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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. IPR2018-01425
`Patent No. 9,890,210
`______________________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`
`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 ........................................... 5
`
`Dr. Ferrari’s Admissions Are Admissible .......................................... 6
`C.
`D. Dr. Rapoport’s Admissions Are Admissible .....................................10
`IV. All of Lilly’s Exhibits Are Admissible in Their Entirety .............................12
`V.
`Conclusion ..................................................................................................15
`
`i
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`
`I.
`
`Introduction
`Teva’s Motion raises meritless challenges to evidence undermining its
`
`theories in this proceeding. For example, Teva incorrectly attempts to exclude
`
`Dr. Tan’s
`
`thesis (Ex. 1287/1287A) despite
`
`the “low bar” for document
`
`authentication, relying exclusively and improperly on printed-publication case law.
`
`The Board should also decline Teva’s attempt to exclude more than 20 admissions
`
`in its own experts’ cross-examination transcripts under FRE 403. Finally, there is no
`
`basis to exclude any of Lilly’s evidence regardless of whether it was directly cited
`
`in Lilly’s briefing. Teva’s Motion to Exclude should be denied.
`
`II. Exhibit 1287 Is Admissible
`Teva incorrectly seeks to exclude Exhibit 1287/1287A, the doctoral thesis of
`
`Dr. Keith Tan, under FRE 901. Mot., 1-7. Lilly has more than met the standard for
`
`authentication under FRE 901, which is a “low bar” that is satisfied by “evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.” Fox
`
`Factory, Inc. v. SRAM, LLC, IPR2017-00472, Paper 64 at 64 (PTAB Apr. 18, 2018).
`
`Here, Teva does not dispute that Exhibit 1287 is Dr. Tan’s doctoral thesis,
`
`conceding that it is what it purports to be. See Paper 43 at 2 (referencing Ex. 1287
`
`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]
`
`substance . . . of the item, taken together with all the circumstances,” may
`
`1
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`authenticate). Additionally, because Exhibit 1287 is a Cambridge thesis authored in
`
`1994, obtained from Cambridge Library, it is a self-authenticating ancient document.
`
`FRE 901(b)(8). Thus, there is no basis to exclude Exhibit 1287 under FRE 901.
`
`Every case cited in Teva’s challenge to Exhibit 1287 analyzes public
`
`accessibility for prior art purposes. Mot., 1-7. Challenging public availability,
`
`however, is not properly raised in a motion to exclude. Chi. Mercantile Exch., Inc.
`
`v. 5th Mkt., Inc., CBM2014-00114, Paper 35 at 52 (Aug. 18, 2015). Regardless, Teva
`
`fails to establish why public availability is necessary for authenticating Exhibit 1287.
`
`Lilly does not rely on Exhibit 1287 in its obviousness ground, and Lilly does
`
`not rely on it as prior art. Rather, Lilly cites Exhibit 1287 for purposes that do not
`
`require any showing of public accessibility. For example, Exhibit 1287 rebuts Teva’s
`
`purported personal knowledge that co-authors of the Tan references never
`
`considered antibody humanization (Ex. 2213, ¶¶ 70, 76), as Dr. Tan wrote that there
`
`was “no reason” why humanized anti-CGRP antibodies should not be investigated.
`
`Ex. 1287, 247; Reply, 11. A showing of a public availability is not required to admit
`
`Exhibit 1287 as rebutting Teva’s purported personal—not public—knowledge.
`
`Lilly also cites Exhibit 1287 to rebut Teva’s argument that minor, transient
`
`side effects would have deterred humanization of anti-CGRP antibodies. POR, 22-
`
`25, 38-39. With first-hand knowledge of the blood pressure results in Tan 1995, Dr.
`
`Tan proposed humanizing anti-CGRP antibodies to use as “therapeutic agents” for
`
`2
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`migraine. Ex. 1287, 209, 222-23, 247. Public availability is not required to admit
`
`Exhibit 1287 for the rebuttal purpose of demonstrating that actual researchers in the
`
`field before November 2005 were urging humanization and therapeutic uses of anti-
`
`CGRP antibodies notwithstanding Teva’s hypothetical, unsupported concerns.
`
`Nevertheless, even if it were necessary to establish Exhibit 1287 as a printed
`
`publication, Michael Carney’s declaration
`
`(Ex. 1307) establishes public
`
`accessibility. Dr. Tan’s thesis was authored and submitted to the Cambridge Library
`
`in 1994, stamped by the Library, and would have been cataloged and shelved about
`
`one month later. Ex. 1307, ¶¶ 14-15. Teva disputes that the Library used electronic
`
`MARC records (Mot., 4), but Mr. Carney established that the Library actually
`
`indexed Exhibit 1287 in its electronic MARC records by 2002, at the latest. Ex. 1307,
`
`¶¶ 16-17. Teva’s remaining criticisms of Mr. Carney’s declaration, including his
`
`direct outreach to the Library, ignore that both the 1994 shelving date and the 2002
`
`MARC record date occurred years before Teva’s earliest filing date.
`
`Thus, the Board should admit Exhibit 1287 as authenticated under FRE 901,
`
`and credit the Tan Thesis as a printed publication to the extent necessary.
`
`III. The Cross-Examination Transcripts of Teva’s Witnesses Are Admissible
`Seeking to insulate its witnesses from their damaging cross-examination
`
`testimony, Teva asserts that numerous portions of its own experts’ transcripts should
`
`be excluded under FRE 403 based on form and scope objections. Teva has conducted
`
`3
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`no balancing of its conclusory allegations of prejudice against the probative value of
`
`its experts’ admissions, as required by FRE 403. As set forth below, the full context
`
`of the challenged testimony demonstrates its highly probative value and confirms it
`
`should be admitted for the Board’s consideration. SK Hynix Inc. v. Netlist, Inc.,
`
`IPR2017-00562, Paper 36 at 49 (PTAB July 5, 2018) (“the Board, sitting as a non-
`
`jury tribunal with administrative expertise, is well positioned to determine and assign
`
`appropriate weight to evidence presented,” rather than excluding).
`
`A. Dr. Tomlinson’s Admissions Are Admissible
`Ex. 1301, 115:9-116:21, 154:24-156:21. Teva uses Dr. Tomlinson’s opinions
`
`to support nexus, but seeks to exclude his testimony pertaining to the scope of the
`
`claims and an Ajovy® regulatory document (Ex. 1320) Teva relies upon to support
`
`nexus. Ex. 1301, 115:9-116:21, 154:24-156:21; Ex. 2225, ¶ 102; Mot., 8. Having
`
`affirmatively relied on Dr. Tomlinson’s understanding of the scope of the claims and
`
`his interpretations of Exhibit 1320, Teva cannot fairly exclude his cross-examination
`
`on these same topics as speculative, irrelevant, or outside the scope of direct.
`
`Ex. 1301, 73:22-75:20. Teva relied on Dr. Tomlinson’s testimony disparaging
`
`Tan’s disclosure of a 16% response in the rat saphenous model because it was
`
`purportedly not statistically significant. POR, 16. During cross-examination,
`
`however, Dr. Tomlinson conceded that he forms conclusions and publishes data
`
`analyses based on non-statistically significant results in his own academic work. Ex.
`
`4
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`1301, 73:22-75:20. Dr. Tomlinson’s testimony is therefore not “unrelated” to this
`
`proceeding, as Teva incorrectly contends, because it goes directly to his credibility.
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`Mot., 8; Kumho Tire Co., Ltd. v. Carmichael, 119 S. Ct. 1167, 1176 (1999) (expert
`
`witnesses must “employ[] in the courtroom the same level of intellectual rigor that
`
`characterizes the practice of an expert in the relevant field”).
`
`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
`
`to attempt to establish a nexus between the challenged claims and a license
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`agreement. POR, 45. During cross-examination, however, Dr. Stoner’s admissions
`
`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.
`
`He further acknowledged that the agreement’s royalty obligations would require
`
`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
`
`agreement to the claims, further undermining nexus. Id., 81:9-82:2.
`
`Teva seeks to exclude this damaging testimony as “vague” or calling for a
`
`“legal analysis.” Mot., 8-9. But as the transcript shows, the facts illustrating the
`
`breadth of the license agreement and Dr. Stoner’s failure to perform any
`
`apportionment stand on their own. Moreover, Teva cannot rely on Dr. Stoner’s
`
`contract interpretations as admissible when helpful to its case, but inadmissible as a
`
`5
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`

`

`IPR2018-01425
`Patent No. 9,890,210
`“legal analysis” when unhelpful. Becton, Dickinson & Co. v. B. Braun Melsungen
`
`AG, IPR2017-01586, Paper 83 at 66-67 (PTAB Dec. 12, 2018) (denying motion to
`
`exclude, concluding that “Patent Owner essentially asks us to apply a double
`
`standard here, however, what’s good for the goose is also good for the gander”).
`
`C. Dr. Ferrari’s Admissions Are Admissible
`Ex. 1303, 25:11-17. Teva relies on Dr. Ferrari’s testimony that a minor,
`
`transient increase in blood pressure observed in Tan 1995 would have deterred
`
`humanization of an anti-CGRP antagonist antibody. POR, 5-6, 23-25. During cross-
`
`examination, however, Dr. Ferrari admitted that transient blood pressure increases
`
`observed with the prior-art antimigraine drug sumatriptan (Imitrex®)—which
`
`inhibits CGRP—were “not a major concern.” Ex. 1303, 25:11-17; Ex. 1282, 1521
`
`(lower left corner: “transient increases in blood pressure . . . have been observed”).
`
`Teva seeks to exclude Dr. Ferrari’s admission as lacking foundation. Mot., 9. Yet as
`
`the transcript shows, Dr. Ferrari earlier confirmed that he was an investigator in
`
`sumatriptan clinical trials and had published on its clinical effects in migraine, and
`
`thus had sufficient foundation to discuss sumatriptan’s effects. Ex. 1303, 16:25-30:4.
`
`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
`
`concern” therefore should not be excluded on the ground of foundation. Moreover,
`
`given that he takes the exact opposite position about transient effects in this
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`6
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`

`

`IPR2018-01425
`Patent No. 9,890,210
`proceeding regarding anti-CGRP antagonist antibodies, Dr. Ferrari’s admissions
`
`directly bear on his credibility. Kumho Tire, 119 S. Ct. at 1176.
`
`Ex. 1303, 70:13-75:11. Teva objects to additional Dr. Ferrari testimony about
`
`his work outside this litigation, in which he explained that numerous CGRP pathway
`
`antagonists—BIBN, telcagepant, and “a few more”—were “sufficiently safe” to take
`
`into clinical trials. Ex. 1303, 70:13-75:11; Mot., 10. Teva’s arguments about
`
`vagueness are baseless, particularly given Dr. Ferrari’s clarifying explanation that
`
`“we all felt comfortable . . . to go ahead for clinical trial[s]” with those other CGRP
`
`pathway antagonists, undermining his purported safety concerns in this proceeding.
`
`Ex. 1303, 72:10-24.
`
`Ex. 1303, 38:22-39:10. Although the challenged claims recite only
`
`antibodies—not any particular uses—Dr. Ferrari testified during cross-examination
`
`that the claims do not encompass certain uses of anti-CGRP antagonist antibodies.
`
`Ex. 1303, 38:22-39:10. Teva objects to this testimony as vague and calling for a legal
`
`conclusion. Mot., 9. The question, however, clearly asked for Dr. Ferrari’s personal
`
`view of what Teva’s patent covers, not any legal conclusion. Dr. Ferrari’s
`
`unsupported testimony that the claims require particular uses demonstrates that he
`
`did not apply a correct understanding of the claims in his testimony, undermining its
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`reliability in this proceeding.
`
`Ex. 1303, 54:12-23. Teva relies on Dr. Ferrari’s discussion of purported side
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`7
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`

`

`IPR2018-01425
`Patent No. 9,890,210
`effects observed in animal studies as deterring humanization due to a lack of
`
`established safety. POR, 21-22. During cross-examination, however, Dr. Ferrari
`
`admitted that such animal studies can “never” establish that a drug is safe. Ex. 1303,
`
`54:12-23. These admissions are thus squarely within the scope of Dr. Ferrari’s direct
`
`testimony. Given that Teva’s own patent discloses only animal studies, Dr. Ferrari’s
`
`admissions show that he is improperly holding the prior art to a different, higher
`
`standard than Teva’s own patent.
`
`Ex. 1303, 49:1-20. Dr. Ferrari explained during cross-examination that it was
`
`“well-known that you would significantly reduce the risk of immunological side
`
`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.
`
`Teva objects to this testimony for vagueness, but the witness clearly understood the
`
`question and explained what was “well-known” in the art in 2005. Id.; Mot., 9.
`
`Ex. 1303, 102:9-106:19, 160:2-9, 193:3-10. Teva further complains about
`
`vagueness for questions about a “Fab fragment,” the population of migraine patients
`
`who experience migraine without aura, and the “significance” of prior art anti-CGRP
`
`treatments that lacked any cardiovascular side effects. Mot., 10. Teva’s arguments
`
`lack merit. Lilly’s questioning specifically asked about Tan’s Fab fragment. Ex.
`
`1303, 160:2-9. Lilly’s questioning about migraine patient populations specifically
`
`defined the population as the “percentage” who do not experience migraine with
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`8
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`

`

`IPR2018-01425
`Patent No. 9,890,210
`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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`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.
`
`Ex. 1303, 108:25-133:7. Teva relied on Dr. Ferrari’s testimony about
`
`numerous early studies to support its hypothetical safety arguments. POR, 21-22.
`
`From page 108:25 to 133:7 of Dr. Ferrari’s cross-examination transcript, Lilly
`
`concisely cross-examined Dr. Ferrari about many of his cited exhibits—Exhibits
`
`2151, 2152, 2079, 2209, 2139, 2070, 2089, 2058, 2154, 2150—typically obtaining
`
`one-word answers agreeing to deficiencies in his cited exhibits. Dr. Ferrari’s
`
`testimony confirms that these exhibits do not indicate that antagonizing endogenous
`
`CGRP—as an anti-CGRP antagonist antibody would have been expected to do—
`
`would have had any effect on cardiovascular or cerebrovascular safety. Ex. 1303,
`
`108:25-133:7. Moreover, Dr. Ferrari repeatedly agreed that the majority of his cited
`
`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
`
`Dr. Ferrari’s clear understanding of the questions and his clear, concise answers,
`
`Teva’s form and legal-conclusion objections are misplaced. Mot., 10.
`
`Ex. 1303, 69:10-16. Dr. Ferrari admitted during cross-examination that he
`
`9
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`

`

`IPR2018-01425
`Patent No. 9,890,210
`generally lacks an adequate understanding of antibodies, failing to grasp the
`
`difference between a polyclonal antibody serum and a monoclonal antibody despite
`
`discussing references concerning both in his declaration. Ex. 1303, 69:10-16; Ex.
`
`2213, ¶ 51. Teva’s objection that the definition of an “antibody serum” as “outside
`
`the scope of this proceeding” is misplaced. Mot., 9-10. Dr. Ferrari’s admissions
`
`about the limits of his knowledge go to the minimal weight that his testimony should
`
`be accorded.
`
`D. Dr. Rapoport’s Admissions Are Admissible
`Ex. 1304, 59:23-71:17. Teva relied on Dr. Rapoport’s discussion of treating
`
`medication overuse headache (“MOH”) as a purported unexpected result. POR, 51;
`
`Ex. 2236, ¶¶ 65-69. During cross-examination, however, Dr. Rapoport
`
`acknowledged that in 2003 he co-authored a paper reporting that a prior art CGRP-
`
`blocking preventative migraine therapy reduced MOH. Ex. 1304, 59:23-71:17
`
`(discussing Ex. 1294, 487 (patients using triptans “stopped overusing acute care
`
`medication during the study”)). Teva now seeks to exclude this testimony because it
`
`relates to a “treatment of a different condition and different therapeutic than those of
`
`concern to this proceeding.” Mot., 10-11. Teva and Dr. Rapoport, however,
`
`affirmatively raised MOH as an unexpected result. POR, 51. Thus, Lilly’s
`
`questioning of Dr. Rapoport, showing that other CGRP-blocking therapies were
`
`previously known to reduce MOH, was fully within the scope of his direct testimony.
`
`10
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`Ex. 1304, 82:17-134:18. Teva relied on Dr. Rapoport’s discussion of industry
`
`acclaim as supporting secondary considerations. POR, 46-48; Ex. 2236, ¶¶ 45-64.
`
`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
`
`2163, 2172, 2167, 2180, 2173, and 2183—obtaining admissions that this evidence
`
`lacks nexus because it addresses many drugs outside the scope of the challenged
`
`claims, such as small molecule drugs and a first-to-market anti-migraine antibody
`
`(Aimovig®) that targets the CGRP receptor. Teva now seeks to exclude this
`
`testimony based on form objections and as outside the scope of Dr. Rapoport’s direct
`
`testimony. Mot., 11. Teva’s arguments should be dismissed, as Lilly’s clear
`
`questioning used Dr. Rapoport’s own cited exhibits to cross-examine him about his
`
`direct testimony concerning secondary considerations, where he admitted that any
`
`alleged praise is not directed to the claimed subject matter but rather to CGRP
`
`antagonism generally, which was already known in the art.
`
`Ex. 1304, 90:10-15, 91:6-10, 142:1-8. Teva complains about vagueness for
`
`questions about the prior art class of triptan drugs and blocking the CGRP pathway.
`
`Mot., 11. Teva’s arguments are meritless. Dr. Rapoport’s admission that a POSA
`
`would have known that triptans inhibit the release of CGRP followed directly from
`
`one of his own publications cited in his declaration (Ex. 2169), in which he wrote
`
`“triptans . . . can inhibit the release [of] CGRP,” citing prior art publications. Ex.
`
`11
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`

`

`IPR2018-01425
`Patent No. 9,890,210
`1304, 89:20-90:15, 82:17-89:19; Ex. 2169, 914. Dr. Rapoport’s testimony about
`
`blocking the CGRP pathway was similarly based on his own publication, in which
`
`he wrote: “it was considered that blocking CGRP or its receptor might . . . prevent
`
`migraine.” Ex. 1304, 90:19-91:10, 142:1-8; Ex. 2169, 915.
`
`Dr. Rapoport’s testimony that blocking the CGRP pathway was the only
`
`antibody characteristic he considered in forming his opinions about long-felt need
`
`also was not premised on any mischaracterization of previous testimony, as Teva
`
`argues. Ex. 1304, 142:1-8; Mot., 11. Rather, the transcript clearly shows the joint
`
`efforts of Lilly’s counsel and Dr. Rapoport to ensure that his testimony was clear.
`
`Ex. 1304, 141:25-142:8 (ensuring a “clear statement on the record”).
`
`Ex. 1304, 143:6-23, 145:23-146:3. While the challenged claims recite only
`
`antibodies—not any particular uses—Dr. Rapoport
`
`testified during cross-
`
`examination that a method of treating headache was “implicit” in the claims. Ex.
`
`1304, 143:6-23. Dr. Rapoport later conceded that the claimed antibodies could be
`
`used for purposes other than therapeutic treatments. Id., 145:23-146:3. Teva objects
`
`to this testimony as vague and calling for a legal conclusion. Mot., 11-12. The
`
`questions, however, clearly asked for Dr. Rapoport’s personal view of what Teva’s
`
`patent covers, not any legal conclusions.
`
`IV. All of Lilly’s Exhibits Are Admissible in Their Entirety
`Teva seeks to exclude certain exhibits and portions of Lilly’s experts’
`
`12
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`

`

`IPR2018-01425
`Patent No. 9,890,210
`testimony on relevance grounds, claiming that “[i]f these exhibits were relevant to
`
`this proceeding, Lilly should have cited them in the Petition or Reply.” Mot., 12-13.
`
`Relevance under FRE 401, however, is a “very low threshold.” Google Inc. v.
`
`Performance Price Holdings, LLC, CBM2016-00049, Paper 37 at 35 (PTAB Sept.
`
`13, 2017). As the Board has previously concluded, “there is no requirement that
`
`Petitioner must cite evidence in its Reply or Opposition to be relevant.” Activision
`
`Blizzard, Inc. v. Acceleration Bay, LLC, IPR2015-01953, Paper 107 at 75 (PTAB
`
`Mar. 23, 2017). Thus, Teva’s request for exclusion should be denied.
`
`Teva also improperly seeks to employ a double standard, omitting that its own
`
`briefing did not cite many exhibits Teva filed or paragraphs of its own declarations,
`
`including Exhibits 2055-2057, 2066-2067, 2070-2071, 2073, 2075, 2077-2078,
`
`2082, 2086, 2088-2089, 2091-2101, 2104-2110, 2112-2122, 2124-2126, 2128-2130,
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`2138-2139, 2142-2143, 2145, 2148-2149, 2154-2156, 2158-2160, 2169, 2175-2178,
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`2181, 2184-2185, 2188, 2190, 2194, 2196, 2199-2203, 2205-2209, 2215-2216,
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`2218, 2220, 2221, 2244-2254, 2256, 2258-2259; Exhibit 2213, ¶¶ 1-3, 13-20;
`
`Exhibit 2225, ¶¶ 1-3, 12-19, 31-36, 42; Exhibit 2231, ¶¶ 1-3, 14-20, 43-48, 73, 75,
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`76; Exhibit 2236, ¶¶ 1-3, 12-20, 25, 69, 70; and Exhibit 2242, ¶¶ 5-14.
`
`Exs. 1247, 1281, 1293, 1296, 1311, 1313, 1314, 1316, and 1317. Dr. Charles
`
`properly relied on these exhibits to support his opinions that a POSA would not have
`
`been concerned about the safety of an anti-CGRP antibody with a longer half-life
`
`13
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`IPR2018-01425
`Patent No. 9,890,210
`and to rebut Dr. Rapoport’s secondary consideration arguments. Ex. 1326, ¶¶ 11-13,
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`15, 17, 92, 93. Similarly, Dr. Balthasar relied on Exhibit 1247 as evidence that a
`
`POSA would have expected longer distribution times and/or higher doses of full-
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`length antibodies to improve distribution to the site of action. Ex. 1325, ¶¶ 24-29.
`
`Exclusion should be denied. Nevro Corp. v. Boston Sci. Neuromodulation Corp.,
`
`IPR2017-01812, Paper 79 at 24 (PTAB Feb. 1, 2019) (denying exclusion of exhibits
`
`experts relied upon “in performing, or supporting, their analyses”).
`
`Exs. 1087, 1110, 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 Kingston, IPR2015-00583, Paper 54 at 58 (PTAB July 27, 2016)
`
`(holding admissible exhibits uncited in briefing but discussed during expert
`
`deposition).
`
`Exs. 1010, ¶¶ 26-27, 34, 60-67, 89, 150; 1011, ¶¶ 62-63; 1325, ¶¶ 1-14, 27-
`
`28; 1326, ¶¶ 7, 11-13, 15, 44, 64, 92-93. The identified portions of Lilly’s experts’
`
`declarations summarize the experts’ qualifications and provide background on the
`
`state of art, and thus are relevant to this case. Ex. 1010, ¶¶ 60-67 (Dr. Charles
`
`explaining that anti-CGRP antagonist antibodies were known treatment options for
`
`CGRP-mediated human diseases); Ex. 1011, ¶¶ 62-63 (Dr. Vasserot discussing
`
`background on human antibodies); Ex. 1325, ¶¶ 1-14 (Dr. Balthasar detailing his
`
`14
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`prior experience and qualifications as an expert). Because the exhibits cited in the
`
`identified portions of Exhibits 1325 and 1326 are admissible, Teva’s request to
`
`exclude those paragraphs should be denied.
`
`V. Conclusion
`Lilly respectfully requests that Teva’s motion to exclude be denied.
`
`Respectfully submitted,
`
`Date: November 1, 2019
`
`By: / William B. Raich /
`William B. Raich (Reg. No. 54,386)
`
`
`
`15
`
`

`

`IPR2018-01425
`Patent No. 9,890,210
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Petitioner’s
`
`Opposition to Patent Owner’s Motion to Exclude was served electronically via
`
`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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