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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 IPR2023-00050
`U.S. Patent No. 8,377,903
`____________________________________________
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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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`IPR2023-00050
`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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` ¶¶ 16, 19, 34-67, 102, 112-114, 118-120, 123, 125, 136, 138, 159-161,
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`166-167, 170-171, 173-174, 176, 187-189, 191, 193, 198, 200, 214,
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`219, 222-223, 227, 233, 235, and 237 as misleading, incomplete, and
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`irrelevant because they lack support for the contentions for which they
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`are cited;
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` ¶¶ 27-33 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 ’903 patent;
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`IPR2023-00050
`Patent Owner’s Objections to Evidence
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` ¶¶ 68-81, 96-101, 103-111, 115-117, 121-122, 124, 126-135, 137,
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`139-158, 162-165,168-169, 172, 175, 177-186, 190, 192, 194-197,
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`199, 216-218, 220-221, 224-226, 228-232, 234, and 236 as
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`misleading, incomplete, and irrelevant because they lack support for
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`the contentions for which they are cited and improperly characterize
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`the teachings of Bodor and Rice;
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` ¶¶ 1, 13-15, 19-26, 96-136, 166, 177, 180-214, and 223 as irrelevant
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`because these paragraphs refer to U.S. Patent No. 7,713,947, which is
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`not at issue in this inter partes review. Further, any probative value of
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`these paragraphs is substantially outweighed by the danger of unfair
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`prejudice, confusing the issues, misleading the fact finder, undue
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`delay, wasting time, needlessly presenting cumulative evidence.
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`Patent Owner further objects to ¶¶ 16, 19, 27-81, 96-200, and 214-237 as not
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`being based on sufficient facts or data, the product of reliable principles and
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`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 ¶¶ 15, 20-26, 82-95, and 201-213 because
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`these paragraphs are not directly cited in the Petition 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 ¶ 10, which contains citations to exhibits
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`IPR2023-00050
`Patent Owner’s Objections to Evidence
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`that are not cited in the Petition, as irrelevant. See Fed. R. Evid. 402.
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`Exhibit 1006.
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`Patent Owner objects to exhibit 1006 under Fed. R. Evid. 401, 402, and 403
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`as 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. Patent Owner further objects to this exhibit
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`under Fed. R. Evid. 401, 402 because the exhibit is not cited in the Petition.
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`To the extent exhibit 1006 is being offered to prove the truth of the matter
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`asserted, the exhibit constitutes inadmissible hearsay.
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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 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, 1031, 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, 1031, 1032, and 1034 under Fed. R. Evid.
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`401, 402, and 403 as lacking relevance and because their probative value is
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`substantially outweighed by the danger of unfair prejudice, confusing the issues,
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`misleading the fact finder, undue delay, and/or wasting time.
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`To the extent exhibits 1007, 1008, 1009, 1013, 1014, 1015, 1024, 1025,
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`IPR2023-00050
`Patent Owner’s Objections to Evidence
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`1027, 1028, 1029, 1030, and 1031 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, 1030, and 1031 under Fed. R. Evid. 901 because the
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`documents 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, 1031, 1032, or 1034 for at least the reasons identified here.
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`Date: January 5, 2024
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`IPR2023-00050
`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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`IPR2023-00050
`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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