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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC and MYLAN
`PHARMACEUTICALS INC.
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`
`___________________
`
`Case IPR2019-002071
`U.S. Patent No. 9,517,219 B2
`___________________
`
`PETITIONERS’ OPPOSITION TO MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
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`
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`
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`Case IPR2019-00207
`Patent 9,517,219 B2
`I.
`Introduction
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`On October 4, 2019 and October 18, 2019, Almirall’s declarants, Dr.
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`Osborne and Dr. Kircik, respectively made critical admissions during cross-
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`examination that undermined Almirall’s case and supported Amneal’s declarant’s
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`(Drs. Michniak-Kohn and Gilmore) opinions. Thereafter, Dr. Michniak-Kohn and
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`Dr. Gilmore, in their Reply declarations, included facts about Almirall’s
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`declarants’ admissions via information from counsel, as opposed to combing
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`through the voluminous transcripts themselves. When questioned by Almirall’s
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`counsel on cross-examination about the genesis of their understanding about these
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`facts, both of Amneal’s experts testified truthfully that they obtained the
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`understanding from counsel. But, relying on information from counsel does not
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`render an expert’s opinions unreliable so long as the expert: disclosed the
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`information relied upon, based their opinions on reliable principles and methods,
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`and reliably applied those principles and methods to the facts of the case.
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`Almirall, concerned about and desperate to escape the adverse consequences
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`likely to stem from the admissions its declarants made, now seeks to exclude the
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`opinions of Drs. Michniak-Kohn and Gilmore without factual or legal support.
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`The Board should deny Almirall’s motion for at least two reasons. First, Almirall
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`did not timely raise the evidentiary basis on which it now moves. Not only does
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`this mean that Almirall did not satisfy its threshold obligation, but failing to timely
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`Case IPR2019-00207
`Patent 9,517,219 B2
`object deprived Amneal an opportunity to cure any issue. Second, the challenged
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`testimony is not unreliable, as Almirall contends. The challenged testimony was
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`based on the experts’ view of the published literature and prior art, their own
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`experience, and their understanding of the technical field. The information
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`supplied by counsel to Amneal’s experts are undisputed facts extracted from the
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`deposition transcripts of Almirall’s declarations—it is the undisputed record, and
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`nothing more. Almirall has not shown that any fact supplied by Amneal’s counsel
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`was incorrect or not in the record. And, Almirall has not articulated any cognizable
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`reason why Amneal’s expert’s opinions are unreliable because some facts were
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`supplied by counsel.
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`II. Argument
`A. Almirall did not timely raise its objection to the now-challenged
`testimony.
`
`For the first time during the deposition of Amneal’s declarants, Dr.
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`Michniak-Kohn and Dr. Gilmore, Almirall raised objection to declaration
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`testimony (not deposition testimony) of those experts because each had relied upon
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`factual information supplied by counsel about deposition admissions of Almirall’s
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`declarants. Almirall’s motion to exclude should be denied because Almirall did not
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`timely raise any objection to the testimony of Dr. Michniak-Kohn and Dr. Gilmore,
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`thereby depriving Amneal the opportunity to potentially cure any objection.
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`Case IPR2019-00207
`Patent 9,517,219 B2
`Rule 42.64(b)(1) states that “[o]nce a trial has been instituted, any objection
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`must be filed within five business days of service of evidence to which the
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`objection is directed. The objection must identify the grounds for the objection
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`with sufficient particularity to allow correction in the form of supplemental
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`evidence.” See 37 CFR § 42.64(b)(1). Almirall never filed its current objection to
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`Dr. Michniak-Kohn’s or Dr. Gilmore’s testimony within five business days of
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`those declaration being filed. Without timely raising its objection, Almirall
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`effectively deprived Amneal of an opportunity to potentially cure any objection by
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`having Dr. Michniak-Kohn and Dr. Gilmore review the deposition transcripts of
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`Almirall’s declarants and state whether they agreed with the information supplied
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`by counsel. That is, following the scriptures of Rule 42.64 would have mooted
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`Almirall’s entire motion to exclude.
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`Recognizing that its failure to timely object is fatal to its motion, Almirall
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`tries to fix the problem by claiming that during these depositions “it became clear
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`that [Almirall’s declarants] had come to [their] understanding of Almirall’s
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`experts’ deposition testimony via counsel rather by relying on the deposition
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`transcripts themselves.” See Paper 43, 5-6, n2. Almirall’s excuse is unavailing.
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`Almirall acts as if it seeks to exclude deposition evidence under Rule 42.64(a)
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`rather than declaration evidence under Rule 42.64(b). Since Almirall is seeking to
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`exclude declaration evidence, any objection to that evidence at the depositions was
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`Case IPR2019-00207
`Patent 9,517,219 B2
`untimely because those depositions occurred more than five business days from
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`filing. In fact, Dr. Michniak-Kohn and Dr. Gilmore were deposed on December 6
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`and December 12, respectively, which were more than five business days after
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`November 1 when Amneal’s Reply declarations were filed. Paper 32; Paper 33.
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`Moreover, it is illogical that Almirall somehow needed to wait until the
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`depositions of Drs. Michniak-Kohn and Gilmore, as the context of the information
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`supplied by counsel was clear. As Almirall’s motion highlights, each time Dr.
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`Michniak-Kohn and Dr. Gilmore relied upon information from counsel they started
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`the sentence with “I understand.” Paper 43, 2-5, 7-9. Even if Almirall needed
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`deposition testimony, it should have objected within the time allotted and then
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`obtained any clarification at the deposition. Because Almirall failed to diligently
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`review the declarations of Dr. Michniak-Kohn and Dr. Gilmore and file any
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`objections within five business days, Almirall’s motion to exclude should be
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`denied on this basis alone.
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`B.
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`The now-challenged testimony is not inadmissible under Fed. R.
`Evid. 702.
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`In a cursory one-paragraph argument for each declarant, Almirall argues that
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`certain paragraphs from Dr. Michniak-Kohn’s and Dr. Gilmore’s declarations
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`should be excluded as unreliable because Dr. Michniak-Kohn and Dr. Gilmore did
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`not themselves comb through the transcripts of Almirall’s declarants to determine
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`the veracity of those statements. But, that is irrelevant, particularly where Almirall
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`Case IPR2019-00207
`Patent 9,517,219 B2
`has not demonstrated that any of the factual statements supplied by counsel was
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`inaccurate. Accordingly, and for the reasons below, the now-challenged testimony
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`of Dr. Michniak-Kohn and Dr. Gilmore is not unreliable.
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`As an initial matter, expert testimony is unreliable only if it, inter alia, (1)
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`does not disclose the facts and data upon which it is based, (2) is not the product of
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`reliable principles and methods, and (3) the expert has not reliably applied the
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`principles and methods to the facts of the case. See Fed. R. Evid. 702. Each of the
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`identified paragraphs in Dr. Michniak-Kohn’s declaration and Dr. Gilmore’s
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`declaration contain proper opinion testimony based on those expert’s view of the
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`published literature and prior art, their own experience, and their own
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`understanding of the technical field (formulation for Dr. Michniak-Kohn and the
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`diagnoses, treatment, prescription, and administration of acne and rosacea products
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`for Dr. Gilmore). See AMN1043, ¶¶ 4, 15, 26, 35–37, 55, 59, 68, 70–73, 75, 78,
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`83, and 86; AMN1044, ¶¶ 8, 16, 17, 21, 26, 28, 37, 38, 40, and 46. In each case,
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`Dr. Michniak-Kohn and Dr. Gilmore disclosed the facts upon which they relied,
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`how and where they obtained those facts, offered testimony based on reliable
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`principles and methods, and reliably applied those principles and methods to the
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`facts of this case. Therefore, Almirall overreaches by asking the Board to exclude
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`the entirety of the challenged paragraphs.
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`Case IPR2019-00207
`Patent 9,517,219 B2
`Almirall’s sole complaint is that Dr. Michniak-Kohn and Dr. Gilmore relied
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`on factual information supplied by counsel concerning the deposition statements
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`and admissions by Almirall’s declarants. But, reliance on information from counsel
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`is not unreliable.2 Consistent with Fed R. Evid. 702, the context of the declaration
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`statements discloses the source of the information (which was later confirmed at
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`deposition), and the declarations explicitly disclose the content of the information
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`supplied by counsel. Moreover, the information supplied by counsel is nothing
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`more than confirmatory evidence that supports the already-stated opinions of Dr.
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`Michniak-Kohn and Dr. Gilmore based on those expert’s view of the published
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`literature and prior art, their own experience, and their own understanding of the
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`technical field. Indeed, setting aside paragraph 71 of Dr. Michniak-Kohn’s
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`declaration, there is not any instance where the information supplied by counsel
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`forms the sole basis for any of Dr. Michniak-Kohn’s or Dr. Gilmore’s opinions.
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`Next, Almirall complains that it was deprived of the opportunity to examine
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`Dr. Michniak-Kohn and Dr. Gilmore on the challenged portions of Dr. Michniak-
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`Kohn’s and Dr. Gilmore’ declarations. See Paper 43, 6, 9. But that is not at all the
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`case. Almirall had every opportunity to cross-examine Dr. Michniak-Kohn and Dr.
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`Gilmore during their depositions, as to any material in their declarations and cited
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`2 By that same rationale, Almirall’s declarant Dr. Osborne’s testimony in
`paragraphs 29, 34, 87, 88, 109, 173, and 195 would similarly be unreliable because
`Dr. Osbourne also relied in part on information from counsel. See Ex. 2057, ¶¶ 29,
`34, 87, 88, 109, 173, and 195.
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`Case IPR2019-00207
`Patent 9,517,219 B2
`exhibits. In fact, Almirall spent much time at both depositions examining the
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`witness on the published literature and prior art, their own experience, and their
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`own understanding of the technical field. See AMN2068, 21:6-23:8, 39:15-40:10,
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`65:6-11, 94:12-95:9, 97:6-98:4; AMN2069, 55:10-57:12, 66:17-70:5, 121:17-
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`125:17.
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`Almirall was also not deprived of the opportunity to cross-examine Dr.
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`Michniak-Kohn or Dr. Gilmore about the “veracity” of the information supplied by
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`counsel. A review of the deposition transcript of Dr. Gilmore shows that Almirall’s
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`counsel asked questions unrelated to the “veracity.” For example, in Dr. Gilmore’s
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`deposition, Almirall’s counsel repeatedly asked Dr. Gilmore on the substance of
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`her conversations with counsel, which is unrelated to the “veracity” of any the
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`information supplied by counsel. EX2069, 170:1-174:15. If Almirall wanted to see
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`if either expert agreed with the veracity of information supplied by counsel,
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`Almirall’s counsel could have easily provided the deposition transcript of
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`Almirall’s experts to Dr. Michniak-Kohn and Dr. Gilmore at their depositions and
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`then questioned Dr. Michniak-Kohn and Dr. Gilmore about any potential
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`discrepancy between the representation from counsel and the testimony of
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`Almirall’s declarants. In fact, Almirall’s counsel was instructed by Amneal’s
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`counsel to do exactly that. EX2069, 174:16-176:15. Almirall’s counsel refusal to
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`do so because there is no discrepancy, and their refusal reveals that Almirall was
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`Case IPR2019-00207
`Patent 9,517,219 B2
`more interested in manufacturing a baseless reason to try to exclude portions of
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`these declarations than it was in questioning Dr. Michniak-Kohn or Dr. Gilmore
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`about the “veracity” of the information from counsel. EX2069, 174:16-175:3.
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`Even if Almirall tried to question Dr. Michniak-Kohn and Dr. Gilmore about
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`the veracity of the information supplied by counsel, Almirall would have found
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`that the information supplied by counsel was entirely consistent with the testimony
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`of Almirall’s declarants. The table below shows that the factual information
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`supplied by counsel to Dr. Michniak-Kohn was accurate.
`
`Information supplied by counsel
`
`1st bullet, pg. 2
`2nd bullet, pg. 2
`3rd bullet, pg. 2
`4th bullet, pg. 3
`5th bullet, pg. 3
`6th bullet, pg. 3
`7th bullet, pg. 3
`8th bullet, pg. 3
`9th bullet, pg. 3
`10th bullet, pg. 3
`11th bullet, pg. 4
`12th bullet, pg. 4
`13th bullet, pg. 4
`14th bullet, pg. 5
`15th bullet. pg. 5
`16th bullet, pg. 5
`17th bullet, pg. 5
`
`Deposition testimony of Almirall’s
`experts
`AMN1040, 11:18-12:15, 13:24-14:7
`AMN1040, 114:19-22
`AMN1040, 18:23-20:19
`AMN1040, 112:3-114:2
`AMN1040, 24:9-25:14
`AMN1040, 141:5-10; 142:4-143:15
`AMN1040, 44:16-45:14
`AMN1040, 50:3-51:4; 52:20-25
`AMN1040, 53:12-57:12
`AMN1040, 76:23-82:8; 108:11-15
`AMN1040, 76:23-82:8; 108:11-15
`AMN1040, 84:5-19
`AMN1040, 42:23-43:4
`AMN1040, 95:24-96:10; 94:5-15
`AMN1040, 92:18-93:9
`AMN1040, 84:5-19
`AMN1057, 120:19-121:20; AMN1039,
`150:10-151:14
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`Case IPR2019-00207
`Patent 9,517,219 B2
`Similarly, the table below shows that each piece of information supplied by
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`counsel to Dr. Gilmore was accurate.
`
`Information supplied by counsel
`
`1st bullet, pg. 7
`2nd bullet, pg. 7
`3rd bullet, pg. 7
`4th bullet, pg. 7
`5th bullet, pg. 7
`6th bullet, pg. 8
`
`7th bullet, pg. 8
`8th bullet, pg. 8
`9th bullet, pg. 8
`10th bullet, pg. 8
`
`11th bullet, pg. 9
`
`
`
`Deposition testimony of Almirall’s
`experts
`AMN1039, 72:22-75:9; 79:9-81:11
`AMN1039, 56:15-57:10
`AMN1057, 88:5-89:8; 106:22-107:5
`AMN1039, 35:18-36:5
`AMN1039, 150:10-152:18
`AMN1039, 150:16-29; 151:15-25;
`72:6-25
`AMN1039, 149:15-150:9
`AMN1039, 70:9-12; 71:11-72:21
`AMN1039, 57:22-58:13; 61:18-24
`AMN1057, 88:8-97:6
`AMN1039, 60:113-61:17; 134:13-
`136:8; AMN1057, 80:11-25
`AMN1039, 149:15-150:9
`
`Finally, Almirall’s evidentiary challenge does not go to the admissibility of
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`the testimony in the challenged paragraphs. Rather, the Board has broad discretion
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`to assign the weight to be accorded expert testimony. Yorkey v. Diab, 601 F.3d
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`1279, 1284 (Fed. Cir. 2010). Here, the Board should not exclude the challenged
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`testimony but simply assign it the weight the Board believes that testimony
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`deserves.
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`III. Conclusion
`For the foregoing reasons, the Board should not exclude the challenged
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`testimony of Dr. Michniak-Kohn and Dr. Gilmore.
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Respectfully submitted,
`
`
`Dennies Varughese (Reg. No. 61,868)
`Lead Attorney for Petitioners
`
`
`Date: January 24, 2020
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`14444203.3
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the above-captioned “Petitioners’
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`Opposition to Motion To Exclude Evidence” was served in its entirety on January
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`24, 2020, upon the following parties via electronic mail:
`
`
`
`James Trainor
`
`
`RJ Shea
`
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`Telephone (212) 430-2600
`Facsimile (650)938-5200
`jtrainor@fenwick.com
`rshea@fenwick.com
`
`Jennifer R. Bush
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`Telephone (650) 988-8500
`Facsimile (650) 938-5200
`jbush@fenwick.com
`
`
`
`
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`
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`
`
`Elizabeth B. Hagen
`FENWICK & WEST LLP
`1191 Second Avenue, 10th Floor
`Seattle, WA 98101
`Telephone (206) 389-4510
`Facsimile (206)389-4511
`ehagan@fenwick.com
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`Dennies Varughese, Pharm.D.
`Date: January 24, 2020
`1100 New York Avenue, N.W. Registration No. 61,868
`Washington, D.C. 20005-3934
`Lead Attorney for Petitioners
`(202) 371-2600
`
`
`
`
`
`
`
`
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