Paper No. __
`Filed: July 30, 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 IPR2015-01096
`Patent 6,315,720
`________________
`
`
`
`
`
`PATENT OWNER EXHIBIT LIST AS OF
`July 30, 2015 PURSUANT TO 37 C.F.R. § 42.63(e)
`
` 04841-00006/7050187.1
`
`
`Filed: July 30, 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 IPR2015-01096
`Patent 6,315,720
`________________
`
`
`
`
`
`PATENT OWNER EXHIBIT LIST AS OF
`July 30, 2015 PURSUANT TO 37 C.F.R. § 42.63(e)
`
` 04841-00006/7050187.1
`
`
`
`
`
`Case IPR2015-01096
`Patent 6,315,720
`Patent Owner’s Exhibit List
`
`
`DESCRIPTION
`
`EXHIBIT
`NO.
`Exhibit 2001 Thalomid® June 2014 Package Insert
`Dr. V. Pannikar, WHO, “The Return of Thalidomide:
`New Uses and Renewed Concerns.”
`Exhibit 2003 Revlimid® February 2015 Package Insert
`Exhibit 2004 Pomalyst® April 2015 Package Insert
`
`Exhibit 2002
`
`Exhibit 2005 FDA website, “About the FDA;” (2014).
`
`Exhibit 2006
`
`Uhl, Kathleen, et al. “Thalidomide Use in the US, Experience with
`Pregnancy Testing in the S.T.E.P.S.® Programme;” (2006).
`Exhibit 2007 Celgene Thalomid® NDA submission re: Enhanced S.T.E.P.S.®
`Exhibit 2008 Thalomid® September 2001 Package Insert
`Exhibit 2009 September 2001 Thalomid® Package Insert approval letter
`Exhibit 2010 May 2006 Thalomid® FDA approval letter
`Exhibit 2011 December 2005 Revlimid® FDA approval letter
`Exhibit 2012 February 2013 Pomalyst® FDA approval letter
`
`Exhibit 2013 Koren, G., et al “Drugs in Pregnancy;” (1998).
`
`Exhibit 2014
`
`Honigfeld, G., “Effects of the Clozapine National Registry System
`on Incidence of Death Related to Agranulocytosis;” (1996).
`
`Exhibit 2015 Celgene January 2005 Form 8-K
`
`Exhibit 2016
`
`Exhibit 2017
`
`Kirn, T. “Mandatory FDA restrictions on the way for isotretinoin:
`voluntary programs deemed ineffective;” (2005).
`PR Newswire “Isotretinoin Makers Reach Agreement with
`Celgene on S.T.E.P.S.® Risk Management Patents”
`
`Exhibit 2018 FDA Orphan Drug Designations and Approvals for Thalidomide
`
`Exhibit 2019 FDA Orphan Drug Designations and Approvals for Lenalidomide
`
`Exhibit 2020 FDA Orphan Drug Designations and Approvals for Pomalidomide
`
`Exhibit 2021 Celgene December 2014 Form 10-K
`Center for Drug Evaluation and Research, FDA, “Transcript: 47th
`Meeting of the Dermatologic and Ophthalmic Drugs Advisory
`
`Exhibit 2022
`
`04841-00006/7050187.1
`
`
`
`Case IPR2015-01096
`Patent 6,315,720
`Patent Owner’s Exhibit List
`
`
`EXHIBIT
`NO.
`
`Exhibit 2023
`
`Exhibit 2024
`
`Exhibit 2025
`
`Exhibit 2026
`
`Exhibit 2027
`
`Exhibit 2028
`
`Exhibit 2029
`
`Exhibit 2030
`
`Exhibit 2031
`
`Exhibit 2032
`
`DESCRIPTION
`
`Committee;” (1997).
`
`FDA, “Transcript: Thalidomide: Potential Benefits and Risk Open
`Public Scientific Workshop;” (1997).
`FDA, “Transcript: Thalidomide: Potential Benefits and Risk Open
`Public Scientific Workshop;” (1997).
`Warren, R. “TVAC’s Position On The Return Of Thalidomide,
`Living In A World with THALIDOMIDE: A New Reality;”
`(1998).
`Delaware Department of State: Division of Corporations,
`“Coalition for Affordable Drugs”
`Delaware Department of State: Division of Corporations,
`“Coalition for Affordable Drugs VI LLC – Entity Details”
`The Wall Street Journal, “New Hedge Fund Strategy: Dispute
`the Patent, Short the Stock;” (2015).
`Business Insider, “Hedge Fund Manager Kyle Bass Is Going
`After Big Pharma And Its ‘BS Patents;” (2015).
`Hayman Capital Management, L.P. June 2015 Form ADV Part 2A
`Brochure
`The Wall Street Journal, “Innovate or Else: Kyle Bass Strikes
`Again and Challenges Shire Patents;” (2015).
`Dallas Observer “Dallas’ Erich Spangenberg is Very Proud to be
`America’s Biggest Patent Troll;” (2013).
`
`Exhibit 2033 January 2014 Spangenberg/IPNav email threatening IPRs
`
`Exhibit 2034
`
`Exhibit 2035
`
`Exhibit 2036
`
`Exhibit 2037
`
`Exhibit 2038
`
`Exhibit 2039
`
`January 2014 Spangenberg/IPNav threatened ’501 patent IPR
`petition
`January 2014 Spangenberg/IPNav threatened ’501 patent IPR
`declaration
`January 2014 Spangenberg/IPNav threatened ’720 patent
`obviousness IPR petition
`January 2014 Spangenberg/IPNav threatened ’720 patent
`obviousness IPR declaration
`January 2014 Spangenberg/IPNav threatened ’720 patent
`anticipation IPR petition
`January 2014 Spangenberg/IPNav threatened ’720 patent
`anticipation IPR declaration
`
`04841-00006/7050187.1
`
`
`
`Case IPR2015-01096
`Patent 6,315,720
`Patent Owner’s Exhibit List
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`Exhibit 2040 January 2014 Spangenberg/IPNav patent family tree
`
`Exhibit 2041 July 2014 IRDP email threatening IPRs
`
`Exhibit 2042 July 2014 IRDP threatened ’501 patent IPR petition
`
`Exhibit 2043 July 2014 IRDP threatened ’501 patent IPR declaration
`
`Exhibit 2044 July 2014 IRDP threatened ’720 patent obviousness IPR petition
`
`Exhibit 2045
`
`July 2014 IRDP threatened ’720 patent obviousness IPR
`declaration
`
`Exhibit 2046 July 2014 IRDP threatened ’720 patent anticipation IPR petition
`
`Exhibit 2047
`
`July 2014 IRDP threatened ’720 patent anticipation IPR
`declaration
`
`Exhibit 2048 July 2014 IRDP patent family tree
`
`Exhibit 2049
`
`Exhibit 2050
`
`Exhibit 2051
`
`Exhibit 2052
`
`Exhibit 2053
`
`Law360, “Shire Drugs Are Next Targets of Hedge Fund’s AIA
`Reviews;” (2015).
`Hayman Capital Management, L.P. “Statement of J. Kyle Bass
`Chief Investment Officer, Hayman Capital Management, L.P.;”
`(2015).
`Reuters, “U.S. hedge fund plans to take on big pharma over
`patents;” (2015).
`Pharma: The Catalyst, “What They Are Saying: Close Patent
`Loopholes That Threaten Innovation for Patients;” (2015).
`IP Watchdog, “Senator Coons – Patents Are about the American
`Dream;” (2015).
`
`
`
`04841-00006/7050187.1
`
`
`
`Case IPR2015-01096
`Patent 6,315,720
`Patent Owner’s Exhibit List
`
`
`Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` QUINN EMANUEL URQUHART &
` SULLIVAN, LLP
` 51 Madison Avenue, 22nd Floor
` New York, NY 10010
` Tel: (212) 849-7000
` Fax: (212) 849-7100
` nickcerrito@quinnemanuel.com
`
`
`
` Anthony M. Insogna (Reg. No. 35,203)
` JONES DAY
` 12265 El Camino Real
` Suite 200
` San Diego, CA 92130
` Tel: (858) 314-1200
` Fax: (858) 314-1150
` aminsogna@jonesday.com
`
`
`
` Attorneys for Celgene Corporation
`
`Date: July 30, 2015
`
`04841-00006/7050187.1
`
`
`
`
`
`
`
`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
`________________
`
`
`CERTIFICATE OF SERVICE
`
`04841-00006/7050187.1
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certify that PATENT
`
`OWNER EXHIBIT LIST AS OF July 30, 2015 PURSUANT TO 37 C.F.R. §
`
`42.63(e) was served on July 30, 2015 by filing this document through the Patent
`
`Review Processing System, as well as e-mailing a copy to
`
`sarah.spires@skiermontpuckett.com, parvathi.kota@skiermontpuckett.com, and
`
`paul.skiermont@skiermontpuckett.com.
`
`
`
`Date: July 30, 2015
`
` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
`F. Dominic Cerrito (Reg. No. 38,100)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Anthony M. Insogna (Reg. No. 35,203)
`JONES DAY
`12265 El Camino Real
`Suite 200
`San Diego, CA 92130
`Tel: (858) 314-1200
`Fax: (858) 314-1150
`aminsogna@jonesday.com
`
`Attorneys for Celgene Corporation
`
`
`
` 04841-00006/7050187.1
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