Paper No. ___
`Filed: May 2, 2017
`
`
`
`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
`Patent 8,927,592
`_____________________________
`
`
`
`PETITIONER MYLAN LABORATORIES LIMITED’S
` UPDATED LIST OF EXHIBITS
`
`
`
`
`
`
`Filed: May 2, 2017
`
`
`
`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
`Patent 8,927,592
`_____________________________
`
`
`
`PETITIONER MYLAN LABORATORIES LIMITED’S
` UPDATED LIST OF EXHIBITS
`
`
`
`
`
`
`
`UPDATED LIST OF EXHIBITS
`
`Exhibit No.
`
`Description
`
`1001
`
`U.S. Patent No. 8,927,592 to Gupta
`
`1002
`
`Declaration of Dr. Rahul Seth
`
`1003
`
`Curriculum Vitae of Dr. Rahul Seth
`
`1004
`
`File History of 8,927,592 to Gupta
`
`1005
`
`U.S. Provisional Patent Application No. 61/256,160
`
`1006
`
`U.S. Provisional Patent Application No. 61/293,903
`
`1007
`
`U.S. Provisional Patent Application No. 61/355,834
`
`1008
`
`Sanofi-Aventis; XRP6258 Plus Prednisone Compared to
`Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic
`Prostate Cancer (TROPIC). Archived Oct. 23, 2008.
`(https://web.archive.org/web/20081023121613/http://clinicaltrials.g
`ov/ct2/show/NCT00417079) (last accessed: March 14, 2017)
`
`1009
`
`Winquist et al., CAN. J. UROL. 15 (2008)
`
`1010
`
`Pivot et al., ANN. ONCOL. 19 (2008) 1547-1552
`
`1011
`
`U.S. Patent No. 7,241,907 to Didier et al.
`
`1012
`
`Mita et al., CLIN. CANCER RES., 15 (2009)
`
`1013
`
`Tannock et al., N. ENGL. J. MED., 351 (2004) 1502-1512
`
`1014
`
`3:15-cv-03392 Complaint (D.N.J.)
`
`1015
`
`Booth et al., NAT. REV. DRUG DISCOV. 3 (2003) 609-610
`
`1016
`
`STEDMAN’S MEDICAL DICTIONARY, 27th Edition, 2000
`
`1017
`
`J. S. Abrams et al., CANCER SUPP. 74 (1994) 1164-1176
`
`
`
`-1-
`
`
`
`1018
`
`Kelland et al., CANCER CHEMOTHER. PHARMACOL. 30 (1992) 444-
`450
`
`1019
`
`Verweij, et al., ANN. ONCOL. 5 (1994) 495-505
`
`1020
`
`Galletti, et al., CHEM. MEDCHEM., 2 (2007) 920-942
`
`1021
`
`Attard, et al., PATHOL. BIOL., 54 (2006) 72-84
`
`1022
`
`Beardsley, et al., CURR. OPIN. SUPPORT PALLIAT. CARE, 2 (2008)
`161-166
`
`1023
`
`El-Maraghi and Eisenhauer, J. CLIN. ONCOL. 26 (2008) 1346-1354
`
`1024
`
`The Taxotere® Label
`
`1025
`
`Liu, WATER INSOLUBLE DRUG FORMULATION, First Edition, (2000)
`525-568
`
`1026
`
`Affidavit of C. Butler, The Internet Archive
`
`1027
`
`Rosenberg, et al., CANCER, 110 (2007) 556-563
`
`1028
`
`Gayther, et al., CANCER RES. 60 (2000) 4513-4518
`
`1029
`
`Ratain and Sargent, EUR. J. CANCER, 45 (2009) 257-280
`
`1030
`
`Moul, REV. UROL. 6 (2004) S10-S17
`
`1031
`
`Joint Statement on Claim Construction, 3:15-cv-03392 (D.N.J.)
`
`1032
`
`J. B. Brady, Urological Institute Johns Hopkins Medical
`Institutions, New Drugs for Prostate Cancer: Chemotherapy
`Transformed, 2003
`
`1033
`
`Hospers, et al., CURR. PHARM. DES. 14 (2008) 3020-3032
`
`1034
`
`Zhu, et al., CANCER EPIDEMIOL. BIOMARKERS PREV. 15 (2006) 3-5
`
`1035
`
`Markman Hearing Transcript (excerpted), 3:15-cv-03392 (D.N.J.)
`
`1036 (served
`but not filed)
`
`Liu, WATER INSOLUBLE DRUG FORMULATION, First Edition (2000),
`excerpt
`
`
`
`-2-
`
`
`
`1037 (served
`but not filed)
`
`J. B. Brady, Urological Institute Johns Hopkins Medical
`Institutions, New Drugs for Prostate Cancer: Chemotherapy
`Transformed, 2003
`
`1038 (served
`but not filed)
`
`Declaration of Patrick M. Medley
`
`1039
`
`Amended claim construction memorandum and order, Sanofi-
`Aventis v. Fresenius Kabi USA et al., Lead Coordinated Case No.
`14-7869 (D.N.J.)
`
`1040
`
`[Expunged]
`
`1041
`
`Transcript of Deposition of Dr. Oliver Sartor
`
`1042
`
`Transcript of Deposition of Michael E. Tate (Confidential)
`
`1043
`
`Reply Declaration of Dr. Rahul Seth (Confidential)
`
`1044
`
`Declaration of Robert McSorley (Confidential)
`
`1045
`
`2008 NCCN Antiemesis Guidelines, Internet Archive
`(https://web.archive.org/web/20081001233326/http://www.nccn.or
`g/professionals/physician_gls/PDF/antiemesis.pdf) (Oct. 1, 2008)
`(last accessed: March 14, 2017)
`
`1046
`
`Takenaka, et al., INT. J. UROL., 15 (2008)
`
`1047
`
`Trudeau, et al., J. CLIN. ONCOL., 14 (1996)
`
`1048
`
`Hudis, et al., J. CLIN. ONCOL., 14 (1996)
`
`1049
`
`Doenicke, et al., INFLAM. RES., 53 (2004)
`
`1050
`
`Cabrespine, et al., UROLOGY, 67 (2006)
`
`1051
`
`Padhani, et al., BR. J. RADIOL., 74 (2001)
`
`1052
`
`NCT00168701 ClinicalTrials.gov Listing (Biogen Exhibit 1022A)
`
`1053
`
`Michael, et al., PROSTATE CANCER PROSTATIC DIS.,12 (2009)
`
`1054
`
`Briefing Document for EOP2 Meeting (1996) (Confidential)
`
`
`
`-3-
`
`
`
`1055
`
`Defendant’s Answer to the Complaint, Separate Defenses and
`Counterclaims, C.A. No.: 3:15-cv-3392, District of New Jersey,
`filed July 16, 2015
`
`1056
`
`Mylan Form 2016 Form 10-K
`
`1057
`
`Hoechst Aktiengesellschaft German Company, Encyclopaedia
`Britannica, April 21, 2009
`(https://www.britannica.com/topic/Hoechst-Aktiengesellschaft)
`(last accessed: March 14, 2017)
`
`1058
`
`Intentionally left blank
`
`1059
`
`Approved Drug Products with Therapeutic Equivalence
`Evaluations (ORANGE BOOK), 31st Edition, 2011
`
`1060
`
`The Docetaxel Label (updated March 2012)
`
`1061
`
`1062
`
`1063
`
`1064
`
`Brooks, FDA Grants Expanded Indication for Enzalutamide
`(Xtandi) MEDSCAPE, 2004
`(http://www.medscape.com/viewarticle/831548) (last accessed:
`March 13, 2017)
`
`Mitoxantrone Drug Information
`(http://chemocare.com/chemotherapy/drug-info/Mitoxantrone.aspx)
`(last accessed: March 14, 2017)
`
`Estramustine Drug Information
`(http://chemocare.com/chemotherapy/drug-info/estramustine.aspx)
`(last accessed: March 14, 2017)
`
`Ketoconazole in Advanced Prostate Cancer: Have Tolerability
`Concerns Been Overstated? DRUG THER PERSPECT. 15 (2000)
`(http://www.medscape.com/viewarticle/406391) (last accessed:
`March 14, 2017)
`
`1065
`
`Jevtana Market Share US Performance Post Launch, Sanofi
`Oncology, SA_JEV_2152659 – 670 (Confidential)
`
`1066
`
`Off-Label Drug Use, American Cancer Society
`(https://www.cancer.org/treatment/treatments-and-side-
`effects/treatment-types/chemotherapy/off-label-drug-use.html) (last
`accessed: March 14, 2017)
`
`
`
`-4-
`
`
`
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`Corrected: www.pbm.va.gov, Cabazitaxel (Jevtana®), National
`Drug Monograph, March 2011, 2.2.
`
`Monthly Pulsing Study Report (Wave 28), October 30, 2014,
`Sanofi, SA_JEV_0836005 – 056 (Confidential)
`
`Jevtana ATU Report—Wave 5, Final Report, August 2013, Sanofi,
`SA_JEV_0866535 – 703 (Confidential)
`
`Monthly Jevtana Prostate Cancer Treatment Report, August 2014
`Results, Sanofi, SA_JE_0843600 – 656 (Confidential)
`
`Jevtana Weekly Performance Update, October 17, 2012, Sanofi,
`SA_JEV_1041118 – 158 (Confidential)
`
`Jevtana Global Brand Team Meeting, July 23, 2013, Sanofi,
`SA_JEV_1025400 – 488 (Confidential)
`
`Cost to Develop and Win Marketing Approval for a New Drug is
`$2.6 Billion, Tufts Center for the Study of Drug Development
`(November 18, 2014)
`(http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cos
`t_study) (last accessed: March 14, 2017)
`
`Monthly Pulsing Study Report, April (Wave 27), July 24, 2014,
`Sanofi, SA_JEV_0859285 – 353 (Confidential)
`
`Ma, et al., A Statistical Analysis of the Magnitude and Composition
`of Drug Promotion in the United States in 1998, CLIN. THERAP. 25
`(2003) 1503-1517
`
`Promotional Spending for Prescription Drugs, Congressional
`Budget Office, Economic and Budget Issue Brief, (Dec. 2, 2009) 1-
`8
`
`Manchanda, et al., The Effects and Role of Direct-to-Physician
`Marketing in the Pharmaceutical Industry: An Integrative Review,
`YALE J. HEALTH POL’Y L. & ETHICS 5 (2005) 785-822
`
`Wazana, Physicians and the Pharmaceutical Industry: Is a Gift
`Ever Just a Gift?, JAMA 283 (2000) 373-380
`
`
`
`-5-
`
`
`
`1079
`
`November GBT Meeting, Sanofi Oncology, SA_JEV_0244978 –
`5028 (Confidential)
`
`1080
`
`U.S. Patent No. 5,428,072
`
`1081
`
`U.S. Patent No. 5,698,582
`
`1082
`
`U.S. Patent No. 5,847,170
`
`1083
`
`U.S. Patent No. 6,331,635
`
`1084
`
`U.S. Patent No. 6,372,780
`
`1085
`
`U.S. Patent No. 6,387,946
`
`1086
`
`U.S. Patent No. 4,814,470
`
`1087
`
`U.S. Patent No. 5,714,512
`
`1088
`
`U.S. Patent No. 5,750,561
`
`1089
`
`Cabazitaxel IMS 2009-10 DollarsDoses (Confidential)
`
`1090
`
`Cabazitaxel IMS 2011-16 DollarsDoses (Confidential)
`
`1091
`
`Approved Drug Products with Therapeutic Equivalence
`Evaluations (ORANGE BOOK), 36st Edition, 2016
`
`1092
`
`Sanofi Form 2016 Form 20-F
`
`1093
`
`FDA Approves New Treatment for Advanced Prostate Cancer, U.S.
`Food & Drug Administration, 2010
`(https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncement
`s/ucm216143.html) (last accessed: March 14, 2017)
`
`1094 (served
`but not filed)
`
`1095 (served
`but not filed)
`
`Evidentiary Declaration of Mr. Robert McSorley (Confidential)
`
`Second Evidentiary Declaration of Patrick M. Medley
`
`
`
`-6-
`
`
`
`1096
`
`1097
`
`Wells Fargo Securities, Equity Research: Johnson & Johnson (June
`27, 2013) (CabRef0012609-CabRef0012617). (Served but not filed
`by Patent Owner as Exhibit 2256)
`
`Wells Fargo Securities, Equity Research: Johnson & Johnson (June
`26, 2014) (CabRef0012618-CabRef0012627). (Served but not filed
`by Patent Owner as Exhibit 2257)
`
`
`
`
`
`
`
`-7-
`
`
`
`CERTIFICATE OF SERVICE
`
`
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Petitioner Mylan Laboratories Limited’s Updated List of Exhibits, Exhibit
`
`1096, and Exhibit 1097, on this 2nd day of May, 2017, on the Patent Owner at the
`
`correspondence address of the Patent Owner as follows:
`
`Dominick A. Conde
`William E. Solander
`Jason A. Leonard
`Whitney L. Meier
`Daniel J. Minion
`Joshua I. Rothman
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 1014-3800
`Email: dconde@fchs.com
`Email: wsolander@fchs.com
`Email: jleonard@fchs.com
`Email: wmeier@fchs.com
`Email: dminion@fchs.com
`Email: jrothman@fchs.com
`
`
`
`
`
`Dated: May 2, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`
`/ Steven W. Parmelee /
`Steven W. Parmelee,
`Reg. No. 31,990
`
`
`
`
`
`-8-
`
`
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