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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`ELI LILLY AND COMPANY,
` Petitioner
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`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner
`
`_____________________
`
`Case IPR2018-01425
`Patent 9,890,210 B2
`_____________________
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`TEVA PHARMACEUTICALS INTERNATIONAL
`GMBH’S REPLY IN SUPPORT OF THE MOTION TO EXCLUDE
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`
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`Case IPR2018-01425
`Patent No. 9,890,210
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`TABLE OF CONTENTS
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`
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`I.
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`II.
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`Exhibit 1287 lacks foundation and should be excluded. ................................ 1
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`Lilly relies upon inadmissible deposition testimony. ......................... 4
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`III. Multiple exhibits are irrelevant, prejudicial, and lack probative
`value. ............................................................................................................... 4
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`IV. Conclusion ...................................................................................................... 5
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`Case IPR2018-01425
`Patent No. 9,890,210
`The Board should grant Teva’s Motion to Exclude Evidence (“Motion”)
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`because Lilly’s Opposition to the Motion (“Opposition”) misrepresents the law and
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`offers irrelevant arguments that fail to rebut Teva’s showing that the challenged
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`evidence is inadmissible, as explained below.
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`I.
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`Exhibit 1287 lacks foundation and should be excluded.
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`Teva’s Motion addresses and identifies several reasons why Exhibit 1287 is
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`inadmissible in these proceedings and should be excluded under FRE 901. Motion,
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`2-7. Significantly, the evidentiary flaws associated with authentication of EX1287
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`remain unrebutted. Id. Lilly’s Opposition does not address the lack of evidence
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`regarding the cataloguing and shelving practices of the Cambridge University
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`Library (“CUL”), the confusion and inconsistency regarding EX1287’s purported
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`dates of availability and cataloguing, Lilly’s provision of inadmissible hearsay
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`evidence as supplemental evidence (Ms. Clarke’s email), or the fact that even her
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`hearsay statement casts doubt on the authenticity of EX1287. None of Lilly’s
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`arguments in reply remedy the foundational defects for EX1287.
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`First, Lilly argues that because Teva refers to EX1287 as a “dissertation by
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`Dr. Tan,” “Teva does not dispute that Exhibit 1287 is Dr. Tan’s doctoral thesis.”
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`Opposition, 1 (citing Teva’s Motion to Strike, Paper 43, 2). Reference to the
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`purported identity of an exhibit, however, does not indicate acceptance of that
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`identity. Id. As is apparent from Teva’s Motion, Teva has consistently objected to
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`Patent No. 9,890,210
`and maintained that Lilly has not authenticated EX1287 as Dr. Tan’s thesis.
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`Motion, 3; EX1303, 176:2-18; Paper 39, 2.
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`Next, Lilly casts Teva’s arguments regarding EX1287 as one of public
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`accessibility, “not properly raised in a motion to exclude.” Opposition, 2. But Lilly
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`itself linked EX1287’s foundation to “public availability” after Teva objected.
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`EX1307, ¶19. Authentication necessarily requires producing evidence sufficient to
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`support a finding that the item (a thesis) is what the proponent claims it is—a
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`document, which in Lilly’s words, purports to be evidence from “actual researchers
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`in the field before November 2005.” FRE 901(a); Opposition, 2-3. Teva cited to
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`cases relating to public availability because those cases identify the evidence that is
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`necessary to establish the origin and public availability of EX1287 before 2005.
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`Opposition, 2. And as explained in Teva’s Motion, the absence of such evidence
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`undermines Lilly’s efforts to authenticate EX1287 under FRE 901—Lilly’s Reply
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`provides nothing to supplement that lack of evidence.
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`Faced with a gap in its authentication evidence, Lilly argues that it used
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`EX1287 for purposes that don’t require prior art status. Id., 2-3. Lilly’s assertion is
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`irrelevant—a document must be authenticated regardless of Lilly’s intended use.
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`Further, Lilly supports its flawed assertion by a selective and misleading quotation
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`from a single non-precedential decision. Id., 2 (citing Chi. Mercantile Exch., Inc. v.
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`5th Mkt., Inc., CBM2014-00114, Paper 35 (PTAB Aug. 18, 2015) (“CME”)). The
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`CME panel acknowledged that “a motion to exclude is not the proper vehicle to
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`challenge the sufficiency of the evidence used to demonstrate that [an exhibit]
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`qualifies as a prior art printed publication within the meaning of § 102(b).” Chi.
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`Mercantile Exch., CBM2014-00114, Paper 35 at 52. However, Lilly neglected to
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`disclose that the panel then held that “addressing the admissibility of evidence,
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`e.g., authenticity or hearsay, underlying the factual determinations of whether [the
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`exhibit] is a prior art printed publication may be the subject of a motion to
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`exclude.” Id. The CME panel properly analyzed whether there was “credible or
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`sufficient evidence as to where [the exhibit in question was] obtained” and when it
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`“was made available publicly.” Id., 53. Applying just such an analysis—as
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`performed in Teva’s Motion—shows that EX1287 lacks sufficient foundation.
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`Finally, Lilly’s argument that EX1287 is a “self-authenticating ancient
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`document” also lacks merit. Opposition, 1-2. Lilly offers a conclusory assertion
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`sans support that a Cambridge thesis purportedly from 1994 would qualify as an
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`ancient document. Id. Lilly’s assertion suffers from a critical flaw: Lilly has not
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`presented sufficient evidence to establish the baseline facts regarding EX1287’s
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`identity or date of publication. Nor has Lilly established that such date of
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`publication would be considered “ancient.” Therefore, Lilly has not adequately
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`authenticated EX1287 or established it as a self-authenticating document. The
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`Board should exclude EX1287 from this record.
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`Patent No. 9,890,210
`II. Lilly relies upon inadmissible deposition testimony.
`Lilly’s Opposition fails to remedy the evidentiary defects resulting from
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`Lilly’s improper questioning of Teva’s experts. Instead, Lilly has improperly used
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`ten pages of its Opposition to offer further argument on why it believes the
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`evidence to be “highly probative.” Opposition, 3-12.1 But whether the evidence is
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`probative does not address or cure the flaws in Lilly’s questioning. Teva objected
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`because the improper form of the questions asked means that the testimony is
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`meaningless and prone to misunderstanding. Motion, 7-8. These serious flaws
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`render the testimony highly prejudicial to Teva, regardless of why Lilly views it as
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`useful. Indeed, Lilly’s reliance on misinterpreted or misrepresented evidence is a
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`hallmark of its approach in this case. See, e.g., POR, 3-4, 15-19; Surreply, 7-8.
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`Further, the purported relevance is not pertinent to Teva’s scope objections
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`because cross-examination may not go beyond the subject matter of the direct
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`testimony. FRE 611. Thus, the testimony to which Teva offered scope objections
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`should be excluded regardless of the degree of relevance. FRE 611.
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`III. Multiple exhibits are irrelevant, prejudicial, and lack probative
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`1 Lilly’s Opposition arguments regarding the purported relevance of
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`evidence should be given no weight because they are belated new arguments that
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`are not presented elsewhere (e.g., in its Reply). See, e.g., Smith & Nephew, Inc. v.
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`Conformis, Inc., IPR2017-00115, Paper 33 (PTAB Apr. 19, 2018).
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`Patent No. 9,890,210
`value.
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`Teva objected to all or part of Exhibits 1010, 1011, 1247, 1261, 1262, 1264,
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`1265, 1267-1279, 1281, 1286, 1293, 1296, 1311, 1313, 1314, 1316, 1317, 1325,
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`and 1326 as irrelevant, prejudicial, and lacking probative value. Lilly’s Opposition
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`provides broad and vague descriptions of how these exhibits were introduced into
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`this proceeding. While there is no “requirement” that a petitioner cite evidence for
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`it to be relevant, that does not mean all evidence introduced via expert declarations
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`is admissible despite being irrelevant, prejudicial, and lacking probative value.
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`Activision Blizzard, Inc. v. Acceleration Bay, LLC, IPR2015-01953, Paper 107, 75
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`(PTAB Mar. 23, 2017). Neither Teva nor the Board should have to hunt along a
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`trail from Lilly’s papers, to declarations cited in those papers, and to exhibits cited
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`in those declarations, to discern relevance. “Judges are not like pigs, hunting for
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`truffles buried in briefs.” adidas AG v. Nike, Inc., IPR2016-00922, Paper 31, 52
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`(PTAB Feb. 19, 2019) (quoting United States v. Dunkel, 927 F.2d 955, 956 (7th
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`Cir. 1991)).
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`IV. Conclusion
`Accordingly, the challenged evidence does not meet the threshold of
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`admissibility and should be excluded from the record.
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`Date: November 8, 2019
`14093774
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`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`/Deborah A. Sterling/
`Deborah A. Sterling, Ph.D.
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`Case IPR2018-01425
`Patent No. 9,890,210
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the above-captioned “Teva
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`Pharmaceuticals International GmbH’s Reply in Support of the Motion to
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`Exclude” was served in its entirety on November 8, 2019, via electronic mail upon
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`the following counsel for Petitioner:
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`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
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`
`
`
`William B. Raich
`
`
`Erin M. Sommers
`
`
`Pier D. DeRoo
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`
`
`Yieyie Yang
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`
`
`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
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: November 8, 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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