`
`Date Filed: October 6, 2016
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64
`TO EVIDENCE SUBMITTED BY MYLAN DURING
`A PRELIMINARY PROCEEDING
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Aventis Pharma S.A. (“Aventis”)
`
`objects to the admissibility of the following exhibits on the grounds set forth
`
`below. All evidence objected to below was submitted by Petitioner Mylan
`
`Laboratories Limited (“Mylan”) with its Petition seeking inter partes review of
`
`U.S. Patent No. 8,927,592 (“the ’592 patent”). The Board instituted review of the
`
`’592 patent on September 22, 2016. See Paper 9. Therefore, these objections are
`
`timely.
`
`In this paper, a reference to “F.R.E.” means the Federal Rules of Evidence,
`
`and a reference to “C.F.R.” means the Code of Federal Regulations. All objections
`
`under F.R.E. 802 (hearsay) apply to the extent Mylan relies on the exhibits
`
`identified in connection with that objection for the truth of the matters asserted
`
`therein.
`
`Aventis objects as follows:
`
`Exhibit 1002 Seth Declaration
`
`Aventis objects to Exhibit 1002 under F.R.E. 702 (improper expert
`
`testimony) and F.R.E. 703 (bases for expert opinion) as the testimony is not based
`
`on sufficient facts or data, is not the product of reliable principles and methods,
`
`and the principles and methods have not been reliably applied to the facts of the
`
`case.
`
`1
`
`
`
`Aventis objects to Exhibit 1002 under 35 U.S.C. § 312(a)(3); 37 C.F.R.
`
`§§ 42.65(a) and 42.104(b)(5); and F.R.E. 702 (improper expert testimony), 402
`
`(relevance), and 403 (confusing, waste of time) for failing to identify with
`
`particularity the underlying facts and data on which the opinion in based: ¶¶ 15,
`
`43-44, 46-47, 57, 69-73, 91, 97-98, 116, 132, 145, 167, 181, 183, 198, 201, 217-
`
`220, 223-226 fail to cite any support at all, or include statements that do not cite
`
`any support, and ¶¶ 25-27, 48, 60-61, 71, 73, 76, 98 include statements that cite or
`
`refer to entire articles or other references without identifying which aspects of
`
`those references are relied upon.
`
`Aventis objects to Exhibit 1002 ¶¶ 25-26, 28-30, 51-52, 55, 78, 82-93, 95-
`
`97, 99-109, 111, 134, 203-204, 216-219 under F.R.E. 402 (relevance) and 403
`
`(confusing, waste of time) as these paragraphs are not cited in Mylan’s Petition.
`
`Aventis further objects to Exhibit 1002 ¶¶ 73, 162-169, 171, 173-196, 198,
`
`200-202, 206-212, 220-221 under F.R.E. 402 (relevance) and 403 (confusing,
`
`waste of time) as these paragraphs are cited in Mylan’s Petition only with respect
`
`to grounds for which inter partes review was not authorized.
`
`Aventis also objects to Exhibit 1002 ¶¶ 25-27, 42, 48-50, 52-53, 55, 57, 59-
`
`80, 82-111, 115-123, 126-130, 132-135, 137, 139-143, 145-155, 157-181, 183-186,
`
`188-189, 191-192, 194-199, 201-212, 215-216, 219-223, 225-226 under F.R.E.
`
`702 (improper expert testimony), 703 (bases for expert opinion), 402 (relevance),
`
`2
`
`
`
`and 403 (confusing, waste of time) as these paragraphs include expert opinion
`
`based on documents that are inadmissible (Exhibits 1008-1013, 1015-1034) under
`
`at least F.R.E. 802 (hearsay), 702 (improper expert testimony), 703 (bases for
`
`expert opinion), 402 (relevance), or 403 (confusing, waste of time).
`
`Aventis also objects to Exhibit 1002 ¶¶ 79-80, 142, 198, 223-224 under
`
`F.R.E. 702 (improper expert testimony), 703 (bases for expert opinion), 402
`
`(relevance), and 403 (confusing, waste of time). The declarant is not stated to have
`
`expertise with respect to solid state forms of drugs, improving solubility of drugs,
`
`or design and economics of clinical trials.
`
`Exhibit 1004 File History
`
`Aventis objects to Exhibit 1004 under F.R.E. 901 (authenticity), 403
`
`(confusing, waste of time), and 106 (completeness) because it is not a certified
`
`copy of the file history, and it includes only a portion of a larger document that in
`
`fairness ought to be considered in connection with Exhibit 1004. For example,
`
`Exhibit 1004 is missing publications that were part of the file history.
`
`Exhibit 1008 Tropic Listing
`
`Aventis objects to Exhibit 1008 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time). Exhibit 1008 on its
`
`face does not demonstrate that the information within it was publicly available by
`
`October 23, 2008. Exhibit 1026, the Affidavit of Christopher Butler, does not state
`
`3
`
`
`
`that the declarant has any personal knowledge that the information in Exhibit 1008
`
`was publicly available in 2008. Instead, Exhibit 1026 states that the date assigned
`
`by the Internet Archive “applies to the HTML file but not to image files linked
`
`therein. Thus images that appear on a page may not have been archived on the
`
`same date as the HTML file.” Exh. 1026 at 1. Exhibit 1026 does not identify what
`
`content in Exhibit 1008 is part of the HTML file versus images that might have
`
`been archived on a different date. Furthermore, Exhibit 1008 contains
`
`substantially the same disclosure as a listing for the TROPIC study at
`
`clinicaltrials.gov last updated on December 28, 2006 that was previously
`
`considered by the patent examiner during prosecution of the ’592 patent; therefore
`
`Exhibit 1008 needlessly confuses the issues, wastes time, and presents cumulative
`
`evidence of the materials that were previously considered by the patent examiner.
`
`See Exh. 2100; Exh. 1001 at 2; Exh. 1004 at 1891.
`
`Exhibit 1009 Winquist
`
`Aventis objects to Exhibit 1009 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time). Exhibit 1009 contains substantially the same
`
`disclosure as the National Horizon Scanning Center (University of Birmingham),
`
`Cabazitaxel (XRP-6258) for Hormone Refractory, Metastatic Prostate Cancer –
`
`Second Line after Docetaxel (April 2009) that was previously considered by the
`
`patent examiner during prosecution of the ’592 patent; therefore Exhibit 1009
`
`4
`
`
`
`needlessly confuses the issues, wastes time, and presents cumulative evidence of
`
`the materials that were previously considered by the patent examiner. See Exh.
`
`2078; Exh. 1001 at 3; Exhibit 1004 at 123.
`
`Exhibit 1010 Pivot
`
`Aventis objects to Exhibit 1010 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time). Exhibit 1010 was previously considered by
`
`the patent examiner during prosecution of the ’592 patent; therefore Exhibit 1010
`
`needlessly confuses the issues, wastes time, and presents cumulative evidence of
`
`the materials that were previously considered by the patent examiner. See Exh.
`
`1001 at 3; Exh.1004 at 123.
`
`Exhibit 1011 U.S. Patent No. 7,241,907
`
`Aventis objects to Exhibit 1011 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time). Exhibit 1011 was previously considered by
`
`the patent examiner during prosecution of the ’592 patent; therefore Exhibit 1011
`
`needlessly confuses the issues, wastes time, and presents cumulative evidence of
`
`the materials that were previously considered by the patent examiner. See Exh.
`
`1001 at 1; Exh.1004 at 1889.
`
`Exhibit 1012 Mita
`
`Aventis objects to Exhibit 1012 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time). Exhibit 1012 was previously considered by
`
`5
`
`
`
`the patent examiner during prosecution of the ’592 patent; therefore Exhibit 1012
`
`needlessly confuses the issues, wastes time, and presents cumulative evidence of
`
`the materials that were previously considered by the patent examiner. See Exh.
`
`1001 at 1; Exh.1004 at 117.
`
`Exhibit 1013 Tannock
`
`Aventis objects to Exhibit 1013 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time). Exhibit 1013 was previously considered by
`
`the patent examiner during prosecution of the ’592 patent; therefore Exhibit 1013
`
`needlessly confuses the issues, wastes time, and presents cumulative evidence of
`
`the materials that were previously considered by the patent examiner. See Exh.
`
`1001 at 1; Exh.1004 at 118.
`
`Exhibit 1015 Booth
`
`Aventis objects to Exhibit 1015 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time). Exhibit 1015 was previously considered by
`
`the patent examiner during prosecution of the ’592 patent; therefore Exhibit 1015
`
`needlessly confuses the issues, wastes time, and presents cumulative evidence of
`
`the materials that were previously considered by the patent examiner. See Exh.
`
`1001 at 2; Exh.1004 at 116.
`
`6
`
`
`
`Exhibit 1016 Stedman’s Medical Dictionary
`
`Aventis objects to Exhibit 1016 under F.R.E. 802 (hearsay), 702 (improper
`
`expert testimony), 703 (bases for expert opinion), 402 (relevance), and 403
`
`(confusing, waste of time) because it is not relevant to any issue in this proceeding,
`
`and it is not the type of document upon which a person of ordinary skill in the art
`
`at the time of the invention would rely.
`
`Exhibit 1017 Abrams
`
`Aventis objects to Exhibit 1017 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time).
`
`Exhibit 1018 Kelland
`
`Aventis objects to Exhibit 1018 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time).
`
`Exhibit 1019 Verweij
`
`Aventis objects to Exhibit 1019 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time).
`
`Exhibit 1020 Galletti
`
`Aventis objects to Exhibit 1020 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time).
`
`7
`
`
`
`Exhibit 1021 Attard
`
`Aventis objects to Exhibit 1021 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time). Exhibit 1021 was previously considered by
`
`the patent examiner during prosecution of the ’592 patent; therefore Exhibit 1021
`
`needlessly confuses the issues, wastes time, and presents cumulative evidence of
`
`the materials that were previously considered by the patent examiner. See Exh.
`
`1001 at 3; Exh.1004 at 123.
`
`Exhibit 1022 Beardsley
`
`Aventis objects to Exhibit 1022 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time). Exhibit 1022 was previously considered by
`
`the patent examiner during prosecution of the ’592 patent; therefore Exhibit 1022
`
`needlessly confuses the issues, wastes time, and presents cumulative evidence of
`
`the materials that were previously considered by the patent examiner. See Exh.
`
`1001 at 1; Exh.1004 at 123.
`
`Exhibit 1023 El-Maraghi and Eisenhaur
`
`Aventis objects to Exhibit 1023 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time).
`
`8
`
`
`
`Exhibit 1024 Taxotere Label
`
`Aventis objects to Exhibit 1024 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time). It is not clear from
`
`the face of Exhibit 1024 when it was first published.
`
`Exhibit 1025 Liu
`
`Aventis objects to Exhibit 1025 under F.R.E. 802 (hearsay), 702 (improper
`
`expert testimony), 703 (bases for expert opinion), 402 (relevance), and 403
`
`(confusing, waste of time) because it is not relevant to any issue in this proceeding,
`
`and it is not the type of document upon which a person of ordinary skill in the art
`
`at the time of the invention would rely.
`
`Aventis also objects to Exhibit 1025 under 37 C.F.R. § 42.63 and F.R.E. 106
`
`as Exhibit 1025 is a piece of a larger document that in fairness ought to be
`
`considered in connection with Exhibit 1025, and Exhibit 1025 does not contain
`
`page 267, which is cited on page 24 of the Petition and ¶ 79 of Exhibit 1002.
`
`Exhibit 1026 Butler Affidavit
`
`Aventis objects to Exhibit 1026 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time). Exhibit A to
`
`Exhibit 1026 on its face does not demonstrate that the information within it was
`
`publicly available by October 23, 2008. The Affidavit of Christopher Butler does
`
`not state that the declarant has any personal knowledge that the information in
`
`9
`
`
`
`Exhibit A was publicly available in 2008. Instead, the affidavit states that the date
`
`assigned by the Internet Archive “applies to the HTML file but not to image files
`
`linked therein. Thus images that appear on a page may not have been archived on
`
`the same date as the HTML file.” Exh. 1026 at 1. Exhibit 1026 does not identify
`
`what content in Exhibit A thereto is part of the HTML file versus images that
`
`might have been archived on a different date. Furthermore, Exhibit A to Exhibit
`
`1026 contains substantially the same disclosure as a listing for the TROPIC study
`
`at clinicaltrials.gov last updated on December 28, 2006 that was previously
`
`considered by the patent examiner during prosecution of the ’592 patent; therefore
`
`Exhibit 1026 needlessly confuses the issues, wastes time, and presents cumulative
`
`evidence of the materials that were previously considered by the patent examiner.
`
`See Exh. 2100; Exh. 1001 at 2; Exh. 1004 at 1891.
`
`Exhibit 1027 Rosenberg
`
`Aventis objects to Exhibit 1027 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 802 (hearsay), 402 (relevance), and 403
`
`(confusing, waste of time) as the document is not cited in the Petition and Mylan
`
`has failed to identify which aspects of the document are relied upon.
`
`Exhibit 1028 Gayther
`
`Aventis objects to Exhibit 1028 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 802 (hearsay), 402 (relevance), and 403
`
`10
`
`
`
`(confusing, waste of time) as the document is not cited in the Petition and Mylan
`
`has failed to identify which aspects of the document are relied upon.
`
`Exhibit 1029 Ratain and Sargent
`
`Aventis objects to Exhibit 1029 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 802 (hearsay), 402 (relevance), and 403
`
`(confusing, waste of time) as the document is not cited in the Petition and Mylan
`
`has failed to identify which aspects of the document are relied upon.
`
`Exhibit 1030 Moul
`
`Aventis objects to Exhibit 1030 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time).
`
`Exhibit 1031 Joint Statement on Claim Construction, 3:15-cv-03392
`
`Aventis objects to Exhibit 1031 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time) because the document was published in 2015,
`
`which is after the relevant filing date. It is not relevant to any issue in this
`
`proceeding.
`
`Exhibit 1032 Brady Urological Institute
`
`Aventis objects to Exhibit 1032 under 37 C.F.R. § 42.63 and F.R.E. 901
`
`(authenticity), 802 (hearsay), 402 (relevance), and 403 (confusing, waste of time).
`
`It is not clear from the face of Exhibit 1032 when it was first published. The
`
`bottom of first and top of the second page are illegible because the text is cut off.
`
`11
`
`
`
`Exhibit 1033 Hospers
`
`Aventis objects to Exhibit 1033 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 802 (hearsay), 402 (relevance), and 403
`
`(confusing, waste of time) as the document is not cited in the Petition and Mylan
`
`has failed to identify which aspects of the document are relied upon.
`
`Exhibit 1034 Zhu
`
`Aventis objects to Exhibit 1034 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2), and 42.104(b)(5) and F.R.E. 802 (hearsay), 402 (relevance), and 403
`
`(confusing, waste of time) as the document is not cited in the Petition and Mylan
`
`has failed to identify which aspects of the document are relied upon.
`
`Exhibit 1035 Markman Hearing Transcript, 3:15-cv-03392
`
`Aventis objects to Exhibit 1035 under F.R.E. 802 (hearsay), 402 (relevance),
`
`and 403 (confusing, waste of time) because the document was published in 2016,
`
`which is after the relevant filing date. It is not relevant to any issue in this
`
`proceeding.
`
`Aventis also objects to Exhibit 1035 under F.R.E. 106 (completeness)
`
`because it includes only a portion of a larger document that in fairness ought to be
`
`considered in connection with Exhibit 1035.
`
`12
`
`
`
`October 6, 2016
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Attorney for Patent Owner,
`Aventis Pharma S.A.
`
`13
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO EVIDENCE
`
`SUBMITTED BY MYLAN DURING A PRELIMINARY PROCEEDING was
`
`served on October 6, 2016 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`sparmelee@wsgr.com
`
`mrosato@wsgr.com
`
`jmills@wsgr.com
`
`October 6, 2016
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`14