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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. IPR2018-01712
`Patent No. 9,884,908
`______________________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`
`Table of Contents
`I.
`Introduction ...................................................................................................... 1
`Exhibit 1287 Is Admissible ............................................................................. 1
`II.
`III. The Cross-Examination Transcripts of Teva’s Witnesses Are
`Admissible ....................................................................................................... 4
`A. Dr. Tomlinson’s Admissions Are Admissible ...................................... 4
`B.
`Dr. Stoner’s Admissions Are Admissible ............................................. 5
`C.
`Dr. Ferrari’s Admissions Are Admissible ............................................. 6
`D. Dr. Rapoport’s Admissions Are Admissible .......................................10
`E.
`Dr. Foord’s Admissions Are Admissible ............................................12
`IV. All of Lilly’s Exhibits Are Admissible in Their Entirety ..............................13
`V.
`Conclusion .....................................................................................................15
`
`i
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`
`I.
`
`Introduction
`Teva’s Motion should be denied, as it 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, improperly relying 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 briefing.
`
`II. Exhibit 1287 Is Admissible
`Teva incorrectly seeks to exclude Exhibit 1287/1287A, the doctoral thesis of
`
`Dr. Keith Tan, under FRE 901. Mot., 2-7. 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. See
`
`Paper 38 at 2 (referencing Ex. 1287 as a “dissertation by Dr. Tan”). Mr. Carney also
`
`fully authenticates the thesis, explaining how he obtained it directly from the
`
`University of Cambridge Library and how it was catalogued. Ex. 1307, ¶¶ 6-19. The
`
`content of Exhibit 1287 also mirrors Tan 1994 and Tan 1995, further confirming that
`
`it is Dr. Tan’s 1994 thesis. See, e.g., Ex. 1287, 194-97, 209-10, 222-23, 247; Ex.
`
`1
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`1021, 708-09; Ex. 1022, 565, 568, 571; FRE 901(b)(4); Minerva Surgical, Inc. v.
`
`Hologic, Inc., IPR2016-00868, Paper 63 at 53 (PTAB Dec. 15, 2017) (appearance,
`
`contents, substance, and circumstance of an item may 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).
`
`Establishing public accessibility or prior-art status is unnecessary for
`
`authenticating Exhibit 1287, contrary to Teva’s arguments. Mot., 2-7. Indeed,
`
`challenging public availability is not properly raised in a motion to exclude, and Teva
`
`has not challenged the admissibility of any evidence supporting public availability,
`
`e.g., the Carney declaration. Chi. Mercantile Exch., Inc. v. 5th Mkt., Inc., CBM2014-
`
`00114, Paper 35 at 52 (Aug. 18, 2015). Rather, Teva explicitly and improperly argues
`
`the “sufficiency” of the evidence for proving public availability, which the Board
`
`prohibits. Trial Practice Guide, 79 (Nov. 2019) (“A motion to exclude . . . may not
`
`be used to challenge the sufficiency of the evidence to prove a particular fact.”);
`
`Mot., 2 (citing Conoco Inc. v. Dep't of Energy, 99 F.3d 387, 391-92 (Fed. Cir. 1996),
`
`which analyzed “business records” under FRE 803(6), not public accessibility).
`
`Moreover, instead of relying on Exhibit 1287 as an asserted reference or prior
`
`art, Lilly cites Exhibit 1287 for reasons that do not require any showing of public
`
`availability. For example, Exhibit 1287 rebuts Teva’s purported personal knowledge
`
`that co-authors of the Tan references never considered developing therapeutic anti-
`
`2
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`CGRP antibodies (Ex. 2270, ¶¶ 147, 152), as Dr. Tan wrote that there was “no
`
`reason” not to investigate humanized anti-CGRP antibodies for treating diseases
`
`such as migraine. Ex. 1287, 247; Reply, 6, 15-16. Public availability is not required
`
`to admit Exhibit 1287 to rebut Teva’s purported personal—not public—knowledge.
`
`Lilly also cites Exhibit 1287 to rebut Teva’s argument that minor, transient
`
`side effects would diminish an expectation to treat migraine with an anti-CGRP
`
`antibody. Reply, 15-16; POR, 27-29. With first-hand knowledge of the blood
`
`pressure results in Tan 1995, Dr. Tan proposed developing and using humanized anti-
`
`CGRP antibodies as “therapeutic agents” for 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.
`
`Nevertheless, even if it were necessary to establish Exhibit 1287 as a printed
`
`publication, Mr. Carney’s declaration 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., 4-5), 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
`
`3
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`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
`
`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. 2217 (filed as Ex. 1320 in this
`
`4
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`proceeding))1 he relied upon to support nexus. Ex. 1301, 115:9-116:21, 154:24-
`
`156:21; Ex. 2273, ¶ 123; Mot., 8. Having affirmatively relied on Dr. Tomlinson’s
`
`understanding of the scope of the claims and his interpretations of Exhibit 2217,
`
`Teva cannot fairly exclude his cross-examination on these same topics as
`
`speculative, irrelevant, or outside the scope of direct.
`
`Ex. 1301, 211:16-21. Dr. Tomlinson admitted that strong binding affinity is a
`
`desirable characteristic for therapeutic antibodies. Ex. 1301, 211:16-21; Reply, 20.
`
`Given his acknowledgment that his own contemporaneous publication states that an
`
`“ideal” therapeutic antibody “would have very high affinity . . . for its target,” Teva’s
`
`form objections are meritless. Ex. 1301, 214:6-217:11; Ex. 1266, 521; Mot., 8.
`
`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
`
`agreement. POR, 55, 62-63. During cross-examination, however, Dr. Stoner’s
`
`admissions directly contradicted any nexus, as he conceded that the license covers
`
`188 patents, from 8 different patent families, spread across 65 countries. Ex. 1302,
`
`45:20-46:19; Reply, 27. He further acknowledged that the agreement’s royalty
`
`
`1 To streamline discovery, the parties agreed to the admissibility of deposition
`
`transcripts from related cases IPR2018-01422 through -01427 in this proceeding.
`
`5
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`obligations would require continued payments even if all challenged patents are
`
`invalidated. Ex. 1302, 179:14-180:19. 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. It is improper for Teva to apply the “double
`
`standard” it seeks here, relying on Dr. Stoner’s contract interpretations when helpful
`
`to its case, but arguing they are inadmissible legal analyses when unhelpful. Becton,
`
`Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 83 at 66-67
`
`(PTAB Dec. 12, 2018).
`
`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
`
`treating migraine with an anti-CGRP antibody. POR, 5-6, 27-29. 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”);
`
`6
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`Reply, 14-15. 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 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 proceeding regarding anti-CGRP antagonist antibodies, Dr. Ferrari’s admissions
`
`directly bear on his credibility. 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”).
`
`Ex. 1303, 54:12-23. Teva relies on Dr. Ferrari’s discussion of purported side
`
`effects observed in animal studies as deterring treating migraine with an anti-CGRP
`
`antibody due to a lack of established safety. POR, 25-27. During cross-examination,
`
`however, Dr. Ferrari admitted that such animal studies can “never” establish that a
`
`drug is safe. Ex. 1303, 54:12-23; Reply, 3. 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.
`
`7
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`Ex. 1303, 61:15-65:12. Teva relied on Dr. Ferrari’s claim construction
`
`testimony for the term “effective amount.” POR, 12. During cross-examination,
`
`however, Dr. Ferrari conceded that antagonizing the CGRP pathway has the
`
`biochemical response of preventing cAMP formation, which is all that the ’908
`
`patent requires in its definition of “effective amount.” Ex. 1303, 61:15-62:12; Reply,
`
`2-3; Ex. 1001, 19:3-22, 26:20-28. He clearly understood counsel’s questions. Thus,
`
`Teva’s scope and vagueness objections are both incorrect.
`
`Ex. 1303, 73:8-18, 102:9-106:19, 193:3-10. Teva further complains about
`
`vagueness for questions about the population of migraine patients who experience
`
`migraine without aura and the “significance” of prior art anti-CGRP treatments that
`
`lacked cardiovascular side effects. Mot., 9-10. Teva’s arguments lack merit. Lilly’s
`
`questioning about migraine patient populations specifically defined the population
`
`as the “percentage” who do not experience migraine with aura, for which Dr. Ferrari
`
`admitted there was no link between migraine and ischemic stroke. Ex. 1303, 193:3-
`
`10; Reply, 17-18. Lilly’s questioning about “significance” and sufficient safety
`
`regarding the lack of cardiovascular side effects with BIBN4096BS observed during
`
`human clinical trials also was not vague. Dr. Ferrari clarified that “BIBN did not
`
`result in any change” in cardiovascular function. Ex. 1303, 102:9-106:19, 73:8-18.
`
`Ex. 1303, 108:25-133:7. Teva relied on Dr. Ferrari’s testimony about
`
`numerous early studies to support its hypothetical safety arguments. POR, 25-27.
`
`8
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`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; Reply, 16. Moreover, Dr. Ferrari repeatedly agreed that the majority
`
`of his cited exhibits “did not study the effects of a CGRP antagonist at all.” Ex. 1303,
`
`111:18-20, 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 that he 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. 2270, ¶ 128; Reply, 14. Thus, Teva’s
`
`objection that the definition of an “antibody serum” as “outside the scope of this
`
`proceeding” is misplaced. Mot., 9. Dr. Ferrari’s admissions about the limits of his
`
`knowledge go to the minimal weight that his testimony should be accorded.
`
`9
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`Ex. 1345, 52:6-54:7, 61:5-65:2. Dr. Ferrari admitted that BIBN4069BS acted
`
`outside of the blood-brain barrier (“BBB”) and that none of the examples in Teva’s
`
`patent evaluate the ability of an anti-CGRP antibody to cross the BBB. Ex. 1345,
`
`52:6-54:7, 61:5-65:2; Reply, 7. Teva incorrectly seeks to exclude these admissions
`
`by implausibly arguing that questions about the “periphery,” as well as
`
`BIBN4069BS’s “effects” on inhibiting CGRP’s “increases in the diameter of the
`
`middle meningeal artery” outside the BBB, were vague. Mot., 11-12. Dr. Ferrari and
`
`Lilly’s counsel worked together to ensure clear answers. Ex. 1345, 62:14-63:12.
`
`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, 59-
`
`60; Ex. 2264, ¶¶ 69-73. In 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”)); Reply, 26. 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. Teva and Dr. Rapoport, however,
`
`affirmatively raised MOH as an unexpected result. POR, 59-60. Thus, Lilly’s
`
`questioning of Dr. Rapoport, showing that other CGRP-blocking therapies were
`
`10
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`previously known to reduce MOH, was fully within the scope of his direct testimony.
`
`Ex. 1304, 74:17-75:12. Teva relied on Dr. Rapoport’s testimony concerning
`
`secondary considerations, but he failed to consider nexus in forming his opinions.
`
`POR, 54-58. During cross-examination, and contrary to Teva’s improper form
`
`objection, Dr. Rapoport volunteered that there are 250 different forms of headache,
`
`of which migraine is only one. Ex. 1304, 74:17-75:12; Reply, 22. This further
`
`illustrates the lack of nexus between Teva’s patent claims (e.g., generically reciting
`
`“headache”) and Ajovy® and Emgality®, which are only approved for migraine.
`
`Ex. 1304, 82:17-134:18. Teva relied on Dr. Rapoport’s discussion of industry
`
`acclaim as supporting secondary considerations. POR, 55-57; Ex. 2264, ¶¶ 49-68.
`
`From page 82:17 to 134:18 of the transcript, Lilly asked Dr. Rapoport about many
`
`of his cited exhibits (Exs. 2163, 2172, 2167, 2180, 2173, 2183) and he admitted 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. Reply, 25. Teva’s form and
`
`scope objections (Mot., 10-11) 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.
`
`11
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`Ex. 1304, 119:1-15. During cross-examination, Dr. Rapoport conceded that
`
`Exhibit 2167 undermines Teva’s allegations about purported skepticism in the art.
`
`Ex. 1304, 119:1-5; Reply, 26. Teva’s scope objection is misplaced, as Dr. Rapoport
`
`discussed and relied upon Ex. 2167 in his declaration. E.g., Ex. 2264, ¶ 50.
`
`Ex. 1304, 142:1-8. During cross-examination, Dr. Rapoport admitted that
`
`blocking the CGRP pathway was the only antibody characteristic he considered in
`
`forming his opinions about long-felt need. Ex. 1304, 142:1-8. Teva’s vagueness and
`
`mischaracterization objections are misplaced (Mot., 11), as the transcript clearly
`
`shows the joint efforts of Lilly’s counsel and Dr. Rapoport to ensure that the
`
`questions and his testimony were clear. Ex. 1304, 141:25-142:8 (ensuring a “clear
`
`statement on the record”). Moreover, Dr. Rapoport’s testimony about blocking the
`
`CGRP pathway related to discussions about his own publication, which states: “it
`
`was considered that blocking CGRP or its receptor might . . . prevent migraine.” Id.,
`
`90:19-91:10, 142:1-8; Ex. 2169, 915.
`
`E. Dr. Foord’s Admissions Are Admissible
`Ex. 1343, 76:12-77:8. Dr. Foord admitted during cross-examination it was
`
`“unlikely” that BIBN4096BS—a molecule proven to treat migraine in a clinical trial
`
`involving 126 human patients—crossed the BBB. Ex. 1343, 76:12-77:8; Ex. 1025,
`
`1104, 1109; Reply, 7-8. Teva’s objections for vagueness are incorrect and
`
`unconvincing given Dr. Foord’s repeated testimony volunteering that BIBN4096BS
`
`12
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`was far too large to cross the BBB. See also Ex. 1343, 74:17-75:8.
`
`Ex. 1343, 33:17-34:6. Dr. Foord admitted that the doses of CGRP antagonists
`
`needed to elicit biochemical effects of cAMP formulation are “enormously far apart”
`
`from what would be needed to generate clinical treatment effects, consistent with a
`
`proper construction of “effective amount” in view of Teva’s specification. Ex. 1343,
`
`33:17-34:6; Ex. 1001, 19:3-22; Reply, 2-3. Teva’s vagueness objections are
`
`incorrect, as Dr. Foord clearly understood the question during cross-examination.
`
`IV. All of Lilly’s Exhibits Are Admissible in Their Entirety
`Teva seeks to exclude certain exhibits and portions of Lilly’s experts’
`
`testimony as uncited in Lilly’s briefing and lacking relevance. Mot., 12. 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).
`
`Moreover, “there is no requirement that Petitioner must cite evidence in its Reply or
`
`Opposition to be relevant.” Activision Blizzard, Inc. v. Acceleration Bay, LLC,
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`IPR2015-01953, Paper 107 at 75 (PTAB Mar. 23, 2017). Exclusion should be denied.
`
`Teva also improperly seeks to employ a double standard, omitting that its own
`
`briefing did not cite many exhibits and paragraphs of its own declarations, including
`
`Exs. 2055-2057, 2066-2067, 2070, 2073, 2075, 2077-2078, 2082, 2089,2091-2095,
`
`2097-2110, 2112-2122, 2124-2126, 2130, 2138-2139, 2142-2143, 2145-2146, 2148-
`
`2149, 2154-2156, 2159-2160, 2169, 2175-2178, 2181, 2184, 2188, 2190, 2194,
`
`13
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`2196, 2199-2203, 2205-2209, 2216-2218, 2220-2221, 2237, 2241-2242, 2244-2254,
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`2256, 2258-2259, 2280-2283, 2285, 2287-2288, 2290, 2297, 2301-2302, 2304-2305,
`
`2312-2322, 2324, 2327-2328, 2334, 2344, 2346; Ex. 2264, ¶¶ 1-3, 12-13, 16-20, 41,
`
`43-47, 74; Ex. 2270, ¶¶ 1-3, 13-18, 22-24; Ex. 2273, ¶¶ 1-3, 12-17, 19-24, 26, 33,
`
`35-39, 60-61; and Ex. 2276, ¶¶ 5-14.
`
`Exs. 1293, 1296, 1311, 1313, 1314, 1316, 1317, 1331, 1344, 1347, 1349. Drs.
`
`Charles and Balthasar properly relied on these exhibits to rebut Teva’s arguments
`
`about safety concerns, synaptic cleft size, or secondary considerations. Ex. 1342,
`
`¶¶ 19, 20, 22, 33, 142, 143; Ex. 1341, ¶¶ 37, 38. Exclusion should thus 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”). In addition, Exhibit 1344, the deposition
`
`transcript of Dr. Tomlinson, was properly filed under 37 C.F.R. § 42.53(f)(7).
`
`Exs. 1098, 1261, 1262, 1264, 1265, 1267-1279, 1286, 1291, 1292, 1335,
`
`1336. Lilly properly used these exhibits to cross-examine Teva’s experts on the
`
`substance of their opinions in this case. 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 in expert deposition).
`
`Challenged Paragraphs of Exs. 1018, 1236, 1341, and 1342. The identified
`
`portions of Lilly’s experts’ declarations summarize the experts’ qualifications,
`
`14
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`provide background on the state of art, and list Teva’s claim elements, and thus are
`
`relevant to this case. E.g., Ex. 1018, ¶¶ 40-50 (Dr. Charles providing background on
`
`known CGRP antagonist agents that block the CGRP pathway); Ex. 1236, ¶ 27 (Dr.
`
`Vasserot describing known antibody characteristics and affinity measurement
`
`techniques), ¶¶ 71-72, 75 (listing the claim elements); Ex. 1341, ¶¶ 1-14 (Dr.
`
`Balthasar detailing his qualifications). Because the exhibits cited in the identified
`
`portions of Exhibits 1341 and 1342 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: December 18, 2019
`
`By: / William B. Raich /
`William B. Raich (Reg. No. 54,386)
`
`
`
`15
`
`

`

`IPR2018-01712
`Patent No. 9,884,908
`
`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 December 18, 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: December 18, 2019
`
`
`
`

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