Paper No. 35
`
`Filed: October 7, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP.,
`TEVA PHARMACEUTICALS USA, INC.,
`and FRESENIUS KABI USA, LLC,
`
`PETITIONERS,
`
`V.
`
`ELI LILLY & COMPANY,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2016-002401
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S RESPONSE
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
`
`1 Cases IPR2016-01191 and IPR2016-01343 have been joined with the instant
`proceeding.
`
`
`
`Filed: October 7, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP.,
`TEVA PHARMACEUTICALS USA, INC.,
`and FRESENIUS KABI USA, LLC,
`
`PETITIONERS,
`
`V.
`
`ELI LILLY & COMPANY,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2016-002401
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S RESPONSE
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
`
`1 Cases IPR2016-01191 and IPR2016-01343 have been joined with the instant
`proceeding.
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner submits the following
`
`objections to the evidence that Patent Owner first served on September 30, 2016:
`
`Petitioner’s Objections
`Relevance
`
`Evidence
`Exs. 2020, 2023-2024, 2026, 2043-2049,
`2052, 2053, 2056-2057, 2061, 2065-
`2067, 2069-2071, 2073-2083,2085,
`2088-2099, 2101-2102, 2111-2114,
`2116-2121, 2123
`
`
`The above-listed documents should be excluded because they are not
`
`relevant. See Fed. R. Evid. 401–403. For example, none of Exhibits 2023-2024,
`
`2026, 2043-2049, 2052, 2053, 2056-2057, 2061, 2065-2067, 2069-2071, 2073-
`
`2083, 2085, 2088-2090, 2092-2099, 2101-2102, 2114, 2117, 2119, 2121, or 2123
`
`are cited by Patent Owner in its Response (Paper 32). Petitioner reserves its right to
`
`submit additional objections to these exhibits if and when Patent Owner cites or
`
`relies upon them.
`
`Patent Owner also cites testimony from other IPR proceedings not joined
`
`with the present proceeding, as well as other litigation with different prior art at
`
`issue from the present proceeding. See, e.g., Exs. 2026, 2061, 2092, 2116.
`
`Patent Owner further cites documents including a date of 1999, without
`
`making clear when in 1999 the documents were published, despite admitting that
`
`the “relevant date for analyzing Neptune’s obviousness arguments is June 29, 1999
`
`…” (Paper 32 at 14.) See, e.g., Exs. 2020, 2076. Because it is not possible to
`
`determine whether these exhibits qualify as prior art, it is not clear that these
`1
`
`
`
`
`
`exhibits have any relevance as to what a person of ordinary skill would have
`
`understood as of the relevant date for the obviousness inquiry. Additionally, Patent
`
`Owner cites Exhibit 2091, which has a 2004 publication date, and Exhibit 2044,
`
`which has no publication date, and so are similarly irrelevant to the obviousness of
`
`the patent at issue.
`
`Patent Owner additionally cites what appear to be non-public documents
`
`related to antifolate development, and so are irrelevant as to whether the claimed
`
`invention would have been obvious based on publicly available information. See
`
`Exs. 2111-2113.
`
`Petitioner’s Objections
`Hearsay
`
`Evidence
`2020-2022, 2025, 2026, 2030-2035,
`2037-2038, 2040-2063, 2065-2067,
`2069-2071, 2073-2083, 2085-2114,
`2116, 2122
`
`The above-listed documents should be excluded because they are hearsay
`
`and Patent Owner cannot establish a hearsay exception for admissibility. See
`
`Fed. R. Evid. 801(c)(2).
`
`Evidence
`Exs. 2116, 2118, 2120
`
`The above-listed documents should be excluded because they contain
`
`Petitioner’s Objections
`Fed. R. Evid. 602, 702-703
`
`
`
`content over which the testifier has no personal knowledge, as well as putative
`
`expert testimony that is unqualified, unreliable, and based on facts or data that
`
`
`
`2
`
`
`
`experts in the field would not reasonably rely upon. See Fed. R. Evid. 602, 702-
`
`703; Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993). For example,
`
`Exhibit 2116 contains testimony from Clet Niyikiza regarding topics about which
`
`he had no personal knowledge, and for which he is not qualified to testify as an
`
`expert. Exhibit 2118 contains testimony from Dr. Zeisel regarding topics about
`
`which he had no personal knowledge, and for which he is not qualified to provide
`
`the opinions of a POSA because he is not a medical oncologist as required by both
`
`Petitioner and Patent Owner’s POSA definitions. Exhibit 2120 contains testimony
`
`from Dr. Chabner which repeatedly relies on Dr. Ron Schiff’s expert declaration
`
`and deposition transcript, even though those documents are not evidence in this
`
`proceeding.
`
`Evidence
`Exs. 2032, 2099, 2101, 2111-2113
`
`
`
`Petitioner’s Objections
`Authentication
`
`The above-listed documents should be excluded because they have not been
`
`properly authenticated and are not self-authenticating. See Fed. R. Evid. 901, 902.
`
`For example, Exhibit 2032’s certificate of translation indicates a publication date
`
`of 1988 for the 74th edition, but the scanned cover page indicates a copyright date
`
`of 1998, so it is not clear whether the translation certification relates to Exhibit
`
`2032.
`
`
`
`
`
`3
`
`
`
`Evidence
`Exs. 2099, 2101, 2116
`
`Petitioner’s Objections
`Completeness
`
`The above-listed documents should be excluded because they are not
`
`complete, true and correct copies of the documents. See Fed. R. Evid. 106. For
`
`example, Exhibit 2099 contains unexplained redactions at ELA00007715, Exhibit
`
`2101 contains unexplained redactions at ELAP00008711, and Exhibit 2116
`
`contains direct testimony from Clet Niyikiza from a different proceeding, but omits
`
`the cross-examination testimony.
`
`Evidence
`Ex. 2116
`
`Petitioner’s Objections
`37 C.F.R. § 42.53
`
`The above-listed document should be excluded because it is not submitted in
`
`the form of an affidavit and, despite requests to Patent Owner, an opportunity for
`
`cross-examination has thus far been denied. See 37 C.F.R. §§ 42.51(b)(1)(ii),
`
`42.53.
`
`
`
`4
`
`
`
`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`Lead Counsel for Petitioner
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`Paul J. Skiermont (pro hac vice
`application to be submitted)
`Sadaf R. Abdullah (pro hac vice
`application to be submitted)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6621
`Back-Up Counsel for Petitioner
`
`
`
`5
`
`October 7, 2016
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
`
`counsel for Patent Owner a true and correct copy of the foregoing Petitioner’s
`
`Objections to Patent Owner’s Response Evidence Pursuant to 37 C.F.R. §
`
`42.64(b)(1), by electronic means on October 7, 2016 at the following addresses of
`
`record:
`
`Dov P. Grossman (Reg. No. 72,525)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5812
`Facsimile: 202-434-5029
`dgrossman@wc.com
`Lead Counsel for Patent Owner
`
`James P. Leeds (Reg. No. 35,241)
`ELI LILLY AND COMPANY
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-1667
`Facsimile: 317-277-6534
`leeds_james@lilly.com
`Back-Up Counsel for Patent Owner
`
`John D. Polivick (Reg. No. 57,926)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`jpolivick@rmmslegal.com
`Lead Counsel for Petitioner Apotex
`
`
`
`
`
`
`David M. Krinsky (Reg. No. 72,339)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5338
`Facsimile: 202-480-8302
`dkrinsky@wc.com
`Back-Up Counsel for Patent Owner
`
`Adam L. Perlman (pro hac vice)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5244
`Facsimile: 202-434-5029
`aperlman@wc.com
`Back-Up Counsel for Patent Owner
`
`Deanne M. Mazzochi (Reg. No. 50,158)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`dmazzochi@rmmslegal.com
`Back-Up Counsel for Petitioner Apotex
`
`
`
`Gary J. Speier (Reg. No. 45,458)
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST AND SCHUMAN
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Tel: 612-436-9600
`Fax: 612-436-9605
`gspeier@carlsoncaspers.com
`Lead Counsel for Petitioner Teva
`
`Cynthia Lambert Hardman
`(Reg. No. 45,458)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`chardman@goodwinprocter.com
`Back-Up Counsel for Petitioner Teva
`
`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`
`Lead Counsel for Petitioner
`
`
`
`Patrick C. Kilgore (Reg. No. 69,131)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`pkilgore@rmmslegal.com
`Back-Up Counsel for Petitioner Apotex
`
`Mark D. Schuman (Reg. No. 31,197)
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST AND SCHUMAN
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Tel: 612-436-9600
`Fax: 612-436-9605
`mschuman@carlsoncaspers.com
`Back-Up Counsel for Petitioner Teva
`
`
`Dated: October 7, 2016
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