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`Filed: April 17, 2019
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`Filed on behalf of: Eli Lilly and Company
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`ELI LILLY AND COMPANY
`Petitioner
`v.
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH
`Patent Owner
`______________________
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`
`
`
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`Case IPR2018-01710 (Patent No. 8,586,045)
`Case IPR2018-01711 (Patent No. 9,884,907)
`Case IPR2018-01712 (Patent No. 9,884,908)1
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`_____________________
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`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
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`1
`The word-for-word identical paper is filed in each proceeding identified in the
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`caption. For the Board’s convenience, citations to the POPR refer to the paper filed
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`in IPR2018-01710 involving Teva’s Patent No. 8,586,045.
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`IPR2018-01710, -01711, -01712
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`The Federal Rules of Evidence (“FRE”) generally apply to proceedings
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`before the Board. 37 C.F.R. § 42.62(a). Pursuant to 37 C.F.R. § 42.64(b)(1) and
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`the FRE, Patent Owner Eli Lilly and Company (“Lilly” or “Patent Owner”)
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`submits the following objections to certain exhibits submitted by Petitioner Teva
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`Pharmaceuticals International GMBH (“Teva” or “Petitioner”). These objections
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`apply equally to Petitioner’s reliance on these exhibits in any subsequently filed
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`documents. These objections are timely filed and served within ten business days
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`of the Board’s decision to institute trial in these proceedings.
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`Exhibit 2001
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`To the extent Teva relies on the content of Exhibit 2001 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2001 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`Exhibit 2002
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`To the extent Teva relies on the content of Exhibit 2002 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2002 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`Exhibit 2003
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`To the extent Teva relies on the content of Exhibit 2003 for the truth of the
`1
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`IPR2018-01710, -01711, -01712
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`matter asserted, Lilly objects to Exhibit 2003 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`Exhibit 2004
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`Lilly objects to Exhibit 2004 under FRE 401-403 as lacking relevance to the
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`instituted grounds. Teva relies on Exhibit 2004 and asserts that CGRP8-37 was
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`identified in 1989. POPR, 6. But Exhibit 2004 does not establish that CGRP8-37
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`was first identified in 1989. Thus, this exhibit does not make any fact more or less
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`probable than it would be without this exhibit. Moreover, Exhibit 2004 is unfairly
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`prejudicial, confuses the issues, misleads the factfinder, and/or is a waste of time.
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`Exhibit 2007
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`Lilly objects to Exhibit 2007 as being duplicative of its Exhibit 1052. “A
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`document already in the record of the proceeding must not be filed again, not even
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`as an exhibit or an appendix, without express Board authorization.” 37 C.F.R.
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`§ 42.6(d). Thus, this exhibit should be expunged.
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`Exhibit 2008
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`To the extent Teva relies on the content of Exhibit 2008 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2008 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`2
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`IPR2018-01710, -01711, -01712
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`Exhibit 2011
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`To the extent Teva relies on the content of Exhibit 2011 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2011 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`Exhibit 2012
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`To the extent Teva relies on the content of Exhibit 2012 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2012 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`Exhibit 2019
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`To the extent Teva relies on the content of Exhibit 2019 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2019 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`Exhibit 2021
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`To the extent Teva relies on the content of Exhibit 2021 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2021 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807. Lilly further objects to Exhibit 2021 because it lacks proper foundation or
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`3
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`IPR2018-01710, -01711, -01712
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`authenticity under FRE 901.
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`In addition, Lilly objects to Exhibit 2021 under FRE 401-403 as lacking
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`relevance to the instituted grounds. Because Exhibit 2021 does not reflect any
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`knowledge of one skilled in the art at the time of the alleged invention, this exhibit
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`does not make any fact more or less probable than it would be without this exhibit.
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`Moreover, Exhibit 2021 is unfairly prejudicial, confuses the issues, misleads the
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`factfinder, and/or is a waste of time.
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`Exhibit 2022
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`To the extent Teva relies on the content of Exhibit 2022 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2022 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807. Lilly further objects to Exhibit 2022 because it lacks proper foundation or
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`authenticity under FRE 901.
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`In addition, Lilly objects to Exhibit 2022 under FRE 401-403 as lacking
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`relevance to the instituted grounds. Teva relies on Exhibit 2022 and asserts that
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`“Merck ultimately discontinued MK-0974.” POPR, 7. Exhibit 2022, which
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`allegedly contains clinical trial search results for MK-0974, does not establish
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`discontinuation of clinical trials for MK-0974. Because Exhibit 2022 does not
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`reflect any knowledge of one skilled in the art at the time of the alleged invention,
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`this exhibit does not make any fact more or less probable than it would be without
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`4
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`this exhibit. Moreover, Exhibit 2022 is unfairly prejudicial, confuses the issues,
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`IPR2018-01710, -01711, -01712
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`misleads the factfinder, and/or is a waste of time.
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`Exhibit 2023
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`To the extent Teva relies on the content of Exhibit 2023 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2023 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807. Lilly further objects to Exhibit 2023 because it lacks proper foundation or
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`authenticity under FRE 901.
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`
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`In addition, Lilly objects to Exhibit 2023 under FRE 401-403 as lacking
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`relevance to the instituted grounds. Because Exhibit 2023 does not reflect any
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`knowledge of one skilled in the art at the time of the alleged invention, this exhibit
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`does not make any fact more or less probable than it would be without this exhibit.
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`Moreover, Exhibit 2023 is unfairly prejudicial, confuses the issues, misleads the
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`factfinder, and/or is a waste of time.
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`Exhibit 2046
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`To the extent Teva relies on the content of Exhibit 2046 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2046 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807. Lilly further objects to Exhibit 2046 because it lacks proper foundation or
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`authenticity under FRE 901.
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`5
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`IPR2018-01710, -01711, -01712
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`In addition, Lilly objects to Exhibit 2046 under FRE 401-403 as lacking
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`relevance to the instituted grounds. Because Exhibit 2046 does not reflect any
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`knowledge of one skilled in the art at the time of the alleged invention, this exhibit
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`does not make any fact more or less probable than it would be without this exhibit.
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`Moreover, Exhibit 2046 is unfairly prejudicial, confuses the issues, misleads the
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`factfinder, and/or is a waste of time.
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`Exhibit 2047
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`To the extent Teva relies on the content of Exhibit 2047 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2047 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`Exhibit 2048
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`To the extent Teva relies on the content of Exhibit 2048 for the truth of the
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`matter asserted, Lilly objects to Exhibit 2048 as inadmissible hearsay (see FRE 801
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`and 802) that does not fall under any exceptions, including FRE 803, 804, 805, and
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`807.
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`6
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`Respectfully submitted,
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`Date: April 17, 2019
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`IPR2018-01710, -01711, -01712
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`By: /William B. Raich/
`William B. Raich (Reg. No. 54,386)
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`7
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`IPR2018-01710, -01711, -01712
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Petitioner’s
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`Objections to Patent Owner’s Evidence was served electronically via email on
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`April 17, 2019, in its entirety on the following:
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`Deborah A. Sterling
`Robert C. Millonig
`Gaby L. Longsworth
`Jeremiah B. Frueauf
`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
`
`
`Patent Owner has consented to service by email.
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`By: /William Esper/
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`Date: April 17, 2019
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