`
`
`
`IN THE 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 IPR2018-01423
`Patent 9,266,951 B2
`_____________________
`
`TEVA PHARMACEUTICALS INTERNATIONAL
`GMBH’S MOTION TO EXCLUDE
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951 B2
`
`TABLE OF CONTENTS
`
`
`
`I.
`
`II.
`
`Exhibit 1287 lacks foundation and should be excluded. ................................ 2
`
`Lilly relies upon inadmissible deposition testimony. ......................... 7
`
`III. Multiple exhibits are not relevant and/or prejudicial. ...................... 12
`
`IV. Portions of Exhibits 1004, 1005, 1321, and 1322 are irrelevant,
`prejudicial, and lack probative value ............................................................ 14
`
`V.
`
`
`Conclusion .................................................................................................... 15
`
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`Patent No. 9,266,951 B2
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`
`Teva Pharmaceuticals International GmbH (“Teva”) submits this motion
`
`pursuant to 37 C.F.R. §§ 42.62 and 42.64(c) and in accordance with Due Date 4 of
`
`the Scheduling Order (Paper 15). Teva requests exclusion of the entirety of
`
`Exhibits 1087, 1110, 1247, 1261, 1262, 1264, 1265, 1267-1279, 1281, 1286, 1287,
`
`1293, 1296, 1302, 1311, 1313, 1314, 1316, and 1317, and portions of Exhibits
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`1004, 1005, 1301, 1302, 1303, 1304, 1321, and 1322. Teva timely objected to all
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`of these exhibits either through written Objections to Evidence or during
`
`deposition proceedings.
`
`The Federal Rules of Evidence (FRE) govern the admissibility of evidence
`
`in inter partes review proceedings. 37 C.F.R. § 42.62. As shown herein, the
`
`challenged exhibits contain irrelevant and prejudicial information under FRE 401,
`
`402, and 403, and/or are unauthenticated in violation of FRE 901. Accordingly, the
`
`Board should exclude the objected-to exhibits in their entirety for the reasons that
`
`follow.
`
`The Board should not dismiss this Motion as moot if the Board does not rely
`
`on the inadmissible evidence in reaching its Final Written Decision. Instead, Teva
`
`respectfully requests that the Board rule on the motion so that petitioner Eli Lilly
`
`and Company (“Lilly”) cannot continue to rely upon the exhibits and paragraphs
`
`identified herein on appeal. Not excluding the exhibits would force Teva to address
`
`them again, e.g., on appeal, thereby wasting party resources.
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`Patent No. 9,266,951 B2
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`I.
`
`Exhibit 1287 lacks foundation and should be excluded.
`
`Teva moves to exclude Exhibit 1287 under FRE 901, because Lilly has
`
`failed to provide sufficient evidence indicating the origin of the exhibit and has not
`
`provided sufficient information regarding its authenticity as a publicly accessible
`
`document. Teva objected to Exhibit 1287 in a timely manner (Paper 39, 2-3;
`
`EX1303, 176:2-18), and Lilly’s efforts to correct the evidentiary deficiencies with
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`supplemental evidence only serve to highlight why Exhibit 1287 should be
`
`excluded from this proceeding.
`
`Exhibit 1287 is purported to be the doctoral thesis of Keith Tan from the
`
`University of Cambridge. “Whether a reference is publicly accessible is
`
`determined on a case-by-case basis based on the ‘facts and circumstances
`
`surrounding the reference’s disclosure to members of the public.’” Actavis, Inc. v.
`
`Research Corp. Techs., Inc., IPR2014-01126, DI, 9 (citing In re Lister, 583 F.3d
`
`1307, 1311 (Fed. Cir. 2009)) (holding that the proponent “provide[d] no competent
`
`evidence to show that the library allows public access to the thesis”). For a thesis
`
`allegedly found within a library, “[d]etermining public accessibility of a thesis for
`
`prior art purposes requires a showing of both shelving and meaningful
`
`indexing/cataloging” at that library. Kayak Software Corp. v. International
`
`Business Machines Corp., CBM2016-00076, Paper 16, 8 (citing In re Cronyn, 890
`
`F.2d 1158, 1161 (Fed. Cir. 1989); In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986);
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`In re Bayer, 568 F.2d 1357, 1358–59 (CCPA 1978)). Further, evidence relating to
`
`public accessibility at a library must be “sufficiently probative of [the] Library’s
`
`indexing/cataloging practices” on the asserted prior art date. Kayak Software,
`
`CBM2016-00076, Paper 16, 8. And if a proponent of evidence provides evidence
`
`of current library practice, the proponent must then also “provide[] some analysis
`
`as to how the [evidence]… could be interpreted as supporting the conclusion that
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`an analogous cataloging system existed [on the asserted prior art date].” Id. at 10.
`
`Lilly introduced Exhibit 1287 late in this proceeding, during the deposition
`
`of Teva’s expert Dr. Ferrari on August 15, 2019. EX1303, 176:2-18. Teva
`
`immediately objected to its use as lacking foundation (among other objections). Id.
`
`As originally presented to Dr. Ferrari, Exhibit 1287 contained no indication of
`
`where the document came from or how it was obtained, no indication of whether it
`
`was publicly accessible, and no indication of when (if ever) the document became
`
`publicly available before November 14, 2005. EX1303, 176:2-24. Lilly
`
`subsequently filed a version of Exhibit 1287 with Lilly’s Reply (Paper 37) that was
`
`allegedly the same as that presented during Dr. Ferrari’s deposition. Teva then
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`renewed its objection to Exhibit 1287 as lacking foundation under FRE 901. Paper
`
`39, 2. After receiving Teva’s renewed objection, Lilly served supplemental
`
`evidence on Teva in the form of a new version of Exhibit 1287 (i.e., Exhibit
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`Patent No. 9,266,951 B2
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`1287A)1 and a declaration from Michael P. Carney, a Research Analyst in the
`
`employ of counsel for Lilly. EX1307, ¶2. The dates in Mr. Carney’s declaration
`
`related to EX1287A present a confusing picture about when Mr. Carney obtained
`
`EX1287A: Mr. Carney claims to have obtained the thesis on August 30, 2019
`
`(EX1307, ¶13), while Exhibit 1287A contains a reference to being delivered
`
`September 5, 2019 (EX1307, 19), and Mr. Carney provided a catalog listing dated
`
`September 3, 2019 (EX1307, 296). None of these dates precede Lilly’s
`
`introduction of Exhibit 1287 on August 15, 2019.
`
`Moreover, Mr. Carney’s declaration and the new version of Exhibit 1287 do
`
`not cure the deficiencies in the authentication of Exhibit 1287. A large portion of
`
`Mr. Carney’s declaration deals only with his opinion regarding “Standard Library
`
`Practice” and a two-paragraph explanation of MARC Records. EX1307, ¶¶6-12.
`
`This testimony has little relevance to the issue at hand, as Mr. Carney does not
`
`present any proof that such standard practice or that MARC Records were used by
`
`the Cambridge University Library (“CUL”), the purported source of EX1287, as of
`
`
`1 EX1287A appears to differ from EX1287 only in that it contains an
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`additional page at the beginning, purporting to be a receipt for supplying Keith
`
`Tan’s thesis to “Michel Carney” after he ordered a copy “for the purposes of
`
`parliamentary or judicial proceedings.” EX1287A, 1.
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`November 2005.
`
`Mr. Carney also appended a September 3, 2019 CUL catalog entry
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`(EX1307, Exhibit C2) and a purported MARC Record for the Tan thesis allegedly
`
`from CUL’s web page (Id., Exhibit D3). These purported 2019 entries refer to
`
`multiple different dates, which at best indicate creation of a catalog entry. The
`
`present-day catalog entries, however, do not establish that Exhibit 1287 was
`
`publicly available before November 2005. Neither the present-day catalog entries
`
`nor the Carney Declaration in general provides any evidence to demonstrate actual
`
`shelving in the CUL or even meaningful indexing of the Tan thesis before
`
`November 14, 2005.
`
`To establish a connection between catalog entries and public availability, it
`
`is necessary to provide information regarding a library’s indexing and cataloging
`
`practice to its making a thesis available. Kayak Software, Paper 16, 8-10. Lilly fails
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`to provide such necessary information. Lilly, and its declarant Mr. Carney,
`
`produced only an email exchange with the CUL asking to “obtain[] a declaration of
`
`
`2 Mr. Carney avers he accessed Exhibit C on August 27, which is not the
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`same September 3 date shown on Exhibit C. Lilly did not file a copy of Exhibit C
`
`from August 27.
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`3 Exhibit D does not contain any source information or date of access.
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`date availability” from that library.4 EX1307, 300. But neither Mr. Carney nor
`
`Lilly has presented such a declaration from CUL. Instead, Mr. Carney appended an
`
`email from Louise Clarke, the apparent “Superintendent, Manuscripts Reading
`
`Room” at CUL, to his declaration. This email exchange (EX1307, Exhibit E) fails
`
`to cure any of these evidentiary deficiencies.
`
`First, Ms. Clarke’s email reply is the epitome of hearsay. It is an out-of-court
`
`statement (an email) offered to prove the truth of whether CUL made the Tan
`
`thesis publicly available. Ms. Clarke has not offered sworn testimony, and Teva
`
`has not been presented the opportunity to depose Ms. Clarke.
`
`Second, Lilly has not established that Ms. Clarke is qualified to testify to
`
`CUL’s shelving or indexing practices now or before 2005. Nor has Lilly
`
`established that Ms. Clarke is qualified to testify to when the public would have
`
`access to a shelved or indexed thesis.
`
`Third, even if Ms. Clarke’s email reply is considered, it does not support Mr.
`
`
`4 Exhibit E, containing Mr. Carney’s purported email exchange with CUL,
`
`appears incomplete as his August 9, 2019 solicitation of “a declaration of date
`
`availability” refers to a “similar . . . attached deceleration [sic] for this
`
`dissertation.” EX1307, 300. Exhibit E does not contain a copy of the referenced
`
`“similar” declaration.
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`Carney’s arguments about availability. Ms. Clarke was unable to offer any
`
`documentation about the Tan thesis and expressly stated that “[w]e do not have the
`
`paperwork with the date of deposit of the thesis in the University Library, which is
`
`when the thesis would’ve become publically available.” EX1307, 300. It is unclear
`
`who or what “we” refers to in Ms. Clarke’s email and whether “we” refers to an
`
`entity with actual knowledge of CUL practice. Id. And Ms. Clarke also did not
`
`profess to know the CUL filing and accessibility standards when the Tan thesis
`
`was allegedly submitted to the library or, indeed, at any time before November
`
`2005. Id. She stated only what the current processes “are” and hazarded a guess as
`
`to what would have been “most likely” to occur. Id.
`
`Beyond Ms. Clarke’s email, Mr. Carney offers no evidence as to what
`
`CUL’s policy was regarding indexing and cataloging practice or whether (much
`
`less when) Tan’s thesis would have actually been made publicly available before
`
`November 14, 2005. Accordingly, Lilly has not established sufficient foundation
`
`for Exhibit 1287 under FRE 901, and it should be excluded from this proceeding.
`
`II. Lilly relies upon inadmissible deposition testimony.
`Teva also moves to exclude various sections of expert deposition testimony
`
`based on improper questioning by Lilly. As discussed in detail below, the improper
`
`form of the questions asked in these portions of testimony means that the testimony
`
`is meaningless, prone to misunderstanding, and/or beyond the scope of the experts’
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`direct testimony. These flaws mean that the testimony outlined below would be
`
`prejudicial to Teva if it were not excluded from the proceeding, as well as
`
`potentially confusing the issues and wasting the time of the parties and Board.
`
`Accordingly, the identified portions of testimony are inadmissible under FRE 403
`
`and should be excluded. Objectionable portions of testimony include:
`
` EX1301: 36:16-39:11; 27:25-28:6 – Teva objected to a series of questions in
`
`these passages for improper form because of their lack of specificity about
`
`which patent and which claim is being discussed.
`
` EX1301, 73:22-75:20 – Teva objected to questions in this passage for
`
`relevance, because they pertained to a publication unrelated to the subject
`
`matter of this proceeding. Teva also objected to a question in this passage
`
`for improper form because of vagueness with respect to the meaning of “a
`
`statistical analysis.”
`
` EX1301, 115:9-116:21 – Teva objected to a question in this passage,
`
`because it called for unfounded speculation from the witness about the state
`
`of mind of others.
`
` EX1301, 154:24-156:21 – Teva objected to a question in this passage as
`
`lacking relevance and being out of scope, because it called for legal analysis
`
`of claim scope of antagonists disclosed in a non-prior art paper.
`
` EX1302, 45:20-46:19, 81:9-82:2 – Teva objected to the passage starting on
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`page 45 for improper form because of its vagueness and ambiguity with
`
`respect to the meaning of “patent portfolio license.” And Teva objected to
`
`the passage starting on page 81 as mischaracterizing the witness’s previous
`
`testimony.
`
` EX1302, 179:14-180:19 – Teva objected to this passage, because it was
`
`beyond the scope of the declarant’s direct testimony in that it related to legal
`
`analysis of a contract hypothetical.
`
` EX1303, 25:11-17 – Teva objected to this question for lack of foundation
`
`regarding discussion of sumatriptan’s effects on blood pressure.
`
` EX1303, 38:22-39:10 – Teva objected to the question in this passage for
`
`improper form because of its vagueness with regard to referencing “anything
`
`else” and with regard to which “humanized antibodies” were being
`
`referenced. Additionally, the question improperly called for a legal
`
`conclusion regarding claim scope.
`
` EX1303, 49:1-20 – Teva objected to the question in this passage for
`
`improper form because of vagueness with regard to the meaning of “as an
`
`expert in the field” and for general lack of clarity with regard to the
`
`“antibody” and “disease” being referenced.
`
` EX1303, 54:12-23 – Teva objected to the question in this passage, because it
`
`was beyond the scope of the declarant’s direct testimony in that it related to
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`toxicity studies in animals.
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` EX1303, 69:10-16 – Teva objected to the question in this passage, because
`
`the definition of “antibody serum” is outside the scope of this proceeding.
`
` EX1303, 70:13-75:11 – Teva objected to questions in this passage for
`
`improper form because of vagueness with respect to the meaning of
`
`“sufficiently safe.”
`
` EX1303, 102:9-106:19 – Teva objected to questions within this passage for
`
`improper form, in that they were compound questions or contained vague
`
`language regarding “significance.”
`
` EX1303, 108:25-133:7 – Teva objected to many questions by Lilly in this
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`extremely large cite for, inter alia, improper form because of vagueness,
`
`compound questions, lack of foundation for discussion of experimental
`
`results, and calling for legal conclusions regarding claim scope.
`
` EX1303, 160:2-9 – Teva objected to the question in this passage for
`
`improper form because of vagueness with regard to the meaning of “the Fab
`
`fragment.”
`
` EX1303, 193:3-10 – Teva objected to the question in this passage for
`
`improper form because of vagueness with regard to what subpopulation of
`
`patients was being discussed and with regard to what the question meant
`
`with regard to “the percentage of patients.”
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` EX1304, 59:23-71:17 – Teva objected to this section of testimony as lacking
`
`relevance and being out of the scope of the declarant’s direct testimony in
`
`that it related to treatment of a different condition and different therapeutic
`
`than those of concern to this proceeding.
`
` EX1304, 82:17-134:18 – Teva objected to many questions by Lilly in this
`
`extremely large cite for, inter alia, improper form, in that they were
`
`compound questions or contained vague language, and asking a range of
`
`questions beyond the scope of direct testimony (which was limited to
`
`objective indicia of nonobviousness).
`
` EX1304, 90:10-15 – Teva objected to the questions in this passage for
`
`improper form because of vagueness with regard to which “triptans” were
`
`being referenced.
`
` EX1304, 91:6-10 – Teva objected to the questions in this passage for
`
`improper form because of vagueness with regard to what was meant by
`
`“blocking the CGRP pathway.”
`
` EX1304, 142:1-8 – Teva objected to the questions in this passage for
`
`improper form because of vagueness with regard to what was meant by
`
`“block[ing] the CGRP pathway.” Teva also objected to this question,
`
`because it was premised on a mischaracterization of the witness’s previous
`
`testimony.
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` EX1304, 143:6-23 – Teva objected to the questions in this passage for
`
`improper form because of vagueness with regard to “it” and the “antibody
`
`that’s identified here.” Additionally, the questions improperly called for a
`
`legal conclusion regarding claim scope.
`
` EX1304, 145:23-146:3 – Teva objected to the question in this passage for
`
`improper form because of vagueness with regard to what was meant by “a
`
`pharmacokinetic study.” Teva also objected to the question in this passage,
`
`because it was beyond the scope of the declarant’s direct testimony, in that it
`
`related to pharmacokinetics, which was not the subject of direct testimony.
`
`III. Multiple exhibits are not relevant and/or prejudicial.
`Lilly submitted dozens of exhibits that it failed to cite in its Petition or
`
`Reply, rendering them irrelevant and/or prejudicial. Exhibits 1087, 1110, 1247,
`
`1261, 1262, 1264, 1265, 1267-1279, 1281, 1286, 1293, 1296, 1311, 1313, 1314,
`
`1316, and 1317 appear nowhere in either Lilly’s Petition or Reply and only appear
`
`buried in its expert declarations (Exhibits 1329 and 1330) submitted with the
`
`Reply.
`
`Evidence is relevant if it “has any tendency to make a fact more or less
`
`probable than it would be without the evidence” and “the fact is of consequence in
`
`determining the action.” FRE 401. Lilly’s failure to cite Exhibits 1087, 1110, 1247,
`
`1261, 1262, 1264, 1265, 1267-1279, 1281, 1286, 1293, 1296, 1311, 1313, 1314,
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`1316, and 1317 demonstrates that these exhibits do not have a tendency to make
`
`any fact of consequence more or less probable. If these exhibits were relevant to
`
`this proceeding, Lilly should have cited them in the Petition or Reply. This
`
`evidence is, therefore, inadmissible as irrelevant. See FRE 402 (“Irrelevant
`
`evidence is not admissible.”).
`
`If this evidence was actually submitted for the Board to consider, then this
`
`evidence should be excluded under FRE 403 as unfairly prejudicial. Exhibits 1087,
`
`1110, 1247, 1261, 1262, 1264, 1265, 1267-1279, 1281, 1286, 1293, 1296, 1311,
`
`1313, 1314, 1316, and 1317 were not cited or discussed in the Petition or Reply, so
`
`Lilly would have vastly overshot the word limits of its Petition and Reply had
`
`these exhibits been appropriately cited and discussed. Because “[a]rguments must
`
`not be incorporated by reference from one document into another document,” 37
`
`C.F.R. § 42.6(a)(3), any attempt by Lilly to reply upon these exhibits is prejudicial
`
`to Teva. Teva would be prejudiced if Lilly is allowed to disregard the rules and
`
`effectively incorporate this information by reference.
`
`Accordingly, Exhibits 1087, 1110, 1247, 1261, 1262, 1264, 1265, 1267-
`
`1279, 1281, 1286, 1293, 1296, 1311, 1313, 1314, 1316, and 1317 should be
`
`excluded as irrelevant and/or prejudicial.
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`IV. Portions of Exhibits 1004, 1005, 1321, and 1322 are irrelevant,
`prejudicial, and lack probative value
`
`Multiple paragraphs in Lilly’s supporting expert declarations (Exhibits 1004,
`
`1005, and 1321) were never cited in Lilly’s Petition or Reply. Accordingly, Teva
`
`moves to exclude paragraphs 31-32, 65-72, 98, 157, and 175-176 in Exhibit 1004,
`
`paragraphs 21, 27, 54, and 128-129 in Exhibit 1005, and paragraphs 1-14 in
`
`Exhibit 1321 as irrelevant, prejudicial, and lacking probative value. Teva timely
`
`objected to these paragraphs of Exhibits 1004, 1005, and 1321, and Lilly failed to
`
`cure these objections. Paper 16, 1-2; Paper 39, 1-2.
`
`Evidence is relevant if it “has any tendency to make a fact more or less
`
`probable than it would be without the evidence” and “the fact is of consequence in
`
`determining the action.” FRE 401. Lilly’s failure to cite these paragraphs
`
`demonstrates that they do not have a tendency to make any fact of consequence
`
`more or less probable. If these portions of the declarations were relevant to this
`
`proceeding, Lilly should have cited them in the Petition or Reply. These portions
`
`of Exhibits 1004, 1005, and 1321 are, therefore, inadmissible as irrelevant. See
`
`FRE 402 (“Irrelevant evidence is not admissible.”).
`
`Also, it is unlikely that Lilly could have properly discussed the omitted
`
`paragraphs in the space it had left in its Petition or Reply. If these paragraphs were
`
`relevant, Lilly’s attempt to incorporate them by reference into the Petition or Reply
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`should be rejected as prejudicial under FRE 403.
`
`Teva also moves to exclude paragraphs 27-28 Exhibit 1321 and paragraphs
`
`7, 11-13, 15, 44, 64, and 92-93 of Exhibit 1322 to the extent that they rely on
`
`evidence that is excluded for the reasons discussed elsewhere in this motion. Paper
`
`16, 1-2; Paper 39, 1-2. Inclusion of these paragraphs of the declaration would be
`
`irrelevant and prejudicial to Teva, and accordingly, those paragraphs should be
`
`excluded under FRE 403.
`
`V. Conclusion
`For the foregoing reasons, the challenged evidence does not meet the
`
`threshold for admissibility and should be excluded from the record.
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`Deborah A. Sterling, Ph.D.
`Date: October 25, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Counsel for Patent Owner
`(202) 371-2600
`
`
`
`14051815
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`
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Teva
`
`Pharmaceuticals International GmbH’s Motion to Exclude” was served in its
`
`entirety on October 25, 2019, via electronic mail upon the following counsel for
`
`Petitioner:
`
`
`
`William B. Raich
`
`
`Erin M. Sommers
`
`
`Pier D. DeRoo
`
`
`
`Yieyie Yang
`
`
`
`John Williamson
`
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`
`
`901 New York Avenue, NW
`
`Washington, DC 20001
`william.raich@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`yieyie.yang@finnegan.com
`john.williamson@finnegan.com
`
`
`
`Sanjay M. Jivraj
`Mark J. Stewart
`Eli Lilly and Company
`Lilly Corporate Center Patent Dept.
`Indianapolis, IN 46285
`jivraj_sanjay@lilly.com
`stewart_mark@lilly.com
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: October 25, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Counsel for Patent Owner
`(202) 371-2600
`
`
`
`
`
`
`
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