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`Paper No. ___
`Date Filed: May 10, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS LABORATORIES FL, INC.,
`AMNEAL PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF
`NEW YORK, LLC, DR. REDDY’S LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, LTD., SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC., TEVA
`PHARMACEUTICALS USA, INC., WEST-WARD PHARMACEUTICAL
`CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`________________
`
`Case IPR2016-013321
`________________
`
`Patent No. 8,822,438 B2
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`UNDER 37 C.F.R. § 42.64(C)
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`
`1 Case IPR2016-00853 has been joined with this proceeding.
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`

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`IPR2016-01332
`U.S. Patent 8,822,438
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`Patent Owner, Janssen Oncology, Inc., respectfully submits this opposition
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`to Petitioners’ Motion to Exclude (Paper 72 (“Mot.”)). For the reasons discussed
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`below, the Motion should be denied in its entirety.2
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`I.
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`Petitioners Waived by Serving Boilerplate Objections
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`As a threshold matter, Petitioners waived the arguments in their Motion to
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`Exclude because they did not serve objections that “identify the grounds for the
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`objection with sufficient particularity to allow correction in the form of
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`supplemental evidence” as required by 37 C.F.R. § 42.64(b)(1). Petitioners’
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`March 15, 2017 objections to Patent Owner’s evidence (Paper 37 (“Pet. Obj.”))
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`reproduced Patent Owner’s entire exhibit list in table format, alongside letters
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`coded according to a two-page “Objection Key.” Pet. Obj., Paper 37 at 1-14 (table
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`of objections), 15-16 (“Objection Key”). An example is below:
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`
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`Id. at 12. The result is a morass of over 950 largely generic objections. Petitioners
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`also objected to all paragraphs in Patent Owner’s Response and declarations “that
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`2 Petitioners’ Motion summarizes their 37 C.F.R. § 42.64(b)(1) objections. Patent
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`Owner addresses herein objections Petitioners purport to explain in their Motion.
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`See 37 C.F.R. § 42.64(c) (motions to exclude “must explain the objections”).
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`1
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`IPR2016-01332
`U.S. Patent 8,822,438
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`rely on exhibits objected to” by Petitioners. Id. at 14. Petitioners’ shotgun
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`approach violates the very purpose of § 42.64(b)(1). Accordingly, Petitioners’
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`motion to exclude should be denied for failure to comply with § 42.64(b)(1). See
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`Legend3d, Inc. v. Prime Focus Creative Servs. Can. Inc., IPR2016-00806, Paper
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`22 at 2 (Oct. 24, 2016) (criticizing objections that “were generic and failed to
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`identify the basis of the objection with particularity”).
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`II.
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`Petitioners’ Objections to Patent Owner’s Response Are Unfounded
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`Petitioners’ request to exclude Patent Owner’s Response is unfounded. “[A]
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`motion to exclude applies to evidence and not a paper, such as Patent Owner’s
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`Response.” Maxlinear, Inc. v. Cresta Tech. Corp., IPR2015-00594, Paper 90 at 6,
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`n.9 (Aug. 15, 2016). In addition, Petitioners did not particularly identify the
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`challenged portions of Patent Owner’s Response in either their § 42.64(b)(1)
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`objections or their Motion. Id.; see Pet. Obj., Paper 37 at 14 (“Petitioner objects to
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`paragraphs in the Patent Owner’s Response . . . that rely on exhibits objected to in
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`this Petitioner’s Objection to Evidence.”); Mot., Paper 72 at 4 (asking the Board to
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`exclude “material on at least” pages enumerated).
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`III. Patent Owner’s Reliance Upon the Amerigen IPR Is Proper
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`Petitioners offer no legitimate reason to exclude declarations and deposition
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`transcripts from Amerigen Pharms. Ltd. v. Janssen Oncology, Inc., IPR2016-00286
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`(the “Amerigen IPR”). Exs. 2010, 2037, 2120, 2122, 2124, 2125, and 2127 (“the
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`2
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Amerigen testimony”). The Amerigen IPR involves the same attack on the ’438
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`patent as here, by a generic drug maker similarly situated as Petitioners (Amerigen
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`and Petitioners are co-defendants in parallel district court ANDA litigation).
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` The Amerigen IPR record is inextricably intertwined with this proceeding.
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`When Petitioner Mylan originally brought this IPR, it moved to join the Amerigen
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`IPR, filing a copycat of Amerigen’s petition. Paper 3. Mylan stated in its Motion
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`for Joinder that its petition asserted “the same grounds of invalidity” as Amerigen,
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`and that “while the Petitioner in the Mylan IPR and the Petitioner in the Amerigen
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`IPR have relied upon testimony from separate experts in their respective petitions,
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`the conclusions and underlying reasoning of the experts are congruent.” Id. at 1, 5.
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`Indeed, Mylan’s expert, Dr. Garnick, used the declaration of Amerigen’s expert,
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`Dr. Serels (Exs. 2010, 2120), as a template for his own declaration. Ex. 2126
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`(Garnick) at 109:3-110:3. The other Petitioners copied Mylan’s submissions to
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`obtain institution and joinder. See IPR2017-00853, Paper 9 (Motion for Joinder) at
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`1 (“the Petition and supporting expert declarations are identical”).
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`The Board’s institution decision here noted that Petitioner raised “the same
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`grounds of unpatentability” as in the Amerigen IPR, and that “Mylan supports its
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`assertions in its Petition with substantially the same art and arguments proffered by
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`Amerigen in the Amerigen IPR.” Paper 21 at 3. The Board’s institution decision
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`also incorporated by reference its analysis from the Amerigen IPR, which relied on
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`3
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`IPR2016-01332
`U.S. Patent 8,822,438
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`the Serels declaration (Exs. 2010, 2120). See Paper 21 at 5 (citing IPR2016-00286,
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`Paper 14 at 4-15; see id. at 9-10, 13, 14 (referencing Serels)).
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`Petitioners now ask the Board to ignore what Amerigen’s experts have said,
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`presumably because their testimony is no longer congruent with their positions.
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`For example, Dr. Serels stated that “mineralocorticoid excess would not occur with
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`ketoconazole,” that PSA data in Gerber is insufficient to make “a definite
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`conclusion” that patients administered ketoconazole and prednisone experienced a
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`clinical response, that ZYTIGA® therapy is commercially successful, and that it
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`would not be so but for co-administration with prednisone. Ex. 2122 (Serels) ¶10;
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`Ex. 2037 (Serels) at 71:6-12, 176:24-177:7. Petitioners cannot have it both ways.
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`Having leveraged the Amerigen IPR to gain institution of their own IPR,
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`Petitioners cannot now disavow any connection. For this reason alone, Petitioners’
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`request to exclude the undisputedly relevant Amerigen testimony should be denied.
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`A. The Amerigen Testimony Is Not Impermissible Hearsay
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`Petitioners’ hearsay attack on the Amerigen testimony fails for multiple
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`additional reasons. First, declarations and testimony from another proceeding
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`clearly can be offered into evidence. The proponent is not required to make the
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`witnesses available for cross examination as a matter of routine discovery because
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`that right is limited to “affidavit testimony prepared for the proceeding.” 37
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`C.F.R. § 42.51(b)(1)(ii) (emphasis added); GEA Process Eng’g v. Steuben Foods,
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`4
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Inc., IPR2014-00041, Paper 41 at 2-3 (June 11, 2014) (denying, over objections for
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`hearsay and violation of § 42.5(b)(1)(ii), petitioner’s request to cross examine
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`witnesses whose declarations were prepared for a parallel reexamination
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`proceeding); see also CBS Interactive Inc. v. Helferich Patent Licensing, LLC,
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`IPR2013-00033, Paper 85 at 2 (Sept. 3, 2013). Patent Owner informed Mylan of
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`this fact and, contrary to Petitioners’ representations, Patent Owner has never
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`admitted the Amerigen testimony is hearsay. Mot., Paper 72 at 5 (citing Ex. 1149).
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`Moreover, Mylan never pressed the Board to cross examine the Amerigen
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`declarants, or to attend their depositions, and thus there is no basis now for
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`Petitioners to complain that they did not have the opportunity to probe the
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`admissions of Amerigen’s experts. Nor have Petitioners identified the specific
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`testimony they would have questioned on cross examination. Indeed, Amerigen’s
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`declarants are adverse to Patent Owner, and as stated earlier, Mylan sought to join
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`the Amerigen IPR. Having sat on their hands, Petitioners are not in a position to
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`exclude testimony from Amerigen’s experts that turned out contrary to Petitioners’
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`present positions. Nor, on these facts, is the significance of the Amerigen
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`testimony diminished by any lack of cross examination.
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`Second, a statement is not hearsay unless it is offered “to prove the truth of
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`the matter asserted in the statement.” Fed. R. Evid. 801(c)(2); Olympus Am. Inc. v.
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`Perfect Surgical Techniques, Inc., IPR2014-00233, Paper 56 at 40 (June 8, 2015)
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`5
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`IPR2016-01332
`U.S. Patent 8,822,438
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`(rejecting hearsay objection because statement not considered for truth). Patent
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`Owner offers the Amerigen testimony for the fact that Amerigen’s experts made
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`the statements, not for their truth. The Amerigen testimony shows that the various
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`Petitioners’ experts interpret the same prior art quite differently. E.g., compare Ex.
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`2122 (Serels Reply Decl.) ¶10 (“mineralocorticoid excess would not occur with
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`ketoconazole”) with Ex. 1002 (Garnick) ¶ 33 (discussing “mineralocorticoid
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`excesses induced by ketoconazole”); see also Ex. 2037 (Serels) at 71:6-12 (Zytiga
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`would not be successful without prednisone co-administration); Ex. 1002
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`(Garnick) ¶ 93 (Zytiga’s success is only due to abiraterone acetate). This casts
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`doubt on Petitioners’ assertion that the analysis is straightforward. The statements
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`of Amerigen’s experts also reflect on the credibility of Petitioners’ arguments and
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`their declarants and should be considered for that purpose. E.g., compare Pet.,
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`Paper 1 at 6 (person of skill motivated by prednisone’s possible anti-cancer effects)
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`with Ex. 1002 (Garnick) ¶ 89; Ex. 2120 (Serels) ¶ 74 (no expectation of anti-cancer
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`effect from prednisone). Patent Owner therefore provides citations to Amerigen
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`declarants alongside citations to Petitioners’ declarants for comparison. See Patent
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`Owner Response (“POR”), Paper 35 at 2 (citing Exs. 2122 (Serels), 2037 (Serels),
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`2126 (Garnick), 2127 (Serels)); see also id. at 3, 7, 12-15, 17-20, 29, 31, 35, 36,
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`38, 39, 41, 46. Similarly, the fact that Amerigen’s experts provided testimony
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`consistent with Patent Owner’s positions and declarations goes to the credibility of
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`6
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`IPR2016-01332
`U.S. Patent 8,822,438
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`the parties and declarants simply because the statements were made, and is not
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`hearsay when used for this purpose. See, e.g., id. at 19 (citing Ex. 2037 (Serels);
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`2040 (Auchus)); id. at 21, 23-24, 26, 27, 38, 40, 42, 61. Moreover, Petitioners
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`failed to identify any statement in the Amerigen testimony they seek to exclude.
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`Petitioners’ reliance on the nonprecedential decision in U.S. Endodontics,
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`LLC v. Gold Standard Instruments, LLC is misplaced. PGR2015-00019, Paper 54
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`(Dec. 28, 2016). U.S. Endodontics was a post grant review involving challenges to
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`enablement and written description. Id. at 5-6. There the Board excluded a
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`declaration from the file history of a related patent because it was offered by the
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`patent owner to prove test results relevant to a claim limitation. Id. at 38, 40.
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`Here, by contrast, Patent Owner is not relying on a friendly witness’s out-of-court
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`testimony to fill an evidentiary gap in its case. Instead, Patent Owner is offering
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`statements by adverse witnesses in a parallel IPR proceeding, concerning the same
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`patent, that (1) Mylan sought to join and (2) the Board relied upon in its institution
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`decision. Kirk v. Raymark Industries, Inc. is also unpersuasive because that case
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`involved a jury trial, and the proponent did not argue the challenged testimony was
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`not offered for its truth. 61 F.3d 147, 163-166 (3d Cir. 1995).
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`Finally, even if the Amerigen testimony were deemed hearsay, it should be
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`admitted under the residual exception of Fed. R. Evid. 807. The Amerigen
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`testimony (1) “has equivalent circumstantial guarantees of trustworthiness”
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`7
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`IPR2016-01332
`U.S. Patent 8,822,438
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`because it was provided by adverse witnesses under oath in a parallel IPR; (2) is, to
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`the extent it is deemed hearsay, “evidence of a material fact,” (e.g., Ex. 2122
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`(Serels) ¶10 (“mineralocorticoid excess would not occur with ketoconazole”)); (3)
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`is more probative than other evidence Patent Owner can “obtain through
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`reasonable efforts” because it came from an adversary, and (4) “will best serve the
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`purposes of these rules and the interests of justice” because it is undisputedly
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`relevant and the Board can assign it proper weight. Fed. R. Evid. 807(a).
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`B.
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`Petitioners’ 403 Attack on the Amerigen Testimony Is Baseless
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`Petitioners’ Rule 403 prejudice argument has no merit. “The Board, sitting
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`as a non-jury tribunal with administrative expertise, is well-positioned to determine
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`and assign appropriate weight and/or relevance to evidence presented.” Square,
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`Inc. v. Unwired Planet, LLC, CBM2014-00156, Paper 40 at 37 (Dec. 22, 2015)
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`(denying motion to exclude under Rule 403). Petitioners’ citation to Fed. R. Civ.
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`P. 32(a)(1)(A) is unhelpful because it does not apply here. Motorola Mobility,
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`LLC v. Intellectual Ventures I, LLC, CBM2015-00004, Paper 33 at 11 (Mar. 21,
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`2016) (“Petitioner’s citation to the Federal Rules of Civil Procedure (FRCP) is
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`unpersuasive because the Board has not adopted those rules.”). Petitioners cannot
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`exclude testimony simply because it is unfavorable to them.
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`C.
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`Petitioners Have No Basis for Excluding Exhibits 2010 and 2037
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`Dr. Serels’ deposition (Ex. 2037) from the Amerigen IPR should not be
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`8
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`IPR2016-01332
`U.S. Patent 8,822,438
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`excluded for the additional reason that it is among the materials Dr. Rettig
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`considered. Ex. 2038 (Rettig) at 103; see Fed. R. Evid. 703; 37 C.F.R. § 42.65(a).
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`Likewise, Exhibit 2010 (Serels Decl., Garnick Dep. Ex. 2) should not be excluded
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`because Dr. Garnick testified to using it as a template for his declaration, though he
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`failed to list it as a material considered. Ex. 2126 (Garnick) at 109:3-110:3; Ex.
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`1002 (Garnick) at 12-14. Petitioners also waived objections to Exhibit 2010
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`because it was introduced at Dr. Garnick’s deposition and used without objection.
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`E.g., Ex. 2126 (Garnick) at 109:20-110:15; 37 C.F.R. § 42.64(a) (“An objection to
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`the admissibility of deposition evidence must be made during the deposition”).
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`IV. Petitioners Offer No Legitimate Basis for Excluding the Amerigen
`Patent Owner Response
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`Petitioners have incorrectly objected to Exhibit 2151, Patent Owner’s
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`Response from the Amerigen IPR, as hearsay and violating the word limit of
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`§ 42.24(b). Exhibit 2151 is cited once by Patent Owner to draw parallels between
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`this proceeding and the Amerigen IPR. POR, Paper 35 at 2 (“As Amerigen’s
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`expert Dr. Serels admitted – whose opinion Mylan’s expert Dr. Garnick simply
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`parrots – ‘mineralocorticoid excess would not occur with ketoconazole.’”).
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`Exhibit 2151 is not hearsay because it is not offered “to prove the truth of the
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`matter asserted in the statement,” but to show the consistency of Patent Owner’s
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`positions and to cast doubt on the credibility of Petitioners and Dr. Garnick. Fed.
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`R. Evid. 801(c)(2). Exhibit 2151 does not violate the word limit because Patent
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`Owner has not relied on it in lieu of advancing arguments in the papers.
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`V.
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`Petitioners’ Objection to the de Bono Declaration Is Unfounded
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`The de Bono declaration (Exhibit 2118) is a declaration by one of the ’438
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`patent inventors and relates to inventorship. The declaration was prepared for and
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`submitted in parallel district court proceedings against Petitioners.
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`Under Fed. R. Evid. 703, the Board may consider otherwise inadmissible
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`facts or data relied upon by an expert if “experts in the particular field would
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`reasonably rely on those kinds of facts or data in forming an opinion on the
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`subject.” Nestlé Healthcare Nutrition, Inc. v. Steuben Foods, Inc., IPR2015-
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`00249, Paper 76 at 10-23 (June 2, 2016) (denying hearsay objections under Fed. R.
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`Evid. 703).3 Dr. Rettig relied upon Exhibit 2118 in his analysis of unexpected
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`results. Rettig Decl., Ex. 2038 ¶240 (citing Ex. 2118 ¶12)). Dr. de Bono’s
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`declaration is inventor testimony regarding clinical trials related to the claimed
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`invention and is among the “kinds of facts or data” a technical expert “would
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`reasonably rely on . . . in forming an opinion on the subject” of unexpected results.
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`Fed. R. Evid. 703. Petitioners make no argument to the contrary. Exhibit 2118
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`should therefore be considered as fact underlying Dr. Rettig’s opinions.
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`Petitioners mention that Dr. de Bono was not deposed in this matter. But a
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`3 Rule 703 contains a caveat related to disclosing facts or data to a jury, but it is
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`inapplicable here. 37 C.F.R. § 42.62(b).
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`10
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`IPR2016-01332
`U.S. Patent 8,822,438
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`declarant from another proceeding is not subject to deposition as a matter of
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`routine discovery. See Section III.A, supra (citing 37 C.F.R. § 42.51(b)(1)(ii);
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`GEA Process Eng’g, IPR2014-00041, Paper 41 at 2-3). Petitioners never sought
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`relief from the Board to depose Dr. de Bono, and on January 10, 2017 they
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`deposed Dr. de Bono in the district court action for which the de Bono declaration
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`was prepared. In addition, all exhibits to the de Bono declaration were served on
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`Petitioners in the parallel district court litigation. Petitioners never requested that
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`they be produced here. Nestlé, IPR2015-00249, Paper 76 at 22 (noting “Petitioner
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`could have sought to compel production” of declaration exhibits). Petitioners’
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`request to exclude Exhibit 2118 lacks merit and should be denied.
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`VI. Petitioners’ Objections to Exhibit 2134 Are Incorrect and Petitioners
`Waived Their Objection to the Vellturo Declaration
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`Exhibit 2134 contains tables and graphs of ZYTIGA® market share data
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`that Patent Owner’s economic expert, Dr. Vellturo, relied upon as part of his
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`economic analysis of commercial success. E.g., Ex. 2044 (Vellturo) ¶¶48-52,
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`Appendices C-D. Exhibit 2134 contains the only ZYTIGA® market share data in
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`the record that extends throughout 2016, and it shows that ZYTIGA® has a
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`growing lead over its competitor Xtandi. See Ex. 2134 at 8. Petitioners have
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`raised scattergun objections to Exhibit 2134 on grounds of authentication, hearsay,
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`and Fed. R. Evid. 106, 403, and 1006, as well as related objections to Dr.
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`11
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Vellturo’s declaration (Ex. 2044) and deposition (Ex. 1136). None are meritorious.
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`Indeed, even if any of Petitioners’ objections had merit, Exhibit 2134 should
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`still be considered under Fed. R. Evid. 703 because market share is one of the
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`“kinds of facts or data” an economist “would reasonably rely on . . . in forming an
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`opinion on the subject” of commercial success. Fed. R. Evid. 703; Vellturo Dep.,
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`Ex. 1136 at 82:14-17; Nestlé, IPR2015-00249, Paper 76 at 10-23 (denying
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`objections under Fed. R. Evid. 703). Nevertheless, Patent Owner further addresses
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`each of the specific objections below.
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`Authentication: Under Rule 901(a), an exhibit is authenticated if the
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`proponent provides “evidence sufficient to support a finding that the item is what
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`the proponent claims it is.” Evidence that authenticates a document includes
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`“[t]estimony that an item is what it is claimed to be” and “the appearance, contents,
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`substance, internal patterns, or other distinctive characteristics of the item, taken
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`together with all the circumstances.” Fed. R. Evid. 901(b)(1), (4).
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`Dr. Vellturo’s declaration describes Exhibit 2134 as “Janssen’s own
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`estimates of ZYTIGA®’s share of patients within the mCRPC marketplace, as
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`compiled in Janssen’s ordinary course of business and provided to me by Janssen.”
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`Ex. 2044 (Vellturo) ¶48. That is what Patent Owner claims Exhibit 2134 is, and
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`the content of Exhibit 2134 is consistent with Dr. Vellturo’s description. Exhibit
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`2134 cites IMS DDD and Symphony Health Solutions as sources for its data, as
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`12
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`IPR2016-01332
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`would be expected. See Ex. 2134 at 2, 6, 9; see also Ex. 1136 (Vellturo Dep.) at
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`84:4-19, 85:16-86:5; 93:13-94:17, 95:17-97:21, 98:10-99:13 (describing IMS and
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`Symphony data); id. at 88:13-14 (“I work with IMS, I know this material very
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`well.”). Exhibit 2134’s data is in line with earlier market share figures from
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`unchallenged exhibits, and Petitioners’ economic expert Dr. Hofmann did not call
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`into question the data in Exhibit 2134. See Exhibit 2044 (Vellturo) Appendix C-1.
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`Dr. Vellturo recalled Exhibit 2134 was prepared “very late in 2016, perhaps earlier
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`2017,” the correct time frame. Vellturo Dep., Ex. 1136, at 84:20-85:1. Dr.
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`Vellturo further testified that he sees “documents like this within the – within the
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`product and brand management sectors of pharmaceutical companies all the time.
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`These are absolute and relative historic performance indicators that are used in the
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`ordinary course of business.” Id. at 82:14-17. This evidence is more than
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`sufficient to authenticate Exhibit 2134.
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`Petitioners’ cases on authenticity are inapt. Standard Innovation Corp. v.
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`Lelo, Inc. addressed two inapplicable issues––websites not authenticated by any
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`evidence and a screenshot of a downloaded pdf with no information of the source.
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`IPR2014-00148, Paper 42 at 10-13 (Apr. 23, 2015). TRW Auto. U.S. LLC v.
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`Magna Elecs. Inc. involved an alleged prior art paper whose authenticity was
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`supported only by a footnote citing the paper’s alleged bibliography. IPR2014-
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`01347, Paper 25 at 5-12 (Jan. 6, 2016). Here, Exhibit 2134 is not a website, and its
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`IPR2016-01332
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`authenticity is shown by Dr. Vellturo’s declaration and deposition testimony, the
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`document’s contents, and their consistency with data from other exhibits.
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`Rule 1006: Petitioners’ objection to Exhibit 2134 under Fed. R. Evid. 1006
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`is incorrect because Dr. Vellturo may rely on Exhibit 2134 under Fed. R. Evid.
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`703. Further, Patent Owner informed Petitioners that the source of the data in
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`Exhibit 2134 is IMS DDD and Symphony claims data, as indicated in the
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`document itself. See Exhibit 1150; see also Exhibit 2134 at 2, 6, 9 (identifying
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`data sources). Petitioners never sought relief from the Board to obtain this
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`underlying data. Nestlé, IPR2015-00249, Paper 76 at 22 (noting “Petitioner could
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`have sought to compel production”). And Petitioners’ economic expert himself
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`relied on a website referencing unproduced IMS sales data. Hofmann Decl., Ex.
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`1017 at 33 (Attachment B-1 citing Ex. 1055). Petitioners’ reliance on United
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`States v. Mitchell is inapposite, since that case addressed the use of summarized,
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`voluminous phone records by the government in a criminal trial, and did not
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`address expert testimony. 816 F.3d 865, 875 (D.C. Cir. 2016).
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`Hearsay: Similarly, Petitioners’ hearsay objection fails because Dr.
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`Vellturo may rely on Exhibit 2134 under Fed. R. Evid. 703, as discussed above.
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`Rule 106: Petitioners’ objection to Exhibit 2134 under Fed. R. Evid. 106 as
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`incomplete is legally incorrect. Rule 106 is not a basis for excluding evidence, it is
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`a basis for admitting additional evidence “that in fairness ought to be considered at
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`IPR2016-01332
`U.S. Patent 8,822,438
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`the same time.” Fed. R. Evid. 106. Petitioners offer no additional evidence to be
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`considered with Exhibit 2134, nor did they seek relief to obtain any, and
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`Petitioners’ economic expert never questioned the data in Exhibit 2134.
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`Rule 403: No prejudice to Petitioners warrants excluding Exhibit 2134. Its
`
`probative value exceeds any prejudicial effect because it is the only ZYTIGA®
`
`market share data in the record that extends through 2016 and Petitioners had
`
`ample opportunity to offer their views on the exhibit. The Board can assign
`
`Exhibit 2134 appropriate weight. Square, CBM2014-00156, Paper 40 at 37.
`
`Vellturo Declaration: The Board should reject Petitioners’ request to
`
`exclude portions of the Vellturo Declaration (Ex. 2044) for two additional reasons.
`
`First, Paragraphs 48-52 and Appendix C and C-1 of the Vellturo declaration
`
`include evidence Petitioners have not objected to, such as discussions of
`
`ZYTIGA® market share data from unchallenged exhibits. E.g., Vellturo Decl.,
`
`Ex. 2044 Appendix C, C-1 (citing Exs. 2139-2145 for market share data), ¶48 n.10
`
`(citing Exs. 2139-2149), ¶49 (citing Ex. 2044 Appendix C), ¶51 (citing Appendix
`
`B), ¶52 (drawing conclusions from data). Second, Petitioners waived their
`
`argument by failing to serve § 42.64(b)(1) objections particularly identifying the
`
`challenged parts of Dr. Vellturo’s declaration. See Pet. Objections, Paper 37 at 14.
`
`VII. Conclusion
`
`For the foregoing reasons, Petitioners’ Motion to Exclude should be denied.
`
`15
`
`
`
`

`

`IPR2016-01332
`U.S. Patent 8,822,438
`
`
`
`Dated: May 10, 2017
`
`Respectfully submitted,
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER &
`FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`Bindu Donovan (pro hac vice)
`Paul J. Zegger (Reg. No. 33,821)
`Todd L. Krause (Reg. No. 48,860)
`Alyssa B. Monsen (pro hac vice)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`
`Counsel for Patent Owner
`
`16
`
`
`
`
`
`
`
`
`
`

`

`IPR2016-01332
`U.S. Patent 8,822,438
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Opposition to Petitioners’ Motion to Exclude Evidence Under 37 C.F.R. §
`
`42.64(c) was served on counsel of record on May 10, 2017 by filing this document
`
`through the End-to-End System, as well as delivering a copy via electronic mail to
`
`counsel of record for the Petitioners at the following addresses:
`
`Brandon M. White – bmwhite@perkinscoie.com
`Crystal R. Canterbury – ccanterbury@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`Shannon Bloodworth – sbloodworth@perkinscoie.com
`Emily J. Greb – egreb@perkinscoie.com
`Robert D. Swanson – rswanson@perkinscoie.com
`
`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
`
`
`
`Date: May 10, 2017
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`17
`
`
`
`
`
`

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