UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
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`Case IPR2023-00049
`U.S. Patent No. 7,713,947
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE FILED AND SERVED
`WITH PETITIONER’S REPLY PURSUANT TO 37 C.F.R. § 42.64
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`Case IPR2023-00049
`U.S. Patent No. 7,713,947
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE FILED AND SERVED
`WITH PETITIONER’S REPLY PURSUANT TO 37 C.F.R. § 42.64
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`IPR2023-00049
`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
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`objections to evidence filed and served with Petitioner’s Reply (“Reply”).
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`Patent Owner’s objections apply equally to Petitioner’s reliance on these
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`exhibits in any subsequently filed documents. These objections are timely,
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`having been filed within five business days of service of evidence to which the
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`objection is directed (June 20, 2024).
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`Exhibit 1047 (Rebuttal Declaration of Benjamin M Greenberg, M.D.)
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`Patent Owner objects to Exhibit 1047 as misleading, incomplete, lacking
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`relevance, and because any probative value is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, misleading the fact finder,
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`undue delay, wasting time, and/or needlessly presenting cumulative evidence.
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`See Fed. R. Evid. 106 and 401-403. Patent Owner also objects to the extent the
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`content of the declaration is not discussed in the Reply and represents an
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`improper incorporation by reference to impermissibly expand the page limit for
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`the Reply. See 37 C.F.R. § 42.6(a)(3). In particular, Patent Owner objects to:
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` ¶¶ 2-4, 6-7, 9, 11-12, 14, 17, 19, 22, and 33 as misleading, incomplete,
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`and irrelevant because they lack support for the contentions for which
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`they are cited;
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` ¶ 34 as misleading, incomplete, and irrelevant because it lacks support for
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`the contentions for which it is cited and improperly characterizes the
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`- 1 -
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`IPR2023-00049
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`teachings of the ’947 patent;
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` ¶¶ 5, 8, 10, 13, 15-16, 18, 20-21, 23-32, and 34-39 as misleading,
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`incomplete, and irrelevant because they lack support for the contentions
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`for which they are cited and improperly characterize the teachings of
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`Bodor and Rice;
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` ¶¶ 4-5, 9, 11-14, 16, 18-21, 25, 29-31, 33-34, 38-39 as misleading,
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`incomplete, and irrelevant because they lack support for the
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`contentions for which they are cited and/or improperly characterize
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`the testimony and opinions of Dr. Lublin;
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` ¶¶ 3, 7, 34 and 39 as irrelevant because these paragraphs refer to U.S.
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`Patent No. 8,377,903, which is not at issue in this inter partes review.
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`Further, any probative value of these paragraphs is substantially
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`outweighed by the danger of unfair prejudice, confusing the issues,
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`misleading the fact finder, undue delay, wasting time, needlessly
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`presenting cumulative evidence.
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`Patent Owner further objects to ¶¶ 2-39 as not being based on sufficient
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`facts or data, the product of reliable principles and methods, and/or not
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`reflecting a reliable application of the principles and methods to the facts. See
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`Fed. R. Evid. 702-703.
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`Patent Owner further objects to ¶¶ 1-4, 6-9, 11-12 and 31-33 because
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`IPR2023-00049
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`these paragraphs are not directly cited in the Reply and the relevance of these
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`paragraphs is not apparent. See Fed. R. Evid. 401-402.
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`Patent Owner further objects to ¶¶ 9, 18, 21-22, 28, which cite to exhibits
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`that are not cited in the Reply, as irrelevant. See Fed. R. Evid. 402.
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`Exhibit 1039
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`Patent Owner objects to Exhibit 1039 under Fed. R. Evid. 401-403 as
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`lacking relevance and because its probative value is substantially outweighed by
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`the danger of unfair prejudice, confusing the issues, misleading the fact finder,
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`undue delay, and/or wasting time.
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`Patent Owner objects to Exhibit 1039 as inadmissible hearsay, to the
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`extent it is being offered to prove the truth of the matter asserted.
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`Patent Owner further objects to Exhibit 1039 under Fed. R. Evid. 901
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`because the document lacks authentication.
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`Patent Owner further objects to any paragraph of Exhibit 1047 to the
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`extent it relies on Exhibit 1039 for at least the reasons identified here.
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`Exhibits 1041, 1042, 1045
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`Patent Owner objects to Exhibit 1041 under Fed. R. Evid. 106 as an
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`incomplete and/or inaccurate transcript of the April 18, 2024 Deposition of Dr.
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`Nicholas Bodor because the transcript does not include any forthcoming errata
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`sheet, which must in fairness be considered at the same time as the exhibit.
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`IPR2023-00049
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
`Patent Owner objects to Exhibit 1042 under Fed. R. Evid. 106 as an
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`incomplete and/or inaccurate transcript of the June 14, 2024 Deposition of Dr.
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`Fred Lublin because the transcript does not include any forthcoming errata
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`sheet, which must in fairness be considered at the same time as the exhibit.
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`Patent Owner objects to Exhibit 1045 under Fed. R. Evid. 106 as an
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`incomplete and/or inaccurate transcript of the June 7, 2024 Deposition of Dr.
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`Alain Munafo because the transcript does not include any forthcoming errata
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`sheet, which must in fairness be considered at the same time as the exhibit.
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`Patent Owner further objects to Exhibits 1041, 1042, 1045 for the same
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`reasons as the objections stated in those transcripts.
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`Patent Owner further objects to any paragraph of Exhibits 1047 to the
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`extent it relies on Exhibits 1041, 1042, 1045, for at least the reasons identified
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`here.
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`Date: June 27, 2024
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`Respectfully submitted,
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`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
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`Counsel for Patent Owner
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`IPR2023-00049
`Patent Owner’s Objections to Evidence Filed and Served with Petitioner’s Reply
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`CERTIFICATE OF SERVICE
`I hereby certify that, on June 27, 2024, I caused a true and correct copy of
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`the following document:
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`Patent Owner’s Objections to Evidence Filed and Served with
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`Petitioner’s Reply Pursuant to 37 C.F.R. § 42.64 to be served via e-mail, as
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`consented to by Petitioner, on the following attorneys of record:
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`
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`Philip.Segrest@huschblackwell.com
`Nathan.Sportel@huschblackwell.com
`Steve.Howe@huschblackwell.com
`Don.Mizerk@huschblackwell.com
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`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
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`- 5 -
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