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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`ELI LILLY AND COMPANY,
`Petitioner,
`v.
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner.
`______________________
`
`Case No. IPR2018-01427
`Patent No. 8,597,649
`______________________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`IPR2018-01427
`Patent No. 8,597,649
`
`Table of Contents
`I.
`Introduction ................................................................................................. 1
`Exhibit 1287 Is Admissible .......................................................................... 1
`II.
`III. The Cross-Examination Transcripts of Teva’s Witnesses Are
`Admissible ................................................................................................... 3
`A. Dr. Tomlinson’s Admissions Are Admissible .................................... 4
`B.
`Dr. Stoner’s Admissions Are Admissible ........................................... 6
`
`Dr. Ferrari’s Admissions Are Admissible .......................................... 7
`C.
`D. Dr. Rapoport’s Admissions Are Admissible .....................................11
`IV. All of Lilly’s Exhibits Are Admissible in Their Entirety .............................13
`V.
`Conclusion ..................................................................................................15
`
`i
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`IPR2018-01427
`Patent No. 8,597,649
`
`I.
`
`Introduction
`Teva’s Motion raises meritless challenges to evidence undermining its
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`theories in this proceeding. For example, Teva incorrectly attempts to exclude
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`Dr. Tan’s
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`thesis (Ex. 1287/1287A) despite
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`the “low bar” for document
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`authentication, relying exclusively and improperly on printed-publication case law.
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`The Board should also decline Teva’s attempt to exclude more than 20 admissions
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`in its own experts’ cross-examination transcripts under FRE 403. Finally, there is no
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`basis to exclude any of Lilly’s evidence regardless of whether it was directly cited
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`in Lilly’s briefing. Teva’s Motion to Exclude should be denied.
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`II. Exhibit 1287 Is Admissible
`Teva incorrectly seeks to exclude Exhibit 1287/1287A, the doctoral thesis of
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`Dr. Keith Tan, under FRE 901. Mot., 1-7. Lilly has more than met the standard for
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`authentication under FRE 901, which is a “low bar” that is satisfied by “evidence
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`sufficient to support a finding that the item is what the proponent claims it is.” Fox
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`Factory, Inc. v. SRAM, LLC, IPR2017-00472, Paper 64 at 64 (PTAB Apr. 18, 2018).
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`Here, Teva does not dispute that Exhibit 1287 is Dr. Tan’s doctoral thesis,
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`conceding that it is what it purports to be. See Paper 43 at 2 (referencing Ex. 1287
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`as a “dissertation by Dr. Tan”); Minerva Surgical, Inc. v. Hologic, Inc., IPR2016-
`
`00868, Paper 63 at 53 (PTAB Dec. 15, 2017) (“the appearance, contents, [and]
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`substance . . . of the item, taken together with all the circumstances,” may
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`1
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`IPR2018-01427
`Patent No. 8,597,649
`authenticate). Additionally, because Exhibit 1287 is a Cambridge thesis authored in
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`1994, obtained from Cambridge Library, it is a self-authenticating ancient document.
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`FRE 901(b)(8). Thus, there is no basis to exclude Exhibit 1287 under FRE 901.
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`Every case cited in Teva’s challenge to Exhibit 1287 analyzes public
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`accessibility for prior art purposes. Mot., 1-7. Challenging public availability,
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`however, is not properly raised in a motion to exclude. Chi. Mercantile Exch., Inc.
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`v. 5th Mkt., Inc., CBM2014-00114, Paper 35 at 52 (Aug. 18, 2015). Regardless, Teva
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`fails to establish why public availability is necessary for authenticating Exhibit 1287.
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`Lilly does not rely on Exhibit 1287 in its obviousness ground, and Lilly does
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`not rely on it as prior art. Rather, Lilly cites Exhibit 1287 for purposes that do not
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`require any showing of public accessibility. For example, Exhibit 1287 rebuts Teva’s
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`purported personal knowledge that co-authors of the Tan references never
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`considered antibody humanization (Ex. 2141, ¶¶ 70, 76), as Dr. Tan wrote that there
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`was “no reason” why humanized anti-CGRP antibodies should not be investigated.
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`Ex. 1287, 247; Reply, 11. A showing of a public availability is not required to admit
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`Exhibit 1287 as rebutting Teva’s purported personal—not public—knowledge.
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`Lilly also cites Exhibit 1287 to rebut Teva’s argument that minor, transient
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`side effects would have deterred humanization of anti-CGRP antibodies. POR, 24-
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`26, 43-44. With first-hand knowledge of the blood pressure results in Tan 1995, Dr.
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`Tan proposed humanizing anti-CGRP antibodies to use as “therapeutic agents” for
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`2
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`IPR2018-01427
`Patent No. 8,597,649
`migraine. Ex. 1287, 209, 222-23, 247. Public availability is not required to admit
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`Exhibit 1287 for the rebuttal purpose of demonstrating that actual researchers in the
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`field before November 2005 were urging humanization and therapeutic uses of anti-
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`CGRP antibodies notwithstanding Teva’s hypothetical, unsupported concerns.
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`Nevertheless, even if it were necessary to establish Exhibit 1287 as a printed
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`publication, Michael Carney’s declaration
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`(Ex. 1307) establishes public
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`accessibility. Dr. Tan’s thesis was authored and submitted to the Cambridge Library
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`in 1994, stamped by the Library, and would have been cataloged and shelved about
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`one month later. Ex. 1307, ¶¶ 14-15. Teva disputes that the Library used electronic
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`MARC records (Mot., 4), but Mr. Carney established that the Library actually
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`indexed Exhibit 1287 in its electronic MARC records by 2002, at the latest. Ex. 1307,
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`¶¶ 16-17. Teva’s remaining criticisms of Mr. Carney’s declaration, including his
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`direct outreach to the Library, ignore that both the 1994 shelving date and the 2002
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`MARC record date occurred years before Teva’s earliest filing date.
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`Thus, the Board should admit Exhibit 1287 as authenticated under FRE 901,
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`and credit the Tan Thesis as a printed publication to the extent necessary.
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`III. The Cross-Examination Transcripts of Teva’s Witnesses Are Admissible
`Seeking to insulate its witnesses from their damaging cross-examination
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`testimony, Teva asserts that numerous portions of its own experts’ transcripts should
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`be excluded under FRE 403 based on form and scope objections. Teva has conducted
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`3
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`
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`IPR2018-01427
`Patent No. 8,597,649
`no balancing of its conclusory allegations of prejudice against the probative value of
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`its experts’ admissions, as required by FRE 403. As set forth below, the full context
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`of the challenged testimony demonstrates its highly probative value and confirms it
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`should be admitted for the Board’s consideration. SK Hynix Inc. v. Netlist, Inc.,
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`IPR2017-00562, Paper 36 at 49 (PTAB July 5, 2018) (“the Board, sitting as a non-
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`jury tribunal with administrative expertise, is well positioned to determine and assign
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`appropriate weight to evidence presented,” rather than excluding).
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`A. Dr. Tomlinson’s Admissions Are Admissible
`Ex. 1301, 27:25-28:6, 36:16-39:11. Teva relied exclusively on Dr.
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`Tomlinson’s declaration to attempt to establish a nexus between the challenged
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`claims and purported secondary considerations based on two highly optimized
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`antibodies, Ajovy® and Emgality®. POR, 55. During cross-examination, however,
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`Dr. Tomlinson’s admissions confirmed that the claims are not commensurate in
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`scope to Ajovy® or Emgality® because they vastly encompass all types of antibody
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`fragments, as well as numerous antibody classes. Ex. 1301, 27:25-28:6; 36:16-39:11.
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`Teva now seeks to exclude this testimony because of a “lack of specificity about
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`which patent and which claim is being discussed.” Mot., 8. Lilly’s questions,
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`however, specifically identified the patents. Ex. 1301, 27:25-28:6; 36:16-39:11.
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`Counsel had also provided Dr. Tomlinson with each patent and oriented him to the
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`claims. Id., 23:25-26:18, 9:18-23, 13:7-16. Teva’s arguments are meritless.
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`4
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`IPR2018-01427
`Patent No. 8,597,649
`Ex. 1301, 115:9-116:21, 154:24-156:21. Teva uses Dr. Tomlinson’s opinions
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`to support nexus, but seeks to exclude his testimony pertaining to the scope of the
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`claims and an Ajovy® regulatory document (Ex. 2217) he relied upon to support
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`nexus. Ex. 1301, 115:9-116:21, 154:24-156:21; Ex. 2137, ¶118; Mot., 8. Having
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`affirmatively relied on Dr. Tomlinson’s understanding of the scope of the claims and
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`his interpretations of Exhibit 2217, Teva cannot fairly exclude his cross-examination
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`on these same topics as speculative, irrelevant, or outside the scope of direct.
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`Ex. 1301, 211:16-21. Dr. Tomlinson admitted that strong binding affinity is a
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`desirable characteristic for therapeutic antibodies. Ex. 1301, 211:16-21. Given his
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`acknowledgment that his own contemporaneous publication states that an “ideal”
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`therapeutic antibody “would have very high affinity . . . for its target,” Teva’s
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`vagueness objections are unconvincing. Id., 214:6-217:11; Ex. 1266, 521; Mot., 8-
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`9.
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`Ex. 1301, 73:22-75:20. Teva relied on Dr. Tomlinson’s testimony disparaging
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`Tan’s disclosure of a 16% response in the rat saphenous model because it was
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`purportedly not statistically significant. POR, 17. During cross-examination,
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`however, Dr. Tomlinson conceded that he forms conclusions and publishes data
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`analyses based on non-statistically significant results in his own academic work. Ex.
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`1301, 73:22-75:20. Dr. Tomlinson’s testimony is therefore not “unrelated” to this
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`proceeding, as Teva incorrectly contends, because it goes directly to his credibility.
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`5
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`IPR2018-01427
`Patent No. 8,597,649
`Mot., 8; Kumho Tire Co., Ltd. v. Carmichael, 119 S. Ct. 1167, 1176 (1999) (expert
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`witnesses must “employ[] in the courtroom the same level of intellectual rigor that
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`characterizes the practice of an expert in the relevant field”).
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`B. Dr. Stoner’s Admissions Are Admissible
`Ex. 1302, 45:20-46:19, 81:9-82:2, 179:14-180:19. Teva relied on Dr. Stoner
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`to attempt to establish a nexus between the challenged claims and a license
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`agreement. POR, 55. During cross-examination, however, Dr. Stoner’s admissions
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`directly contradicted any nexus, as he conceded that the license covers 188 patents,
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`within 8 different patent families, spread across 65 countries. Ex. 1302, 45:20-46:19.
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`He further acknowledged that the agreement’s royalty obligations would require
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`continued payments even if all challenged patents are invalidated. Id., 179:14-
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`180:19. Dr. Stoner testified that he did not perform any apportionment of the
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`agreement to the claims, further undermining nexus. Id., 81:9-82:2.
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`Teva seeks to exclude this damaging testimony as “vague” or calling for a
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`“legal analysis.” Mot., 9. But as the transcript shows, the facts illustrating the breadth
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`of the license agreement and Dr. Stoner’s failure to perform any apportionment stand
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`on their own. Moreover, Teva cannot rely on Dr. Stoner’s contract interpretations as
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`admissible when helpful to its case, but inadmissible as a “legal analysis” when
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`unhelpful. Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586,
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`Paper 83 at 66-67 (PTAB Dec. 12, 2018) (denying motion to exclude, concluding
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`6
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`IPR2018-01427
`Patent No. 8,597,649
`that “Patent Owner essentially asks us to apply a double standard here, however,
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`what’s good for the goose is also good for the gander”).
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`C. Dr. Ferrari’s Admissions Are Admissible
`Ex. 1303, 25:11-17. Teva relies on Dr. Ferrari’s testimony that a minor,
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`transient increase in blood pressure observed in Tan 1995 would have deterred
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`humanization of an anti-CGRP antagonist antibody. POR, 5-6, 25-26. During cross-
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`examination, however, Dr. Ferrari admitted that transient blood pressure increases
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`observed with the prior-art antimigraine drug sumatriptan (Imitrex®)—which
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`inhibits CGRP—were “not a major concern.” Ex. 1303, 25:11-17; Ex. 1282, 1521
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`(lower left corner: “transient increases in blood pressure . . . have been observed”).
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`Teva seeks to exclude Dr. Ferrari’s admission as lacking foundation. Mot., 9. Yet as
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`the transcript shows, Dr. Ferrari earlier confirmed that he was an investigator in
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`sumatriptan clinical trials and had published on its clinical effects in migraine, and
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`thus had sufficient foundation to discuss sumatriptan’s effects. Ex. 1303, 16:25-30:4.
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`Dr. Ferrari’s admission that he dismisses, in his own practice, transient blood
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`pressure increases described in the FDA-approved Imitrex® label as “not a major
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`concern” therefore should not be excluded on the ground of foundation. Moreover,
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`given that he takes the exact opposite position about transient effects in this
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`proceeding regarding anti-CGRP antagonist antibodies, Dr. Ferrari’s admissions
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`directly bear on his credibility. Kumho Tire, 119 S. Ct. at 1176.
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`7
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`IPR2018-01427
`Patent No. 8,597,649
`Ex. 1303, 70:13-75:11. Teva objects to additional Dr. Ferrari testimony about
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`his work outside this litigation, in which he explained that numerous CGRP pathway
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`antagonists—BIBN, telcagepant, and “a few more”—were “sufficiently safe” to take
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`into clinical trials. Ex. 1303, 70:13-75:11; Mot., 10. Teva’s arguments about
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`vagueness are baseless, particularly given Dr. Ferrari’s clarifying explanation that
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`“we all felt comfortable . . . to go ahead for clinical trial[s]” with those other CGRP
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`pathway antagonists, undermining his purported safety concerns in this proceeding.
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`Ex. 1303, 72:10-24.
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`Ex. 1303, 38:22-39:10. Although the challenged claims recite only
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`antibodies—not any particular uses—Dr. Ferrari testified during cross-examination
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`that the claims do not encompass certain uses of anti-CGRP antagonist antibodies.
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`Ex. 1303, 38:22-39:10. Teva objects to this testimony as vague and calling for a legal
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`conclusion. Mot., 9. The question, however, clearly asked for Dr. Ferrari’s personal
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`view of what Teva’s patent covers, not any legal conclusion. Dr. Ferrari’s
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`unsupported testimony that the claims require particular uses demonstrates that he
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`did not apply a correct understanding of the claims in his testimony, undermining its
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`reliability in this proceeding.
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`Ex. 1303, 54:12-23. Teva relies on Dr. Ferrari’s discussion of purported side
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`effects observed in animal studies as deterring humanization due to a lack of
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`established safety. POR, 23-24. During cross-examination, however, Dr. Ferrari
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`8
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`IPR2018-01427
`Patent No. 8,597,649
`admitted that such animal studies can “never” establish that a drug is safe. Ex. 1303,
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`54:12-23. These admissions are thus squarely within the scope of Dr. Ferrari’s direct
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`testimony. Given that Teva’s own patent discloses only animal studies, Dr. Ferrari’s
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`admissions show that he is improperly holding the prior art to a different, higher
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`standard than Teva’s own patent.
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`Ex. 1303, 49:1-20. Dr. Ferrari explained during cross-examination that it was
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`“well-known that you would significantly reduce the risk of immunological side
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`effects to an antibody” by humanizing, and that references to an antibody for
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`therapeutic uses as of 2005 would suggest a humanized antibody. Ex. 1303, 49:1-20.
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`Teva objects to this testimony for vagueness, but the witness clearly understood the
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`question and explained what was “well-known” in the art in 2005. Id.; Mot., 9-10.
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`Ex. 1303, 102:9-106:19, 160:2-9, 193:3-10. Teva further complains about
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`vagueness for questions about a “Fab fragment,” the population of migraine patients
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`who experience migraine without aura, and the “significance” of prior art anti-CGRP
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`treatments that lacked any cardiovascular side effects. Mot., 10-11. Teva’s arguments
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`lack merit. Lilly’s questioning specifically asked about Tan’s Fab fragment. Ex.
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`1303, 160:2-9. Lilly’s questioning about migraine patient populations specifically
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`defined the population as the “percentage” who do not experience migraine with
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`aura, for which Dr. Ferrari admitted there was no link between migraine and
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`ischemic stroke. Id., 193:3-10. Lilly’s questioning about “significance” in terms of
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`9
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`IPR2018-01427
`Patent No. 8,597,649
`the absence of any cardiovascular side effects with BIBN4096BS also was not
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`vague. Dr. Ferrari clarified that “BIBN did not result in any change” in
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`cardiovascular function. Id., 102:9-106:19.
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`Ex. 1303, 108:25-133:7. Teva relied on Dr. Ferrari’s testimony about
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`numerous early studies to support its hypothetical safety arguments. POR, 23-24.
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`From page 108:25 to 133:7 of Dr. Ferrari’s cross-examination transcript, Lilly
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`concisely cross-examined Dr. Ferrari about many of his cited exhibits—Exhibits
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`2151, 2152, 2079, 2209, 2139, 2070, 2089, 2058, 2154, 2150—typically obtaining
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`one-word answers agreeing to deficiencies in his cited exhibits. Dr. Ferrari’s
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`testimony confirms that these exhibits do not indicate that antagonizing endogenous
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`CGRP—as an anti-CGRP antagonist antibody would have been expected to do—
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`would have had any effect on cardiovascular or cerebrovascular safety. Ex. 1303,
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`108:25-133:7. Moreover, Dr. Ferrari repeatedly agreed that the majority of his cited
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`exhibits “did not study the effects of a CGRP antagonist at all.” Id., 111:18-20,
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`123:18-20, 127:13-15, 128:12-14, 129:16-18, 130:19-21, 132:4-6, 133:5-7. Given
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`Dr. Ferrari’s clear understanding of the questions and his clear, concise answers,
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`Teva’s form and legal-conclusion objections are misplaced. Mot., 10.
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`Ex. 1303, 69:10-16. Dr. Ferrari admitted during cross-examination that he
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`generally lacks an adequate understanding of antibodies, failing to grasp the
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`difference between a polyclonal antibody serum and a monoclonal antibody despite
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`10
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`IPR2018-01427
`Patent No. 8,597,649
`discussing references concerning both in his declaration. Ex. 1303, 69:10-16; Ex.
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`2141, ¶ 51. Teva’s objection that the definition of an “antibody serum” as “outside
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`the scope of this proceeding” is misplaced. Mot., 10. Dr. Ferrari’s admissions about
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`the limits of his knowledge go to the minimal weight that his testimony should be
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`accorded.
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`D. Dr. Rapoport’s Admissions Are Admissible
`Ex. 1304, 59:23-71:17. Teva relied on Dr. Rapoport’s discussion of treating
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`medication overuse headache (“MOH”) as a purported unexpected result. POR, 60;
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`Ex. 2165, ¶¶ 65-69. During cross-examination, however, Dr. Rapoport
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`acknowledged that in 2003 he co-authored a paper reporting that a prior art CGRP-
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`blocking preventative migraine therapy reduced MOH. Ex. 1304, 59:23-71:17
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`(discussing Ex. 1294, 487 (patients using triptans “stopped overusing acute care
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`medication during the study”)). Teva now seeks to exclude this testimony because it
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`relates to a “treatment of a different condition and different therapeutic than those of
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`concern to this proceeding.” Mot., 11. Teva and Dr. Rapoport, however, affirmatively
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`raised MOH as an unexpected result. POR, 60. Thus, Lilly’s questioning of Dr.
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`Rapoport, showing that other CGRP-blocking therapies were previously known to
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`reduce MOH, was fully within the scope of his direct testimony.
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`Ex. 1304, 82:17-134:18. Teva relied on Dr. Rapoport’s discussion of industry
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`acclaim as supporting secondary considerations. POR, 55-57; Ex. 2165, ¶¶ 45-64.
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`11
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`IPR2018-01427
`Patent No. 8,597,649
`From page 82:17 to 134:18 of Dr. Rapoport’s cross-examination transcript, Lilly
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`concisely cross-examined Dr. Rapoport about many of his cited exhibits—Exhibits
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`2163, 2172, 2167, 2180, 2173, and 2183—obtaining admissions that this evidence
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`lacks nexus because it addresses many drugs outside the scope of the challenged
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`claims, such as small molecule drugs and a first-to-market anti-migraine antibody
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`(Aimovig®) that targets the CGRP receptor. Teva now seeks to exclude this
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`testimony based on form objections and as outside the scope of Dr. Rapoport’s direct
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`testimony. Mot., 11. Teva’s arguments should be dismissed, as Lilly’s clear
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`questioning used Dr. Rapoport’s own cited exhibits to cross-examine him about his
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`direct testimony concerning secondary considerations, where he admitted that any
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`alleged praise is not directed to the claimed subject matter but rather to CGRP
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`antagonism generally, which was already known in the art.
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`Ex. 1304, 90:10-15, 91:6-10, 142:1-8. Teva complains about vagueness for
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`questions about the prior art class of triptan drugs and blocking the CGRP pathway.
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`Mot., 11-12. Teva’s arguments are meritless. Dr. Rapoport’s admission that a POSA
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`would have known that triptans inhibit the release of CGRP followed directly from
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`one of his own publications cited in his declaration (Ex. 2169), in which he wrote
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`“triptans . . . can inhibit the release [of] CGRP,” citing prior art publications. Ex.
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`1304, 89:20-90:15, 82:17-89:19; Ex. 2169, 914. Dr. Rapoport’s testimony about
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`blocking the CGRP pathway was similarly based on his own publication, in which
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`12
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`IPR2018-01427
`Patent No. 8,597,649
`he wrote: “it was considered that blocking CGRP or its receptor might . . . prevent
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`migraine.” Ex. 1304, 90:19-91:10, 142:1-8; Ex. 2169, 915.
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`Dr. Rapoport’s testimony that blocking the CGRP pathway was the only
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`antibody characteristic he considered in forming his opinions about long-felt need
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`also was not premised on any mischaracterization of previous testimony, as Teva
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`argues. Ex. 1304, 142:1-8; Mot., 12. Rather, the transcript clearly shows the joint
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`efforts of Lilly’s counsel and Dr. Rapoport to ensure that his testimony was clear.
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`Ex. 1304, 141:25-142:8 (ensuring a “clear statement on the record”).
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`Ex. 1304, 143:6-23, 145:23-146:3. While the challenged claims recite only
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`antibodies—not any particular uses—Dr. Rapoport
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`testified during cross-
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`examination that a method of treating headache was “implicit” in the claims. Ex.
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`1304, 143:6-23. Dr. Rapoport later conceded that the claimed antibodies could be
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`used for purposes other than therapeutic treatments. Id., 145:23-146:3. Teva objects
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`to this testimony as vague and calling for a legal conclusion. Mot., 12. The questions,
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`however, clearly asked for Dr. Rapoport’s personal view of what Teva’s patent
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`covers, not any legal conclusions.
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`IV. All of Lilly’s Exhibits Are Admissible in Their Entirety
`Teva seeks to exclude certain exhibits and portions of Lilly’s experts’
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`testimony on relevance grounds, claiming that “[i]f these exhibits were relevant to
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`this proceeding, Lilly should have cited them in the Petition or Reply.” Mot., 13.
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`13
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`IPR2018-01427
`Patent No. 8,597,649
`Relevance under FRE 401, however, is a “very low threshold.” Google Inc. v.
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`Performance Price Holdings, LLC, CBM2016-00049, Paper 37 at 35 (PTAB Sept.
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`13, 2017). As the Board has previously concluded, “there is no requirement that
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`Petitioner must cite evidence in its Reply or Opposition to be relevant.” Activision
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`Blizzard, Inc. v. Acceleration Bay, LLC, IPR2015-01953, Paper 107 at 75 (PTAB
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`Mar. 23, 2017). Thus, Teva’s request for exclusion should be denied.
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`Teva also improperly seeks to employ a double standard, omitting that its own
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`briefing did not cite many exhibits Teva filed or paragraphs of its own declarations,
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`including Exhibits 2054-2057, 2066-2067, 2070-2071, 2073, 2075, 2077-2078,
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`2082, 2086, 2088-2089, 2091-2095, 2097-2101, 2104-2106, 2108-2110, 2112-2121,
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`2124-2126, 2130, 2132, 2139, 2142-2143, 2145, 2148-2149, 2154-2156, 2158-2160,
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`2169, 2175-2178, 2181, 2184-2185, 2188, 2190, 2194, 2196, 2199-2203, 2205-
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`2209, 2215-2218, 2220, 2221, 2244-2253, 2256, 2258, 2259; Exhibit 2141, ¶¶ 1-3,
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`13-20; Exhibit 2137, ¶¶ 1-3, 12-19, 31-36, 42; Exhibit 2054, ¶¶ 1-3, 14-20, 43-48,
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`73, 75, 76; Exhibit 2165, ¶¶ 1-3, 12-20, 25, 69, 70; and Exhibit 2123, ¶¶ 5-14.
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`Exs. 1247, 1281, 1293, 1296, 1311, 1313, 1314, 1316, and 1317. Dr. Charles
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`properly relied on these exhibits to support his opinions that a POSA would not have
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`had safety concerns with an anti-CGRP antibody and to rebut Dr. Rapoport’s
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`secondary consideration arguments. Ex. 1330, ¶¶ 11-13, 15, 17, 92, 93. Dr. Balthasar
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`relied on Exhibit 1247 as evidence that longer distribution times and/or higher doses
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`14
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`IPR2018-01427
`Patent No. 8,597,649
`would be expected to improve antibody distribution to the site of action. Ex. 1329,
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`¶¶ 24-29. Exclusion should be denied. Nevro Corp. v. Boston Sci. Neuromodulation
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`Corp., IPR2017-01812, Paper 79 at 24 (PTAB Feb. 1, 2019) (denying exclusion of
`
`exhibits experts relied upon “in performing, or supporting, their analyses”).
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`Exs. 1261, 1262, 1264, 1265, 1267-1279, and 1286. Lilly properly used these
`
`exhibits to cross-examine Teva’s experts on the substance of their opinions in this
`
`case. Exclusion should be denied. Samsung Elecs. Co., Ltd. v. Queen’s Univ. at
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`Kingston, IPR2015-00583, Paper 54 at 58 (PTAB July 27, 2016) (holding admissible
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`exhibits uncited in briefing but discussed during expert deposition).
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`Exs. 1002, ¶¶ 34, 87; 1329, ¶¶ 1-14, 27-28; 1330, ¶¶ 7, 11-13, 15, 44, 64,
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`92-93. The identified portions of Lilly’s experts’ declarations summarize the experts’
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`qualifications and provide background on the state of art, and thus are relevant to
`
`this case. Ex. 1002, ¶ 34 (Dr. Charles providing background on human antibodies);
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`Ex. 1329, ¶¶ 1-14 (Dr. Balthasar detailing his prior experience and qualifications as
`
`an expert). Because the exhibits cited in the identified portions of Exhibits 1329 and
`
`1330 are admissible, Teva’s request to exclude those paragraphs should be denied.
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`V. Conclusion
`Lilly respectfully requests that Teva’s motion to exclude be denied.
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`Respectfully submitted,
`
`Date: November 1, 2019
`
`By: / William B. Raich /
`William B. Raich (Reg. No. 54,386)
`
`
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`15
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`IPR2018-01427
`Patent No. 8,597,649
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Petitioner’s
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`Opposition to Patent Owner’s Motion to Exclude was served electronically via
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`email on November 1, 2019, in its entirety on the following:
`
`Deborah A. Sterling
`Robert C. Millonig
`Gaby L. Longsworth
`Jeremiah B. Frueauf
`Olga A. Partington
`Dennies Varughese
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue, NW
`Washington, DC 20005
`dsterling-PTAB@sternekessler.com
`bobm-PTAB@sternekessler.com
`glongs-PTAB@sternekessler.com
`jfrueauf-PTAB@sternekessler.com
`opartington-PTAB@sternekessler.com
`dvarughe-PTAB@sternekessler.com
`
`
`Patent Owner has consented to service by email.
`
`
`
`
`
`
`
`By: / William Esper /
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
`Date: November 1, 2019
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`
`
`