UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
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`EXCLUDE EVIDENCE
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`1 Cases IPR2017-00578 and IPR2017-00596 have been joined with this
`proceeding.
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
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`EXCLUDE EVIDENCE
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`1 Cases IPR2017-00578 and IPR2017-00596 have been joined with this
`proceeding.
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`I. INTRODUCTION
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`Mylan’s motion to exclude is a surreply in disguise. After Allergan filed its
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`surreply—a surreply that the Board authorized after Allergan objected to the new
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`evidence and theories presented for the first time in Mylan’s reply——Mylan
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`sought leave to respond. The Board denied Mylan’s request. The evidentiary
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`objections Mylan now raises in its motion to exclude are actually pretexts for
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`presenting substantive arguments that the Board prohibited Mylan from filing.
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`Mylan’s true objection is to the substance of Allergan’s evidence and arguments.
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`Mylan’s motion is improper and should be denied.
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`II. EX. 2008 IS ADMISSIBLE
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`EX. 2008 is the RESTASIS® label. Allergan relies on EX. 2008 to show
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`that RESTASIS® is indicated for increasing tear production. Allergan further
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`relies on EX. 2008 to show that FDA relied on Schirmer tests with anesthesia in
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`approving RESTASIS® for tear production. Mylan objects that EX. 2008 is
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`hearsay. However, EX. 2008 falls within the public record exception set forth in
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`F.R.E. 803(8). See Sabel v. Mead Johnson & Co., 737 F. Supp. 135, 143 (D. Mass.
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`1990) (letter from an FDA director recommending a boxed warning be included on
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`defendants’ label fell within public record exception, as it “was prepared pursuant
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`to the FDA’s statutory responsibility to regulate the safe marketing of prescription
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`2
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`drugs.”); Musgrave v. Breg, Inc., No. 2:09-CV-01029, 2011 WL 4502032, at *6
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`(S.D. Ohio Sept. 28, 2011) (“FDA bulletins to healthcare professionals” fell within
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`public record exception because “they are statements directly from the FDA setting
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`forth matters observed pursuant to duty imposed by law as to which matters there
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`was a duty to report.”). Exhibit 2008 is admissible.
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`Mylan’s real objection is to Allergan’s argument that, taken together with
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`EX. 2078, EX. 2008 demonstrates FDA concluded that the claimed 0.05%
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`CsA/1.25% castor oil formulation was statistically better at increasing tear
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`production than the 0.1% CsA/1.25% castor oil formulation and the castor oil
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`vehicle for certain populations of patients. This is not an evidentiary objection.
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`Rather, it is an attempt to circumvent the Board’s order barring Mylan from
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`submitting additional briefing.
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`III. PARAGRAPHS 48 OF EX. 2024 AND 33 AND 47 OF EX. 2025 ARE
`ADMISSIBLE
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`EX. 2024 is Dr. Sheppard’s declaration. In Paragraph 48, Dr. Sheppard
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`notes that Drs. Attar and Schiffman also reached the same conclusions that he
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`independently reached.
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`EX. 2025 is Dr. Loftsson’s declaration. Paragraph 33 sets forth Dr.
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`Loftsson’s analysis of the Phase 3 clinical data presented in Sall Fig. 2. In
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`paragraph 47, Dr. Loftsson notes that Drs. Attar and Schiffman also reach the same
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`conclusions that he independently reached.
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`3
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`Attorney Docket No: 13351-0008IP2
`As Mylan admits, both Dr. Sheppard and Dr. Loftsson made clear that they
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`reached their opinions independently of the tear production and corneal staining
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`data included in the Schiffman and Attar declarations. See EX. 1037 at 53:20-
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`54:2, 54:22-55:4; EX. 1036 at 41:3-42:16. Both relied instead on the data
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`presented in Sall and other evidence in the IPR record. Stating that their
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`independent conclusions were consistent with the conclusions that Drs. Schiffman
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`and Attar reached is completely different from relying on the tear production and
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`corneal staining data included in the Schiffman and Attar declarations. Mylan’s
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`arguments to the contrary are baseless.
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`IV. EX. 2038 AND THE PARAGRAPHS OF DR. MANESS’
`DECLARATION THAT CITE IT ARE ADMISSIBLE
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`EX. 2038 is the deposition testimony of David LeCause obtained in the
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`related district court litigation involving the RESTASIS® patents that is pending in
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`the Eastern District of Texas. Dr. Maness (EX. 2028) relied on Mr. LeCause’s
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`testimony as well as conversations with Mr. LeCause. Mylan now seeks to
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`exclude EX. 2038, as well as paragraphs of Dr. Maness’ declaration that rely on
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`Mr. LeCause, because Mylan did not have the opportunity to depose Mr. LeCause.
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`Mylan’s position is meritless.
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`First, Mylan is not entitled to depose Mr. LeCause simply because Dr.
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`Maness relied on his deposition testimony or had conversations with him. Mr.
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`4
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`Attorney Docket No: 13351-0008IP2
`LeCause does not fall into any of the categories of routine discovery enumerated in
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`37 C.F.R. § 42.51(b)(1) (i)-(iii). In response to Mylan’s request to depose Mr.
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`LeCause, Allergan told Mylan to seek leave to file a motion for additional
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`discovery if it wanted to depose Mr. LeCause. Mylan did nothing. By not availing
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`itself of the appropriate procedures, Mylan waived any objection to Mr. LeCause’s
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`testimony and statements.
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`Second, as an expert Dr. Maness is entitled to rely on evidence regardless of
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`whether the evidence itself is admissible. In IPR2015-00249, the Board addressed
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`a similar situation. There, the Patent Owner’s expert relied on the deposition
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`testimony of a witness given in a different IPR proceeding. The Board held that
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`because the Patent Owner’s expert provided an opinion on the deposition
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`testimony, the deposition should be admitted so that the expert’s opinion could be
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`properly considered. The Board stated:
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`Patent Owner argues that even if the Spinak Deposition is
`hearsay, it is admissible under Fed. R. Evid. 703. We agree. Federal
`Rule of Evidence 703 permits an expert to base an opinion on facts or
`data in the case that an expert has been made aware of if experts in the
`field would reasonably have relied on such facts or data in forming an
`opinion …. Mr. Spinak testified regarding FDA validation of an
`aspetic bottling system, and it was reasonable for Dr. Sharon to rely
`upon such information.
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`5
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`Attorney Docket No: 13351-0008IP2
`Nestle Healthcare Nutrition, Inc. v. Steuben Foods, Inc., IPR2015-00249, Paper
`No. 76, p. 13 (PTAB June 2, 2016).
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`The rules are clear—Dr. Maness is entitled to rely on Mr. LeCause’s
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`testimony and statements, and the deposition is admissible. Moreover, Mylan had
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`the opportunity to cross-examine Dr. Maness about the basis of his opinions when
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`it deposed Dr. Maness, including testimony and information from Mr. LeCause.
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`See Ex. 1034. Nothing more is required and Mylan chose not to seek leave for
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`additional discovery from Mr. LeCause.
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`For at least these reasons, the Board should deny Mylan’s motion to exclude
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`EX. 2038 or the portions of Dr. Maness’ testimony that rely on testimony or
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`statements by Mr. LeCause.
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`V. MYLAN’S OBJECTIONS TO EX. 2077, 2078, AND 2079 ARE AN
`UNAUTHORIZED REPLY TO ALLERGAN’S SURREPLY
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`Mylan objects that EXS. 2077, 2078, and 2079, as well as Allergan’s
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`surreply, represent “new evidence or new theories not previously asserted in its
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`Response.” Petitioner’s Motion to Exclude, p. 6. Mylan further objects that
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`Allergan failed to provide expert testimony with these exhibits. Id., pp. 10
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`(“Allergan offers Exhibit 2077 without foundation or expert analysis”), 13
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`(“Allergan’s failure to provide any declarant for cross-examination regarding [EX.
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`6
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`Attorney Docket No: 13351-0008IP2
`2078] raises serious questions as to its authenticity and reliability”), and 15 (“None
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`of Allergan’s declarants discuss Ex. 2079 in their declaration”).
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`Mylan’s objections are ironic. The Board granted the surreply because
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`Mylan’s reply, accompanied by three declarations from entirely new declarants,
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`improperly raised issues and theories for the first time. In effect, Mylan’s reply
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`was really a new petition, offering new evidence and theories of unpatentability.
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`Allergan’s arguments and evidence are “new” to the extent they are responding to
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`Mylan’s new theories. Mylan’s criticism assumes that Allergan somehow should
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`have anticipated these new arguments—essentially requiring Allergan to be a seer.
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`As for the lack of supporting expert declarations, Allergan agrees that such
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`declarations would have been helpful in responding to Mylan’s new arguments and
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`declarations. However, the Board did not authorize Allergan to submit expert
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`declarations, e.g., from a biostatistician or a clinician, to rebut Mylan’s new
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`declarations and arguments. Mylan’s criticism underscores the prejudice Allergan
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`suffers from the lack of a full and fair opportunity to rebut Mylan’s new
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`declarations and arguments with its own experts at this stage of the proceedings.
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`Indeed, the Board should grant Allergan’s motion to exclude Mylan’s new
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`declarations on the basis of the due process violation created by Mylan’s tactics.
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`Mylan’s real objection to EXs. 2077, 2078, and 2079, and Allergan’s
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`surreply, relates to the substance of the arguments. Mylan desperately wants an
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`7
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`Attorney Docket No: 13351-0008IP2
`opportunity for additional substantive briefing. However, when Mylan requested
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`leave to file additional briefing, the Board refused. Denied authorization to file
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`additional briefing, Mylan simply uses its motion to exclude as a vehicle for
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`presenting rebuttal arguments. Mylan’s motion to exclude is nothing more than an
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`end run around the Board’s refusal to grant Mylan’s request for additional briefing.
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`A. EX. 2077 is Admissible
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`EX. 2077 is the Nussenblatt paper cited in the Kaswan paper (EX. 1011)
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`upon which Mylan’s new expert, Dr. Calman, relies to support his theory that both
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`the 0.05% CsA/1.25% castor oil and 0.1% CsA/1.25% castor oil emulsions result
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`in amounts of CsA in the lacrimal gland that are above a “therapeutic threshold.”
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`EX. 1039, ¶ 81. Nussenblatt contradicts Dr. Calman’s opinion by showing that
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`Kaswan mistakenly substituted units of ng CsA/mL reported in Nussenblatt for ng
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`CsA/g tissue. The former is a measure of serum level, not tissue concentration. In
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`addition, Nussenblatt says nothing about the level of CsA in the ocular tissues
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`necessary to increase tear production in dry eye patients. EX. 2082 at 143:16-
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`145:9.
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`Dr. Calman admitted he had not considered Nussenblatt when offering his
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`opinion regarding the alleged therapeutic threshold. Id. at 133:11-134:19. He
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`further agreed that Nussenblatt described serum concentrations, not tissue
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`concentrations. Id. at 141:9-143:14. Although Dr. Calman attempted to backtrack
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`Attorney Docket No: 13351-0008IP2
`and offered a post hoc explanation during his deposition, in part by relying upon
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`Oellerich (EX. 1058, a paper relating to rejection in organ transplants), he never
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`contradicted the fundamental point that the therapeutic threshold of CsA in
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`lacrimal tissue for increasing tear production simply was not known.
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`B. EX. 2078 is Admissible
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`EX. 2078 is document from FDA entitled “Medical Officer’s Review of
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`NDA 21-023.” It contradicts Mylan’s argument, raised for the first in its reply,
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`that there is no statistical difference between the claimed 0.05% CsA/1.25% castor
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`oil formulation and the 0.1% CsA/1.25% castor oil formulation described in the
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`prior art Ding ‘979 patent. Mylan supports its arguments with declarations from
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`Drs. Bloch and Calman (EXs. 1040 and 1039). But what is the basis of their so-
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`called “statistical” analysis? Dr. Bloch relied on numbers that he “gleaned”
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`(in other words, estimated) from Sall Fig. 2 using a ruler and magnifying glass.
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`EX. 1040 at ¶¶ 26, 44; EX. 2083 at 40:4-41:4. Dr. Calman criticized Sall for using
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`categorized Schirmer scores rather than individual Schirmer scores. EX. 1039 at ¶
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`66. He also attempted to “infer” raw Schirmer scores from the categorized
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`Schirmer scores disclosed in Sall. Id. at ¶ 68.
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`On the basis of their scientifically unsound “analyses,” Drs. Bloch and
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`Calman concluded there was no statistical difference between the two
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`formulations. EX. 2078, from FDA, belies their conclusions.
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`9
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`Attorney Docket No: 13351-0008IP2
`EX. 2078 demonstrates that it was FDA who requested and relied on
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`categorized Schirmer scores in approving RESTASIS®. EX. 2078 at 26, 29. EX.
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`2078 demonstrates that it was FDA who concluded that the 0.05% CsA/1.25%
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`castor oil emulsion was statistically better at increasing tear production, as
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`measured by STT with anesthesia, than both the 0.1% CsA/1.25% castor oil
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`emulsion and the vehicle for clinically relevant dry eye patient populations. EX.
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`2078 at 26, 29. EX. 2078 demonstrates that on this basis, FDA approved
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`RESTASIS® for increasing tear production. Id. at 29-30; see also EX. 2008 at 1.
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`FDA found that there is a real, statistically significant, and clinically
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`meaningful difference between the two emulsions with respect to tear production.
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`EX. 2078 at 26. This finding is fatal to Mylan’s statistical analysis. Mylan
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`attempts to distract attention from EX. 2078 by criticizing Allergan’s declarants for
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`not discussing it, and for not providing a declarant for cross-examination. Motion
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`to Exclude, pp. 13-14. But Allergan could not have known that Mylan would
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`submit a new statistical analysis and theory of unpatentability in its reply,
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`supported by two new expert declarations.
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`If Allergan had had the opportunity to submit a declaration from its own
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`biostatistician, the biostatistician would have testified regarding the data shown in
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`Sall Fig. 2 and EX. 2078. However, Allergan lacked the opportunity to present
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`10
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`Attorney Docket No: 13351-0008IP2
`such a declaration at this late stage of the proceedings—again highlighting the lack
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`of due process.
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` EX. 2078 reports FDA’s Medical Officer’s Review and conclusions. It is
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`subject to the public records exception for hearsay in F.R.E. 803(8) for the reasons
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`discussed above for EX. 2008. FDA’s conclusions and analysis are more reliable
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`than the “guesstimates” that Mylan’s reply declarants provided. It is Mylan’s
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`declarants’ testimony that should be excluded.
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`C. EX. 2079 is Admissible
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`EX. 2079 is a correction to the Sall paper (EX. 1007). It was published in a
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`peer-reviewed article (“Ophthalmology”) by one of the authors of the Sall paper.
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`It points out and corrects errors in the original Sall paper relating to Figs. 1 and 4,
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`thus clarifying the record. Mylan’s objection is baffling. Mylan’s real objective is
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`to renew its complaint that Allergan did not produce the raw data that Dr.
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`Schiffman used to create the figures in his declaration. When Allergan agreed not
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`to rely on Dr. Schiffman’s figures but instead to rely solely on Sall, the Board
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`denied Mylan’s request for the raw data. Mylan never requested raw data for the
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`purpose of attacking the Phase 3 clinical data reported in Sall—a peer-reviewed
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`paper that included data with error bars and p-values. Mylan never established any
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`reason to doubt the data presented in Sall, especially given that in its petition
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`Mylan and its original expert, Dr. Amiji, relied upon Sall.
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`11
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`Attorney Docket No: 13351-0008IP2
`Once again, Mylan’s actions reveal that its reply was really an attempt to
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`present entirely new theories of unpatentability without affording Allergan a full
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`and fair opportunity to respond.
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`VI. CONCLUSION
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`For at least the foregoing reasons, Mylan’s motion to exclude should be
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`denied in its entirety. Moreover, the Board should disregard Mylan’s arguments
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`that purport to be related to evidentiary objections but, in fact, are unauthorized
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`attorney argument.
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`Date:/July 27, 2017/
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`
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`Customer Number 26191
`Fish & Richardson P.C.
`Telephone: (612) 337-2509
`Facsimile: (612) 288-9696
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`Respectfully submitted,
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`/Dorothy P. Whelan/
`Dorothy P. Whelan, Reg. No. 33,814
`Michael J. Kane, Reg. No. 39,722
`Attorneys for Allergan, Inc.
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`12
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
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`that on July 27, 2017, a complete and entire copy of this Patent Owner Allergan,
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`Inc.’s Opposition to Petitioner’s Motion to Exclude Evidence was provided via
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`electronic service, to the Petitioner by serving the correspondence address of
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`record as follows:
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`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`Wendy L. Devine
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`wdevine@wsgr.com
`
`
`Michael R. Dzwonczyk
`Azy S. Kokabi
`Travis B. Ribar
`Sughrue Mion, PLLC
`2100 Pennsylvania Ave., NW, Suite 800
`Washington, DC 20037
`mdzwonczyk@sughrue.com
`akokabi@sughrue.com
`tribar@sughrue.com
`sblackston@sughrue.com
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`13
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`Attorney Docket No: 13351-0008IP2
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`Gary J. Speier
`Mark D. Schuman
`Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, Minnesota 55402
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`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
`IPRCyclosporine@carlsoncaspers.com
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` /Jessica K. Detko/
`
`Jessica K. Detko
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(612) 337-2516
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`14
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