`Date Served: February 23, 2017
`
`Filed on behalf of: Aventis Pharma S.A.
`
`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 EXHIBIT LIST 8
`
`
`
`Aventis
`Exhibit No.
`
`2001
`
`2002
`
`2003
`
`EXHIBIT LIST 8
`
`Description
`
`June 23, 2016 Declaration of Dr. Oliver Sartor.
`
`Curriculum Vitae of Dr. Oliver Sartor.
`
`A Randomized, Open Label, Phase 3 Study of Larotaxel IV every 3
`
`Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2
`
`Weeks in 3-Week Cycles in Patients with Metastatic Cancer (MBC)
`
`Progressing After Taxanes and Anthracycline Therapy (EFC6089),
`
`available at EFC6089_summary.pdf.
`
`2004
`
`Antonarakis & Eisenberger, Phase III Trials with Docetaxel-Based
`
`Combinations for Metastatic Castration-Resistant Prostate Cancer:
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`Time to Learn From Past Experiences, 31(14) J. Clin. Oncol. 1709-
`
`12 (2013).
`
`2005
`
`Armstrong & George, New Drug Development in Metastatic
`
`Prostate Cancer, 26(4) Urologic Oncol.: Seminars & Original
`
`Investigations 430-37 (2008).
`
`2006
`
`Beer et al., Double-Blinded Randomized Study of High-Dose
`
`Calcitriol plus Docetaxel Compared with Placebo plus Docetaxel
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`1
`
`
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`
`ASCENT Investigators, 25(6) J. Clin. Oncol. 669-74 (2007).
`
`2007
`
`Berry et al., Phase III Study of Mitoxantrone plus Low Dose
`
`Prednisone Versus Low Dose Prednisone Alone in Patients with
`
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`
`Urol. 2439-43 (2002).
`
`2008
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`
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`
`Cancer, Business Wire News HQ Press Release (September 12,
`
`2013), available at http://news.bms.com/press-release/rd-
`
`news/Bristol-myers-squibb-reports-results-Phase-3- trial-yervoy-
`
`ipilimumab-previousl.
`
`2009
`
`Cabral, Factors Determining Cellular Mechanisms of Resistance to
`
`Antimitotic Drugs, 4(1) Drug Resistance Updates 3-8 (2001).
`
`2010
`
`Carducci et al., A Phase 3 Randomized Controlled Trial of the
`
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`
`Refractory Prostate Cancer, 110(9) Cancer 1959-66 (2007).
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`2011
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`
`the Treatment of Prostate Cancer: A New Era Has Begun, 32(4) J.
`
`Clin. Oncol. 362-64 (2014).
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`2
`
`
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`
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`
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`
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`
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`2015
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`Dieras et al., Phase II Multicenter Study of Larotaxel (XRP9881), a
`
`Novel Taxoid, in Patients with Metastatic Breast Cancer Who
`
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`2016
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`
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`
`2017
`
`Halabi et al., Prostate-Specific Antigen Changes as Surrogate for
`
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`
`Prostate Cancer Treated with Second-Line Chemotherapy, 31(31)
`
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`
`2018
`
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`
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`
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`
`(2008).
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`3
`
`
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`Larotaxel Every 3 Weeks vs. Capecitabine in Patients with
`
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`
`Anthracycline Therapy, available at
`
`https://clinicaltrials.gov/ct2/show/NCT00081796?term
`
`=larotaxel&rank=7.
`
`2023
`
`Larotaxel plus Cisplatin vs. Gemcitabine plus Cisplatin in First
`
`Line Treatment of Patients with Locally Advanced/Metastatic
`
`Bladder Cancer, available at
`
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`
`ank=4.
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`2024
`
`Larotaxel vs. 5-FU in Patients with Pancreatic Cancer Previously
`
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`
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`
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`
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`
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`
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`
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`
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`
`12.htm.
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`
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`
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`
`?term=SPARC&cond=prostate&rank=3.
`
`2033
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`(2005).
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`
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`
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`
`October 2007 Ixempra® Label.
`
`June 2015 Jevtana® Label.
`
`Sanofi-Aventis Press Release, Phase III Data Showing Improved
`
`Survival with Jevtana® (cabazitaxel) Injection in Second-Line
`
`Advanced Prostate Cancer Published in the Lancet (October 1,
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`
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`
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`Combination with Docetaxel or Mitoxantrone as Second-Line
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