Paper No. 54
`Filed: May 27, 2016
`
`
`
`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 IPR2015-01096
`Patent 6,315,720
`___________________
`
`
`
`PETITIONER’S CURRENT EXHIBIT LIST AS OF MAY 27, 2016
`PURSUANT TO 37 C.F.R. § 42.63(e)
`
` 
`
` 
`
`
`
`

`
` 
`
`PETITIONER’S CURRENT EXHIBIT LIST
`(UPDATED MAY 27, 2016)
`
`Exhibit
`Exhibit Description
`No.
`1001 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”)
`1002 U.S. Patent No. 6,315,720 Prosecution History (“’720
`prosecution history”)
`1003 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”)
`1004 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”)
`1005 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”)
`1006 “THALOMID™ (thalidomide) Capsules Revised Package
`Insert” (Jul. 15, 1998) (“Thalomid PI”)
`1007 “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”)
`1008 “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”)
`1009 U.S. Patent No. 5,832,449 to David W. Cunningham, filed
`on Nov. 13, 1995, and issued on Nov. 3, 1998
`(“Cunningham”)
`1010 U.S. Patent No. 6,055,507 to David W. Cunningham, filed
`on Aug. 20, 1998, and issued on Apr. 25, 2000
`(“Cunningham Divisional”)
`1011 “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”)
`1012 “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
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`1
` 
`
`

`
` 
`
`1013 Transcript of the FDA’s “Forty-Seventh Meeting of the
`Dermatologic and Opthalmic Drugs Advisory Committee,”
`Sept. 4, 1997 (“FDA Meeting Part 1”)
`1014 Transcript of the FDA’s “Forty-Seventh Meeting of the
`Dermatologic and Opthalmic Drugs Advisory Committee,”
`Sept. 5, 1997 (“FDA Meeting Part 2”)
`1015 “CDC Meeting: 03/26/1997 Minutes and Agenda Regarding
`Thalidomide” (“CDC Meeting”)
`1016 “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”)
`1017 “Review of computer applications in institutional
`pharmacy—1975–1981,” Ken W. Burleson, Am. J. Hosp.
`Pharm. (1982) 39:53–70 (“Burleson”)
`1018 “Challenges of thalidomide distribution in a hospital
`setting,” Daniel P. Keravich and Charles E. Daniels, Am. J.
`Health-Syst. Pharm. (Sept. 1, 1999) 56:1721–75
`(“Keravich”)
`1019 “The Assessment of Refill Compliance Using Pharmacy
`Records: Methods, Validity, and Applications,” John F.
`Steiner and Allan V. Prochazka, J. Clin. Epidemiol. (1997)
`50:1, 105–16 (“Steiner”)
`1020 “Therapeutic Antibiotic Monitoring: Surveillance Using a
`Computerized Expert System,” Stanley L. Pestotnik et al.,
`Am. J. Med. (Jan. 1990) 88:43–48 (“Pestotnik”)
`1021 Declaration of Jeffrey Fudin, R.Ph., B.S., Pharm.D.,
`DAAPM, FCCP, FASHP (“Fudin Decl.”)
`1022 Curriculum Vitae for Jeffrey Fudin, R.Ph., B.S., Pharm.D.,
`DAAPM, FCCP, FASHP (“Fudin CV”)
`1023 “Joint Claim Construction and Prehearing Statement,”
`Celgene Corp. v. Natco Pharma Ltd., NJD-2-10-cv-05197,
`Jul. 18, 2011 (“Celgene Claim Construction Brief”)
`1024 “Interactive Voice Response Systems in Clinical Research
`and Treatment,” James C. Mundt, Psychiatric Services (May
`1997) 48:5, 611–12, 623 (“Mundt”)
`“Center for Drug Evaluation and Research Approval
`Package for: Application Number NDA 20-785
`Approval Letter(s),” Sept. 19, 1997, and Jul. 16, 1998
`
`1025
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`04/23/15
`
`2
` 
`
`

`
` 
`
`(“FDA Thalomid Approval Letters”)
`1026 Orange Book Drug Product Listing Corresponding to the
`‘501 Patent, as published by the U.S. Food and Drug
`Administration on August 4, 2015
`1027 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
`1028 Pricing Information for Revlamid® (lenalidomide) capsules
`from “Information for Vermont Prescribers of Prescription
`Drugs,” from Medi-Span and Celgene Corporation (July 1,
`2015)
`1029 Pricing Information for Thalomid® (thalidomide) capsules
`from “Information for Vermont Prescribers of Prescription
`Drugs,” from Medi-Span and Celgene Corporation (July 1,
`2015)
`1030 Pricing Information for Pomalyst® (pomalidomide) capsules
`from “Information for Vermont Prescribers of Prescription
`Drugs,” from Medi-Span and Celgene Corporation (July 1,
`2015)
`1031 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
`1032 Celgene Corp. v. Natco Pharma Ltd., U.S. Dist. Ct. New
`Jersey, Complaint, Case No: 2:10-cv-05197-SDW-SCM
`1033 Celgene Corp. v. Lannett Holdings Inc., et al., Complaint,
`U.S. Dist. Ct. New Jersey, Case No. 2:15-cv-00697-SDW-
`SCM
`1034 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
`1035 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
`1036 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
`1037 October 24, 2014, Court Order granting Celgene Motion to
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`3
` 
`
`

`
` 
`
`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
`1038 Orange Book Patents Corresponding to Celgene’s
`Thalomid® (thalidomide) capsules, as published by the U.S.
`Food and Drug Administration on August 6, 2015
`1039 Orange Book Patents Corresponding to Celgene’s
`Revlamid® (lenalidomide) capsules, as published by the
`U.S. Food and Drug Administration on August 6, 2015
`1040 Orange Book Patents Corresponding to Celgene’s
`Pomalyst® (pomalidomide) capsules, as published by the
`U.S. Food and Drug Administration on August 6, 2015
`1041 To Promote Innovation: The Proper Balance of Competition
`and Patent Law and Policy—A Report by the Federal Trade
`Commission October 2003
`1042 “Evergreening: A Deceptive Device in Patent Rights,”
`Gaurav Dwivedi et al., Tech. in Society (2010) 32:324-330
`1043 “Pay-for-Delay: How Drug Company Pay-Offs Cost
`Consumers Billions,” FTC Staff Study January 2010
`1044 May 28, 2015 Statement of the Federal Trade Commission
`on FTC v. Cephalon, Inc.
`1045 “The Impact of Exempting the Pharmaceutical Industry from
`Patent Reviews,” Dean Baker, Center for Economic and
`Policy Research (July 2015)
`1046 Declaration of Juan (Julie) Wu, Ph.D., M.S. (“Wu Decl.”)
`1047 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)
`1048 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)
`1049 LexisNexis SHEPARD’S® Report on Neumann v. Vidal, 710
`F.2d 856 (D.C. Cir. 1983)
`1050 Curriculum Vitae of Juan (Julie) Wu, Ph.D., M.S.
`1051 Diether et al, “It’s SHO Time! Short-Sale Price Tests and
`Market Quality,” J. Fin., 64: 37-73 (2009)
`1052 Timeline Summarizing Legislation and Regulation on Short
`Selling
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`08/13/15 
`
`08/13/15 
`
`4
` 
`
`

`
` 
`
`1053 Excerpts from 2010 SEC 2010 Amendments to Regulation
`SHO, final rule 34-61595
`1054 Karpoff et al, “Short Sellers and Financial Misconduct,” J.
`Fin. 65: 1879-1913 (2010)
`
`1055 Fang et al, “Short Selling and Earnings Management: A
`Controlled Experiment,” J. Fin., (forthcoming, 2015)
`1056 Ekkehart Boehmer and Juan (Julie) Wu, “Short Selling and
`the Price Discovery Process,” Rev. Fin. Stud. 26: 287-322
`(2013)
`1057 Boehmer et al., “Shackling Short Sellers: The 2008 Shorting
`Ban,” Rev. Fin. Stud. 26: 1363-1400 (2013)
`
`1058 Massa et al., “The Invisible Hand of Short Selling: Does
`Short Selling Discipline Earnings Management?” Rev. Fin.
`Stud. (forthcoming, 2015)
`1059 Massa et al., “Governance through Threat: Does Short
`Selling Improve Internal Governance?” (INSEAD Working
`Paper 2013/83/FIN)
`1060 He et al., “Short Sellers and Innovation: Evidence from a
`Quasi-natural Experiment,” (Kelley School of Business
`Research Paper No. 2014-14)
`1061 Dechow et al., “Short-Sellers, Fundamental Analysis and
`Stock Returns,” J. Fin. Econ. 61:77–106 (2001)
`
`1062 Akbas et al., “Peer stock short interest and future returns,”
`(Working Paper, 2015)
`
`1063 Engelberg et al., “How are Shorts Informed? Short-Selling,
`News and Information Processing,” J. Fin. Econ. 105: 260-
`278 (2012)
`1064 Diether et al., “Short-Sale Strategies and Return
`Predictability,” Rev. Fin. Stud. 22: 575-607 (2009)
`
`1065 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
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`08/13/15 
`
`5
` 
`
`

`
` 
`
`
`
`
`1066 Oct. 12, 2011 Information Disclosure Statement,
`Application No. 12/966,240 (resulting in U.S. Patent No.
`8,204,763)
`1067 Sep. 19, 2011 Information Disclosure Statement,
`Application No. 12/966,261 (resulting in U.S. Patent No.
`8,315,886)
`1068 Federal Register Volume 62, Number 53 (March 19, 1997)
`1069 Declaration of Paul J. Skiermont
`1070 Declaration of Sadaf R. Abdullah
`1071 Declaration of Sadaf R. Abdullah
`1072 Bwire, et al., “Managing the Teratogenic Risk of
`Thalidomide and Lenalidomide: An Industry Perspective,”
`Expert Opinion on Drug Safety. 10(1): 1-8 (2011).
`(Previously introduced as Ex. 1070 in Dr. Fudin’s
`deposition.)
`1073 DiPiro, “2013 Rho Chi Lecture: Writing the Headlines of
`Tomorrow,” American Journal of Pharmaceutical
`Education. 77(5): 1-4 (2013).
`1074 05/02/2016 – 05/03/2016 Deposition Transcripts of Dr.
`DiPiro Volumes 1 and 2 SEALED
`1074 05/02/2016 – 05/03/2016 Deposition Transcripts of Dr.
`DiPiro Volumes 1 and 2 PUBLIC
`1075 04/13/2016 – 04/14/2016 Deposition Transcripts of Dr. Frau
`Volumes 1 and 2 SEALED
`1075 04/13/2016 – 04/14/2016 Deposition Transcripts of Dr. Frau
`Volumes 1 and 2 PUBLIC
`1076 Center for Drug Evaluation and Research, FDA, “Transcript:
`47th Meeting of the Dermatologic and Ophthalmic Drugs
`Advisory Committee;” (1997).
`1077 Video excerpt Dr. Frau deposition 75:22 – 77:2
`1078 Video excerpt Dr. Frau deposition 81:12 – 83:5
`1079 Video excerpt Dr. Frau deposition 129:11 – 133:7
`1080 Video excerpt Dr. Frau deposition 152:12 – 154:21
`1081 Video excerpt Dr. Frau deposition 185:12 – 187:8
`
`01/25/16
`
`01/25/16
`
`01/25/16
`11/30/15
`03/14/16
`03/14/16
`05/27/16
`
`05/27/16
`
`05/27/16
`
`05/27/16
`
`05/27/16
`
`05/27/16
`
`05/27/16
`
`05/27/16
`05/27/16
`05/27/16
`05/27/16
`05/27/16
`
`6
` 
`
`

`
`May 27, 2016
`
`/Parvathi Kota/
`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
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`Paul J. Skiermont (pro hac vice)
`Sadaf R. Abdullah (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
`
`
` 
`
`Respectfully submitted,
`
`
`
`
`
`
`
`7
` 
`
`

`
` 
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
`
`counsel for Patent Owner a true and correct copy of the foregoing Petitioner’s
`
`Exhibit List as of May 27, 2016 Pursuant to 37 C.F.R. § 42.63(e), by electronic
`
`means on May 27, 2016 at the following address of record:
`
`/Parvathi Kota/
`
`
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`
`Counsel for Petitioner
`
`
`
`  
`
`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: May 27, 2016