Paper No. _____
`Filed: August 13, 2015
`
`
`
`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 NO.: IPR2015-01096
`PATENT NO. 6,315,720
`FILED: OCTOBER 23, 2000
`ISSUED: NOVEMBER 13, 2001
`INVENTORS: BRUCE A. WILLIAMS, JOSEPH K. KAMINSKI
`
`TITLE: METHODS FOR DELIVERING A DRUG TO A PATIENT WHILE
`AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN
`OR SUSPECTED OF BEING CAUSED BY THE DRUG
`___________________
`
`
`
`PETITIONER’S CURRENT EXHIBIT LIST OF AUGUST 13, 2015
`PURSUANT TO 37 C.F.R. § 42.63(e)
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`1
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`Exhibit
`No.
`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`PETITIONER’S CURRENT EXHIBIT LIST
`(August 13, 2015)
`
`
`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”)
` “THALOMID™ (thalidomide) Capsules Revised Package
`Insert” (Jul. 15, 1998) (“Thalomid PI”)
` “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 Divisional”)
` “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
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`04/23/15
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`2
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`1013
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`1014
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
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` Transcript of the FDA’s “Forty-Seventh Meeting of the
`Dermatologic and Opthalmic Drugs Advisory Committee,”
`Sept. 4, 1997 (“FDA Meeting Part 1”)
` Transcript of the FDA’s “Forty-Seventh Meeting of the
`Dermatologic and Opthalmic 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”)
` “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”)
` “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”)
` “Therapeutic Antibiotic Monitoring: Surveillance Using a
`Computerized Expert System,” Stanley L. Pestotnik et al.,
`Am. J. Med. (Jan. 1990) 88:43–48 (“Pestotnik”)
` 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”)
` “Joint Claim Construction and Prehearing Statement,”
`Celgene Corp. v. Natco Pharma Ltd., NJD-2-10-cv-05197,
`Jul. 18, 2011 (“Celgene Claim Construction Brief”)
` “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
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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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`3
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`

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`
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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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`1034
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`1035
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`1036
`
`1037
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`(“FDA Thalomid Approval Letters”)
` Orange Book Drug Product Listing Corresponding to the
`‘501 Patent, as published by the U.S. Food and Drug
`Administration on August 4, 2015
` 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
`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)
` 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
` Celgene Corp. v. Natco Pharma Ltd., U.S. Dist. Ct. New
`Jersey, Complaint, Case No: 2:10-cv-05197-SDW-SCM
` Celgene Corp. v. Lannett Holdings Inc., et al., Complaint,
`U.S. Dist. Ct. New Jersey, Case No. 2:15-cv-00697-SDW-
`SCM
` 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
` 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
` October 24, 2014, Court Order granting Celgene Motion to
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`4
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`1038
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`1039
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`1040
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`1041
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`1042
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`1043
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`1044
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`1045
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`1046
`1047
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`1048
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`1049
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`1050
`1051
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`1052
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`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
` Orange Book Patents Corresponding to Celgene’s
`Thalomid® (thalidomide) capsules, as published by the U.S.
`Food and Drug Administration on August 6, 2015
` Orange Book Patents Corresponding to Celgene’s
`Revlamid® (lenalidomide) capsules, as published by the
`U.S. Food and Drug Administration on August 6, 2015
` 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
` 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)
` Declaration of Juan (Julie) Wu, Ph.D., M.S. (“Wu Decl.”)
` 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)
` Curriculum Vitae of Juan (Julie) Wu, Ph.D., M.S.
` 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
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`5
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`1053
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`1054
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`1055
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`1056
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`1057
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`1058
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`1059
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`1060
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`1061
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`1062
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`1063
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`1064
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`1065
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` Excerpts from 2010 SEC 2010 Amendments to Regulation
`SHO, final rule 34-61595
` 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
`(2013)
` Boehmer et al., “Shackling Short Sellers: The 2008 Shorting
`Ban,” Rev. Fin. Stud. 26: 1363-1400 (2013)
` Massa et al., “The Invisible Hand of Short Selling: Does
`Short Selling Discipline Earnings Management?” Rev. Fin.
`Stud. (forthcoming, 2015)
` Massa et al., “Governance through Threat: Does Short
`Selling Improve Internal Governance?” (INSEAD Working
`Paper 2013/83/FIN)
` He et al., “Short Sellers and Innovation: Evidence from a
`Quasi-natural Experiment,” (Kelley School of Business
`Research Paper No. 2014-14)
` Dechow et al., “Short-Sellers, Fundamental Analysis and
`Stock Returns,” J. Fin. Econ. 61:77–106 (2001)
` 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)
` Diether et al., “Short-Sale Strategies and Return
`Predictability,” Rev. Fin. Stud. 22: 575-607 (2009)
` 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
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`August 13, 2015
`
`
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`Paul J. Skiermont (pro hac vice requested)
`SKIERMONT PUCKETT LLP
`2200 Ross Ave. Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6621
`Back-Up Counsel for Petitioner
`
`
`
`
`
`Respectfully submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`SKIERMONT PUCKETT LLP
`2200 Ross Ave. Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`Lead Counsel for Petitioner
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on August 13, 2015, a copy of PETITIONER’S
`
`CURRENT EXHIBIT LIST OF AUGUST 13, 2015 PURSUANT TO 37 C.F.R. §
`
`42.63(e) , was served by filing this document through the Patent Review
`
`Processing System, as well as emailing copies to nickcerrito@quinnemanuel.com
`
`and aminsogna@jonesday.com.
`
`
`
`Date: August 13, 2015
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`
`
`
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`
`
`/Sarah E. Spires/
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`7