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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
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`v.
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`ALMIRALL, LLC
`Patent Owner.
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
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`OPPOSITION TO PETITIONERS’
`MOTION TO EXCLUDE EVIDENCE
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`Patent Owner Almirall, LLC (“Almirall”) responds to each of the arguments
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`raised in Petitioners’ Motion to Exclude Evidence (Paper 34). Petitioners’ motion
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`to should be denied for at least the following reasons:
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`I.
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`THE BOARD SHOULD NOT EXCLUDE THE CONTESTED
`PORTIONS OF DR. KLIBANOV’S DECLARATION (EX. 2003)
`Petitioners seek to exclude certain paragraphs of the Declaration of
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`Almirall’s expert Dr. Klibanov (Ex. 2003) as irrelevant and unfairly prejudicial
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`because Almirall did not cite these paragraphs in its papers. See Paper 34 at 3–5.
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`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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`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
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`or less probable than it would be without the evidence.” Fed. R. Evid. 401
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`(emphasis added). This threshold for admissibility is quite low. Laird Techs., Inc.
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`v. GrafTech Int’l Holdings, Inc., IPR2014-00025, Paper 45 at 44 (Mar. 25, 2015);
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`1
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`OddzOn Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396, 1407 (Fed. Cir. 1997).
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`Unremarkably flowing from its competence to evaluate the weight of record
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`evidence is the Board’s pronouncement that, “[r]ather than excluding evidence that
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`is allegedly confusing, misleading, untimely, and/or irrelevant, we will simply not
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`rely on it or give it little weight, as appropriate, in our analysis.” SK Hynix Inc. v.
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`Netlist, Inc., IPR2017-00562, Paper 36 at 49 (July 5, 2018) (denying motion to
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`exclude paragraphs of expert declarations and exhibits not cited in briefing). And,
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`in the inter partes review context, “the better course is to have a complete record
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`of the evidence to facilitate public access as well as appellate review.” Id.
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`The paragraphs Petitioners seek to exclude are in any case relevant:
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`Paragraphs 1–20: pertain to (i) Dr. Klibanov’s background and
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`qualifications as an expert in this proceeding; (ii) the materials he considered
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`in forming his opinions; (iii) an overview of his opinions in this proceeding;
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`and (iv) the legal principles he assumed and relied upon in rendering his
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`expert opinions.
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`Paragraphs 21–40: recite the claims of the ʼ926 patent, review its
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`prosecution history, and describe Dr. Klibanov’s understanding regarding
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`the effective filing date.
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` Paragraphs 43, 61, 62, 64, 66–68 & 71-77: conceern Dr. Klibanov’s
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`understanding of the background of the invention.
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`2
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`Paragraphs 78–80, 88–90, 92–98 & 100: set forth Dr. Klibanov’s
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`understanding of the prior art references—Garrett, Nadau-Fourcade, and
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`Bonacucina—asserted by Petitioners in their two Grounds.
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`Paragraphs 104–112, 116–122 & 125–136: relate to Dr. Klibanov’s
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`understanding of additional prior art references cited to by Petitioners and
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`their experts, though not comprising either of their Grounds.
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`Paragraphs 137–143, 146–148, 152–158, 164–167, 169–171, 173, 175–181,
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`183–192, 194–196 & 200: provide transitions, context, and analyses for
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`surrounding paragraphs
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`Paragraphs 202–217: respond to the portion of Dr. Michniak-Kohn’s
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`Declaration (Ex. 1002), offered by Petitioners, regarding objective indicia of
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`non-obviousness.
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`Paragraph 218: provides a conclusion.
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`Paragraphs 161, 162, 163 & 168: are expressly cited in Patent Owner’s
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`Response. See Paper 23 at 28, 44, & 45.
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`Petitioners, not surprisingly, fail to explain how these paragraphs are unfairly
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`prejudicial to Petitioners. The Board accordingly should deny Petitioners’ motion
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`to exclude certain portions of Exhibit 2003.
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`3
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`II. THE BOARD SHOULD NOT EXCLUDE THE CONTESTED
`PORTIONS OF DR. HARPER’S DECLARATION (EX. 2022)
`Petitioners likewise seek to exclude certain paragraphs of the Declaration of
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`Almirall’s clinician-expert, Dr. Harper (Ex. 2022), as irrelevant and unfairly
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`prejudicial because Almirall did not cite these paragraphs in its papers. See Paper
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`34 at 3–5. Petitioners’ arguments are no more availing in respect of Dr. Harper’s
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`Declaration. The relevance of the challenged paragraphs of Exhibit 2022 similarly
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`cannot credibly be questioned:
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`Paragraphs 1–22, 32 & 36–37: pertain to (i) Dr. Harper’s background and
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`qualifications as an expert in this proceeding; (ii) the materials she
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`considered in forming her opinions; (iii) an overview of her opinions in this
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`proceeding; and (iv) the legal principles she assumed and relied upon in
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`rendering her expert opinions.
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`Paragraphs 23–31: recite the claims of the ʼ926 patent.
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`Paragraph 35: reflects the indisputable agreement between Dr. Harper and
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`her Petitioners’ counterpart, Dr. Gilmore, as to the appropriate qualifications
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`of a clinical person of ordinary skill in the art.
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`Paragraphs 38–39, 65 & 78–80: provide context regarding the surrounding
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`paragraphs that set forth the background and state of the art relating to the
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`invention.
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`4
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`Paragraphs 85–94: pertain to Dr. Harper’s understanding of the prior art
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`references—Garrett, Nadau-Fourcade, and Bonacucina—asserted by
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`Petitioners as the bases of their two Grounds.
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`Paragraphs 96–112 & 115: relate to Dr. Harper’s understanding of
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`additional prior art references cited to by Petitioners and their experts,
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`though not comprising either of their Grounds.
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`Paragraphs 132, 150 & 163: provide transitions between sections.
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`Paragraphs 173–199: pertain to the analyses set forth in the proceeding
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`paragraphs, and why Petitioners’ arguments do not alter that analysis.
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`Paragraph 200: provides a conclusion.
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`Here again, Petitioners fail to explain how these paragraphs are unfairly prejudicial
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`to Petitioners. Accordingly, the Board should deny Petitioners’ motion to exclude
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`certain portions of Exhibit 2022.
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`III. THE BOARD SHOULD NOT EXCLUDE THE CONTESTED
`EXHIBITS CITED IN THE DECLARATIONS OF DR. KLIBANOV
`AND DR. HARPER
`In addition to paragraphs of expert reports, Petitioners seek to exclude
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`certain exhibits as “irrelevant and/or prejudicial” because they are not cited in
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`Almirall’s papers. Paper 34 at 3–5. These exhibits, with the exception of the
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`curricula vitae of Dr. Klibanov and Dr. Harper (Exs. 2004 and 2023,
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`5
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`respectively)1, are all cited as materials considered by either Dr. Klibanov and/or
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`Dr. Harper in forming the opinions set forth in their declarations. See Ex. 2003 ¶
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`13; Ex. 2022 ¶ 13). These exhibits are also cited and discussed throughout their
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`respective declarations. See Ex. 2003 ¶¶ 12, 62, 66, 67; Ex. 2022 ¶¶ 11, 48–50, 54,
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`73–74, 76–84, 139–140, 144, 158, 162. Accordingly, these exhibits are relevant,
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`and should not be excluded. See Apple Inc. v. Smartflash LLC, CBM2014-00106,
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`Paper 52 at 25 (Sept. 25, 2015) (declining to exclude exhibits not cited in the
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`papers, explaining that “[b]ecause [the expert] attests that he reviewed these
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`exhibits in reaching the opinions he expressed in this case, Patent Owner has not
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`shown that they are irrelevant under FRE 401 and 402”). Nor have Petitioners
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`shown that these exhibits are unduly prejudicial. See SK Hynix Inc. v. Netlist, Inc.,
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`Paper 36 at 49.
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`To the extent Petitioners’ objection is rooted in a concern that Almirall will
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`advance at the oral hearing arguments regarding these documents not presented in
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`1 That experts’ curricula vitae are irrelevant and/or prejudicial because not
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`discussed in a party’s papers is preposterous. Curricula vitae are relevant to the
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`expert’s qualifications, and Petitioners have not offered an explanation of why
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`expert curricula vitae are prejudicial. To the contrary, Petitioners submitted
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`curricula vitae of their own experts. See Exs. 1003, 1019.
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`6
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`previously submitted papers, it is baseless. Almirall intends to comply fully with
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`the Board’s Rules (e.g., Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug.
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`14, 2012); Trial Practice Guide Update (August 2018) at 23). Almirall expects that
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`Petitioners will do the same with respect to the numerous exhibits filed by
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`Petitioners not cited in any of Petitioners’ submitted papers. E.g., Exs. 1003, 1006,
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`1012, 1019, 1022, 1023, 1025, 1027, 1029, 1030, 1032, 1036–1039, 1041, 1059.
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`IV. THE BOARD SHOULD NOT EXCLUDE EXHIBIT 2043
`Whether Exhibit 2043 was publicly available on February 5, 2007 or at some
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`other date does not affect its relevance to this proceeding. Exhibit 2043 is relied
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`on by Dr. Harper as supporting the data presented in two unchallenged exhibits:
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`Exhibits 2042 and Exhibit 2006. See Ex. 2022 ¶ 144 n.6; id. ¶¶ 142–147. As it is
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`not being presented as prior art, but as merely corroborating what was in the 2007
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`patent application (Ex. 2006) and the 2012 article (Ex. 2042), the date is not being
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`presented for the truth of the matter asserted, and Exhibit 2043 is not inadmissible
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`hearsay. Finally, Exhibit 2043 is self-authenticating on its face. It bears the dated
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`signatures of the study director, study biostatistician, president of QLT, and
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`medical writer of QLT attesting that “[t]his Study Report is written as an accurate
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`record of the conduct and the results of the study.” Ex. 2043 at 1–2. Moreover, it
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`also bears the dated signature of QLT’s senior manager of clinical quality attesting
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`that it has been reviewed for accuracy and completeness. Id. at 2. Federal Rule of
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`7
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`Evidence 901(b)(4) provides that “[t]he appearance, contents, substance, internal
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`patterns, or other distinctive characteristics of the item, taken together with all the
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`circumstances” are enough to satisfy the authentication requirement. The
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`distinctive characteristics of Exhibit 2043—particularly the attestations as to the
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`nature of the record—together with its content, and the repetition of its content in
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`Exhibits 2006 and 2042, form circumstances sufficient to demonstrate its
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`authenticity.
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`V. CONCLUSION
`Almirall does not contest the exclusion of Exhibit 2044. For the reasons
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`stated above, the Board should otherwise deny Petitioners’ motion to exclude.
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`Dated: May 8, 2019
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`Respectfully submitted,
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`FENWICK & WEST LLP
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`By:/ James S. Trainor /
`James S. Trainor (Reg. No. 52,297)
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`Attorneys for Patent Owner
`Almirall, LLC
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`8
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`IPR2018-00608
`Opposition to Petitioners’ Motion to Exclude
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on May 8, 2019, the
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`foregoing OPPOSITION TO PETITIONERS’ MOTION TO EXCLUDE
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`EVIDENCE was served by electronic mail on the following counsel of record for
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`petitioner:
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`Dennies Varughese (dvarughe-PTAB@skgf.com)
`Adam C. LaRock (alarock-PTAB@skgf.com)
`PTAB@skgf.com
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW, Suite 600
`Washington, DC 20005
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`Dated: May 8, 2019
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`Respectfully submitted,
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`FENWICK & WEST LLP
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`By:/ James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
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`Attorneys for Patent Owner
`Almirall, LLC
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