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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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`TWI PHARMACEUTICALS, INC.,
`Petitioner,
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`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
`PURSUANT TO 37 C.F.R. § 42.64
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`Pursuant to 37 C.F.R. § 42.64, Patent Owner submits the following
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`IPR2023-00049
`Patent Owner’s Objections to Evidence
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`objections to evidence served with the Petition for inter partes review (“Petition”).
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`Patent Owner’s objections apply equally to Petitioner’s reliance on these exhibits
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`in any subsequently filed documents. These objections are timely, having been
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`filed within ten business days of the Institution Decision (December 20, 2023).
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`Exhibit 1005 (Declaration of Benjamin Greenberg, M.D.).
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`Patent Owner objects to exhibit 1005 as misleading, incomplete, and 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, undue
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`delay, and/or wasting time. See Fed. R. Evid. 106, 401, 402, and 403. In
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`particular, Patent Owner objects to:
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` ¶¶ 15, 19, 34-67, 102, 112-114, 118-120, 123, 125, 159-161, 166-167,
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`170, 173-174, 176, 187-189, 191, 193, 198, 200, 204, 210, 212, and
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`237 as misleading, incomplete, and irrelevant because they lack
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`support for the contentions for which they are cited;
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` ¶¶ 20-26 as misleading, incomplete, and irrelevant because they lack
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`support for the contentions for which they are cited and improperly
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`characterize the teachings of the ’947 patent;
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` ¶¶ 68-81, 96-101, 103-111, 115-117, 121-122, 124, 126-135, 162-165,
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`168-169, 172, 175, 177-186, 190, 192, 194-197, 199, 201-203, 205-
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`- 1 -
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`IPR2023-00049
`Patent Owner’s Objections to Evidence
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`209, 211, and 213 as misleading, incomplete, and irrelevant because
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`they lack support for the contentions for which they are cited and
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`improperly characterize the teachings of Bodor and Rice;
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` ¶¶ 1, 13-14, 16, 19, 27-33, 96, 136-158, 161, 166, 171, 177, and 214-
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`236 as irrelevant because these paragraphs refer to U.S. Patent No.
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`8,377,903, which is not at issue in this inter partes review. Further,
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`any probative value of these paragraphs is substantially outweighed
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`by the danger of unfair prejudice, confusing the issues, misleading the
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`fact finder, undue delay, wasting time, needlessly presenting
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`cumulative evidence.
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`Patent Owner further objects to ¶¶ 15, 19-26, 34-81, 96-135, 159-213, and
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`237 as not being based on sufficient facts or data, the product of reliable principles
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`and methods, and/or does not reflect a reliable application of the principles and
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`methods to the facts. See Fed. R. Evid. 702, 703.
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`Patent Owner further objects to ¶¶ 16, 27-33, 82-95, 136-158, 160, 171-176,
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`and 214-236 because these paragraphs are not directly cited in the Petition and the
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`relevance of these paragraphs is not apparent. See Fed. R. Evid. 401, 402.
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`Patent Owner further objects to ¶¶ 1, 10, 27-33, 35, 139-140, and 221, which
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`contain citations to exhibits that are not cited in the Petition, as irrelevant. See Fed.
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`R. Evid. 402.
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`- 2 -
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`Exhibits 1006 and 1031.
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`IPR2023-00049
`Patent Owner’s Objections to Evidence
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`Patent Owner objects to exhibits 1006 and 1031 under Fed. R. Evid. 401,
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`402, and 403 as lacking relevance and because their probative value is substantially
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`outweighed by the danger of unfair prejudice, confusing the issues, misleading the
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`fact finder, undue delay, and/or wasting time. Patent Owner further objects to
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`these exhibits under Fed. R. Evid. 401, 402 because the exhibits are not cited in the
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`Petition.
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`To the extent exhibits 1006 and 1031 are being offered to prove the truth of
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`the matter asserted, the exhibits constitute inadmissible hearsay.
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`Patent Owner further objects to exhibit 1031 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 1005 to the extent it
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`relies on exhibit 1006 or 1031 for at least the reasons identified here.
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`Exhibits 1007, 1008, 1009, 1010, 1013, 1014, 1015, 1024, 1025, 1027,
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`1028, 1029, 1030, 1032, and 1034.
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`Patent Owner objects to exhibits 1007, 1008, 1009, 1010, 1013, 1014, 1015,
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`1024, 1025, 1027, 1028, 1029, 1030, 1032, and 1034 under Fed. R. Evid. 401, 402,
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`and 403 as lacking relevance and because their probative value is substantially
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`outweighed by the danger of unfair prejudice, confusing the issues, misleading the
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`fact finder, undue delay, and/or wasting time.
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`- 3 -
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`To the extent exhibits 1007, 1008, 1009, 1013, 1014, 1015, 1024, 1025,
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`IPR2023-00049
`Patent Owner’s Objections to Evidence
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`1027, 1028, 1029, and 1030 are being offered to prove the truth of the matter
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`asserted, the exhibits constitute inadmissible hearsay.
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`Patent Owner further objects to exhibits 1008, 1009, 1013, 1014, 1015,
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`1024, 1025, 1027, 1028, and 1030 under Fed. R. Evid. 901 because the documents
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`lack authentication.
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`Patent Owner further objects to any paragraph of exhibit 1005 to the extent it
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`relies on exhibit 1007, 1008, 1009, 1010, 1013, 1014, 1015, 1024, 1025, 1027,
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`1028, 1029, 1030, 1032, or 1034 for at least the reasons identified here.
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`- 4 -
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`Date: January 5, 2024
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`IPR2023-00049
`Patent Owner’s Objections to Evidence
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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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`- 5 -
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`IPR2023-00049
`Patent Owner’s Objections to Evidence
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`CERTIFICATE OF SERVICE
`I hereby certify that, on January 5, 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 Pursuant to 37 C.F.R. § 42.64
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`to be served via e-mail, as consented to by Petitioner, on the following attorneys of
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`record:
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`Philip.Segrest@huschblackwell.com
`Nathan.Sportel@huschblackwell.com
`Steve.Howe@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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`- 6 -
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