`
`Paper No. ___
`Filed: July 20, 2017
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`
`
`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’ MOTION TO EXCLUDE EVIDENCE
`37 C.F.R. §42.64
`
`
`
`
`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).
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`I.
`
`INTRODUCTION
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`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c), Petitioners respectfully move
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`to exclude (A) Patent Owner’s reliance on EX2008 to prove a difference between
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`the 0.05% and 0.10% CsA formulations; (B) paragraphs 48 and 33, 47 respectively
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`of the Sheppard and Loftsson declarations (EX2024 and EX2025) relying on
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`Schiffman and Attar Exhibits and testimony that are entitled to no weight pursuant
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`to Paper 33; (C) the LeCause deposition transcript (EX2038); (D) paragraphs (e.g.,
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`31, 34, 36-38, 50-51, 59-60, 65, 67-68, 74-76, 88-89, and 96) of the Maness
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`declaration (EX2028) relying on the LeCause deposition transcript (EX2038); and
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`(E) three new exhibits (EX2077-EX2079) belatedly served with Allergan’s Sur-
`
`Reply to assert new arguments fourth months after Allergan’s PORs were due.
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`The Federal Rules of Evidence apply to inter partes proceedings. 37 C.F.R.
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`§ 42.62; LKQ Corp. v. Clearlamp, LLC, IPR2013-00020, Paper 17, at 3 (Mar. 5,
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`2013). This Motion addresses issues in Petitioner’s Objections to Evidence (Paper
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`Nos. 11, 17, 48 and the July 12-14, 2017 depositions of Petitioners’ witnesses.
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`II. ARGUMENT
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`A. EX2008 Should Be Excluded Under F.R.E. 801-805.
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`Allergan describes EX2008 as “RESTASIS® label.” Sur-Reply at i.
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`Petitioner objected to EX2008 “To the extent that Patent Owner relies on EX. 2008
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`or on any statements in EX. 2008 for the truth of the matter asserted” because
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`-1-
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`“such statements are inadmissible hearsay when offered by Patent Owner.” Paper
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`11 at 5-6 (citing F.R.E. 801, 802, 803, 805). Allergan cited EX2008 to argue that
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`“FDA relied upon the Schirmer tests with anesthesia in approving
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`RESTASIS®….” POR at 11-12 (citing EX2008 at 5 (clinical studies)). In its Sur-
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`Reply, Allergan argued for the first time ever that “FDA concluded that the 0.05%
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`CsA emulsion was statistically better at increasing tear production…than both the
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`0.1% CsA emulsion and vehicle for certain patient populations. EX. 2078 at 26. On
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`this basis, FDA approved RESTASIS® for increasing tear production.” Paper 42 at
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`6-7 & n.4 (citing EX2008 at 1).
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`Each of these statements is an improper attempt by Allergan to rely on out-
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`of-court statements contained in EX2008 without the benefit of any expert
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`analysis. Notably, EX2008 contains no comparison between the two CsA
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`formulations and thus contradicts Allergan’s unsupported attorney argument that
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`sub-group results purportedly discussed in EX2078 were the basis for FDA’s
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`decision. Allergan’s mischaracterization of the statements in EX2008 illustrates
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`why out-of-court statements should be subjected to cross-examination. The
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`statements relied upon by Allergan are inadmissible hearsay for the purposes for
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`which Allergan offers them, and they should be excluded to the extent Allergan
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`relies upon them as asserting superiority of the 0.05% CsA formulation over the
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`0.10% CsA formulation.
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`-2-
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`
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`B.
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`Paragraphs 48 of EX2024 and 33 and 47 of EX2025 Should Be
`Excluded or Afforded No Weight Per Order of Paper 33.
`
`Following Allergan’s refusal to provide the data underlying Schiffman
`
`Exhibits B, D-F and Attar Exhibits C-D, the Board issued an order establishing that
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`these exhibits, as well as testimony and arguments based thereon would be
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`“entitled to no weight.” Paper 33 at 3 (Board ruling “because Patent Owner will
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`not produce the clinical trial data underlying Schiffman Exhibits B, D, E, F and
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`Attar Exhibits C and D, those exhibits and related testimony are entitled to no
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`weight and will not be considered in determining the patentability of the
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`challenged claims”); see also Paper 22 at 2 (order authorizing Motion for
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`Discovery for “the data underlying the study results…rel[ied] upon to establish
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`criticality of, and unexpected results for, the claimed combination of cyclosporin A
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`and castor oil.”); Paper 23 (Motion for Discovery); Paper 28 at 5 (order granting-
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`in-part Petitioners’ Motion for Discovery).
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`EX2024 and EX2025 are the Sheppard and Loftsson declarations,
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`respectively. Drs. Sheppard and Loftsson both confirmed they studied the
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`declarations of Drs. Schiffman and Attar prior to submitting their declarations in
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`the current proceeding. EX1037 (Sheppard deposition transcript), 52:14-55:4,
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`259:16-260:5; EX1036 (Loftsson deposition transcript), 22:4-23:23, 41:3-42:16.
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`Despite asserting that they did not rely on these declarations to form their own
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`opinions, Drs. Sheppard and Loftsson admitted to (1) adopting language from the
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`-3-
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`
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`Schiffman and Attar declarations into their own declarations (EX1037, 260:7-
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`261:7 (Dr. Sheppard’s inclusion of the phrase “‘optimal therapeutic effectiveness’
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`in paragraph 48” of his declaration was “not anything I meant. That’s something
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`they[Drs. Schiffman and Attar] said.”)); (2) drawing conclusions of “unexpectedly
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`and surprisingly critical results” that must be viewed in the “context [of] referring
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`to these declarations by Drs. Schiffman and Attar,” (id.); and relying upon
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`Schirmer Tear Testing figures embedded in the Attar declaration for their analysis
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`of Sall Figure 2. EX1036, 200:20-201:22 (Dr. Loftsson clarifying the basis for his
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`conclusions in paragraph 33, and noting he “notice[d]…some comparison there of
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`these two formulations which confirmed my observation” within “Attar declaration
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`figures” which included “figures about Schirmer tear testing.”); id. at 204:4-14
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`(when asked if he had “any recollection of relying on anything other than Sall,”
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`responded “Like I said before, I did see – I did mention Attar before”).
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`Thus, pursuant to the Board’s orders, paragraph 48 of EX2024 and
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`paragraphs 33 and 47 of EX2025 and Drs. Sheppard and Loftsson’s analysis of
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`Sall Figure 2 relying on the excluded portions of the Schiffman and Attar
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`declarations should be excluded.
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`C. EX2038 Should Be Excluded Under F.R.E. 602, 901, 801-805, and
`37 C.F.R. § 42.53(a).
`
`Allergan describes EX2038 as the deposition testimony of Allergan
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`employee David LeCause. POR at 12. This deposition testimony was obtained in
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`-4-
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`
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`the course of a different proceeding involving the ’930, ’111, ’556, ’162, ’048, and
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`’191 patents, Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-
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`01455, filed by Allergan, Inc. in the Eastern District of Texas. Petitioner objected
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`to the submission of and reliance upon EX2038 in Paper 17 at 7-9.
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`Patent Owner’s submission of EX2038 in these proceedings is an improper
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`attempt to insulate Mr. LeCause from cross-examination. Petitioners requested that
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`Allergan produce Mr. LeCause for deposition in these IPR proceedings; Allergan
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`refused. EX1134. Allergan’s refusal to submit Mr. LeCause to cross-examination
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`in these proceedings violates the Board’s rules requiring that uncompelled direct
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`testimony be submitted in the form of an affidavit and that the witness be subject to
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`cross-examination during the discovery period. 37 C.F.R. § 42.53(a), (d).
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`EX2038 should also be excluded because Allergan has failed to provide any
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`foundation for this exhibit or to establish its authenticity. F.R.E. 901, 601; Paper 17
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`at 7-9. No witness with personal knowledge has authenticated EX2038. Moreover,
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`the transcript itself and Mr. LeCause’s purported statements therein constitute
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`inadmissible hearsay when offered by Patent Owner because they are statements
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`not made under oath in these proceedings and are statements offered for the truth
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`of the matters asserted. F.R.E. 801-805. For each of these reasons, EX2038 should
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`be excluded or at least afforded no weight.
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`-5-
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`D.
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`Paragraphs 31, 34, 36-38, 50-51, 59-60, 65, 67-68, 74-75, 88-89,
`and 96 of EX2028 Should Be Excluded Because They Rely Upon
`EX2038.
`
`Paragraphs 31, 34, 36-38, 50-51, 59-60, 65, 67-68, 74-76, 88-89, and 96 of
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`EX2028 rely upon EX2038 and/or a purported “Conversation with David
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`LeCause,” and thus constitute an improper attempt to circumvent the Board’s rules
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`regarding cross-examination of witnesses, as discussed above in Section II.C.
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`These paragraphs of EX2028, cited by Allergan (POR at 12, 40-42; Sur-Reply at
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`12-13) should be excluded, or at least entitled to no weight, for the same reasons
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`discussed above in Section II.C. Petitioner objected to reliance on EX2038 and
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`private conversations with Mr. LeCause in Exhibit 2028 in Paper 17 at 7-9.
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`E.
`
`EX2077, EX2078, EX2079 and Allergan’s Sur-Replies Contain
`Improper New Arguments.
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`Patent Owner requested a Sur-Reply to address purported “new arguments”
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`raised in Petitioners’ Reply. Allergan did not ask the Board for, nor did the Board
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`grant Allergan permission, to submit new evidence or new theories not previously
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`asserted in its Response. Nonetheless, Allergan belatedly produced Exhibits 2077-
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`2079 nearly four months after the time for its Responses had lapsed. Petitioner
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`objected to these late submissions in Paper 48 and at the depositions of Dr. Calman
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`and Dr. Bloch. EX2082 (Calman deposition transcript), 133:1-9 (objecting to
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`EX2077); EX2083 (Bloch deposition transcript), 77:15-22 (objecting to EX2079).
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`These new arguments and exhibits violate Board rules and the procedural
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`-6-
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`
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`order in these proceedings. 37 C.F.R. 42.23(b) (reply may only respond to
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`arguments raised in the corresponding paper); Paper 10 (scheduling order). For
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`example, Allergan submitted EX2077 to purportedly undermine the discussion of
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`the CsA concentration taught in the prior art Kaswan reference (EX1011) to satisfy
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`the therapeutic threshold for treating uveitis (Sur-Reply at 11-12), but both the
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`Kaswan reference and corresponding discussion were submitted for each of the
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`Petitions and Amiji declarations. See e.g., IPR2016-01127, Petition at 16-17, 54;
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`EX1002, ¶¶51, 145. The therapeutic CsA threshold was not a new argument, was
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`not raised for the first time in Petitioner’s Reply, and was properly responsive to
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`Patent Owner’s submission for the first time with its POR of PK data (EX1027,
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`EX2026-2027) to attempt to support its “thermodynamics” argument.
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`As another example, Allergan improperly attempts to introduce new bases
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`for its alleged unexpected results, which rely upon EX2078 and EX2079 for
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`support. Sur-Reply at 4-5, 7, 12 (relying on EX2078); id. at 6 (relying on EX2079).
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`Allergan’s Patent Owner Responses and declarations offered in support thereof
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`asserted only Sall Figure 2 as evidence of purportedly unexpected results. POR at
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`34-36. Indeed, Allergan’s declarants testified that Sall Figure 2 was the sole basis
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`of the “criticality” and unexpected results asserted. EX1037, 246:1-249:12 (Dr.
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`Sheppard excluded all data except for Sall Figure 2 from his declaration); EX1036,
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`200:14-202:21 (Dr. Loftsson did not identify “anything in Sall besides Figure 2”
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`-7-
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`on which he relied to support conclusions of “formulations act[ing] differently,” or
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`that the claimed emulsion “is critical for increasing tear production in patients with
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`dry eye.”). Yet Allergan’s Sur-Reply newly asserts—without expert support—each
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`of Sall Figures 1, 3-4 as evidence of a “meaningful difference” between the 0.05%
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`and 0.10% CsA formulation. Sur-Reply at 6 n.3. Allergan’s belated reliance on
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`these figures (and belated production of the new Figure 4) has deprived the Board
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`and Petitioner of a complete expert analysis with regard to Sall Figures 3-4,
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`deprives Petitioner of Due Process, and violates Board rules and the scheduling
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`orders in these proceedings.
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`Allergan additionally submitted EX2079 with its Sur-Reply after it belatedly
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`decided to rely upon a corrected version of Sall Figure 4 to establish criticality and
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`unexpected results. Earlier, Allergan’s Dr. Rhett Schiffman confirmed that Sall
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`Figure 4 did not reflect the underlying data because it was simply a re-scaled
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`version of Figure 3 that was mistakenly published in Sall. EX1035 (Schiffman
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`deposition transcript), 59:3-61:4. After withholding the clinical data underlying
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`Sall Figures 1-4, Allergan belatedly offers EX2079 as a replacement summary of
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`undisclosed underlying data in support of its new argument based on Sall Figure 4.
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`This is improper and violates the Board’s scheduling orders requiring Allergan to
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`provide its Patent Owner Response nearly four months ago. Paper 10 (scheduling
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`order).
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`-8-
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`Allergan’s Sur-Reply further asserts that EX2078 demonstrates criticality
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`and unexpected results, arguing that the 0.05% CsA formulation increased tearing
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`by at least 10 mm in a statistically significantly larger number of ITT and
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`Sjögren’s patients taking anti-inflammatory medicines or using punctal plugs as
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`compared to treatment with the 0.10% CsA formulation. Sur-Reply at 4-5, 7, 12.
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`But Allergan never argued increased tearing in the ITT anti-inflammatory/punctal
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`plugs subgroup or the Sjögren’s anti-inflammatory/punctal plugs subgroup as a
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`basis for criticality or unexpected results in any of its prior Responses and cannot
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`do so now. Paper 16 (POR); 37 C.F.R. 42.23(b).
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`Further, Allergan attempts to link EX2078 to conclusions made in the
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`Restasis® label, EX2008. Sur-Reply at 6-7; see also Paper 11 at 5-6 (objecting to
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`EX2008). The Restasis® label does not discuss the 0.1% CsA formulation, let alone
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`report the Schirmer Tear Test performance of patients taking the 0.1% CsA
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`formulation. Rather, the label reports 10 mm increases in Schirmer Tear Tests
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`administered to 15% of patients taking Restasis for six months, versus 5% of
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`patients taking just the vehicle. EX2008. Allergan attempts to rely upon Table 4 of
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`EX2078 to fill this gap, yet Table 4 does not report values of 15% and 5% for these
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`formulations for any group or subgroup.
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`By failing to produce these documents four months ago with its PORs and
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`by refusing to produce the underlying clinical data requested in Petitioners’ Motion
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`-9-
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`for Discovery (Papers 22, 23), Allergan attempts to circumvent the Board’s
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`discovery and scheduling orders and insulate this information from reasoned expert
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`analysis. For these reasons, they should be excluded.
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`1. EX2077 Should Be Excluded Under F.R.E. 602, 701, 702.
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`Allergan presents EX2077 as a reference to which EX1011 cites in its
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`discussion of CsA concentrations sufficient to treat ocular disorders. Sur-Reply at
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`11-12. None of Allergan’s declarants discusses EX2077 in their declaration,
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`provides any foundation for this document, identifies the source of this document,
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`or purports to have any knowledge regarding the document or the information
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`contained therein. In short, Allergan offers Exhibit 2077 without foundation or
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`expert analysis, in violation of F.R.E. 602, 701, 702.
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`Moreover, Allergan has ignored the only expert testimony that actually
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`analyzes EX2077, and this testimony flatly contradicts the attorney argument in
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`Allergan’s Sur-Reply. EX2082 (Calman deposition transcript), 127:11-132:13
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`(discussing the teachings of EX1011); id. at 132:14-155:11 (discussing EX2077).
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`Allergan’s unsupported attorney argument is that serum concentrations of CsA
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`known to result in therapeutic efficacy across multiple tissue types are irrelevant to
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`the tissue concentrations of CsA known to result in therapeutic efficacy. Sur-Reply
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`at 11-12. However, Allergan elicited testimony from Dr. Calman explaining that
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`consistent therapeutic results of CsA in many different tissue types (including
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`-10-
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`
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`ocular tissue) at similar serum and tissue concentrations indicate that the tissues
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`were taking up CsA at concentrations consistent with the serum concentration and
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`that these concentrations were therapeutically effective in the tissues. EX2082
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`(Calman deposition testimony), 132:14-155:11. Dr. Calman also confirmed that the
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`Oellerich reference upon which he relied in addition to Kaswan indicates that
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`serum levels provide a basis for establishing therapeutically efficacious tissue
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`levels. Id.; EX1039, ¶79, citing EX1058. Allergan’s Sur-Reply failed to inform the
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`Board of this testimony and offered EX2077 entirely without foundation.
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`As another example, Allergan also offered unsupported attorney argument
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`that a difference in units in one place in EX2077 and the prior art disclosure in
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`EX1011 undermines the prior art teachings of EX1011 regarding therapeutically
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`efficacious levels of CsA. Sur-Reply at 11-12 Allergan again ignores the
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`foundational testimony that it elicited on this subject from Dr. Calman, who noted
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`that Allergan’s argument was based on clear typographical errors and a failure to
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`read the reference in its totality as would be done by a person of ordinary skill in
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`the art. EX2082 (Calman deposition transcript), 135:23-7 (“what they found in
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`Table 1 was that the 80-microgram injection was not effective and that the 500-
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`milligram, which I think is probably a microgram, injection was effective. In fact,
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`let’s go back to materials and methods. It would almost be impossible for it to be
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`milligrams.”); id. at 137:14-138:10 (when asked about Table 2, wherein “the
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`-11-
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`
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`results there are being reported in milligrams per milliliter,” Dr. Calman responded
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`“I think that’s wrong too. There’s just no way you can get those kinds of levels. [Q.
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`Okay.] It wouldn’t dissolve. We know that cyclosporin has very low solubility in
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`aqueous solution, and the vitreous humor is an aqueous solution with some
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`collagen strands. It’s not an oily tissue. There’s just no way. And I’m just seeing
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`lots of typos in this paper.”).
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`Dr. Calman’s testimony is corroborated by the prior art Kaswan reference,
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`which similarly interpreted “levels ranging from 50 to 200 ng/gm” to be
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`comparable to the “50 to 300 ng/mL” reported by Nussenblatt. EX1011 at 653.
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`Moreover, Allergan elicited testimony from Dr. Calman establishing that “the
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`difference [in units] is essentially immaterial,” concluding “I’m convinced as a
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`scientist reading the totality of this data that those are the kinds of tissue levels that
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`are adequate for efficacy in a variety of tissues,” and reminding Allergan’s counsel
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`that “it’s not a high school student, but a POSA” reviewing the relevant art.
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`EX2082 (Calman deposition transcript), 138:11-143:14, 148:12-149:11; 151:5-
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`152:25. Because Allergan failed to provide any foundation for EX2077 in its Sur-
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`Reply, EX2077 should be excluded.
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`2. EX2078 Should Be Excluded Under F.R.E. 602, 701, 702, 901,
`801-805, 1002, 1006, 37 C.F.R. §§ 42.53(a), 42.65(a).
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`Allergan describes EX2078 as a “Medical Officer’s Review of NDA 21-
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`023.” Sur-Reply at v. Allergan failed to provide declarations from the author(s) of
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`-12-
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`
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`EX2078, and thus fails to provide adequate foundation for the document and the
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`statements contained therein as either lay testimony or expert testimony of any
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`particular declarant. F.R.E. 602, 701, 702; 37 C.F.R. § 42.53(a). None of
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`Allergan’s declarants discuss EX2078 in their declaration, provide any foundation
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`for this document, identify the source of this document, or purport to have any
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`knowledge regarding the document or the information contained therein.
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`Allergan has also failed to authenticate EX2078. The facial unreliability of
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`data in EX2078 raise a substantial question as to its authenticity: the data in Table
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`4 contain a percentage of “responders” for the ITT-anti-inflammatory/punctal
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`plugs subpopulation (18%) that does not match the number of persons reported in
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`the sub group (10/109, 9.1% for the 0.05% CsA group vs. 10/106, 9.4% for the
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`0.1% CsA group). Results varied widely between the two U.S. Studies (192371-
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`002, -003) and also were not reproducible in the European studies (192371-501, -
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`503), at least one of which reported a numerically higher result for the 0.1% CsA
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`formulation than for the 0.05% formulation. EX2078 at 26. Allergan’s failure to
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`provide any declarant for cross-examination regarding this document raises serious
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`questions as to its authenticity and reliability, including the methodology for
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`completing the studies and analyzing the data. F.R.E. 602, 701, 702, 901.
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`EX2078 itself and the statements contained therein are offered by Allergan
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`for the truth of the matter asserted (alleged superiority of the 0.05% CsA
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`-13-
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`
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`formulation over the 0.10% CsA formulation and this alleged finding being an
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`alleged basis of FDA approval), and are therefore inadmissible hearsay. F.R.E.
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`801-805. Moreover, EX2078 does not provide support for Allergan’s argument
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`that the 0.05% CsA formulation was approved by the FDA because it was
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`allegedly unexpectedly critical or superior over the 0.10% CsA formulation.
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`EX2078 does not make any conclusion of any significant difference between the
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`two CsA formulations in any population or subpopulation (EX2078 at 29), and the
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`p-values provided on page 26 of the report provide a comparison to the vehicle, not
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`between CsA groups. Id. at 26; see also EX2001 at 307-8 (Study 192371-002, -003
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`“Objective: To evaluate the safety and efficacy of cyclosporine 0.05% and 0.1%
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`ophthalmic emulsions compared with vehicle….”), 316 & Table 3.7.3.6-5 (P-value
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`reflects among-group differences; both CsA formulations favored vs vehicle).
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`Allergan chose not to authenticate EX2078, or to provide a witness to lay
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`foundation for EX2078, and indeed, chose to withhold EX2078 until after all
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`substantive papers and depositions of Allergan witnesses in these proceedings were
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`scheduled to be completed. Moreover, Allergan did not produce the raw data
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`purportedly summarized in EX2078, and EX2078 lacks foundation as a summary
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`to prove content. F.R.E. 1002, 1006; 37 C.F.R. §42.65(a). For each of these
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`reasons, EX2078 should be excluded.
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`3. EX2079 Should Be Excluded Under F.R.E. 602, 701-702, 801-
`805, 1002, 1006, and 37 C.F.R. § 42.65(a).
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`-14-
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`Allergan describes EX2079 as a “Correction to Sall article (Ex. 1007).” Sur-
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`Reply at v, 6. Allergan failed to provide declarations from the author(s) of
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`EX2079, and thus fails to provide adequate foundation for the document and the
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`statements contained therein as either lay testimony or expert testimony of any
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`particular declarant. F.R.E. 602, 701, 702. None of Allergan’s declarants discuss
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`EX2079 in their declaration, provide any foundation for this document, identify the
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`source of this document, or purports to have any knowledge regarding the
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`document or the information it describes. Additionally, the statements contained in
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`EX2079 are offered by Allergan for the truth of the matter asserted (alleged
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`superiority of the 0.05% CsA formulation over the 0.10% CsA formulation), and
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`are therefore inadmissible hearsay. F.R.E. 801-805.
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`Moreover, Allergan did not produce the raw data purportedly summarized in
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`EX2079, and it lacks foundation as a summary to prove content. F.R.E. 1002,
`
`1006; 37 C.F.R. §42.65(a). For each of these reasons, EX2079 should be excluded.
`
`III. CONCLUSION
`
`For the foregoing reasons, Petitioner requests that this Motion to Exclude be
`
`granted.
`
`Dated: July 20, 2017
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`-15-
`
`
`
`
`
`
`
`
`
`
`
`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)
`
`-16-
`
`
`
`
`
`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)
`
`-17-
`
`
`
`
`
`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.
`
`-18-
`
`
`
`
`
`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)
`
`-19-
`
`
`
`
`
`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)
`
`-20-
`
`
`
`
`
`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)
`
`Lamb
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