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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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`PATENT OWNER’S OBJECTIONS TO REPLY EVIDENCE
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`Pursuant to 37 C.F.R. § 42.64, Patent Owner Almirall, LLC (“Almirall”)
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`hereby objects to the admissibility of evidence Petitioners Amneal Pharmaceuticals
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`LLC and Amneal Pharmaceuticals of New York, LLC (collectively, “Amneal”)
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`submitted with their Reply to Patent Owner’s Response (Paper 29):
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`1.
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`Almirall objects to Exhibit 1035 as lacking authentication under FRE
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`901. Exhibit 1035 purports to be a publication from 2012 but there is no evidence
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`establishing that it contains true and correct content. Accordingly, Amneal has not
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`provided evidence sufficient to support a finding that Exhibit 1035 “is what
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`[Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit 1035 as
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`irrelevant under FRE 401 and 402. Exhibit 1035 purports to be a publication from
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`December 2012. There is no evidence that Exhibit 2012 is a prior art publication
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`available to the public before November 20, 2012, the earliest date to which U.S.
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`patent No. 9,161,926 claims priority. See Ex. 1001 at cover, 1:8–12. Almirall
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`further objects to Exhibit 1035 as inadmissible hearsay under FRE 801 and 802.
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`Amneal failed to examine Dr. Harper, a purported author of this document,
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`regarding Exhibit 1035. See generally Ex. 1049 (transcript of March 11, 2019
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`deposition of Dr. Harper).
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`2.
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`Almirall objects to Exhibit 1036 as irrelevant under FRE 401 and 402
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`because Amneal did not rely upon or discuss this exhibit in its Reply. This exhibit
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`1
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`is only cited in the Second Declaration of Dr. Gilmore. Ex. 1034 ¶ 21. Any use of
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`this exhibit would be improper incorporation by reference under 37 C.F.R.
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`§ 42.6(a)(3).
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`3.
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`Almirall objects to Exhibit 1037 as irrelevant under FRE 401 and 402
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`because Amneal did not rely upon or discuss this exhibit in its Reply. This exhibit
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`is only cited in the Second Declaration of Dr. Gilmore. Ex. 1034 ¶ 20. Any use of
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`this exhibit would be improper incorporation by reference under 37 C.F.R.
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`§ 42.6(a)(3).
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`4.
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`Almirall objects to Exhibit 1038 as irrelevant under FRE 401 and 402
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`because Amneal did not rely upon or discuss this exhibit in its Reply. This exhibit
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`is only cited in the Second Declaration of Dr. Gilmore. Ex. 1034 ¶ 20. Any use of
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`this exhibit would be improper incorporation by reference under 37 C.F.R.
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`§ 42.6(a)(3).
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`5.
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`Almirall objects to Exhibit 1039 as irrelevant under FRE 401 and 402
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`because Amneal did not rely upon or discuss this exhibit in its Reply. This exhibit
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`is only cited in the Second Declaration of Dr. Gilmore. Ex. 1034 ¶ 20. Any use of
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`this exhibit would be improper incorporation by reference under 37 C.F.R.
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`§ 42.6(a)(3).
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`6.
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`Almirall objects to Exhibit 1040 as irrelevant under FRE 401 and 402
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`because Amneal did not rely upon or discuss this exhibit in its Reply. This exhibit
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`2
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`is only cited in the Second Declaration of Dr. Gilmore. Ex. 1034 ¶ 20. Any use of
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`this exhibit would be improper incorporation by reference under 37 C.F.R.
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`§ 42.6(a)(3).
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`7.
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`Almirall objects to Exhibit 1041 as irrelevant under FRE 401 and 402
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`because it has no tendency to make any fact of consequence in determining this
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`action more or less probable than it would be without this exhibit. Almirall further
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`objects to Exhibit 1041 as lacking authentication under FRE 901. Exhibit 1041
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`purports to be a printout or partial printout of a webpage but there is no evidence
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`establishing that it contains true and correct content. Accordingly, Amneal has not
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`provided evidence sufficient to support a finding that Exhibit 1041 “is what
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`[Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit 1041 as
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`inadmissible hearsay under FRE 801 and 802. Amneal has provided no evidence
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`of the truth of the assertions in Exhibit 1041.
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`8.
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`Almirall objects to Exhibit 1042 as irrelevant under FRE 401 and 402
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`because it has no tendency to make any fact of consequence in determining this
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`action more or less probable than it would be without this exhibit. Almirall further
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`objects to Exhibit 1042 as lacking authentication under FRE 901. Exhibit 1042
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`purports to be a printout or partial printout of a webpage but there is no evidence
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`establishing that it contains true and correct content. Accordingly, Amneal has not
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`provided evidence sufficient to support a finding that Exhibit 1042 “is what
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`3
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`[Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit 1042 as
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`inadmissible hearsay under FRE 801 and 802. Amneal has provided no evidence
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`of the truth of the assertions in Exhibit 1042.
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`9.
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`Almirall objects to Exhibit 1043 as irrelevant under FRE 401 and 402
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`because it has no tendency to make any fact of consequence in determining this
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`action more or less probable than it would be without this exhibit. Almirall further
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`objects to Exhibit 1043 as lacking authentication under FRE 901. Exhibit 1043
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`purports to be a printout or partial printout of a webpage but there is no evidence
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`establishing that it contains true and correct content. Accordingly, Amneal has not
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`provided evidence sufficient to support a finding that Exhibit 1043 “is what
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`[Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit 1043 as
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`inadmissible hearsay under FRE 801 and 802. Amneal has provided no evidence
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`of the truth of the assertions in Exhibit 1043.
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`10. Almirall objects to Exhibit 1044 as irrelevant under FRE 401 and 402
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`because it has no tendency to make any fact of consequence in determining this
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`action more or less probable than it would be without this exhibit. Almirall further
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`objects to Exhibit 1044 as lacking authentication under FRE 901. Exhibit 1044
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`purports to be a printout or partial printout of a webpage but there is no evidence
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`establishing that it contains true and correct content. Accordingly, Amneal has not
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`provided evidence sufficient to support a finding that Exhibit 1044 “is what
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`4
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`[Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit 1044 as
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`inadmissible hearsay under FRE 801 and 802. Amneal has provided no evidence
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`of the truth of the assertions in Exhibit 1044.
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`11. Almirall objects to Exhibit 1045 as irrelevant under FRE 401 and 402
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`because it has no tendency to make any fact of consequence in determining this
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`action more or less probable than it would be without this exhibit. Almirall further
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`objects to Exhibit 1045 as lacking authentication under FRE 901. Exhibit 1045
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`purports to be a printout or partial printout of a webpage but there is no evidence
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`establishing that it contains true and correct content. Accordingly, Amneal has not
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`provided evidence sufficient to support a finding that Exhibit 1045 “is what
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`[Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit 1045 as
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`inadmissible hearsay under FRE 801 and 802. Amneal has provided no evidence
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`of the truth of the assertions in Exhibit 1045.
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`12. Almirall objects to Exhibit 1046 as irrelevant under FRE 401 and 402
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`because it has no tendency to make any fact of consequence in determining this
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`action more or less probable than it would be without this exhibit. Almirall further
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`objects to Exhibit 1046 as lacking authentication under FRE 901. Exhibit 1046
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`purports to be a printout or partial printout of a webpage but there is no evidence
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`establishing that it contains true and correct content. Accordingly, Amneal has not
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`provided evidence sufficient to support a finding that Exhibit 1046 “is what
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`5
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`[Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit 1046 as
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`inadmissible hearsay under FRE 801 and 802. Amneal has provided no evidence
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`of the truth of the assertions in Exhibit 1046.
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`13. Almirall objects to Exhibit 1047 as irrelevant under FRE 401 and 402
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`because it has no tendency to make any fact of consequence in determining this
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`action more or less probable than it would be without this exhibit. Almirall further
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`objects to Exhibit 1047 as lacking authentication under FRE 901. Exhibit 1047
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`purports to be a printout or partial printout of a webpage but there is no evidence
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`establishing that it contains true and correct content. Accordingly, Amneal has not
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`provided evidence sufficient to support a finding that Exhibit 1047 “is what
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`[Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit 1047 as
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`inadmissible hearsay under FRE 801 and 802. Amneal has provided no evidence
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`of the truth of the assertions in Exhibit 1047.
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`14. Almirall objects to Exhibit 1048 as irrelevant under FRE 401 and 402
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`because Amneal did not cite, rely upon, or discuss this exhibit in its Reply or in
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`any expert declaration. Almirall also objects to Exhibit 1048 as irrelevant under
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`FRE 401 and 402 because it has no tendency to make any fact of consequence in
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`determining this action more or less probable than it would be without this exhibit.
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`Almirall further objects to Exhibit 1048 as lacking authentication under FRE 901.
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`Exhibit 1048 purports to be a printout or partial printout of a webpage but there is
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`6
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`no evidence establishing that it contains true and correct content. Accordingly,
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`Amneal has not provided evidence sufficient to support a finding that Exhibit 1048
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`“is what [Amneal] claims it is.” See FRE 901. Almirall further objects to Exhibit
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`1048 as inadmissible hearsay under FRE 801 and 802. Amneal has provided no
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`evidence of the truth of the assertions in Exhibit 1048.
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`15. Almirall objects to Exhibit 1053 as irrelevant under FRE 401 and 402
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`because Amneal did not substantively discuss this exhibit in its Reply. Any use of
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`this exhibit would be improper incorporation by reference under 37 C.F.R.
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`§ 42.6(a)(3). Almirall further objects to Exhibit 1053 as lacking authentication
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`under FRE 901. Exhibit 1053 purports to be an article published in 2014, and
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`Amneal’s expert Dr. Michniak-Kohn describes it as describing the regulatory
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`status of DGME in 2012. See Ex. 1050 ¶ 31. There is no evidence establishing
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`that it contains true and correct content. Accordingly, Amneal has not provided
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`evidence sufficient to support a finding that Exhibit 1053 “is what [Amneal] claims
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`it is. See FRE 901. Almirall further objects to Exhibit 1053 as inadmissible
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`hearsay under FRE 801 and 802. Amneal has provided no evidence of the truth of
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`the assertions in Exhibit 1053.
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`16. Almirall objects to Exhibit 1054 as lacking authentication under FRE
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`901. Exhibit 1054 appears to be a portion of a printout of a webpage. There is no
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`evidence establishing that it contains true and correct content. Accordingly,
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`7
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`Amneal has not provided evidence sufficient to support a finding that Exhibit 1054
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`“is what [Amneal] claims it is. See FRE 901. Almirall further objects to Exhibit
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`1054 as irrelevant under FRE 401 and 402. If the content is taken as true, the
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`information on the printout relates to 2019. There is no evidence that Exhibit 1054
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`is a prior art publication that is available to the public. Therefore, Exhibit 1054 is
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`inadmissible as not relevant.
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`17. Almirall objects to Exhibit 1055 as lacking authentication under FRE
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`901. Exhibit 1054 appears to be a portion of a printout of a webpage. There is no
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`evidence establishing that it contains true and correct content. Accordingly,
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`Amneal has not provided evidence sufficient to support a finding that Exhibit 1055
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`“is what [Amneal] claims it is. See FRE 901. Almirall further objects to Exhibit
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`1055 as irrelevant under FRE 401 and 402. If the content is taken as true, the
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`information on the printout relates to 2019. There is no evidence that Exhibit 1055
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`is a prior art publication that is available to the public. Therefore, Exhibit 1055 is
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`inadmissible as not relevant.
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`18. Almirall objects to Exhibit 1059 as irrelevant under FRE 401 and 402
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`because Amneal did not rely upon or discuss this exhibit in its Reply. Although
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`Almirall’s Reply cited to Exhibit 1059 in two places (Paper 29 at 9, 16), both
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`citations are clearly intended to be to Exhibit 1058, as from context both purport to
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`be citations to Dr. Klibanov’s deposition transcript (Ex. 1058) and include page
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`8
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`and line numbers as found in a deposition transcript, with no correlation to the
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`document filed as AMN1059. This exhibit is only cited with a pinpoint citation
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`that corresponds to the document filed as AMN1059 in the Second Declaration of
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`Dr. Michniak-Kohn (Ex. 1050 ¶ 65). Accordingly, any use of this exhibit would
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`be improper incorporation by reference under 37 C.F.R. § 42.6(a)(3).
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`19. Any paragraph of Exhibit 1034 and/or Exhibit 1050 that relies on any
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`of the exhibits identified above is objected to for the same reason(s) as Almirall’s
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`objection(s) to the underlying exhibit.
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`These objections are made and filed within five business days of March 18,
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`2019, the date of service of Petitioners’ Reply. 37 C.F.R. § 42.64(b)(1).
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`Dated: March 25, 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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`9
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`IPR2018-00608
`Patent Owner’s Objections to Reply Evidence
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on March 25, 2019, the
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`foregoing PATENT OWNER’S OBJECTIONS TO REPLY EVIDENCE was served by
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`electronic mail on the following counsel of record for 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: March 25, 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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