Paper No. 9
`Date Filed: May 24, 2016
`
`
`
`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 IPR2016-00627
`U.S. Patent No. 5,847,170
`________________
`
`
`
`PATENT OWNER’S EXHIBIT LIST 1
`
`1
`
`
`
`
`
`
`Date Filed: May 24, 2016
`
`
`
`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 IPR2016-00627
`U.S. Patent No. 5,847,170
`________________
`
`
`
`PATENT OWNER’S EXHIBIT LIST 1
`
`1
`
`
`
`
`
`
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`
`
`EXHIBIT LIST 1
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Aventis Pharma S.A.
`
`(“Aventis”) respectfully submits the following current exhibit list.
`
`Aventis
`
`Exhibit No.
`
`Description
`
`2001
`
`de Bono et al., “Prednisone plus cabazitaxel or mitoxantrone for
`
`metastatic castration-resistant prostate cancer progressing after
`
`docetaxel treatment: a randomised open-label trial,”
`
`376(9747):1147-54, Lancet, 2010 (“de Bono”)
`
`2002
`
`FDA News Release, “FDA Approves New Treatment for Advanced
`
`Prostate Cancer,” (Jun. 17, 2010, last accessed on May 23, 2016 at
`
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/)
`
`European Patent Application Publication No. 0604910 (“EP’910”)
`
`European Patent Application Publication No. 0639577 (“EP’577”)
`
`Reserved
`
`Reserved
`
`United States Patent No. 5,229,526 (“’526 patent”)
`
`Reserved
`
`United States Patent No. 5,319,112 (“’112 patent”)
`
`2
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`
`
`
`
`
`
`Aventis
`
`Exhibit No.
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`Description
`
`2010
`
`Vrignaud et al., “Preclinical profile of cabazitaxel,” 8:1851-67,
`
`Drug Des. Devel. Ther., 2014 (“Vrignaud 2014”)
`
`2011
`
`Excerpt from June 26, 1996 Information Disclosure Statement
`
`2012
`
`2013
`
`2014
`
`submission from the File History of U.S. Patent No. 5,847,170
`
`PCT Patent Application Publication No. WO94/07878 (“WO’878”)
`
`European Patent Application Publication No. 0336841 (“EP’841”)
`
`Morrow & Cowan, “Antineoplastic Drug Resistance and Breast
`
`Cancer,” 698:289-312, Ann. N.Y. Acad. Sci., 1993 (“Morrow”)
`
`2015
`
`Rowinsky et al., “Taxol: the First of the Taxanes, an Important
`
`New Class of Antitumor Agents,” 19(6): 646-62, Semin. Oncol.,
`
`1992 (“Rowinsky”)
`
`2016
`
`Ojima et al., “Synthesis and biological activity of 3’-alkyl- and 3’-
`
`alkenyl-3’-dephenyldocetaxels,” 4(21): 2631-34, Bioorg. &
`
`Medicinal Chem. Lett., 1994 (“Ojima I”)
`
`2017
`
`Kingston, Ch. 15, “Recent Advances in the Chemistry and
`
`Structure—Activity Relationships of Paclitaxel,” in Taxane
`
`Anticancer Agents, ACS Symposium Series Vol. 583, pp. 203-16
`
`
`
`3
`
`
`
`
`
`Aventis
`
`Exhibit No.
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`Description
`
`(Georg et al., eds., 1994) (“Kingston 1994”)
`
`2018
`
`Ojima et al., Ch. 19, “Syntheses and Structure—Activity
`
`Relationships of New Taxoids, in Taxane Anticancer Agents ACS
`
`Symposium Series Vol. 583, 262-75 (Georg et al., eds., 1994)
`
`(“Ojima II”)
`
`2019
`
`Commerçon et al., Ch. 17 Practical Semisynthesis and Antimitotic
`
`Activity of Docetaxel and Side-Chain Analogues, in Taxane
`
`Anticancer Agents, ACS Symposium Series Vol. 583, 233-46
`
`(Georg et al., eds., 1994) (“Commerçon”)
`
`2020
`
`Wargin & Lucas, “The clinical pharmacokinetics of vinorelbine
`
`(Navelbine),” 21(5 Suppl. 10):21-27, Semin. Oncol., 1994
`
`(“Wargin”)
`
`2021
`
`Robert, “Epirubicin: Clinical Pharmacology & Dose-Effect
`
`Relationship,” 45 (Suppl. 2):20-30, Drugs, 1993 (“Robert”)
`
`2022
`
`Rahman et al., “Comparative Pharmacokinetics of Free
`
`Doxorubicin & Doxorubicin Entrapped in Cardiolipin Liposomes,”
`
`46(5): 2295-9, Cancer Res., 1986 (“Rahman”)
`
`
`
`4
`
`
`
`
`
`Aventis
`
`Exhibit No.
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`Description
`
`2023
`
`Thürlimann et al., “Dexverapamil to overcome epirubicin
`
`resistance in advanced breast cancer,” 121 (Suppl. 3):R3-R6, J.
`
`Cancer Res. Clin. Oncol., 1995 (“Thürlimann”)
`
`2024
`
`Holmes et al., Ch. 3, “Current Status of Clinical Trials with
`
`Paclitaxel and Docetaxel,” in Taxane Anticancer Agents, ACS
`
`Symposium Series Vol. 583, pp. 31-57 (Georg et al., eds., 1994)
`
`(“Holmes”)
`
`2025
`
`Stierle et al., Ch. 6, “Bioactive Metabolites of the Endophytic Fungi
`
`of Pacific Yew, Taxus brevifolia,” in Taxane Anticancer Agents,
`
`ACS Symposium Series, Vol. 583, pp. 81-97 (Georg et al., eds.,
`
`1994) (“Stierle”)
`
`2026
`
`Guéritte-Voegelein et al., “Relationships between the Structure of
`
`Taxol Analogues and Their Antimitotic Activity,” 34:992-8, J.
`
`Med. Chem., 1991 (“Guéritte-Voegelein”)
`
`2027
`
`Stewart, Lung cancer resistance to chemotherapy in Lung Cancer:
`
`Prevention, Management, and Emerging Therapies, Current
`
`Clinical Oncology 331-93(Humana Press, 2010) (“Stewart”)
`
`
`
`5
`
`
`
`
`
`Aventis
`
`Exhibit No.
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`Description
`
`2028
`
`Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi USA, LLC, C.A.
`
`No. 14-7869, ECF Nos. 51, 51-1 (Oct. 2, 2015 D.N.J.)
`
`2029
`
`Excerpted transcript of the May 12, 2016 videotaped deposition of
`
`2030
`
`2031
`
`Dr. Hervé Bouchard, at 174:1–181:25 (“Bouchard Tr.”)
`
`Reserved
`
`Bissery et al., “Experimental Antitumor Activity of Taxotere (RP
`
`56976, NSC 628503), a Taxol Analogue,” 51(18): 4845-52, Cancer
`
`Res., 1991 (“Bissery”)
`
`2032
`
`Wils et al., “Polarized transport of docetaxel and vinblastine
`
`mediated by P-glycoprotein in human intestinal epithelial cell
`
`monolayers,” 48(7): 1528-30, Biochem. Pharmacol., 1994 (“Wils”)
`
`2033
`
`Vrignaud et al., “Preclinical Antitumor Activity of Cabazitaxel, a
`
`Semisynthetic Taxane Active in Taxane-Resistant Tumors,”
`
`19(11):2973-83, Clin. Cancer Res., 2013 (“Vrignaud 2013”)
`
`Reserved
`
`United States Patent No. 5,005,588 (“’588 patent”)
`
`Reserved
`
`6
`
`2034
`
`2035
`
`2036
`
`
`
`
`
`
`
`Aventis
`
`Exhibit No.
`
`2037
`
`2038
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`Description
`
`Reserved
`
`Ramanathan et al., “A phase II study of milataxel: a novel taxane
`
`analogue in previously treated patients with advanced colorectal
`
`cancer,” 61: 453-58, Cancer Chemother. Pharmacol., 2008
`
`(“Ramanathan”)
`
`2039
`
`Kingston, “Tubulin-Interactive Natural Products as Anticancer
`
`Agents,” 72: 507-15, J. Nat. Prod., 2009 (“Kingston 2009”)
`
`2040
`
`Gallagher et al., “Phase I Clinical & Pharmacokinetic (PK) Trial of
`
`the Novel Taxane BMS-184476 Administered as a 1-Hour IV
`
`Infusion in Combination with Cisplatin Every 21 Days,” Proc. of
`
`ASCO, Vol. 20, Abstract 420, 2001 (“Gallagher”)
`
`2041
`
`Sanofi Press Release, “Jevtana® (cabazitaxel) injection now
`
`available in the U.S.,” July 19, 2010 (“Sanofi Press Release (7-19-
`
`2010)”)
`
`2042
`
`Malhotra et al., “Cabazitaxel: A Novel Drug for Hormone-
`
`Refractory Prostate Cancer,” 13:1-6, Mini Rev. Med. Chem., 2013
`
`(“Malhotra”)
`
`
`
`7
`
`
`
`
`
`Aventis
`
`Exhibit No.
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`Description
`
`2043
`
`Hope, ‘Last hope’ drug for prostate cancer patients is axed from
`
`the NHS, in a move doctors call a ‘travesty,’ Daily Mail (Jan. 9,
`
`2015) (“Hope”)
`
`2044
`
`Sanofi Press Release, “New hope in advanced prostate cancer:
`
`Alberta, Saskatchewan and Ontario fund coverage for Jevtana
`
`[Cabazitaxel], Press Release CNW (Oct. 4, 2012) (quoting Bob
`
`Shiell, Executive Director, Prostate Cancer Canada Network
`
`(PCCN) Calgary (“Sanofi Press Release (10-4-2012)”)
`
`2045
`
`Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi USA, LLC, C. A.
`
`No. 14-7869(MAS)(LHG), ECF No. 1 (D.N.J. Dec. 17, 2014)
`
`2046
`
`Sanofi-Aventis U.S. LLC et al. v. BPI Labs, LLC et al., C. A. No.
`
`14-8081(MAS)(LHG), ECF No. 1 (D.N.J. Dec. 29, 2014)
`
`2047
`
`Sanofi-Aventis U.S. LLC et al. v. Accord Healthcare, Inc., C. A.
`
`No. 14-8079 (MAS)(LHG), ECF No. 1 (D.N.J. Dec. 29, 2014)
`
`2048
`
`Sanofi-Aventis U.S. LLC et al. v. Breckenridge Pharmaceutical,
`
`Inc., C. A. No. 15-289 (MAS)(LHG), ECF No. 1 (D.N.J. Jan. 14,
`
`2015)
`
`
`
`8
`
`
`
`
`
`Aventis
`
`Exhibit No.
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`Description
`
`2049
`
`Sanofi-Aventis U.S. LLC et al. v. Onco Therapies Ltd. (now Mylan
`
`Laboratories Ltd.), C. A. No. 15-290 (MAS)(LHG), ECF No. 1
`
`(D.N.J. Jan. 14, 2015)
`
`2050
`
`Sanofi-Aventis U.S. LLC et al. v. Apotex Corp. et al., C. A. No. 15-
`
`287 (MAS)(LHG), ECF No. 1 (D.N.J. Jan. 14, 2015)
`
`2051
`
`Sanofi-Aventis U.S. LLC et al. v. Actavis LLC, C. A. No. 15-776
`
`(MAS)(LHG), ECF No. 1 (D.N.J. Feb. 2, 2015)
`
`2052
`
`Sanofi-Aventis U.S. LLC et al. v. Dr. Reddy’s Laboratories, Inc., C.
`
`A. No. 16-2259 (MAS)(LHG), ECF No. 1 (D.N.J. Apr. 21, 2016)
`
`2053
`
`Sanofi-Aventis U.S. LLC et al. v. Glenmark Pharmaceuticals Ltd. et
`
`al., C. A. No. 15-2523 (MAS)(LHG), ECF No. 1 (D.N.J. Apr. 6,
`
`2015)
`
`2054
`
`Crawford et al., “Treating Patients with Metastatic Castration
`
`Resistant Prostate Cancer: A Comprehensive Review of Available
`
`Therapies,” 194(6):1537-47, J. Urol., 2015 (“Petrylak”)
`
`2055
`
`Sanofi-Aventis Press Release, “JEVTANA® (cabazitaxel) for
`
`Prostate Cancer Recommended for Approval in the European
`
`
`
`9
`
`
`
`
`
`Aventis
`
`Exhibit No.
`
`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`Description
`
`Union,” (Jan. 21, 2011) (“Sanofi Press Release 1-21-2011”)
`
`2056
`
`Sanofi-Aventis Press Release, “Resilient Sales & Business EPS in
`
`Q3 2010,” (Oct. 28, 2010) (“Sanofi Press Release 10-28-2010”)
`
`Excerpts of U.S. sales from Sanofi Form 20-F from 2010-2015
`
`Jevtana® Prescribing Information (“Label”)
`
`2057
`
`2058
`
`
`
`10
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`Case IPR2016-00627
`U.S. Patent No. 5,847,170
`
`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
`
`
`
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`11
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`May 24, 2016
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`Case IPR2016-00627
`U.S. Patent No. 5,847,170
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNER’S EXHIBIT LIST 1 was served on May 24, 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
`
`May 24, 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
`
`
`12
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