UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WATSON LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORP.
`
`
`Patent Owner.
`
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`
`
`Case No. IPR2017-01622
`Patent No. 9,339,507
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`PETITIONER’S UPDATED EXHIBIT LIST
`(AS OF JANUARY 25, 2018)
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313-1450
`Submitted Electronically via the Patent Review Processing System
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`WATSON LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORP.
`
`
`Patent Owner.
`
`
`
`
`
`
`
`
`
`Case No. IPR2017-01622
`Patent No. 9,339,507
`
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`
`PETITIONER’S UPDATED EXHIBIT LIST
`(AS OF JANUARY 25, 2018)
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313-1450
`Submitted Electronically via the Patent Review Processing System
`
`
`
`PETITIONER’S EXHIBIT LIST
`(as of January 25, 2018)
`
`
`1003
`
`1004
`
`1005
`
`Exhibit Description
`1001
`U.S. Patent No. 9,339,507
`1002
`Declaration of Maureen D. Donovan in Support of the Petition for
`Inter Partes Review of U.S. Patent No. 9,339,507
`Robert Voswinckel, et al. “Inhaled treprostinil sodium for the
`treatment of pulmonary hypertension” Abstract #1414, Circulation,
`110, 17, Supplement (Oct. 2004): III-295 (“Voswinckel”)
`U.S. Patent Application Publication No. 2004/0265238 A1 to Chaudry
`(“Chaudry”)
`Hossein Ardeschi Ghofrani, Robert Voswinckel, et al., “Neue
`Therapieoptionen in der Behandlung der pulmonalarteriellen
`Hypertonie,” Hertz, 30,4 (June 2005): 296-302 (“Ghofrani”)
`Opti-Neb-ir® Operating Instructions, Model ON-100/2 (2005)
`RESERVED
`Venta-Neb-ir® A-I-C-I Operating Instructions, Model VN-100/4
`Annexes to Commission Decision C(2005)3436 of 05 September
`2005, http://ec.europa.eu/health/documents/community-
`register/2005/2005090510259/anx_10259_en.pdf (Annex III –
`Ventavis® Labelling and Package Leaflet)
`U.S. Patent No. 6,606,989 (“Brand ’989”)
`Amendment and Reply Accompanying RCE filed in 12/591,200 (Jul.
`2, 2013) (with accompanying Declaration of Lewis Rubin, M.D.)
`WO 93/00951 to Patton
`Declaration of Scott Bennett, Ph.D.
`Affidavit of Christopher Butler, June 15, 2017
`Affidavit of Christopher Butler, June 16, 2017
`RESERVED
`RESERVED
`U.S. Patent No. 6,521,212 (“Cloutier ’212”)
`U.S. Patent No. 4,306,075 (“Aristoff ’075”)
`U.S. Patent No. 5,190,972 (“Dumble ’972”)
`European Patent Specification 0347243 B1, published January 13,
`1993
`U.S. Patent No. 6,261,539 (“Adjei ’539”)
`European Patent Application Publication No. EP 0372777 A2
`(“Purewal EP ’777”)
`
`1012
`1013
`1014
`1015
`1016
`1017
`1018
`1019
`1020
`1021
`
`1006
`1007
`1008
`1009
`
`1010
`1011
`
`1022
`1023
`
`
`
`
`
`1028
`
`1029
`
`1030
`
`1031
`1032
`
`1033
`
`Exhibit Description
`1024
`U.S. Patent No. 4,895,719 (“Radhakrishnan ’719”)
`1025
`U.S. Patent No. 5,153,222 (“Tadepalli ’222”)
`1026
`U.S. Patent No. 6,357,671 (“Cewers ’671”)
`Gessler, et al., Ultrasonic versus Jet Nebulization of Iloprost in Severe
`1027
`Pulmonary Hypertension, Eur. Respiratory J., 17:14-19 (2001)
`Olschewski H., et al., Aerosolized Prostacyclin and Iloprost in Severe
`Pulmonary Hypertension, 1996 Ann. Intern. Med. 124(9), 820-824
`(1996) (“Olschewski 199”)
`Olschewski, et al., Pharmacodynamics and Pharmacokinetics of
`Inhaled Iloprost, Aerosolized by Three Different Devices, in Severe
`Pulmonary Hypertension, Chest J., 124(4), 1294-1304 (Oct. 2003)
`Byron, Drug Delivery Devices: Issues in Drug Development, Proc.
`Am. Thorac. Soc., 1:321-328 (2004)
`U.S. Patent No. 5,544,646 (“Lloyd”)
`Edwards D.A. et al., Recent Advances in Pulmonary Drug Delivery
`Using Large Porous Inhaled Particles, Journal of Applied Physiology,
`85(2): 379-385 (1998) (“Edwards 1998”)
`Badesch, et al., Prostanoid Therapy for Pulmonary Arterial
`Hypertension, J. of the Am. C. of Cardiology, 43(12):Suppl. S (2004)
`U.S. Patent No. 6,054,486 (“Crow ’486”)
`U.S. Food and Drug Administration, Drug Approval Package:
`Remodulin® (approved on May 21, 2002),
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
`272_Remodulin.cfm (“Remodulin® Approval Package”)
`Electronic Medicines Compendium, Ventavis®,
`http://www.medicines.org.uk/emc/medicine/13743
`European Agency Approves Ventavis for Primary Pulmonary
`Hypertension, P&T Community (Sep. 22, 2003),
`https://www.ptcommunity.com/news/2003-09-22-000000/european-
`agency-approves-ventavis-primary-pulmonary-hypertension
`EU Community Register of Medicinal Products, Homepage,
`http://ec.europa.eu/health/documents/community-
`register/html/index_en.htm
`EMEA Scientific Discussion, Ventavis® (2004),
`http://www.ema.europa.edu/docs/en_GB/document_library/
`EPAR_Scientific_Discussion/human/000474/WC500048688.pdf
`
`1034
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`
`
`
`
`1041
`
`1043
`
`1044
`
`1045
`
`1042
`
`Exhibit Description
`1040
`Muller et al., “Use of Inhaled Iloprost in a Case of Pulmonary
`Hypertension during Pediatric Congenital Heart Surgery,” 99
`Anesthesiology 743-747 (2003)
`Mueller et al., “Inhaled Iloprost in the Management of Pulmonary
`Hypertension in Infants Undergoing Congenital Heart Surgery,”
`21 Eur. J. Anaesthesiology (suppl. 33) 2-36 (2004)
`Commission Decision C(2005)3436 of 05 September 2005,
`http://ec.europa.eu/health/documents/community-
`register/2005/2005090510259/dec_10259_en.pdf
`EU Community Register of Medicinal Products for Human Use,
`Ventavis, http://ec.europa.eu/health/documents/community-
`register/html/h255.htm#
`Summary of Community Decisions, Official Journal of the European
`Union (Oct. 28, 2005) http://eur-lex.europa.eu/legal-
`content/EN/TXT/?uri=uriserv:OJ.C_.2005.268.01.0002.01.ENG&toc=
`OJ:C:2005:268:TOC (noting a modification of marketing approval for
`Ventavis®)
`Electronic Medicines Compendium, Ventavis®,
`http://www.medicines.org.uk/emc/history/13743#version1 (noting a
`change to section 4.2 – Posology and Method of Administration on
`September 22, 2005)
`Voswinckel, R., et al., “Inhaled treprostinil is a potent pulmonary
`vasodilator in severe pulmonary hypertension,” 25 European Heart
`Journal 22, at 218 (2004) (“Voswinckel II”)
`Sulica, R and Poon, M. “Medical Therapeutics for Pulmonary Arterial
`Hypertension From Basic Science and Clinical Trial Design to
`Evidence-Based Medicine.” 3(2) Expert Rev. Cardiovas. Ther. 347-
`360 (2005)
`American Heart Association’s Scientific Sessions 2004 – Largest
`Cardiovascular Meeting Plans to ‘Jazz It Up’ in New Orleans, PR
`Newswire (Oct. 13 2004), http://www.prnewswire.com/news-
`releases/american-heart-associations-scientific-sessions-2004---
`largest-cardiovascular-meeting-plans-to-jazz-it-up-in-new-orleans-
`74293197.html#
`EU Community Register of Medicinal Products, Frequently Asked
`Questions, http://ec.europa.eu/health/documents/community-
`register/register_faq_2015.pdf
`
`1046
`
`1047
`
`1048
`
`1049
`
`
`
`
`
`1051
`
`1052
`
`1053
`
`Exhibit Description
`1050
`Regulation (EC) No 726/2004 of the European Parliament and of the
`Council of 31 March 2004, http://eur-lex.europa.eu/LexUriServ/
`LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF
`Register of Commission Documents, European Union,
`https://ec.europa.eu/transparency/regdoc/index.cfm?fuseaction=home
`Regulation (EC) No. 1049/2001 of the European Parliament and of the
`Council of 30 May 2001,
`http://www.europarl.europa.eu/RegData/PDF/r1049_en.pdf
`Register of the Commission Documents, European Commission,
`https://ec.europa.eu/transparency/regdoc/index.cfm?fuseaction=
`list&n=10&adv=0&coteId=&year=2005&number=
`3436&version=ALL&dateFrom=&dateTo=
`&serviceId=&documentType=&title=&titleLanguage=&titleSearch=
`EXACT&sortBy=NUMBER&sortOrder=DESC (search result for
`document search of Commission reference number ‘3436’ for year
`‘2005’)
`U.S. Patent No. 5,234,953 (“Crow ’953”)
`Declaration of DeForest McDuff, Ph.D.
`U.S. Patent No. 9,358,240
`U.S. Patent No. 6,756,033
`Amendment and Reply filed in 13/469,854 (Jan. 4, 2013) (with
`accompanying Declaration of Lewis Rubin, M.D.)
`Reply in 13/469,854 (June 13, 2014)
`William F. Ganong, Review of Medical Physiology 591-92 (17th ed.
`1995)
`Actelion Pharmaceuticals, “Actelion Announces Full Year 2003
`Financial Results” (March 2, 2004)
`Actelion Pharmaceuticals, “Actelion Announces Full Year 2005
`Financial Results” (Feb. 23, 2006)
`Actelion Pharmaceuticals, Annual Report, 2002
`Actelion Pharmaceuticals, Annual Report, 2006
`Actelion Pharmaceuticals, Annual Report, 2007
`Actelion Pharmaceuticals, Annual Report, 2008
`Actelion Pharmaceuticals, Annual Report, 2010
`Actelion Pharmaceuticals, Annual Report, 2011
`Actelion Pharmaceuticals, Annual Report, 2012
`Actelion Pharmaceuticals, Annual Report, 2013
`Actelion Pharmaceuticals, Annual Report, 2014
`
`1063
`1064
`1065
`1066
`1067
`1068
`1069
`1070
`1071
`
`1054
`1055
`1056
`1057
`1058
`
`1059
`1060
`
`1061
`
`1062
`
`
`
`
`
`1080
`1081
`1082
`1083
`1084
`
`Exhibit Description
`1072
`Actelion Pharmaceuticals, Annual Report, 2015
`1073
`Actelion Pharmaceuticals, Annual Report, 2016
`1074
`Adcirca, FDA Label, 5/2017
`1075
`Adempas, FDA Label, 10/2016
`1076
`Bayer, Annual Report, 2014
`1077
`Bayer, Annual Report, 2015
`1078
`Bayer, Annual Report, 2016
`Highest paid female CEO: Race to save my daughter, CNBC (May 19,
`1079
`2015), http://www.cnbc.com/2015/05/19/
`highestpaidfemaleceoracetosavemydaughter.html
`Cowen and Company, "Biotechnology Quarterly" (Jan. 2011)
`Cowen and Company, “GlaxoSmithKline plc” (Sep. 14, 2015)
`Cowen and Company, “GlaxoSmithKline plc,” (May 16, 2016)
`Cowen and Company, “Therapeutic Categories Outlook,” Feb. 2017
`DiMasi, Joseph A. and Henry G. Grabowski (2012), “R&D Costs and
`Returns to New Drug Development: A Review of the Evidence,” in
`Patricia Danzen and Sean Nicholson, ed., The Oxford Handbook of the
`Economics of the Biopharmaceuticals Industry, New York: Oxford
`University Press
`Approved Drug Products with Therapeutic Equivalance Evaluations
`(“Orange Book”), FDA (30th ed. 2010)
`Approved Drug Products with Therapeutic Equivalance Evaluations
`(“Orange Book”), FDA (37th ed. 2017)
`FDA Drug Details Website, Adcirca,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Adempas,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Flolan,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Letairis,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Opsumit,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`
`1085
`
`1086
`
`1087
`
`1088
`
`1089
`
`1090
`
`1091
`
`
`
`
`
`Exhibit Description
`1092
`FDA Drug Details Website, Orenitram,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Remodulin,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Revatio,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Tracleer,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Tyvaso,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Uptravi,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Veletri,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Ventavis,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`
`1093
`
`1094
`
`1095
`
`1096
`
`1097
`
`1098
`
`1099
`
`1100
`
`1101
`
`1102
`
`1103
`1104
`1105
`1106
`1107
`
`Federal Reserve Website, Data Download, CHF to USD, 1998‐2016,
`Federal Reserve Website, Data Download, USD to EUR, 1999‐2016,
`Federal Reserve Website, Data Download, USD to GBP, 1998‐2016,
`Gilead, Form 10‐K, 2009
`Gilead, Form 10‐K, 2010
`Gilead, Form 10‐K, 2011
`Gilead, Form 10‐K, 2012
`
`https://www.federalreserve.gov/datadownload/Preview.aspx?pi=400&
`rel=H10&preview=H10/ H10/RXI_N.A.SZ (accessed 4/25/2017)
`
`https://www.federalreserve.gov/datadownload/Preview.aspx?pi=400&
`rel=H10&preview=H10/ H10/RXI$US_N.A.EU (accessed 4/25/2017)
`
`https://www.federalreserve.gov/datadownload/Preview.aspx?pi=400&
`rel=H10&preview=H10/ H10/RXI$US_N.A.UK (accessed 4/25/2017)
`Flolan, FDA Label, 4/2015
`
`
`
`
`
`Gilead, Form 10‐K, 2013
`Gilead, Form 10‐K, 2014
`Gilead, Form 10‐K, 2015
`Gilead, Form 10‐K, 2016
`
`Exhibit Description
`1108
`1109
`1110
`1111
`1112
`1113
`
`GlaxoWellcome, Annual Report, 1997
`Grabowski, Henry, John Vernon, and Joseph A. DiMasi (2002),
`“Returns on Research and Development for 1990s New Drug
`Introductions,” Pharmacoeconomics 20(3): 11–29
`GSK, Annual Report, 2010
`GSK, Annual Report, 2011
`GSK, Annual Report, 2012
`GSK, Annual Report, 2013
`GSK, Annual Report, 2016
`Letairis, FDA Label, 10/2015
`Mayo Clinic Website, Pulmonary hypertension, Overview,
`
`1114
`1115
`1116
`1117
`1118
`1119
`1120
`
`1121
`
`1122
`
`1123
`1124
`1125
`1126
`1127
`1128
`1129
`1130
`1131
`1132
`1133
`1134
`1135
`1136
`1137
`
`http://www.mayoclinic.org/diseasesconditions/ pulmonary‐
`hypertension/home/ovc‐20197480 (accessed 3/22/2017)
`Pulmonary Hypertension, https://www.nhlbi.nih.gov/health/health‐
`
`Merck & Co. v. Teva Pharmaceuticals USA, Inc., 395 F.3d 1364 (Fed.
`Cir. 2005)
`NIH Website; National Heart, Lung, and Blood Institute; Types of
`
`topics/topics/pah/types (accessed 5/16/2017)
`Opsumit, FDA Label, 3/2017
`Orenitram, FDA Label, 1/2017
`Pfizer, Annual Report, 2005
`Pfizer, Annual Report, 2006
`Pfizer, Annual Report, 2009
`Pfizer, Annual Report, 2010
`Pfizer, Annual Report, 2011
`Pfizer, Annual Report, 2012
`Pfizer, Annual Report, 2013
`Pfizer, Annual Report, 2014
`Pfizer, Annual Report, 2015
`Pfizer, Annual Report, 2016
`RBC Capital Markets, “Untied Therapeutics Corp.,” 6/13/2011
`Remodulin, FDA Label, 12/2014
`Revatio, FDA Label, 4/2015
`
`
`
`
`
`Exhibit Description
`1138
`St. Louis Federal Reserve, Consumer Price Index,
`https://fred.stlouisfed.org/series/CPIAUCSL (accessed 5/17/2017)
`Tracleer, FDA Label, 10/2016
`Tyvaso, FDA Label, 06/2016
`Uptravi, FDA Label, 12/2015
`UTC, “Q2 2010 United Therapeutics Earnings Conference Call,”
`7/28/2010
`
`1139
`1140
`1141
`1142
`
`1143
`1144
`1145
`1146
`1147
`1148
`1149
`1150
`1151
`1152
`1153
`1154
`1155
`1156
`1157
`1158
`1159
`1160
`1161
`1162
`
`1163
`
`1164
`1165
`
`1166
`
`1167
`
`
`
`UTC, Form 10‐K, 2000
`UTC, Form 10‐K, 2002
`UTC, Form 10‐K, 2003
`UTC, Form 10‐K, 2004
`UTC, Form 10‐K, 2005
`UTC, Form 10‐K, 2006
`UTC, Form 10‐K, 2007
`UTC, Form 10‐K, 2008
`UTC, Form 10‐K, 2009
`UTC, Form 10‐K, 2010
`UTC, Form 10‐K, 2011
`UTC, Form 10‐K, 2012
`UTC, Form 10‐K, 2013
`UTC, Form 10‐K, 2014
`UTC, Form 10‐K, 2015
`UTC, Form 10‐K, 2016
`
`Veletri, FDA Label, 6/2012
`Ventavis, FDA Label, 11/2013
`Reply filed in 13/469,854 (June 13, 2014)
`Substantive Submission filed in 12/591,200 (Nov. 9, 2015) (with
`accompanying Declaration of Dr. Roham T. Zamanian)
`Amendment and Reply filed in 12/591,200 (Feb. 2, 2016) (with
`accompanying Second Declaration of Dr. Roham T. Zamanian)
`Final Rejection of 13/469,854 (Mar. 13, 2014)
`Order (June 21, 2016) (D.I. 48 in C.A. No. 3:15-cv-05723-PGS-LHG
`(D.N.J.)
`Civil Docket for Case No. 3:15-cv-05723-PGS-LHG (D.N.J.)
`(accessed Nov. 8, 2017)
`Declaration of Kurt A. Mathas In Support of Motion for Pro Hac Vice
`Admission
`
`
`
`
`
`
`
`Dated: January 25, 2018
`
`Respectfully submitted,
`
`/Michael K. Nutter/
`Michael K. Nutter, Lead Counsel
`Reg. No. 44,979
`Andrew R. Sommer, Back-Up Counsel
`Reg. No. 53,932
`Kurt A. Mathas, Back-Up Counsel
`WINSTON & STRAWN LLP
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
` Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), I certify that, on January 25,
`
`2018, true and correct copies of the foregoing PETITIONER’S UPDATED
`
`EXHIBIT LIST (AS OF JANUARY 25, 2018), and Exhibit 1167, were served by
`
`via email to the following counsel for the Patent Owner:
`
`Stephen B. Maebius
`Email: smaebius@foley.com
`
`UT240-IPR@foley.com
`
`George Quillin
`Email: gquillin@foley.com
`FOLEY & LARDNER LLP
`
`Shaun R. Snader
`Email: ssnader@unither.com
`UNITED THERAPEUTICS CORP
`
`Douglas Carsten
`Email: dcarsten@wsgr.com
`
`Richard Torczon
`Email: rtorczon@wsgr.com
`
`Robert Delafield
`Email: bdelafield@wsgr.com
`
`Veronica Ascarrunz
`Wilson, Sonsini, Goodrich & Rosati
`Email: vascarrunz@wsgr.com
`WILSON, SONSINI, GOODRICH & ROSATI
`
`
`
`
`
`
`
`
`
`Dated: January 25, 2018
`
`Respectfully submitted,
`
`/Michael K. Nutter/
`Michael K. Nutter, Lead Counsel
`Reg. No. 44,979
`Andrew R. Sommer, Back-Up Counsel
`Reg. No. 53,932
`Kurt A. Mathas, Back-Up Counsel
`WINSTON & STRAWN LLP
`
`
`
`
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