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IPR2016-01284
`U.S. Patent No. 6,900,221
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS
`HOLDINGS INC., and APOTEX HOLDINGS, INC.,
`Petitioners,
`v.
`
`OSI PHARMACEUTICALS, INC.,
`Patent Owner.
`________________
`
`U.S. Patent No. 6,900,221
`________________
`
`Case No.: IPR2016-01284
`________________
`
`PETITIONERS’ OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`

`

`Pursuant to 37 C.F.R. § 42.64, Petitioners Apotex Inc., Apotex Corp., Apotex
`
`Pharmaceuticals Holdings Inc., and Apotex Holdings, Inc. (collectively “Apotex”
`
`or “Petitioners”) submit the following objections to evidence served with the
`
`Response of Patent Owner OSI Pharmaceuticals, Inc. (“OSI” or “Patent Owner”).
`
`I.
`
`Exhibit 2020
`
`Apotex objects to Exhibit 2020, Patent Owner’s Deposition of Dr. Giuseppe
`
`Giaccone. Specifically, Apotex objects to the relevance and probative value of
`
`page and line 8:11-11:1, 14:4-22:4, 22:18-23:22, 24:5-31:5, 33:5-43:19, 49:9-50:3,
`
`55:15-57:14, 59:4-63:10, 63:18-66:2, 66:13-66:18, 70:4-71:22, 74:1-74:20,
`
`80:17-81:20, 84:12-88:13, 92:10-103:1, 106:10-108:3, 112:18-114:22,
`
`118:18-118:20, 122:4-122:6, 123:11-147:12, and 151:14-164:1, in light of the
`
`potential for undue prejudice and confusion of the issues. See Fed. R. Evid. 401,
`
`402, and 403.
`
`Apotex objects to page and line 132:19-135:22, 137:3-138:18, 148:20-150:6,
`
`and 150:22-151:7, as not based on sufficient facts or data. See Fed. R. Evid. 702,
`
`705; 77 Fed. Reg. at 48,763; 37 C.F.R. § 42.65.
`
`II. Exhibit 2021
`
`Apotex objects to Exhibit 2021, Declaration of Dr. Jackson Gibbs.
`
`Specifically, Apotex objects to the relevance and probative value of ¶13, in light of
`
`
`
`2
`
`

`

`the potential for undue prejudice and confusion of the issues. See Fed. R. Evid.
`
`401, 402, and 403.
`
`III. Exhibit 2022
`
`Apotex objects to Exhibit 2022, Declaration of Dr. Paul Bunn. Specifically,
`
`Apotex objects to the relevance and probative value of ¶¶25-27, 34-41, 43, 49, 51-
`
`65, 70-90, 92-101, 105, and 107-109, in light of the potential for undue prejudice
`
`and confusion of the issues. See Fed. R. Evid. 401, 402, and 403.
`
`Apotex objects to ¶¶27, 34-37, 39-41, 49, 52, 66-71, 73, 80, and 107, as not
`
`based on sufficient facts or data, the product of reliable principles and methods,
`
`and/or a reliable application of the principles and methods to the facts. See Fed. R.
`
`Evid. 702, 703, 705; 77 Fed. Reg. at 48,763; 37 C.F.R. § 42.65.
`
`IV. Exhibit 2023
`
`Apotex objects to Exhibit 2023, Declaration of Mark L. Reisenauer.
`
`Specifically, Apotex objects to the relevance and probative value of ¶¶5-17, in
`
`light of the potential for undue prejudice and confusion of the issues. See Fed. R.
`
`Evid. 401, 402, and 403.
`
`Apotex objects to ¶¶5-17, as not based on sufficient facts or data, the
`
`product of reliable principles and methods, and/or a reliable application of the
`
`principles and methods to the facts. See Fed. R. Evid. 702, 703, 705; 77 Fed. Reg.
`
`at 48,763; 37 C.F.R. § 42.65.
`
`
`
`3
`
`

`

`Apotex objects to ¶11, as being judicially estopped in view of OSI’s
`
`assertion that Tarceva’s commercial success was attributed to claims from a
`
`different patent (Reissue Patent RE41,065) in prior litigation before the Court of
`
`the District of Delaware.1 New Hampshire v. Maine, 532 U.S. 742, 749-50 (2001).
`
`Apotex objects to Exhibit 2023, Declaration of Mark L. Reisenauer, in its
`
`entirety, as Apotex is prejudiced by Mr. Reisenauer’s biases arising from his
`
`present and past financial and fiduciary relationship with OSI Pharmaceuticals,
`
`Inc. See Fed. R. Evid. 607; U.S. v. Abel, 469 U.S. 45, 49 (1984).
`
`V. Exhibits 2031, 2032, and 2034-2041
`
`Apotex objects to the relevance and probative value of exhibits 2031, 2032,
`
`and 2034-2041, in light of the potential for undue prejudice and confusion of the
`
`issues. See Fed. R. Evid. 401, 402, and 403.
`
`Date: May 1, 2017
`
`
`
`
`
`
`
`
`
`
`
`By:
`
`Respectfully Submitted,
`
`/W. Blake Coblentz/
`W. Blake. Coblentz
`Reg. No. 57,104
`Cozen O’Connor
`1200 Nineteenth St., N.W.
`Washington, D.C. 20036
`202-912-4837
`
`
`1 See Ex. 1028 at 33.
`
`
`
`4
`
`

`

`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that, on May 1, 2017, I caused a true and accurate copy of
`
`Petitioners’ Objections to Evidence to be served via electronic mail on the
`
`following attorneys of record:
`
`Emily R. Whelan
`Jonathan B. Roses
`Kevin M. Yurkerwich
`Amy K. Wigmore
`Wilmer Cutler Pickering Hale and Dorr LLP
`20 State Street
`Boston, MA 02109
`617-526-6000
`Emily.Whelan@wilmerhale.com
`Jonathan.Roses@wilmerhale.com
`Keven.Yurkerwich@wilmerhale.com
`Amy.Wigmore@wilmerhale.com
`
`
`
`/W. Blake Coblentz/
`W. Blake. Coblentz
`Reg. No. 57,104
`Cozen O’Connor
`1200 Nineteenth St., N.W.
`Washington, D.C. 20036
`202-912-4837
`
`5
`
`
`
`
`
`

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