Paper No. __
`Filed: August 19, 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 IPR2015-01169
`Patent 5,635,517
`________________
`
`PATENT OWNER EXHIBIT LIST AS OF
`August 19, 2015 PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`
`
`
`
`
`

`
`Case IPR2015-01169
`Patent 5,635,517
`Patent Owner’s Exhibit List
`
`
`
`
`EXHIBIT
`NO.
`
`Exhibit 2001
`
`DESCRIPTION
`
`Dr. V. Pannikar, WHO, “The Return of Thalidomide:
`New Uses and Renewed Concerns.”
`
`Exhibit 2002 FDA website, “About the FDA;” (2014).
`
`Exhibit 2003
`
`Exhibit 2004
`
`Exhibit 2005
`
`Smith, R.L. et al. “Studies on the Relationship Between the
`Chemical Structure and Embryotoxic Activity of Thalidomide and
`Related Compounds;” (1965).
`Jonsson, N. Ake, “Chemical structure and teratogenic properties”
`(1972).
`Powell, R.J. “New roles for thalidomide: A unique anti-
`inflammatory, but use it only when no alternatives exist;” (1996).
`
`Exhibit 2006
`
`‘517 File History, Notice of References Cited (1997).
`
`Exhibit 2007
`
`‘517 File History, Information Disclosure Citation (1997).
`
`Exhibit 2008 U.S. Patent No. 5,712,291 (1998).
`
`Exhibit 2009
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`Intentionally left blank
`
`Exhibit 2010
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`Exhibit 2011
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`Exhibit 2012
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`Exhibit 2013
`
`Exhibit 2014
`
`Exhibit 2015
`
`Exhibit 2016
`
`Janeway, Charles, et al. “Immuno Biology 5: The Immune System
`in Health and Diseases;” (2001).
`Medzhitov, Ruslan “Origin and physiological roles of
`inflammation;” (2008).
`Bedarida, Gabriella, et al. “Pharmacodynamics and Drug Action
`H1- and H2-hystamine receptor – mediated vasodilation varies with
`aging in humans;” (1995).
`Van Nueten, J.M., et al. “Serotonin and Vascular Reactivity;”
`(1985).
`Swartz, Stephen “The Role of Prostaglandins in Mediating the
`Effects of Angiotensin Converting Enzyme Inhibitors and Other
`Antihypertensive Drugs;” (1987).
`Bode-Boger, Stefanie, et al. “L-Arginine Induces Nitric Oxide–
`Dependent Vasodilation in Patients With Critical Limb Ischemia;”
`(1996).
`Larkin, S.W. et al. “Prolonged Microvascular Vasodilation
`Induced by Leukotriene B4 in Human Skin Is Cyclooxygenase
`Independent;” (1995).
`
`
`
`

`
`Case IPR2015-01169
`Patent 5,635,517
`Patent Owner’s Exhibit List
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`Exhibit 2017 Bateman, Adrian “Flesh and Bones of Pathology;” (2009).
`
`Exhibit 2018
`
`Exhibit 2019
`
`Exhibit 2020
`
`Exhibit 2021
`
`Exhibit 2022
`
`Exhibit 2023
`
`Exhibit 2024
`
`Krishnamoorthy, Sriram “Inflammation and disease progression;”
`(2006).
`Bouwmeester, Tewis et al. “A physical and functional map of the
`human TNF-α/NF-κB signal transduction pathway;” (2004).
`Page, Theresa et al. “Nonsteroidal Anti-Inflammatory Drugs
`Increase TNF Production in Rheumatoid Synovial Membrane
`Cultures and Whole Blood;” (2010).
`Vane, J.R., et al. “Mechanism of Action of Anti-Inflammatory
`Drugs;” (1996).
`Kurumbail, G., et al. “Structural basis for selective inhibition of
`cyclooxygenase-2 by anti-inflammatory agents;” (1996).
`Marie, C., et al. “Regulation by anti-inflammatory cytokines (IL-4,
`IL-IO, IL-13, TGF) of interleukin-8 production by LPS and/or
`TNFα-activated human polymorphonuclear cells;” (1996).
`Trepicchio, William, et al. “Recombinant Human IL-11 Attenuates
`the Inflammatory Response Cytokine Through Down-Regulation
`of Proinflammatory Release and Nitric Oxide Production;” (1996).
`
`Exhibit 2025 Patrick, Graham, “Drug Development;” (1995).
`
`Exhibit 2026
`
`Exhibit 2027
`
`Exhibit 2028
`
`Exhibit 2029
`
`Exhibit 2030
`
`Exhibit 2031
`
`Partial Testimony of Dr. Clayton Heathcock, Ph.D., In Re
`OxyContin Antitrust Litigation (2013).
`Testimony of Defendants’ Expert Witness, Clayton H. Heathcock,
`Ph.D., Astrazeneca UK Limited et al. v. Watson Laboratories, Inc.
`et al. (2012).
`Hastings, R.C. et al., “Thalidomide analogs with potential activity
`in erythema nodosum leprosum;” (1979).
`Hastings, Robert, “Kellersberger Memorial Lecture 1979:
`Immunosuppressive/Anti—Inflammatory Thalidomide
`Analogues;” (1980).
`Henderson, Andrew, et al. “C/EBP Activators Are Required for
`HIV-1 Replication and Proviral Induction in Monocytic Cell
`Lines;” (1996).
`Herbein, Georges, et al. “The macrophage in HIV-1 infection:
`From activation to deactivation?;” (2010).
`
`Exhibit 2032 Kalebic, Thea, et al. “Suppression of human immunodeficiency
`
`
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`

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`Case IPR2015-01169
`Patent 5,635,517
`Patent Owner’s Exhibit List
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`virus expression in chronically infected monocytic cells by
`glutathione, glutathione ester, and N-acetylcysteine” (1991).
`
`Exhibit 2033 Scifinder, “Thalidomide”
`
`Sekut, L., et al. “Anti-inflammatory activity of salmeterol: down-
`regulation of cytokine production;” (1995).
`Smith, Carla, et al. “Cyclosporin a Blocks Induction of Tumor
`Necrosis Factor-Alpha in Human B Lymphocytes;” (1994).
`Crutchley, David, et al. “Effects of Prostacyclin Analogs on the
`Synthesis of Tissue Factor, Tumor Necrosis Factor-α and
`Interleukin-1β in Human Monocytic THP-1 Cells1;” (1994).
`Olivera, D.L., et al. “Effects of pyridinyl imidazole compounds on
`murine TNF-α production;” (1993).
`Rordorf-Adam, C. et al, “CGP 47969A: A novel inhibitor of the
`synthesis of inflammatory cytokines;” (1994).
`Helm, F., et al. “Comparative Teratological Investigation of
`Compounds structurally and pharmacologically Related to
`Thalidomide;” (1981).
`Barnhill, Raymond, et al. “Thalidomide: Use and possible mode of
`action in reactional lepromatous leprosy and in various other
`conditions;” (1982).
`Schmahl, H.J. et al. “Pharmacokinetics of the Teratogenic and
`Nonteratogenic Thalidomide Analogs EM 12 and Supidimide in
`the Rat and Marmoset Monkey;” (1987).
`Hassan, Khairy, et al. “Antiinflammatory-Immunosuppressive
`Thalidomide Analogs;” (1981).
`King, Barry, et al. “Antiinflammatory-Immunosuppressive
`Thalidomide Analogs;” (1985).
`Sheskin, J., et al. “Trials with Thalidomide Derivatives in Leprosy
`Reactions;” (1968).
`Bruns, Robert, et al. “Rules for Identifying Potentially Reactive or
`Promiscuous Compounds;” (2012).
`Committee on Amines “Aromatic Amines: An Assessment of the
`Biological and Environmental Effects;” (1981).
`Uetrecht, Jack “Reactivity and Possible Significance of
`Hydroxylamine and Nitroso Metabolites of Procainamide:” (1985).
`
`Exhibit 2034
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`Exhibit 2035
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`Exhibit 2036
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`Exhibit 2037
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`Exhibit 2038
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`Exhibit 2039
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`Exhibit 2040
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`Exhibit 2041
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`Exhibit 2042
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`Exhibit 2043
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`Exhibit 2044
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`Exhibit 2045
`
`Exhibit 2046
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`Exhibit 2047
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`
`
`

`
`Case IPR2015-01169
`Patent 5,635,517
`Patent Owner’s Exhibit List
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`Exhibit 2048 Selleckchem.com “Pomadlidomide Datasheet.”
`
`Exhibit 2049 Pomalyst® July 2014 Product Information
`
`Exhibit 2050
`
`Exhibit 2051
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`Exhibit 2052
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`Exhibit 2053
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`Exhibit 2054
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`Exhibit 2055
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`Exhibit 2056
`
`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 2057 January 2014 Spangenberg/IPNav email threatening IPRs
`
`Exhibit 2058
`
`Exhibit 2059
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`Exhibit 2060
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`Exhibit 2061
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`Exhibit 2062
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`Exhibit 2063
`
`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
`
`Exhibit 2064 January 2014 Spangenberg/IPNav patent family tree
`
`Exhibit 2065 July 2014 IRDP email threatening IPRs
`
`Exhibit 2066 July 2014 IRDP threatened ’501 patent IPR petition
`
`Exhibit 2067 July 2014 IRDP threatened ’501 patent IPR declaration
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`
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`

`
`Case IPR2015-01169
`Patent 5,635,517
`Patent Owner’s Exhibit List
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`Exhibit 2068 July 2014 IRDP threatened ’720 patent obviousness IPR petition
`
`Exhibit 2069
`
`July 2014 IRDP threatened ’720 patent obviousness IPR
`declaration
`
`Exhibit 2070 July 2014 IRDP threatened ’720 patent anticipation IPR petition
`
`Exhibit 2071
`
`July 2014 IRDP threatened ’720 patent anticipation IPR
`declaration
`
`Exhibit 2072 July 2014 IRDP patent family tree
`
`Exhibit 2073
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`Exhibit 2074
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`Exhibit 2075
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`Exhibit 2076
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`Exhibit 2077
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`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).
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`

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`Case IPR2015-01169
`Patent 5,635,517
`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: August 19, 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 IPR2015-01169
`Patent 5,635,517
`________________
`
`
`CERTIFICATE OF SERVICE
`
`
`
`

`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certify that PATENT
`
`OWNER EXHIBIT LIST AS OF August 19, 2015 PURSUANT TO 37 C.F.R. §
`
`42.63(e) was served on August 19, 2015 by filing this document through the Patent
`
`Review Processing System, as well as e-mailing a copy to
`
`jblake@merchantgould.com, delhioum@merchantgould.com,
`
`rfletcher@merchantgould.com, broutman@merchantgould.com, and
`
`RevlimidIPR@merchantgould.com.
`
`Date: August 19, 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