`
`
`
`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 IPR2018-01712
`Patent 9,884,908 B2
`_____________________
`
`TEVA PHARMACEUTICALS INTERNATIONAL
`GMBH’S REPLY IN SUPPORT OF THE 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 IPR2018-01712
`Patent No. 9,884,908
`
`TABLE OF CONTENTS
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`
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`I.
`
`II.
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`Exhibit 1287 lacks foundation and should be excluded. ................................ 1
`
`Lilly relies upon inadmissible deposition testimony. ..................................... 3
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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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`
`
`- i -
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`
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`Case IPR2018-01712
`Patent No. 9,884,908
`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 identifies several reasons why Exhibit 1287 is inadmissible
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`here and should be excluded under FRE 901. Motion, 2-7. The evidentiary flaws
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`with EX1287’s authentication remain unrebutted, and none of Lilly’s reply
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`arguments remedy those foundational defects.
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`First, Teva’s reference to EX1287 as a “dissertation by Dr. Tan,” does not
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`indicate acceptance of that identity, as Lilly asserts. Opposition, 1. Teva has
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`consistently objected to and maintained that Lilly has not authenticated EX1287 as
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`Dr. Tan’s thesis. Motion, 2; EX1303, 176:2-18; Paper 34, 2. And Lilly’s mere
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`assertion that Mr. Carney “fully authenticates the thesis” (Opposition, 1) fails to
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`address the numerous failings exposed in Teva’s motion: (1) the lack of evidence
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`of cataloguing and shelving practices at Cambridge University Library; (2) the
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`inconsistency between Lilly’s many purported dates of availability and
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`cataloguing; (3) Lilly’s provision of inadmissible hearsay evidence (Ms. Clarke’s
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`email); and (4) that Ms. Clarke’s hearsay statement itself casts doubt on EX1287’s
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`authenticity.
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`- 1 -
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`
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`Case IPR2018-01712
`Patent No. 9,884,908
`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.” EX1307, ¶19.
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`Authentication necessarily requires producing evidence sufficient to support a
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`finding that the item (a thesis) is what the proponent claims it is—a document,
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`which in Lilly’s words, purports to be evidence from “actual researchers in the
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`field before November 2005.” FRE 901(a); Opposition, 3. Teva cited to cases
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`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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`The absence of such evidence undermines Lilly’s efforts to authenticate EX1287
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`under FRE 901—Lilly’s Reply provides nothing to remedy 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 do not require prior art status. Id., 2-3. Lilly’s assertion
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`is irrelevant—Lilly “must produce evidence” of EX1287’s authenticity regardless
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`of Lilly’s intended use. FRE 901(a). Further, Lilly’s selective and misleading
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`quotation from Chi. Mercantile Exch., Inc. v. 5th Mkt., Inc., CBM2014-00114,
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`Paper 35 (PTAB Aug. 18, 2015) (“CME”) is uncompelling. Id., 2. Lilly neglected
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`to disclose that the panel stated that “addressing the admissibility of evidence, e.g.,
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`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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`- 2 -
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`Case IPR2018-01712
`Patent No. 9,884,908
`exclude.” CME, 52. The CME panel properly analyzed whether there was
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`“credible or sufficient evidence as to where [the exhibit in question was] obtained”
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`and when it “was made available publicly.” Id., 53. Applying that analysis here—
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`as performed in Teva’s Motion—shows that EX1287 lacks sufficient foundation.
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`Lilly’s attorney arguments about purported similarities between EX1287 and
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`Tan 1994 (EX1021) and Tan 1995 (EX1022) also does not establish foundation
`
`because such are not “distinctive characteristics” that would establish identity.
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`Opposition 1-2; FRE 901(b)(4); TRW Automotive U.S. LLC v. Magna Electronics
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`Inc., IPR2014-01348, Paper 25, 10 (PTAB Jan. 15, 2016) (holding “attorney
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`argument” regarding alleged “distinctive characteristics” insufficient to establish
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`foundation).
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`Finally, Lilly’s argument that EX1287 is a “self-authenticating ancient
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`document” suffers from a critical flaw. Opposition, 2. Lilly offers a conclusory
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`assertion sans support that a Cambridge thesis purportedly from 1994 would
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`qualify as an ancient document. Id. But Lilly has not presented sufficient evidence
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`to establish the baseline facts regarding EX1287’s identity or date of publication.
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`Nor has Lilly established that such date of publication—whatever that date may
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`be—qualifies as “ancient.” Therefore, Lilly has not adequately authenticated
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`EX1287 or established it as a self-authenticating document.
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`II. Lilly relies upon inadmissible deposition testimony.
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`- 3 -
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`
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`Case IPR2018-01712
`Patent No. 9,884,908
`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 used most of its
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`Opposition to improperly argue the merits of its case under the guise of explaining
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`why it believes the testimony to be “highly probative.” Opposition, 4-13.1 But
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`whether the evidence is probative does not address or cure the flaws in Lilly’s
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`questioning. Teva objected because the improper form of the questions asked
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`means that the testimony is meaningless and prone to misunderstanding. Motion,
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`7-12. These serious flaws render the testimony highly prejudicial to Teva,
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`regardless of why Lilly views it as useful. Indeed, Lilly’s reliance on
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`misinterpreted or misrepresented evidence is a hallmark of its approach in this
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`case. See, e.g., POR, 2-4, 13-18; Surreply, 6-8, 21-24.
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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 value
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`1 The Board should give Lilly’s Opposition arguments regarding the
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`purported relevance of evidence no weight because they are belated new arguments
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`that are not presented elsewhere (e.g., in its Reply). See, e.g., Smith & Nephew,
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`Inc. v. Conformis, Inc., IPR2017-00115, Paper 33 (PTAB Apr. 19, 2018).
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`- 4 -
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`
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`Case IPR2018-01712
`Patent No. 9,884,908
`Teva objected to all or part of Exhibits 1018, 1098, 1236, 1261-1262, 1264-
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`1265, 1267-1279, 1286, 1291-1293, 1296, 1311, 1313-1314, 1316-1317, 1331,
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`1335-1336, 1341-1342, 1344, 1347, and 1349 as irrelevant, prejudicial, and lacking
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`probative value. Lilly’s Opposition provides broad and vague descriptions of how
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`Lilly introduced these exhibits into this proceeding. While there is no “requirement”
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`that a petitioner cite evidence for it to be relevant, that does not mean all evidence
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`introduced via expert declarations is admissible despite being irrelevant, prejudicial,
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`and lacking probative value. Activision Blizzard, Inc. v. Acceleration Bay, LLC,
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`IPR2015-01953, Paper 107, 75 (PTAB Mar. 23, 2017). Neither Teva nor the Board
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`should have to hunt along a trail from Lilly’s papers, to declarations cited in those
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`papers, and to exhibits cited in those declarations, to discern relevance. “Judges are
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`not like pigs, hunting for truffles buried in briefs.” adidas AG v. Nike, Inc., IPR2016-
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`00922, Paper 31, 52 (PTAB Feb. 19, 2019).
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`IV. Conclusion
`Accordingly, the Board should exclude the challenged evidence from the
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`record because Lilly has not proved its admissibility.
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`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`Date: January 3, 2020
`
`
`
`
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
`
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`- 5 -
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`
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`Case IPR2018-01712
`Patent No. 9,884,908
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Teva
`
`Pharmaceuticals International GmbH’s Reply in Support of the Motion to
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`Exclude” was served in its entirety on January 3, 2020, via electronic mail upon
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`the following counsel for Petitioner:
`
`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
`
`
`
`
`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
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: January 3, 2020
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Counsel for Patent Owner
`(202) 371-2600
`
`
`14325711.3
`
`
`
`
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