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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`____________________________________________
`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`____________________________________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE FILED AND SERVED
`WITH PETITIONER’S REPLY PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`
`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`Pursuant to 37 C.F.R. § 42.64, Patent Owner submits the following
`
`objections to evidence filed and served with Petitioner’s Reply (“Reply”). Patent
`
`Owner’s objections apply equally to Petitioner’s reliance on these exhibits in any
`
`subsequently filed documents. These objections are timely, having been filed
`
`within five business days of service of evidence to which the objection is directed
`
`(April 5, 2024).
`
`Exhibit 1084 (Second Declaration of Aaron E. Miller, M.D.).
`
`Patent Owner objects to Exhibit 1084 as misleading, incomplete, lacking
`
`relevance, and because any probative value is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, misleading the fact finder, undue
`
`delay, wasting time, and/or needlessly presenting cumulative evidence. See Fed.
`
`R. Evid. 106 and 401-403. Patent Owner also objects to the extent the content of
`
`the declaration is not discussed in the Reply and represents an improper
`
`incorporation by reference to impermissibly expand the page limit for the Reply.
`
`See 37 C.F.R. § 42.6(a)(3). In particular, Patent Owner objects to:
`
` ¶¶ 10, 18, 27-35, 62, 93, and 124-125 as misleading, incomplete, and
`
`irrelevant because they lack support for the contentions for which they are
`
`cited and improperly characterize the teachings of the ’903 patent;
`
` ¶¶ 7, 9, 12-14, 16, 21-35, 49-50, 53-55, 59, 61-64, 66-67, 69, 72-74, 76, 78,
`
`80-83, 86, 89-91, 97, 99-102, 104-119, 121-130, and 132-133 as misleading,
`
`- 1 -
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`incomplete, and irrelevant because they lack support for the contentions for
`
`which they are cited;
`
` ¶¶ 8, 10-11, 15, 17-19, 51-52, 56-58, 60, 65, 68, 70-71, 75, 77, 79, 84-85,
`
`87-88, 92-96, 98, 103, 120, and 131 as misleading, incomplete, and
`
`irrelevant because they lack support for the contentions for which they are
`
`cited and improperly characterize the teachings of Bodor and Stelmasiak;
`
` ¶¶ 7-15, 17-19, 22-26, 29-31, 50-55, 57-58, 60, 62-97, 102, 104-115, 117,
`
`119-127, and 129-133 as misleading, incomplete, and irrelevant because
`
`they lack support for the contentions for which they are cited and/or
`
`improperly characterize the testimony and opinions of Dr. Lublin;
`
` ¶¶ 8, 15, 17, 58, 60, 63-65, 91, and 94 as misleading, incomplete, and
`
`irrelevant because they lack support for the contentions for which they are
`
`cited and/or improperly characterize the testimony and opinions of Dr.
`
`Meibohm;
`
` ¶¶ 8 and 58 as misleading, incomplete, and irrelevant because they lack
`
`support for the contentions for which they are cited and/or improperly
`
`characterize the testimony and opinions of Dr. Bodor; and
`
` ¶¶ 16, 18, and 91-93 as irrelevant because these paragraphs refer to art not
`
`relied upon in the Grounds at issue in this inter partes review. Further, any
`
`probative value of these paragraphs is substantially outweighed by the
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`- 2 -
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`danger of unfair prejudice, confusing the issues, misleading the fact finder,
`
`undue delay, wasting time, and/or needlessly presenting cumulative
`
`evidence.
`
`Patent Owner further objects to ¶¶ 7-19, 21-35, and 49-133 as not being
`
`based on sufficient facts or data, the product of reliable principles and methods,
`
`and/or not reflecting a reliable application of the principles and methods to the
`
`facts. See Fed. R. Evid. 702-703.
`
`Patent Owner further objects to ¶¶ 9, 21, and 49, because these paragraphs
`
`are not directly cited in the Reply and the relevance of these paragraphs is not
`
`apparent. See Fed. R. Evid. 401-402. Petitioner includes two citations in the
`
`Reply to all paragraphs in Exhibit 1084. See Reply, 18 (citing “EX1084, ¶¶1-133”
`
`for the assertion that “Merck’s remaining arguments also fail”), 23 (citing
`
`“EX1084, ¶¶1-133” for the assertion that “Merck’s other arguments” should be
`
`rejected). This does not moot Patent Owner’s objection to ¶¶ 9, 21, and 49 because
`
`Petitioner’s wholesale citation to every paragraph in Dr. Miller’s second
`
`declaration amounts to improper incorporation by reference. See 37 C.F.R.
`
`§42.6(a)(3); see also Instrumentation Lab. Co. v. HemoSonics LLC, IPR2017-
`
`00855, Paper 55 at 22-23 (P.T.A.B. Feb. 13, 2019) (declining to consider
`
`paragraphs of declaration “merely because they are cited in the Petition”).
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`- 3 -
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`
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`Patent Owner further objects to ¶ 23, n.1, which cites to an exhibit that is not
`
`cited in the Reply, as irrelevant. See Fed. R. Evid. 402.
`
`Patent Owner further objects to paragraphs that cite to Exhibit 1080 for the
`
`same reasons Patent Owner objects to Exhibit 1080 as discussed below.
`
`
`
`Exhibit 1080 (Declaration of Rodolfo Pinal, Ph.D.).
`
`Patent Owner objects to Exhibit 1080 as misleading, incomplete, lacking
`
`relevance, and because any probative value is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, misleading the fact finder, undue
`
`delay, wasting time, and/or needlessly presenting cumulative evidence. See Fed.
`
`R. Evid. 106 and 401-403. Patent Owner also objects to the extent the content of
`
`the declaration is not discussed in the Reply and represents an improper
`
`incorporation by reference to impermissibly expand the page limit for the Reply.
`
`See 37 C.F.R. § 42.6(a)(3). In particular, Patent Owner objects to:
`
` ¶¶ 14-15, 20, 22, 27-44, 46-49, 51-52, 55, 59, 62-63, 66-68, 70, 74-75, 78-
`
`79, 82-83 as misleading, incomplete, and irrelevant because they lack
`
`support for the contentions for which they are cited;
`
` ¶¶ 16-19, 45, 50, 53-54, 56-58, 60-61, 64-65, 69, 71-73, 76-77, and 80-81 as
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`misleading, incomplete, and irrelevant because they lack support for the
`
`contentions for which they are cited and improperly characterize the
`
`teachings of Bodor and Stelmasiak;
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`- 4 -
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`
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
` ¶¶ 17-18, 67-69, and 78 as misleading, incomplete, and irrelevant because
`
`they lack support for the contentions for which they are cited and/or
`
`improperly characterize the testimony and opinions of Dr. Lublin;
`
` ¶¶ 15, 17-18, 32-34, 41, 43, 67-69, 72-73, and 78 as misleading, incomplete,
`
`and irrelevant because they lack support for the contentions for which they
`
`are cited and/or improperly characterize the testimony and opinions of Dr.
`
`Meibohm;
`
` ¶¶ 15-16, 31, 34, 38, 41-42, 54, 60, and 63 as misleading, incomplete, and
`
`irrelevant because they lack support for the contentions for which they are
`
`cited and/or improperly characterize the testimony and opinions of Dr.
`
`Bodor;
`
` ¶¶ 45, 54, and 62 as misleading, incomplete, and irrelevant because they lack
`
`support for the contentions for which they are cited and/or improperly
`
`characterize the testimony and opinions of Dr. Munafo;
`
` ¶¶ 38, 41, and 63 as misleading, incomplete, and irrelevant because they lack
`
`support for the contentions for which they are cited and/or improperly
`
`characterize the testimony and opinions of Dr. Dandiker; and
`
` ¶¶ 19, 79, and 82 as irrelevant because these paragraphs refer to art not
`
`relied upon in the Grounds at issue in this inter partes review. Further, any
`
`probative value of these paragraphs is substantially outweighed by the
`
`- 5 -
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`
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`danger of unfair prejudice, confusing the issues, misleading the fact finder,
`
`undue delay, wasting time, and/or needlessly presenting cumulative
`
`evidence.
`
`Patent Owner further objects to ¶¶ 14-20, 22, and 27-83 as not being based
`
`on sufficient facts or data, the product of reliable principles and methods, and/or
`
`not reflecting a reliable application of the principles and methods to the facts. See
`
`Fed. R. Evid. 702-703.
`
`Patent Owner further objects to ¶¶ 14 and 19-20 because these paragraphs
`
`are not directly cited in the Petition and the relevance of these paragraphs is not
`
`apparent. See Fed. R. Evid. 401-402. Petitioner includes two citations in the
`
`Reply to all paragraphs in Exhibit 1080. See Reply, 23 (citing “EX1080, ¶¶1-83”
`
`for the assertion that “Merck’s other arguments” should be rejected). This does not
`
`moot Patent Owner’s objection to ¶¶ 14 and 19-20 because Petitioner’s wholesale
`
`citation to every paragraph in Dr. Pinal’s declaration amounts to improper
`
`incorporation by reference. See 37 C.F.R. §42.6(a)(3); see also Instrumentation
`
`Lab. Co. v. HemoSonics LLC, IPR2017-00855, Paper 55 at 22-23 (P.T.A.B. Feb.
`
`13, 2019) (declining to consider paragraphs of declaration “merely because they
`
`are cited in the Petition”).
`
`Patent Owner further objects to ¶¶ 4, 31, 33, 44, 46, 61, 77, and 81, which
`
`cite to exhibits that are not cited in the Reply, as irrelevant. See Fed. R. Evid. 402.
`
`- 6 -
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`
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`Patent Owner further objects to paragraphs that cite Exhibit 1084 for the
`
`same reasons Patent Owner objects to Exhibit 1084 as discussed above.
`
`Exhibits 1068, 1070-1071, 1073, 1075, 1079, and 1081-1083.
`
`Patent Owner objects to Exhibits 1068, 1070-1071, 1073, 1075, 1079, and
`
`1081-1083 under Fed. R. Evid. 401-403 as lacking relevance and because their
`
`probative value is substantially outweighed by the danger of unfair prejudice,
`
`confusing the issues, misleading the fact finder, undue delay, and/or wasting time.
`
`Patent Owner further objects to these exhibits under Fed. R. Evid. 401-402 because
`
`the exhibits are not cited in the Reply.
`
`Exhibits 1055-1056, 1064-1079, and 1081-1083.
`
`Patent Owner objects to Exhibits 1055-1056, 1064-1079, and 1081-1083
`
`under Fed. R. Evid. 401-403 as lacking relevance and because their probative value
`
`is substantially outweighed by the danger of unfair prejudice, confusing the issues,
`
`misleading the fact finder, undue delay, and/or wasting time.
`
`Patent Owner objects to Exhibits 1064-1074, 1076-1079, and 1081-1083 as
`
`inadmissible hearsay, to the extent they are being offered to prove the truth of the
`
`matter asserted.
`
`Patent Owner further objects to Exhibits 1064-1074, 1076-1079, and 1082-
`
`1083 under Fed. R. Evid. 901 because the documents lack authentication.
`
`- 7 -
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`
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`Patent Owner further objects to any paragraph of Exhibits 1080 and 1084 to
`
`the extent they rely on Exhibits 1064-1074, 1076-1079, and 1081-1083, for at least
`
`the reasons identified here.
`
`Exhibits 1059-1063.
`
`
`
`Patent Owner objects to Exhibit 1059 under Fed. R. Evid. 106 as an
`
`incomplete and/or inaccurate transcript of the February 15, 2024 Deposition of Dr.
`
`Nicholas Bodor because the transcript does not include the accompanying errata
`
`sheet, as served by Planet Depos on March 13, 2024. The submitted errata sheet
`
`must in fairness be considered at the same time as the exhibit.
`
`
`
`Patent Owner objects to Exhibit 1060 under Fed. R. Evid. 106 as an
`
`incomplete and/or inaccurate transcript of the February 16, 2024 Deposition of Dr.
`
`Yogesh Dandiker because the transcript does not include the accompanying errata
`
`sheet, as served by Planet Depos on March 20, 2024. The submitted errata sheet
`
`must in fairness be considered at the same time as the exhibit.
`
`
`
`Patent Owner objects to Exhibit 1061 under Fed. R. Evid. 106 as an
`
`incomplete and/or inaccurate transcript of the March 5, 2024 Deposition of Dr.
`
`Fred Lublin because the transcript does not include the accompanying errata sheet,
`
`as served by Planet Depos on April 1, 2024. The submitted errata sheet must in
`
`fairness be considered at the same time as the exhibit.
`
`- 8 -
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`
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`Patent Owner objects to Exhibit 1062 under Fed. R. Evid. 106 as an
`
`
`
`incomplete and/or inaccurate transcript of the March 6, 2024 Deposition of Dr.
`
`Bernd Meibohm because the transcript does not include the accompanying errata
`
`sheet, as served by Planet Depos on April 4, 2024. The submitted errata sheet
`
`must in fairness be considered at the same time as the exhibit.
`
`
`
`Patent Owner objects to Exhibit 1063 under Fed. R. Evid. 106 as an
`
`incomplete and/or inaccurate transcript of the March 27, 2024 Deposition of Dr.
`
`Alain Munafo because the transcript does not include the accompanying errata
`
`sheet, as served by Planet Depos on April 5, 2024. The submitted errata sheet
`
`must in fairness be considered at the same time as the exhibit.
`
`Patent Owner further objects to Exhibits 1059-1063 for the same reasons as
`
`the objections stated in those transcripts.
`
`
`
`Patent Owner further objects to any paragraph of Exhibits 1080 and 1084 to
`
`the extent they rely on Exhibits 1059-1063, for at least the reasons identified here.
`
`
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`- 9 -
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`
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`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`Respectfully submitted,
`
`Date: April 12, 2024
`
`By: /Emily R. Whelan/
`Emily R. Whelan (Reg. No. 50,391)
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`Tel. (617) 526-6567
`Email: Emily.Whelan@wilmerhale.com
`
`
`
`Counsel for Patent Owner
`
`
`
`- 10 -
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`
`
`IPR2023-00481
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`
`
`CERTIFICATE OF SERVICE
`I hereby certify that, on April 12, 2024, I caused a true and correct copy of
`
`the following document:
`
`
`
`Patent Owner’s Objections to Evidence Pursuant to 37 C.F.R. § 42.64
`
`to be served via e-mail, as consented to by Petitioner, on the following attorneys of
`
`record:
`
`
`
`
`
`eellison-PTAB@sternekessler.com
`opartington-PTAB@sternekessler.com
`cvira-PTAB@sternekessler.com
`jcrozendaal-PTAB@sternekessler.com
`cdashe-PTAB@sternekessler.com
`pkhanduri-PTAB@sternekessler.com
`tliu-PTAB@sternekessler.com
`mbond-PTAB@sternekessler.com
`PTAB@sternekessler.com
`
`By: /Cindy Kan/
`Cindy Kan (Reg. No. 76,385)
`Wilmer Cutler Pickering Hale and Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: 212-295-6470
`Email: cindy.kan@wilmerhale.com
`
`
`
`- 11 -
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`
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