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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`
`AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`
`Case IPR2019-002071
`Patent 9,517,219
`
`
`
`
`
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`
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`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
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`
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`
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`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
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`IPR2019-00207
`Patent Owner’s Opposition to Petitioners’ Motion to Exclude Evidence
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`TABLE OF CONTENTS
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`Page
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`3.
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`4.
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`5.
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`INTRODUCTION ..................................................................................................... 1
`ARGUMENT ............................................................................................................. 5
`A
`The Board Should Not Exclude the Warner Declaration
`or Relevant Portions of Dr. Osborne’s Declaration .............................. 5
`1.
`The Warner Declaration Is Not Hearsay ..................................... 5
`2.
`Petitioners Failed to Timely Object to the
`Warner Declaration ..................................................................... 6
`The Warner Declaration Falls Within an Exception
`to the Rule Against Hearsay ....................................................... 7
`Petitioners’ Arguments Go to the Weight, Not
`Admissibility, of the Warner Declaration ................................. 10
`Dr. Osborne’s Expert Testimony Regarding the
`Warner Declaration is Admissible ............................................ 11
`Nor Should the Board Exclude Additional Identified
`Paragraphs of Expert Declarations Unrelated to the
`Warner Declaration ............................................................................. 12
`The Board Should Not Exclude Exhibits 2010-2011,
`2013, 2017-2018, 2021, 2024, 2026-2027, 2029, 2032,
`2038-2040, or 2050-2052 .................................................................... 14
`CONCLUSION ........................................................................................................ 15
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`
`
`B.
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`C.
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`i
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`IPR2019-00207
`Patent Owner’s Opposition to Petitioners’ Motion to Exclude Evidence
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`TABLE OF AUTHORITIES
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`Page(s)
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`CASES
`Actelion Pharms. Ltd. v. Icos Corp.,
`IPR2015-00561, Paper 50 (Aug. 3, 2016) ...................................................... 7, 12
`Almirall, LLC v. Amneal Pharms. LLC,
`C.A. 19-658 (D. Del.) ........................................................................................... 8
`Almirall, LLC v. Taro Pharmaceutical Industries Ltd.,
`C.A. No. 17-cv-663 (D. Del.) ............................................................................... 7
`Apple Inc. v. Smartflash LLC,
`CBM2014-00106, Paper 52 (Sept. 25, 2015) ..................................................... 14
`Apple Inc. v. VirnetX Inc.,
`IPR2016-00332, Paper 29 (June 22, 2017) ................................................. 8, 9, 10
`Donnelly Garment Co. v. NLRB,
`123 F.2d 215 (8th Cir. 1941) .............................................................................. 11
`Funai Elec. Co. v. Gold Charm Ltd.,
`IPR2015-01468, Paper 40 (Dec. 27, 2016)......................................................... 11
`Laird Techs., Inc. v. GrafTech Int’l Holdings, Inc.,
`IPR2014-00025, Paper 45 (Mar. 25, 2015) ........................................................ 13
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995) ................................................................................ 7
`Mexichem Amanco Holdings S.A. v. Honeywell Int’l, Inc.,
`IPR2013-00576, Paper 36 (Sept. 5, 2014) .......................................................... 11
`OddzOn Prods., Inc. v. Just Toys, Inc.,
`122 F.3d 1396 (Fed. Cir. 1997) .......................................................................... 13
`Praxair Distribution, Inc. v. Ino Therapeutics LLC,
`IPR2015-00529, Paper 33 (Dec. 22, 2015)......................................................... 11
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`ii
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`TABLE OF AUTORITIES
`(Continued)
`
`Page(s)
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`
`Senmed, Inc. v. Richard-Allan Med. Indus., Inc.,
`888 F.2d 815 (Fed. Cir. 1989) .............................................................................. 7
`SK Hynix Inc. v. Netlist, Inc.,
`IPR2017-00562, Paper 36 (July 5, 2018) ..................................................... 13, 15
`SteadyMed Ltd. v. United Therapeutics Corp.,
`IPR2016-00006, Paper 82 (Mar. 31, 2017) ........................................................ 11
`
`STATUTES AND RULES
`Fed. R. Evid. 401 ............................................................................................... 13, 15
`Fed. R. Evid. 402 ..................................................................................................... 15
`Fed. R. Evid. 702 ................................................................................................. 4, 11
`Fed. R. Evid. 703 ..............................................................................................passim
`Fed. R. Evid. 801(d)(2) ............................................................................................. 6
`Fed. R. Evid. 803(8) ................................................................................................... 7
`Fed. R. Evid. 804 ............................................................................................... 7, 8, 9
`Fed. R. Evid. 807 ................................................................................................. 9, 10
`
`OTHER AUTHORITIES
`37 C.F.R. § 1.132 ........................................................................................... 1, 2, 8, 9
`37 C.F.R. § 42.64(b)(1) .............................................................................................. 6
`37 C.F.R. § 42.65(a) ................................................................................................. 12
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`iii
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`IPR2019-00207
`Patent Owner’s Opposition to Petitioners’ Motion to Exclude Evidence
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`INTRODUCTION
`The Board should deny Petitioners’ motion to exclude what is effectively
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`any evidence (except its own) referencing or concerning the Warner Declaration,
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`including the Warner Declaration itself. To exclude expert testimony because of
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`its reliance on the Warner Declaration would violate not just the letter of, but
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`universal practice under, the Federal Rules of Evidence. The Warner Declaration
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`is not hearsay, as Petitioners argue, but even if it is so considered, it remains
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`admissible into the record on this proceeding under several exceptions. Indeed,
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`Petitioners’ request is so misguided that it invites legal error. To exclude as
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`hearsay any part of the public file history, including any § 1.132 declaration
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`therein, on review by the same agency of the very patent that concluded that file
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`history would be arbitrary and capricious. Patent Owner does not cavalierly so
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`suggest as a mere matter of attorney rhetoric—rather, it is with all respect for this
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`Board that Patent Owners submits this would be the result, if not as a general rule,
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`at least on the facts and circumstances and surrounding this proceeding in this
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`posture on the eve of trial.
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`To exclude a § 1.132 declaration from post-grant proceedings under the
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`AIA—or, as Petitioners soften it, to give it “little or no weight”—under the present
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`circumstances would have arbitrary and thus unjust consequences for disparately-
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`situated patent owners as regards their property rights. The logical extension of
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`1
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`this result is that, in any inter partes review of a patent with a § 1.132 declaration
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`in its prosecution history, a portion of the public record (and part of the intrinsic
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`evidence considered in claim construction in the same proceeding) would be
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`excluded from any validity assessment of that patent—if the declarant is not
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`subject to deposition. If the declarant cannot be produced for deposition because
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`he is deceased or unwilling, it would be profoundly unfair for the admissibility of
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`any part of the patent’s file history to depend on whether its current owner controls
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`a witness at the time of the post-grant proceeding.
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`Even were the Warner Declaration hearsay, as Petitioners assert, Almirall’s
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`expert—just as Petitioners’ expert—properly may rely on hearsay. It is most
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`fundamental in U.S. trial practice that an expert may rely on hearsay. This happens
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`conceivably every day at trials in state, Article III, and administrative courts
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`throughout the United States. Federal Rule of Evidence 703 decidedly permits—
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`and courts routinely admit—evidence of so-premised expert testimony. Fed. R.
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`Evid. 703 (“An expert may base an opinion on facts or data in the case that the
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`expert has been made aware of or personally observed. If experts in the particular
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`field would reasonably rely on those kinds of facts or data in forming an opinion
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`on the subject, they need not be admissible for the opinion to be admitted.”)
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`Treatment of such opinion testimony is reasonable, logical, and non-prejudicial,
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`not least because documents, data, etc., underlying that expert testimony, akin to
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`2
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`the Warner Declaration here, are typically not hearsay at all: they are not offered
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`for their truth, but rather offered and admitted for the more limited purpose of
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`demonstrating what the expert relied upon in arriving at the opinion testimony
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`separately offered into evidence. The trier of fact then evaluates the credibility of
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`the expert testimony, including by considering the reliability of the disclosed bases
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`of the opinion, documentary or otherwise.
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`Of course, as here, the opponent of that expert testimony is given the
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`opportunity to cross examine the proponent in advance of and at trial. Similarly, as
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`here, the opponent has the opportunity to counter the offered opinion with expert
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`testimony of its own. The opponent is free to offer a contrasting assessment of the
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`very same foundational evidence, including an opinion that the testimonial
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`evidence of the proponent expert is unreliable and should not be credited by the
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`trier of fact. Indeed, this is exactly what has transpired in this proceeding, with one
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`notable exception: here, it was Petitioners’ expert who disclosed an opinion
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`concerning the Warner Declaration in the first instance. It is through the Petition
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`(Paper 3) and the declaration of Petitioners’ expert Dr. Michniak-Kohn in support
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`thereof (Exhibit 1002) that the Warner Declaration was introduced into the record.
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`From none of the foregoing, in any event, does it follow that the expert testimony
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`proffered by Patent Owner is inadmissible under Rules 702, 703, 801, 802, and/or
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`805, as Petitioners assert.
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`3
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`Dr. Warner submitted under penalty of perjury a recitation of experiments he
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`conducted or oversaw, his observations on those experiments, and the data reported
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`in doing so. Ex. 1017 at 289–93. At its root, the Warner Declaration reflects
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`observations of the comparative compatibility of varied components within topical
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`formulations comprising the active pharmaceutical ingredient dapsone. That the
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`reported experiments employ data of the kind on which those skilled in the art
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`would reasonably rely has been confirmed by Petitioners’ own expert. Fed. R.
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`Evid. 703; see Ex. 1002 ¶¶ 99–106 (reciting data from the Warner Declaration
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`without challenging their accuracy); Ex. 2068 at 171:9–172:1 (referring to the
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`experiments described in the Warner Declaration as an example of “routine
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`testing”). And Petitioners’ argument that Dr. Osborne’s testimony is not the result
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`of reliable principles or methods fails because it is based only on the faulty
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`argument that he did not have personal knowledge of the experiments described in
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`the Warner Declaration. As Dr. Michniak-Kohn relied on the Warner Declaration,
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`so did Dr. Osborne. At very least the recitation that is the Warner Declaration
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`cannot be considered “facts or data” any less “sufficient” than this very agency
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`already deemed them to be for purposes of enabling its own conclusion as to the
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`evidentiary value of that recitation. Fed. R. Evid. 702.
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`Whether the examiner was right or wrong, adequately informed or not, is
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`beside the point at this time. The question presently and appropriately before this
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`4
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`Board—on that same evidence considered by the examiner—is not whether either
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`parties’ expert testimony evidence is admissible and available for consideration by
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`this trier of fact, but rather, which parties’ expert evidence is more credible and
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`entitled to more weight. As a practical matter, that question is: Which is so
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`entitled—Almirall’s evidence that the examiner was reasonable, or Petitioners’
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`evidence that the examiner was unreasonable, in forming conclusions regarding the
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`import of the Warner Declaration insofar as it informs the patentability of the
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`challenged claims?
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`As such, even assuming the Warner Declaration is hearsay, Almirall’s expert
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`testimonial evidence concerning it is admissible under Rule 703. Petitioners’
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`argument to the contrary goes to the weight, not admissibility, of that evidence.
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`Petitioners further move to exclude exhibits and evidence relied upon by
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`Almirall’s experts as irrelevant and prejudicial. Fatally, Petitioners have not
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`shown how this relevant evidence, properly considered and relied upon by
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`Almirall’s experts, would confuse the issues or be in any way prejudicial.
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`Petitioners’ motion should be denied in its entirety.
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`ARGUMENT
`A. The Board Should Not Exclude the Warner Declaration or
`Relevant Portions of Dr. Osborne’s Declaration
`1. The Warner Declaration Is Not Hearsay
`As an initial matter, Petitioners themselves relied on the Warner Declaration
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`5
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`in the first instance. See Paper 3 at 18–19, 57–61. Petitioners offered the Warner
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`Declaration, made by a named inventor who was at the time an employee of
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`Almirall’s predecessor-in-interest, as evidence of why no unexpected results
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`demonstrate non-obviousness. Accordingly, the Warner Declaration is not
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`hearsay, and is admissible under Fed. R. Evid. 801(d)(2)(A), (C), or (D).
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`Almirall, moreover, is not relying on the Warner Declaration for its truth.
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`Almirall is not relying on it as proof of unexpected results. Rather, Almirall’s
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`expert relies on the Warner Declaration, in rebuttal to Petitioners’ expert, for the
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`content of what a skilled artisan would consider as part of the record. Dr. Osborne
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`relies on the Warner Declaration to opine that, upon reading that record, a POSA
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`would conclude there were unexpected results. See Ex. 2057 ¶¶ 173–194. It is for
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`the Board to decide whether Dr. Osborne is credible in offering that view.
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`2. Petitioners Failed to Timely Object to the Warner
`Declaration
`Procedurally, Petitioners were required to object to any evidence submitted
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`during a preliminary proceeding “within ten business days of the institution of the
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`trial,” or, after trial has been instituted, “within five business days of service of
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`evidence to which the objection is directed.” 37 C.F.R. § 42.64(b)(1). It was
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`Petitioners who submitted and served upon Almirall the Warner Declaration, as
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`part of Exhibit 1017, in November of 2018. Indeed, Petitioners relied on the
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`Warner Declaration in their Petition. See Paper 3 at 18–19, 57–61. And their
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`6
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`IPR2019-00207
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`expert Dr. Michniak-Kohn devoted several pages to its discussion. Ex. 1002
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`¶¶ 99–106.2 Trial was instituted May 10, 2019. Paper 13. Petitioners lodged no
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`objection within 10 days of institution of trial. Petitioners’ objection to their own
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`evidence is improper, if also curious. See Actelion Pharms. Ltd. v. Icos Corp.,
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`IPR2015-00561, Paper 50 at 40 (Aug. 3, 2016) (denying Patent Owner’s motion to
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`exclude where Patent Owner was first to rely on the evidence).
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`3. The Warner Declaration Falls Within an Exception to the
`Rule Against Hearsay
`Even were the Warner Declaration found to be hearsay, it falls within one of
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`several exceptions to the rule against hearsay. The Warner Declaration is part of the
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`prosecution history of the patent, which is, along with the patent itself, “the
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`undisputed public record.” Markman v. Westview Instruments, Inc., 52 F.3d 967,
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`979 (Fed. Cir. 1995) (quoting Senmed, Inc. v. Richard-Allan Med. Indus., Inc., 888
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`F.2d 815, 819 n.8 (Fed. Cir. 1989)). Thus, it falls under the Public Records
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`exception of Rule 803(8).
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`The Warner Declaration is also former testimony of an unavailable witness,
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`bringing it within the hearsay exception of Rule 804(b)(1). The Warner
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`Declaration is an affidavit filed under oath during prosecution of the ʼ219 patent.
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`This declaration was relied upon by the examiner in allowing the claims. See Ex.
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`2 Almirall was therefore obliged to respond. Paper 20 at 60–64; Ex. 2057 § X.E.
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`7
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`1017 at 466–468, 508–509. Dr. Warner was deposed in a prior litigation, Almirall,
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`LLC v. Taro Pharmaceutical Industries Ltd., C.A. No. 17-cv-663 (D. Del.), by a
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`party similarly challenging the patentability of the claims of the ʼ219 patent,
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`relying on nearly identical prior art. Petitioners are in possession of that deposition
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`transcript. And, Amneal could have cross-examined Dr. Warner on his declaration
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`in the co-pending civil litigation concerning the same patent and prior art. See
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`Almirall, LLC v. Amneal Pharms. LLC, C.A. 19-658 (D. Del.). Thus, it is former
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`testimony offered in a prior proceeding, and was subject to cross-examination. As
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`the Panel has not authorized live testimony by Dr. Warner, he is not available at
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`trial. See Paper 44 at 4. Accordingly, the Warner Declaration falls under the
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`unavailable witness former testimony exception. Fed. R. Evid. 804(a)(5)(A),
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`(b)(1); Apple Inc. v. VirnetX Inc., IPR2016-00332, Paper 29 at 82 (June 22, 2017)
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`(applying FRE 804(b)(1) to a 37 C.F.R. § 1.132 declaration).
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`As a note, Petitioners’ representation of “Almirall’s unwillingness to provide
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`Dr. Warner” lacks candor. As explained on the January 17, 2020 conference call,
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`Dr. Warner is not and has never been an employee of Almirall. Despite this, when
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`the Board ordered Patent Owner to produce Dr. Warner for deposition within just
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`12 business days, in an Order that came only 26 business days prior to hearing after
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`remaining pending for two and a half months (Papers 14, 26, 39), he volunteered to
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`be deposed as early as January 30, 2020. Ex. 1077 at 3–4. It cannot reasonably be
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`8
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`credited that Petitioners have not been offered “a fair opportunity to challenge the
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`testimony,” or that “Almirall appears to be trying to shield Dr. Warner from
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`scrutiny.” Petitioners could have deposed Dr. Warner before trial and cooperated
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`with Almirall to seek modification the December 31 Order, the Scheduling Order,
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`or both. Alternatively, Petitioners could have consented to Almirall’s request for
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`permission to bring Dr. Warner to testify live at trial, where it may have cross- (or
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`even re-cross) examined him. This is important because Dr. Warner is now
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`“unavailable” to testify at trial, following Amneal’s opposition to, and the Board’s
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`declining to authorize live testimony, as set forth in the Board’s Order of January
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`21, 2020. (Paper 44). That is, Dr. Warner’s §1.132 declaration, even if offered for
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`its truth, is admissible under Rule 804. See Fed. R. Evid. 804(a)(5), (b)(1), (b)(6);
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`see also Apple v. VirnetX , IPR2016-00332, Paper 29 at 81–83.
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`Finally, the residual exception to hearsay applies to the Warner Declaration.
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`Federal Rule of Evidence 807 provides a residual exception when: “(1) the
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`statement has equivalent circumstantial guarantees of trustworthiness; (2) it is
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`offered as evidence of material fact; (3) it is more probative on the point for which
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`it is offered than any other evidence that the proponent can obtain through
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`reasonable efforts; and (4) admitting it will best serve the purposes of these rules
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`and the interests of justice.” All four elements of Rule 807 are found here.
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`First, as described above, the Warner Declaration was offered under oath,
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`9
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`IPR2019-00207
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`relied on by a public office, and subject to cross-examination by a party with
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`similar motivation to develop the cross-examination. Accordingly, the declaration
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`has been subject to opportunity for cross-examination, and has circumstantial
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`guarantees of trustworthiness. The Board has found similar sworn declaration
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`testimony admissible under Rule 807. See Apple v. VirnetX, IPR2016-00332,
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`Paper 29 at 81–83.
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`The remaining elements are similarly met. The Warner Declaration concerns
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`a material fact: observation of experiments with formulations embodied in the
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`challenged claims that inform the validity of the ʼ219 patent. Ex. 1017 at 289–93;
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`see id. at 467–68 (examiner concluding that the Warner Declaration “appears to be
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`probative of unexpected properties of the claimed formulation”). Both parties
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`addressed this evidence in the context of unexpected results. Paper 3 at 56–61;
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`Paper 20 at 60–64; Paper 28 at 24–27; Paper 37 at 23. Neither party has proposed
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`that any alternative evidence could be reasonably obtained that is more probative on
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`this point than the declaration that forms part of the file history. And finally,
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`inclusion of the Warner Declaration is in the interest of justice, in that it allows the
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`prosecution history record to be examined and relied upon in its entirety.
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`4. Petitioners’ Arguments Go to the Weight, Not
`Admissibility, of the Warner Declaration
`Petitioners’ argument that the Warner Declaration should be excluded
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`because they were unable to depose Dr. Warner in this proceeding is unfounded.
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`10
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`The Board may, within its discretion, accord appropriate weight to any submitted
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`evidence. See SteadyMed Ltd. v. United Therapeutics Corp., IPR2016-00006,
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`Paper 82 at 85 (Mar. 31, 2017) (“One who is capable of ruling accurately upon the
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`admissibility of evidence is equally capable of sifting it accurately after it has been
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`received ….” (quoting Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th
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`Cir. 1941)). And this is the Board’s preference for addressing declarations
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`submitted during prosecution, where Petitioners cannot depose the declarant. See
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`Praxair Distribution, Inc. v. Ino Therapeutics LLC, IPR2015-00529, Paper 33 at 2
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`(Dec. 22, 2015) (“Nevertheless, depending on the context in which Patent Owner
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`relies on those declarations, the panel may accord the testimony little or no weight
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`as Petitioner has not been offered a fair opportunity to challenge the testimony.”);
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`Mexichem Amanco Holdings S.A. v. Honeywell Int’l, Inc., IPR2013-00576, Paper
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`36 at 3 (Sept. 5, 2014).
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`5. Dr. Osborne’s Expert Testimony Regarding the Warner
`Declaration is Admissible
`Petitioners further seek to exclude the section of Dr. Osborne’s declaration
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`relying upon the Warner Declaration on the basis of hearsay and under Rules 702
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`and 703. Paper 41 at 7–9. As the Warner Declaration itself is not inadmissible
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`hearsay, see supra §§ A.1–3, Petitioners’ argument is without foundation. In any
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`case, Petitioners’ argument further fails because it is basic trial practice that experts
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`may rely on hearsay. Fed. R. Evid. 703; Funai Elec. Co. v. Gold Charm Ltd.,
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`11
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`IPR2015-01468, Paper 40 at 51 (Dec. 27, 2016) (“Even if Exhibits [] are
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`inadmissible, and Mr. Flasck relies on [them], Fed. R. Evid. 703 allows for such
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`reliance.”); accord Actelion, IPR2015-00561, Paper 50 at 40. The Warner
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`Declaration discloses the facts upon which the proffered testimony in Dr. Osborne’s
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`declaration is premised. Petitioner was given and availed itself of the opportunity
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`to cross-examine Dr. Osborne on the contents of his Declaration, including his
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`reliance on the Warner Declaration. To the extent that Petitioners contest those
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`facts, their substantive argument goes to the weight of Dr. Osborne’s testimony, and
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`not its admissibility. See 37 C.F.R. § 42.65(a).
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`B. Nor Should the Board Exclude Additional Identified Paragraphs
`of Expert Declarations Unrelated to the Warner Declaration
`With the remainder of their motion, Petitioners seek to exclude certain
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`exhibits and certain other paragraphs of Dr. Osborne’s and Dr. Kircik’s
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`declarations (Ex. 2055 and Ex. 2057) as “irrelevant and/or prejudicial.” Paper 41
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`at 3. Petitioners apparently performed a text search of Almirall’s papers, and if a
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`paragraph was not expressly cited therein, Petitioners included it in its motion to
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`exclude as “irrelevant and/or prejudicial,” irrespective of the substance of those
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`paragraphs. That is not the law. A cursory review of the record, moreover, reflects
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`the allegedly uncited paragraphs are in fact relevant, undermining Petitioners’
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`premises in any event.
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`Petitioners’ overarching, if tacit, contention that something not directly cited
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`12
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`in a Patent Owner Response or Sur-Reply is per se irrelevant and/or prejudicial is
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`legally incorrect. Evidence is relevant if it “has any tendency to make a fact more or
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`less probable than it would be without the evidence.” Fed. R. Evid. 401. This
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`threshold for admissibility is quite low. Laird Techs., Inc. v. GrafTech Int’l
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`Holdings, Inc., IPR2014-00025, Paper 45 at 44 (Mar. 25, 2015); OddzOn Prods.,
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`Inc. v. Just Toys, Inc., 122 F.3d 1396, 1407 (Fed. Cir. 1997). Rather than excluding
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`evidence that is allegedly confusing, misleading, untimely, and/or irrelevant, [the
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`Board] will simply not rely on it or give it little weight, as appropriate, in our
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`analysis.” SK Hynix Inc. v. Netlist, Inc., IPR2017-00562, Paper 36 at 49 (July 5,
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`2018) (denying motion to exclude paragraphs of expert declarations and exhibits
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`not cited in briefing). In the inter partes review context, “the better course is to have
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`a complete record of the evidence to facilitate public access as well as appellate
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`review.” Id.
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`The portions of Almirall’s expert testimony that Petitioners seek to exclude
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`are in any case relevant. Paragraphs 1–15 and 89 of Exhibit 2055 and Paragraphs
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`1–28 and 109 of Exhibit 2057 pertain respectively to Dr. Kircik’s and Dr. Osborne’s
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`backgrounds and qualifications as experts in this proceeding, the materials they
`
`considered in forming their opinions, and provide an overview of their opinions in
`
`this proceeding. Paragraphs 16–19 of Exhibit 2055 and 28–36 of Exhibit 2057 recite
`
`respectively Dr. Kircik’s and Dr. Osborne’s understanding regarding the claims of
`
`13
`
`
`
`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`the ʼ219 patent. Paragraph 87 of Exhibit 2057 sets forth Dr. Osborne’s
`
`understanding of the effective filing date of the ʼ219 patent. Paragraphs 83–88 of
`
`Exhibit 2055 set forth Dr. Kircik’s understanding of the prior art references asserted
`
`by Petitioners in their two Grounds. Paragraphs 21–22, 90–93, 95, 98–100, and
`
`102–105 of Exhibit 2055 and Paragraphs 37, 88, and 173–174 of Exhibit 2057
`
`provide transition, context, and analysis for the surrounding paragraphs. And,
`
`finally, Paragraphs 113–114 of Exhibit 2055 and Paragraph 197 of Exhibit 2057
`
`provide conclusions. Petitioners fail to explain how these paragraphs are unfairly
`
`prejudicial to Petitioners. The Board accordingly should deny Petitioners’ motion.
`
`C. The Board Should Not Exclude Exhibits 2010-2011, 2013, 2017-
`2018, 2021, 2024, 2026-2027, 2029, 2032, 2038-2040, or 2050-2052
`In addition to paragraphs of Almirall’s experts’ reports, Petitioners seek to
`
`exclude certain exhibits as “irrelevant and/or prejudicial” because they are not
`
`cited in Almirall’s papers. Paper 41 at 3–4. These exhibits are all cited as
`
`materials considered by either Dr. Osborne or Dr. Kircik in forming the opinions
`
`set forth in their declarations. See Ex. 2057 ¶ 27; Ex. 2055 ¶ 13. These exhibits
`
`are also cited and discussed throughout their declarations. See Ex. 2055 ¶¶ 13, 23-
`
`25, 27, 29, 30-31, 34, 47, 52, 59-64, 66, 93, 97, 103-104; Ex. 2057 ¶¶ 27, 85, 142-
`
`143, 168. Almirall’s experts’ reliance on these exhibits renders them relevant. See
`
`Apple Inc. v. Smartflash LLC, CBM2014-00106, Paper 52 at 25 (Sept. 25, 2015)
`
`(declining to exclude exhibits not cited in the papers, explaining that “[b]ecause
`
`14
`
`
`
`IPR2019-00207
`Patent Owner’s Motion to Exclude Evidence
`
`[the expert] attests that he reviewed these exhibits in reaching the opinions he
`
`expressed in this case, Patent Owner has not shown that they are irrelevant under
`
`FRE 401 and 402”). Almirall’s papers explicitly reference portions of its experts’
`
`declarations that rely on these exhibits. See, e.g., Paper 20 at 6-8, 12-15, 18, 30,
`
`35, 37, and 41.3 Petitioners fail to show that these exhibits are unduly prejudicial.
`
`See SK Hynix Inc. v. Netlist, Inc., Paper 36 at 49.
`
`CONCLUSION
`The Board should deny Petitioners’ motion for at least the above reasons.
`
`
`
`Dated: January 24, 2020
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`
`
`
`3 Exhibit 2050 is explicitly discussed in Patent Owner’s Response, but the citation
`
`to the exhibit number was inadvertently omitted. Paper 20 at 41 (discussing “the
`
`FDA’s Inactive Ingredient Guide (“IIG”)” and citing paragraphs of the Osborne
`
`Declaration clarifying that such is Exhibit 2050 (e.g., Ex. 2057 ¶ 143)).
`
`15
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`
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`IPR2019-00207
`Patent Owner’s Opposition to Petitioners’ Motion to Exclude Evidence
`
`CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATION
`
`Pursuant to 37 CFR § 42.24 et seq., the undersigned certifies that this
`
`PATENT OWNER’S OPPOSITION TO PETITIONERS’ MOTION TO
`
`EXCLUDE EVIDENCE complies with the page-limit for motions and
`
`oppositions of 15 pages. The Opposition contains fifteen pages, excluding the parts
`
`exempted from the page limit.
`
`Dated: January 24, 2020
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`
`
`
`
`IPR2019-00207
`Patent Owner’s Opposition to Petitioners’ Motion to Exclude Evidence
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on January 24, 2020, the
`
`foregoing PATENT OWNER’S OPPOSITION TO PETITIONERS’ MOTION
`
`TO EXCLUDE EVIDENCE was served by electronic mail on the following
`
`counsel of record for Petitioners:
`
`Dennies Varughese
`Adam C. LaRock
`Tyler C. Liu
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW, Suite 600
`Washington, DC 20005
`dvarughe-PTAB@skgf.com
`alarock-PTAB@skgf.com
`tliu-PTAB@skgf.com
`
`
`Jitendra Malik
`Alissa M. Pacchioli
`Heike S. Radeke
`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`heike.radeke@kattenlaw.com
`Lance Soderstrom
`Katten Muchin Rosenman LLP
`575 Madison Avenue
`New York, NY 10022-2585
`lance.soderstrom@kattenlaw.com
`
`Dated: January 24, 2020
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`
`
`
`
`
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