Paper No. 39
`Filed: January 25, 2016
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC
`
`PETITIONER
`
`V.
`
`CELGENE CORPORATION
`
`PATENT OWNER
`
`___________________
`
`Case IPR2015-01103
`Patent 6,315,720
`___________________
`
`
`
`PETITIONER’S CURRENT EXHIBIT LIST AS OF JANUARY 25, 2016
`PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`
`
`
`

`
`Exhibit
`No.
`1001
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`1002
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`1003
`
`1004
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`1005
`
`1006
`
`1007
`
`1008
`
`1009
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`1010
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`1011
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`PETITIONER’S CURRENT EXHIBIT LIST
`(UPDATED JANUARY 25, 2016)
`
`
`Exhibit Description
`U.S. Patent No. 6,315,720 to Bruce A. Williams and
`Joseph K. Kaminski, filed on Oct. 23, 2003, and issued
`on Nov. 13, 2001 (“the ’720 Patent”)
`U.S. Patent No. 6,315,720 Prosecution History (“’720
`prosecution history”)
`U.S. Patent No. 6,045,501 to Marc Elsayed and Bruce
`Williams, filed on Aug. 28, 1998, and issued on Apr. 4,
`2000 (“Elsayed”)
`U.S. Patent No. 6,063,026 to Mark A. Schauss and
`Patricia Kane, filed on Mar. 22, 1996, and issued on
`May 16, 2000 (“Schauss”)
`U.S. Patent No. 6,202,923 to Joseph H. Boyer et al., filed
`on Aug. 23,1999, and issued on Mar. 20, 2001 (“Boyer”)
`“Guideline for the clinical use and dispensing of
`thalidomide,” R.J. Powell and J.M.M Gardner-Medwin,
`Postgrad Med. J. (1994) 79,901–904 (“Powell”)
`“Pharmacists’ role in clozapine therapy at a Veterans
`Affairs medical center,” Benjamin R. Dishman et al., Am.
`J. Hosp. Pharm. (Apr. 1,1994) 51, 899–901 (“Dishman”)
`U.S. Patent No. 5,832,449 to David W. Cunningham, filed
`on Nov. 13, 1995, and issued on Nov. 3, 1998
`(“Cunningham”)
`U.S. Patent No. 6,055,507 to David W. Cunningham, filed
`on Aug. 20, 1998, and issued on Apr. 25, 2000
`(“Cunningham Divisonal”)
`“A Pregnancy-Prevention Program in Women of
`Childbearing Age Receiving Isotretinoin,” Allen A.
`Mitchell et al., New Eng. J. Med. (Jul. 13, 1995) 333:2,
`101–06 (“Mitchell”)
`“S.T.E.P.S.TM: A Comprehensive Program for
`Controlling and Monitoring Access to Thalidomide,”
`Jerome B. Zeldis et al., Clinical Therapeutics (1999)
`21:2, 319–30 (“Zeldis”)
`
`Date
`Filed
`
`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`1
` 
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`

`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`Transcript of the FDA’s “Forty-Seventh Meeting of the
`Dermatologic and Ophthalmic Drugs Advisory
`Committee,” Sept. 4, 1997 (“FDA Meeting Part 1”)
`Transcript of the FDA’s “Forty-Seventh Meeting of the
`Dermatologic and Ophthalmic Drugs Advisory Committee,”
`Sept. 5, 1997 (“FDA Meeting Part 2”)
`“CDC Meeting: 03/26/1997 Minutes and Agenda Regarding
`Thalidomide” (“CDC Meeting”)
`“Assessing the Effectiveness of a Computerized Pharmacy
`System,” Reed M. Gardner et al., Decision Support Systems
`in Critical Care, 1994, M.M. Schabot et al., eds.
`(“Gardner”)
`“Review of computer applications in institutional
`pharmacy—1975–1981,” Ken W. Burleson, Am. J. Hosp.
`Pharm. (1982) 39:53–70 (“Burleson”)
`“Interactive Voice Response Systems in Clinical Research
`and Treatment,” James C. Mundt, Psychiatric Services (May
`1997) 48:5, 611–12, 623 (“Mundt”)
`“Passage of Chemicals into Human and Animal Semen:
`Mechanisms and Significance,” Thaddeus Mann and
`Cecelia Lutwak-Mann, CRC Critical Reviews in
`Toxicology (1982) 11:1, 1–14 (“Mann”)
`“Preparing for Thalidomide’s Comeback,” Cori Vanchieri,
`Annals of Internal Med. (Nov. 15 1997) 127:10, 951–54
`(“Vanchieri”)
`“Development of a Computerized Drug Interaction
`Database (MedicomSM) for Use in a Patient Specific
`Environment, Arthur F. Shinn et al., Drug Inform. J. (1983)
`17:205–10 (“Shinn”)
`“Decision support for drug prescription integrated with
`computer- based patient records in primary care,” R.
`Linnarsson, Med. Inform. 18:2, 131–42 (“Linnarsson”)
`“A medication database – a tool for detecting drug
`interactions in hospital,” P.E. Grönroos et al., Eur. J. Clin.
`Pharmacol. (1997) 53:13–17 (“Grönroos”)
`“Prevalence of Alcohol and Drug Abuse in Schizophrenic
`Inpatients,” M. Soyka et al., Eur. Arch. Psychiatry Clin.
`Nerosci. (1993) 242:362–72 (“Soyka”)
`“Alcohol, Cannabis, Nicotine, and Caffeine Use and
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15
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`04/23/15 
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`04/23/15 
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`04/23/15 
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`04/23/15 
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`04/23/15 
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`04/23/15 
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`2
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`

`
`04/23/15 
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`Symptom Distress in Schizophrenia,” Edna Hamera et al., J.
`of Nervous and Mental Disease (Sept. 1995) 183:9, 559–65
`(“Hamera”)
`“Substance Abuse and Schizophrenia: Editors’
`Introduction,” Thomas R. Kosten and Douglas M.
`Ziedonis, Schizophrenia Bulletin (1997) 23:2, 181–86
`(“Kosten”)
`“Substance Abuse and Women on Welfare,” Jeffrey C.
`Menill, National Center on Addiction and Substance
`Abuse at Columbia University, June 1994 (“Menill”)
`Declaration of Jeffrey Fudin, R.Ph., B.S., Pharm.D.,
`DAAPM, FCCP, FASHP (“Fudin Decl.”)
`Curriculum Vitae for Jeffrey Fudin, R.Ph., B.S., Pharm.D.,
`DAAPM, FCCP, FASHP (“Fudin CV”)
`“Center for Drug Evaluation and Research Approval
`Package for
`Application Number: 18-662/S-038 (“Accutane Label”)
`“Joint Claim Construction and Prehearing Statement,”
`Celgene Corp. v. Natco Pharma Ltd., NJD-2-10-cv-05197,
`Jul. 18, 2011 (“Celgene Claim Construction Brief”)
`“Center for Drug Evaluation and Research Approval
`Package for: Application Number NDA 20-785
`Approval Letter(s),” Sept. 19, 1997, and Jul. 16, 1998
`(“FDA Thalomid Approval Letters”)
`“Influence of Socially Desirable Responding in a Study of
`Stress and Substance Abuse,” John W. Welte and Marcia
`Russell, Alcohol. Clin. Exp. Res. (Jul./Aug. 1993) 17:4,
`758–61 (“Welte”)
`“Thalidomide Back—Under Strict Control,” JAMA:
`Medical News and Perspectives (Oct. 8, 1997) 278:14,
`1135–37 (“JAMA”)
`1034 Orange Book Drug Product Listing Corresponding to the
`‘501 Patent, as published by the U.S. Food and Drug
`Administration on August 4, 2015
`1035 Orange Book Drug Product Listing Corresponding to U.S.
`Patent No. 6,315,720, as published by the U.S. Food and
`Drug Administration on August 4, 2015
`Pricing Information for Revlamid® (lenalidomide) capsules 08/12/15 
`
`04/23/15 
`
`04/23/15 
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`04/23/15 
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`04/23/15 
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`04/23/15 
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`04/23/15 
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`04/23/15 
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`04/23/15 
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`08/12/15
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`08/12/15 
`
`1025
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`1026
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`1027
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`1028
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`1029
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`1030
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`1031
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`1032
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`1033
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`1036
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`3
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`

`
`1037
`
`1038
`
`from “Information for Vermont Prescribers of Prescription
`Drugs,” from Medi-Span and Celgene Corporation (July 1,
`2015)
`Pricing Information for Thalomid® (thalidomide) capsules
`from “Information for Vermont Prescribers of Prescription
`Drugs,” from Medi-Span and Celgene Corporation (July 1,
`2015)
`Pricing Information for Pomalyst® (pomalidomide)
`capsules from “Information for Vermont Prescribers of
`Prescription Drugs,” from Medi-Span and Celgene
`Corporation (July 1, 2015)
`1039 Celgene Corp. v. Barr Laboratories, Inc. et al., Complaint,
`filed January 18, 2007, U.S. Dist. Ct. New Jersey, Case No.:
`2:33-av-00001
`1040 Celgene Corp. v. Natco Pharma Ltd., U.S. Dist. Ct. New
`Jersey, Complaint, Case No: 2:10-cv-05197-SDW-SCM
`1041 Celgene Corp. v. Lannett Holdings Inc., et al., Complaint,
`U.S. Dist. Ct. New Jersey, Case No. 2:15-cv-00697-SDW-
`SCM
`1042 Celgene v. Barr, Stipulated Dismissal, dated and filed May
`21, 2010, in U.S. Dist. Ct. New Jersey Case No. 2:07-cv-
`00286-SDW-MCA
`International Union of Bricklayers and Allied Craft
`Workers Local 1 Health Fund v. Celgene Corp., Class
`Action Antitrust Complaint, filed November 7, 2014, U.S.
`Dist. Ct. New Jersey, 2:14-cv-06997-KSH-CLW
`1044 Celgene Letter Motion dated September 3, 2014, to
`Bifurcate and Stay Expert discovery re: REMS Patents, in
`Celgene Corp. v Natco Pharma Ltd., U.S. Dist. Ct. New
`Jersey, Case No: 2:10-cv-05197-SDW-SCM
`1045 October 24, 2014, Court Order granting Celgene Motion to
`Bifurcate and Stay Expert discovery re: REMS Patents, in
`Celgene Corp. v Natco Pharma Ltd., U.S. Dist. Ct. New
`Jersey, Case No: 2:10-cv-05197-SDW-SCM
`1046 Orange Book Patents Corresponding to Celgene’s
`Thalomid® (thalidomide) capsules, as published by the U.S.
`Food and Drug Administration on August 6, 2015
`1047 Orange Book Patents Corresponding to Celgene’s
`Revlamid® (lenalidomide) capsules, as published by the
`
`1043
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`4
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`08/12/15 
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`08/12/15 
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`08/12/15 
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`08/12/15 
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`08/12/15 
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`08/12/15 
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`

`
`U.S. Food and Drug Administration on August 6, 2015
`1048 Orange Book Patents Corresponding to Celgene’s
`Pomalyst® (pomalidomide) capsules, as published by the
`U.S. Food and Drug Administration on August 6, 2015
`To Promote Innovation: The Proper Balance of Competition
`and Patent Law and Policy—A Report by the Federal Trade
`Commission October 2003
`“Evergreening: A Deceptive Device in Patent Rights,”
`Gaurav Dwivedi et al., Tech. in Society (2010) 32:324-330
`“Pay-for-Delay: How Drug Company Pay-Offs Cost
`Consumers Billions,” FTC Staff Study January 2010
`1052 May 28, 2015 Statement of the Federal Trade Commission
`on FTC v. Cephalon, Inc.
`“The Impact of Exempting the Pharmaceutical Industry
`from Patent Reviews,” Dean Baker, Center for Economic
`and Policy Research (July 2015)
`1054 Declaration of Juan (Julie) Wu, Ph.D., M.S. (“Wu Decl.”)
`1055
`Review of Recent Judicial Decisions on Patent Law:
`Hearing Before the Subcomm. on Intellectual Property,
`Competition, and the Internet of the H. Comm. on the
`Judiciary, 112th Cong. 29 (2011)
`America Invents Act: Hearing Before the Subcomm. on
`Intellectual Property, Competition, and the Internet of the
`H. Comm. on the Judiciary, 112th Cong. 52 (2011)
`LexisNexis SHEPARD’S® Report on Neumann v. Vidal,
`710 F.2d 856 (D.C. Cir. 1983)
`1058 Curriculum Vitae of Juan (Julie) Wu, Ph.D., M.S.
`1059 Diether et al, “It’s SHO Time! Short-Sale Price Tests and
`Market Quality,” J. Fin., 64: 37-73 (2009)
`Timeline Summarizing Legislation and Regulation on Short
`Selling
`Excerpts from 2010 SEC 2010 Amendments to Regulation
`SHO, final rule 34-61595
`1062 Karpoff et al, “Short Sellers and Financial Misconduct,” J.
`Fin. 65: 1879-1913 (2010)
`Fang et al, “Short Selling and Earnings Management: A
`Controlled Experiment,” J. Fin., (forthcoming, 2015)
`Ekkehart Boehmer and Juan (Julie) Wu, “Short Selling and
`the Price Discovery Process,” Rev. Fin. Stud. 26: 287-322
`
`1056
`
`1057
`
`1060
`
`1061
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`1063
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`1064
`
`1049
`
`1050
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`1051
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`1053
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`1071
`
`(2013)
`1065 Boehmer et al., “Shackling Short Sellers: The 2008 Shorting
`Ban,” Rev. Fin. Stud. 26: 1363-1400 (2013)
`1066 Massa et al., “The Invisible Hand of Short Selling: Does
`Short Selling Discipline Earnings Management?” Rev. Fin.
`Stud. (forthcoming, 2015)
`1067 Massa et al., “Governance through Threat: Does Short
`Selling Improve Internal Governance?” (INSEAD Working
`Paper 2013/83/FIN)
`1068 He et al., “Short Sellers and Innovation: Evidence from a
`Quasi-natural Experiment,” (Kelley School of Business
`Research Paper No. 2014-14)
`1069 Dechow et al., “Short-Sellers, Fundamental Analysis and
`Stock Returns,” J. Fin. Econ. 61:77–106 (2001)
`1070 Akbas et al., “Peer stock short interest and future returns,”
`(Working Paper, 2015)
`Engelberg et al., “How are Shorts Informed? Short-Selling,
`News and Information Processing,” J. Fin. Econ. 105: 260-
`278 (2012)
`1072 Diether et al., “Short-Sale Strategies and Return
`Predictability,” Rev. Fin. Stud. 22: 575-607 (2009)
`1073 Hedge funds and independent analysts: How independent
`are their relationships?: Hearing before the S. Comm. on
`the Judiciary, 109th Cong. 25 (2006) – June 28, 2006
`Testimony by Professor Owen A. Lamont, Yale School of
`Management
`1074 Oct. 12, 2011 Information Disclosure Statement,
`Application No. 12/966,240 (resulting in U.S. Patent No.
`8,204,763)
`Sep. 19, 2011 Information Disclosure Statement,
`Application No. 12/966,261 (resulting in U.S. Patent No.
`8,315,886)
`1076
`Federal Register Volume 62, Number 53 (March 19, 1997)
`
`1077 Declaration of Paul J. Skiermont
`
`1078 WorldCat results for Menill
`
`Scopus citations for Menill
`
`1075
`
`1079
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`08/12/15 
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`01/25/16
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`01/25/16
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`01/25/16
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`11/30/15
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`1080 Google Scholar citations for Menill
`
`1081 Wayback machine results for Menill
`
`
`
`Respectfully submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`SKIERMONT DERBY LLP
`2200 Ross Ave. Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`Lead Counsel for Petitioner
`
`
`
`
`
`
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`01/25/16
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`01/25/16
`
`
`January 25, 2016
`
`
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`Paul J. Skiermont (pro hac vice)
`SKIERMONT DERBY LLP
`2200 Ross Ave. Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6621
`Back-Up Counsel for Petitioner
`
`
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`7
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`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on January 25, 2016, a copy of PETITIONER’S
`
`EXHIBIT LIST AS OF JANUARY 25, 2016 PURSUANT TO 37 C.F.R. §
`
`42.63(e), was served via email upon the following:
`
`Francis Cerrito
`nickcerrito@quinnemanuel.com
`
`Eric C. Stops
`ericstops@quinnemanuel.com
`
`Frank C. Calvosa
`frankcalvosa@quinnemanuel.com
`
`Anthony Insogna
`aminsogna@jonesday.com
`
`J. Patrick Elsevier
`jpelsevier@jonesday.com
`
`Gasper J. LaRosa
`gjlarosa@jonesday.com
`
`
`Date: January 25, 2016
`
`
`
`
`
`
`
`/Sarah E. Spires/
`
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