmed
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`Petitioners may address the substance and impropriety of the sur-replies. EX1136.
`
`Allergan’s contention that its impropriety is excused by Petitioners’ replies
`
`is false; Petitioners’ replies are directly responsive to Allergan’s Responses and are
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`entirely consistent with the Petition arguments. Paper 52, 2-11. Allergan’s
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`complaint that it was not authorized to submit Sur-reply declarations is undercut by
`
`its failure to timely request them. Id.; EX1135. Even today, Allergan has failed to
`
`provide an adequate proffer identifying any specific declarant or testimony.
`
`II. Allergan’s Reliance on EX2008 and EX2078 Is Improper
`
`Allergan mischaracterizes EX2008 and EX2078 and does not dispute that
`
`they are and contain hearsay, but contends that they satisfy the public record
`
`exception FRE 803(8). Paper 51, 2-3, 11. But the public record exception requires
`
`that the proponent provide foundation establishing the document qualifies as a
`
`
`-1-
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`
`
`
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`public record, which Allergan has failed to do. See United States v. Smart, 87 F.2d
`
`1, 3 (5th Cir. 1936) (“[I]t must be established as within that class of official records
`
`or documents which are excepted from the hearsay rule.”); F.R.E. 803(8)
`
`(proponent of alleged public record must establish that document is a record of a
`
`public office setting out office’s activities and a matter observed while under a
`
`legal duty to report). Neither EX2008 nor EX2078 identify its source, how it came
`
`to be, what official purportedly observed the matters discussed therein, or whether
`
`that official had an official duty to report; nor do Allergan’s Responses, declarants,
`
`or even exhibit lists. EX2083, 100:16-102:13 (“I mean who asked for this report
`
`[in EX2078] to even be done in the first place? Perhaps Allergan did.”).
`
`Even if either of the documents had been authenticated as a public record,
`
`this does not establish that the double hearsay contained in the document is
`
`admissible for the truth of the matters asserted therein. Allergan’s reliance on
`
`EX2008 and EX2078 to explain the FDA’s reasoning for approving RESTASIS®
`
`should be excluded and receive no weight. Even if Allergan had met the threshold
`
`requirements under F.R.E. 803(8), Petitioners’ motion demonstrated that EX2078
`
`contains obvious inaccuracies, indicating a lack of trustworthiness.
`
`
`
`III. EX2024 ¶48 and EX2026 ¶47 Should Be Excluded
`
`Allergan claims that Drs. Sheppard and Loftsson merely claim consistency
`
`with, rather than reliance upon, Schiffman Exhibits B, D-F and Attar Exhibits C-
`
`-2-
`
`
`
`
`
`D. Paper 51, 4. Regardless, Drs. Sheppard and Loftsson are relying upon evidence
`
`that is entitled to no weight to support their own opinions. See Paper 33, 3.
`
`Allergan cannot use its experts to launder evidence lacking evidentiary value.
`
`IV. EX2038 and Allergan’s Reliance Upon It Should Be Excluded
`
`Allergan argues that expert testimony may rely on inadmissible testimony
`
`when other “experts in the field would reasonably have relied on such facts or data
`
`in forming an opinion[.]” Paper 51, 5; F.R.E. 703. Yet, the underlying document is
`
`not admissible for the Board’s substantive reliance. F.R.E. 703 committee notes on
`
`rules—2000 amendment (“[T]he underlying information must not be used for
`
`substantive purposes.”); Flanagan v. Iran, 190 F.Supp.3d 138,173 (D.D.C. 2016)
`
`(“[e]xpert opinions may be based on hearsay … [but] they may not be a conduit for
`
`the introduction of factual assertions that are not based on personal knowledge.”).
`
`With respect to Allergan’s argument that EX2038 should remain in the
`
`record, Petitioners have not requested expungement of EX2038. Instead,
`
`Petitioners have rightfully requested that the exhibit be excluded as a source of
`
`independent evidence and that Dr. Maness’s recitations of it be given no more
`
`weight than the evidence itself would be entitled. Because Mr. LeCause was not
`
`subjected to cross-examination in these proceedings, his deposition testimony is
`
`entitled to no independent evidentiary weight. See 37 C.F.R. § 42.51; 77 Fed. Reg.
`
`48,756, 48,761; HTC Corp. v. NFC Tech. LLC, IPR2014-01198, Paper 41, 5.
`
`-3-
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`
`
`
`
`
`
`Allergan fails to prove that Mr. LeCause’s statements are the kind of
`
`evidence upon which experts in the field would reasonably rely. F.R.E. 703.
`
`“Where an expert’s opinion is based on information supplied by others, the inquiry
`
`into reliability. . .should focus on the reliability of the opinion and its
`
`foundation[.]” Loeffel Steel Products, Inc. v. Delta Brands, Inc., 372 F.Supp.2d
`
`1104, 1119 (N.D. Ill. 2005). Dr. Maness gives no foundation for why an expert in
`
`his field would rely on the statements of Mr. LeCause; he admits he is unaware of
`
`whether or not Mr. LeCause had any economics, pharmaceutical, medical, or
`
`chemical expertise. EX1034, 68:23-70:7. The only qualification Dr. Maness
`
`provided for relying on Mr. LeCause’s statements is Mr. LeCause’s “current title is
`
`vice-president of sales and marketing for the eye care division of Allergan.” Id. at
`
`37:24-38:02. The sole qualification Dr. Maness appears to have relied upon is that
`
`Mr. LeCause is a mouthpiece for Allergan.
`
`
`
`It is unclear to what extent Dr. Maness analyzed Mr. LeCause’s
`
`statements as opposed to simply parroting them. Id. at 65:22-66:4 (“[Q: Are
`
`you…relying on Mr. LeCause as if he is an expert?] You know, I don’t
`
`know.”). Dr. Maness admits portions of his declaration are a mere recitation
`
`of his conversations with Mr. LeCause. Id. at 149:10-20. Allergan should not
`
`be permitted to use Dr. Maness to launder the opinions of Mr. LeCause. U.S.
`
`v. Brownlee, 744 F.3d 479, 482 (7th Cir. 2014) (“An expert who parrots an
`
`-4-
`
`
`
`
`
`out-of-court statement is not giving expert testimony; he is a ventriloquist’s
`
`dummy.”); Arista Records LLC v. Usenet.com, Inc., 608 F.Supp.2d 409, 429
`
`(S.D.N.Y. 2009) (“An expert who simply repeats the hearsay of the client
`
`who retained him, without any independent investigation or analysis, does
`
`not assist the trier of fact[.]”); Robinson v. Ford Motor Co., 967 F.Supp.
`
`482, 487 n.2 (M.D. Ala. 1997); 37 C.F.R. § 42.51.
`
`V. EX2077 Should Be Excluded
`
`Allergan (Paper 51, 8) merely summarizes (inaccurately) EX2077 and fails
`
`to respond to a single evidentiary issue raised by Petitioner. Because EX2077 lacks
`
`foundation, it should be excluded and given no weight, or at least read in context of
`
`Dr. Calman’s testimony. See EX2082, 132:23-155:11.
`
`VI. EX2079 Should Be Excluded
`
`
`
`Allergan contends Petitioners should welcome EX2079 as a correction to
`
`Sall because Petitioners relied upon Sall in the Petitions. Paper 51, 11. Allergan
`
`ignores the fact that a reference may be appropriate for showing use of 0.05% CsA
`
`was obvious but fail to show a statistical difference between 0.05% and 0.1% CsA
`
`formulations. Allergan provides no foundation for using EX2079 to prove the latter
`
`and is belatedly attempting to introduce new bases for patentability. Paper 10 at 3.
`
`VII. CONCLUSION
`
`The aforementioned exhibits and paragraphs should be excluded.
`
`-5-
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`
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`Dated: August 3, 2017
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
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`-6-
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`
`
`Exhibit
`No.
`
`LIST OF EXHIBITS
`
`
`
`Description
`
`1001
`
`U.S. Patent No. 8,685,930 to Acheampong et al.
`
`1002
`
`Declaration of Dr. Mansoor Amiji
`
`1003
`
`Curriculum Vitae of Dr. Mansoor Amiji
`
`1004
`
`File history of U.S. Patent No. 8,685,930 to Acheampong et al.
`
`1005
`
`File history of U.S. Patent Application No. 10/927,857, filed on August
`27, 2010 to Acheampong et al.
`
`1006
`
`U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994
`
`1007
`
`1008
`
`K. Sall, et al., Two Multicenter, Randomized Studies of the Efficacy and
`Safety of Cyclosporine Ophthalmic Emulsion in Moderate to
`Severe Dry Eye Disease, 107 OPHTHALMOLOGY 631 (2000)
`
`A. Acheampong et al., Cyclosporine distribution into the conjunctiva,
`cornea, lacrimal gland, and systemic blood following topical
`dosing of cyclosporine to rabbit, dog, and human eyes, 2
`LACRIMAL GLAND, TEAR FILM, AND DRY EYE SYNDROMES 1001
`(1998)
`
`1009
`
`U.S. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`
`1010
`
`U.S. Patent No. 5,981,607 to Ding et al., filed January 20, 1998
`
`1011
`
`1012
`
`R. Kaswan, Intraocular Penetration of Topically Applied Cyclosporine
`20 TRANSPL. PROC. 650 (1988)
`
`K. Kunert et al., Analysis of Topical Cyclosporine Treatment of Patients
`with Dry Eye Syndrome 118 ARCH OPHTHALMOL 1489 (2000)
`
`1013
`
`Physicians’ Desk Reference for Ophthalmic Medicines (1999)
`
`-7-
`
`
`
`
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`K. Turner et al., Interleukin-6 Levels in the Conjunctival Epithelium of
`Patients with Dry Eye Disease Treated with Cyclosporine
`Ophthalmic Emulsion 19 CORNEA 492 (2000)
`
`D. Stevenson et al. Efficacy and Safety of Cyclosporin A Ophthalmic
`Emulsion in the Treatment of Moderate-to-Severe Dry Eye
`Disease 107 OPHTHALMOL. 967 (2000)
`
`REMINGTON’S 20TH EDITION: THE SCIENCE AND PRACTICE OF PHARMACY
`
`(A. Gennaro ed. 2003)
`
`E. Goto et al. Low-Concentration Homogenized Castor Oil Eye Drops
`for Noninflamed Obstructive Meibomian Gland Dysfunction 109
`OPHTHALMOL. 2030 (2002)
`
`A. Kanpolat et al., Penetration of Cyclosporin A into the Rabbit Cornea
`and Aqueous Humor after Topical Drop and Collagen Shield
`Administration 20 CLAO J 119 (1994)
`
`A. Vieira et al., Effect of ricinoleic acid in acute and subchronic
`experimental models of inflammation, 9 MED. INFLAMM. 223
`(2000)
`
`1020
`
`R. Murphy, The Once and Future Treatment of Dry Eye, REVIEW OF
`OPTOMETRY 1 (2000)
`
`1021
`
`D. Small et al., Blood concentrations of Cyclosporin A During Long-
`Term Treatment with Cyclosporin A Ophthalmic Emulsions in
`Patients with Moderate to Severe Dry Eye Disease 18 J. OC.
`PHARM. THERAP. 411 (2002)
`
`1022
`
`
`
`STEDMAN’S MEDICAL DICTIONARY 27TH EDITION (M.B. Pugh ed. 2000)
`
`1023
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., and Mylan Inc., No.
`2:15-cv-01455
`
`1024
`
`Approved Drug Products with Therapeutic Equivalence Evaluations
`(34th Ed.) (2014) (Excerpts)
`
`-8-
`
`
`
`
`
`1025
`(IPR2016-
`01127)
`
`1025
`(IPR2016-
`01132)
`
`File history of U.S. Patent No. 8,629,111 to Acheampong et al. (Exhibit
`Number Reserved in IPR2016-01128, -01129, -01130, & -01131)
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., No. 2:15-cv-01455
`(Exhibit Number Reserved in IPR2016-01128, -01129, -01130, &
`-01131)
`
`1026
`
`Reserved
`
`Allergan Department of Pharmacokinetics and Drug Metabolism
`Departmental Research Report, Report No: PK-00-163,
`Concentrations of Cyclosporin A in Cornea and Conjunctiva After
`a Single Ophthalmic Dose to New Zealand White Rabbits:
`Evaluation of 7 Ophthalmic Emulsion Formulations
`
`PROTECTIVE ORDER MATERIAL – Allergan R&D Records
`Management, Notebook Number L-2000-7626
`
`PROTECTIVE ORDER MATERIAL – Allergan R&D Records
`Management, Notebook Number L-1998-5709
`
`PROTECTIVE ORDER MATERIAL – Allergan R&D Records
`Management, Notebook Number L-1998-5707
`
`PROTECTIVE ORDER MATERIAL – Allergan R&D Records
`Management, Notebook Number L-2000-7726
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`Orange Book 29th Edition (2009) (excerpts)
`
`1033 Mayssa Attar Professional Linkedin Profile
`
`1034
`
`1035
`
`1036
`
`PROTECTIVE ORDER MATERIAL – Transcript of May 31, 2017
`Deposition of Robert S. Maness, Ph.D.
`
`PROTECTIVE ORDER MATERIAL – Transcript of June 1, 2017
`Deposition of Rhett Schiffman, M.D., M.S.Sc.
`
`PROTECTIVE ORDER MATERIAL – Transcript of June 7, 2017
`Deposition of Thorsteinn Loftsson, Ph.D.
`
`-9-
`
`
`
`
`
`1037
`
`1038
`
`1038
`
`1039
`
`1040
`
`Transcript of June 20, 2017 Deposition of John D. Sheppard, M.D.,
`M.S.Sc.
`
`PROTECTIVE ORDER MATERIAL – Transcript of June 22, 2017
`Deposition of Mayssa Attar, Ph.D.
`
`REDACTED – Transcript of June 22, 2017 Deposition of Mayssa Attar,
`Ph.D.
`
`PROTECTIVE ORDER MATERIAL – Declaration of Andrew F.
`Calman, M.D.
`
`PROTECTIVE ORDER MATERIAL – Declaration of Daniel A. Bloch,
`Ph.D.
`
`1041
`
`PROTECTIVE ORDER MATERIAL – Declaration of Ivan T. Hofmann
`
`1042
`
`Curriculum Vitae of Andrew F. Calman, M.D.
`
`1043
`
`Curriculum Vitae of Daniel A. Bloch, Ph.D.
`
`1044
`
`Curriculum Vitae of Ivan T. Hofmann
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`Facts About Dry Eye, NATIONAL EYE INSTITUTE OFFICE OF SCIENCE
`COMMUNICATIONS, PUBLIC LIAISON, AND EDUCATION, 2013,
`https://nei.nih.gov/health/dryeye/dryeye (downloaded June 26,
`2017)
`
`Niederkorn et al., Desiccating Stress Induces T Cell-Mediated Sjögren’s
`Syndrome-Like Lacrimal Keratoconjunctivitis, J. IMMUNOL.
`176:3950-3957 (2006)
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern, AMERICAN
`ACADEMY OF OPHTHALMOLOGY, 2013
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern Limited
`Revision, AMERICAN ACADEMY OF OPHTHALMOLOGY, 2011
`
`A real tear-jerker: Team creates device to alleviate dry eye, STANFORD
`MEDICINE NEWS CENTER, https://med.stanford.edu/news/all-
`news/2015/01/a- real-tear-jerker-team-creates-device-to-alleviate-
`dry-eye.html (accessed on June 26, 2017)
`
`-10-
`
`
`
`
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`Allergan Granted Marketing Authorization by the FDA for TrueTearTM,
`the First Intranasal Neurostimulating Device Proven to
`Temporarily Increase Tear Production,
`https://www.allergan.com/News/News/Thomson-
`Reuters/Allergan-Granted-Marketing-Authorization-by-the-FD
`(accessed on June 26, 2017)
`
`Dalton, M., Novel neurostimulator device uses nasal cavities to
`stimulate tears, OPHTHALMOLOGY TIMES,
`http://ophthalmologytimes.modernmedicine.com/ophthalmologyti
`mes/news/novel- neurostimulator-device-uses-nasal-cavities-
`stimulate-tears?page=0,1 (accessed on June 26, 2017)
`
`Marsh, P. and Pflugfelder S., Topical Nonpreserved Methylprednisolone
`Therapy for Keratoconjunctivitis Sicca in Sjörgen Syndrome, 106
`OPHTHALMOL. 811 (1999)
`
`PubMed abstract for Sainz de la Maza Serra et al., Nonpreserved
`Topical Steroids and Punctal Occlusion for Severe
`Keratoconjunctivitis Sicca, ARCH. SOC. ESP. OFTALMOL. 10:751-
`756 (2000)
`
`Eadie, S. et al., Kerato-Conjunctivitis Sicca Treated With Cortisone and
`ACTH, BRIT. J. OPHTHAL. (1955), 39:90
`
`Gaulhofer, W. K., The Effect of Cortisone on Sjögren’s Syndrome, ACTA
`MEDICA SCANDINAVICA, Vol. CXLIX, fase. VI, 1954
`
`Rolando, M. et al., Topical Non-Preserved Diclofenac Therapy for
`Keratoconjunctivitis Sicca, ADVANCES IN EXPERIMENTAL
`MEDICINE AND BIOLOGY (LACRIMAL GLAND, TEAR FILM & DRY
`EYE SYNDROMES 3) 506:1237-1240 (2002)
`
`1057
`
`Glenn, C. New Thinking Spurs New Products, REV. OPHTHALMOL. 1(2),
`FEB. 2003.
`
`1058
`
`Oellerich et al., Lake Louise Consensus Conference on Cyclosporin
`Monitoring in Organ Transplantation: Report of the Consnsus
`Panel, THERAPEUTIC DRUG MONITORING 17:642-654 (1995)
`
`-11-
`
`
`
`
`
`1059
`
`Foulks, G.N., et al., 2007 Report of the International Dry Eye Workshop
`(DEWS) 5 OCULAR SURF. (2007) 65-202
`
`1060
`
`1061
`
`1062
`
`Avunduk et al., The Comparison of Efficacies of Topical
`Corticosteroids and Nonsteroidal Anti-inflammatory Drops on
`Dry Eye Patients: A Clinical and Immunocytochemical Study,
`AM. J. OPHTHAL.136:593-602 (2003)
`
`Lamberts, D.W., Clinical Diseases of the Tear Film, in The Cornea, 3rd
`Ed., (eds. Smolin & Thoft (1994))
`
`Akpek et al., Ocular Rosacea: Patient Characteristics and Follow-up,
`OPHTHALMOL. 104:1863-67 (1997)
`
`1063
`
`Allergan Form 10-K for the year ended December 31, 2015
`
`1064
`
`Drugs@FDA: FDA Approved Drug Products, New Drug Application
`No. 050790, https://www.accessdata.fda.gov/scripts/cder/daf
`/index.cfm?event=overview.process&ApplNo=050790, accessed
`June 20, 2017
`
`1065
`
`Allergan Form 10-K for the year ended December 31, 2009
`
`1066
`
`Allergan Introduces RESTASIS MULTIDOSE (Cyclosporine
`Ophthalmic Emulsion) 0.05 %, a New Delivery System for the
`One and Only FDA Approved Treatment to Help Patients
`Produce More of Their Own Tears, CISION PR NEWSWIRE,
`http://www.prnewswire.com/news-releases/allergan-introduces-
`restasis-multidose-cyclosporine-ophthalmic-emulsion-005-a-new-
`delivery-system-for-the-one-and-only-fda-approved-treatment-to-
`help-patients-produce-more-of-their-own-tears-300353429.html#,
`accessed June 20, 2017
`
`1067
`
`FDA Label for Restasis MultiDose™
`
`1068
`
`Allergan Form 10-K for the year ended December 31, 1993
`
`-12-
`
`
`
`
`
`1069
`
`1070
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations, Patent and Exclusivity for: N050790,
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?P
`roduct_No=001&Appl_No=050790&Appl_type=N, accessed
`June 21, 2017
`
`Kymionis et al., Treatment of chronic dry eye: focus on cyclosporine,
`CLIN OPTHALMOL., 2(4):829-836, 2008,
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699789/,
`accessed June 20, 2017
`
`1071
`
`Chronic Dry Eye Disease, https://www.restasis.com/What-Is-Chronic-
`Dry-Eye-Disease, accessed June 21, 2017
`
`1072
`
`Allergan Form 10-K for the year ended December 31, 2002
`
`1073
`
`1074
`
`1075
`
`Keratoconjunctivitis Sicca, MERCK MANUAL,
`http://www.merckmanuals.com/home/eye-disorders/corneal-
`disorders/keratoconjunctivitis-sicca, accessed June 21, 2017
`
`Abelson and Smith, A Stepwise Approach to Acute Dry Eye, REVIEW OF
`OPHTHALMOLOGY,
`https://www.reviewofophthalmology.com/article/a-stepwise-
`approach-to-acute-dry-eye, accessed June 22, 2017
`
`Javadi and Feizi, Dry Eye Syndrome, J. OPHTHALMIC VIS. RES. 6(3):192-
`198, 2011, https://www.ncbi.nlm.nih.gov/pmc/articles/
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`
`1076
`
`https://www.xiidra.com/, accessed June 22, 2017
`
`1077
`
`1078
`
`FDA approves new medication for dry eye disease, FDA News Release,
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncement
`s/ucm510720.htm, accessed June 22, 2017
`
`Bailey, G., Shire gets FDA nod for Xiidra (lifitegrast) for dry eye,
`OPTOMETRY TIMES OPTOMETRY ALCON,
`http://optometrytimes.modernmedicine.com/optometrytimes/news
`/shire-gets-fda-nod-xiidra-lifitegrast-dry-eye, accessed June 22,
`2017
`
`-13-
`
`
`
`
`
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`
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`
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`
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`
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`
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`
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`
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`
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`(AGN_RES1123159)
`
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`(AGN_RES1147478)
`
`PROTECTIVE ORDER MATERIAL – Allergan, 2016 U.S. Eye Care
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`(AGN_RES0614120)
`
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`
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`
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`
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`
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`
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`Healthcare/Institutional/Government: Managed Healthcare
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`
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`
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`
`-17-
`
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`
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`
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`
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`
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`(AGN_RES1146945)
`
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`(AGN_RES1147652)
`
`1130
`
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`
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`
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`
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`
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`(AGN_RES1153653)
`
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`modifies multidrug resistance, BR. J. CANCER, 62:591-594 (1990)
`
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`Pro Hav Vice Admission
`
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`
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`
`1135
`
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`
`1136
`
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`Owner’s Sur-reply
`
`-18-
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Petitioners’ Reply in Support of Petitioners’ Motion to Exclude
`
`Evidence and Exhibits 1135-1136 on this 3rd day of August, 2017, on the Patent
`
`Owner at the correspondence address of the Patent Owner as follows:
`
`Dorothy P. Whelan
`Michael Kane
`Susan Morrison Colletti
`Robert M. Oakes
`Jonathan Singer
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP1@fr.com
`Email: IPR13351-0008IP2@fr.com
`Email: IPR13351-0008IP3@fr.com
`Email: IPR13351-0008IP4@fr.com
`Email: IPR13351-0008IP5@fr.com
`Email: IPR13351-0008IP6@fr.com
`Email: PTABInbound@fr.com
`
`And on the remaining Petitioners as follows:
`
`
`Gary Speier
`Mark Schuman
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Email: gspeier@carlsoncaspers.com
`Email: mschuman@carlsoncaspers.com
`Attorneys for Teva Pharmaceuticals USA, Inc.
`
`
`
`-19-
`
`
`
`
`
`
`
`Michael Dzwonczyk
`Azadeh Kokabi
`Travis Ribar
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave., NW
`Washington, DC 20037
`Email: mdzwonczyk@sughrue.com
`Email: akokabi@sughrue.com
`Email: tribar@sughrue.com
`Attorneys for Akorn Inc.
`
`Dated: August 3, 2017
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
`
`
`
`-20-
`
`
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