IPR2018-00625
`Patent No. 9,492,392
`Petitioner’s Updated Exhibit List
`Attorney Docket No. KASHIV 7.1R-004
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`KASHIV PHARMA, LLC,
`
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P.,
`THE P.F. LABORATORIES, INC., and
`PURDUE PHARMACEUTICALS L.P.,
`
`Patent Owners.
`____________________
`
`IPR2018-00625
`Patent No. 9,492,392
`
`__________________________________________________________________
`
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`5523961_1.docx
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petitioner’s Updated Exhibit List
`EXHIBIT LIST
`
`1004
`1005
`
`1008
`1009
`
`1010
`1011
`
`1012
`
`1006
`1007
`
`Exhibit # Reference
`U.S. Patent No. 9,492,392 (“the ’392 Patent”)
`1001
`1002
`U.S. Patent No. 1,479,293 (“the ’293 Patent”)
`Finding of Facts and Conclusion of Law, Purdue Pharma
`1003
`L.P. et al. v. Amneal Pharmaceuticals LLC, No. 13-cv-3372
`(S.D.N.Y. Apr. 8, 2015) (“SDNY Decision”)
`U.S. Patent No. 8,337,888 (“the ’888 Patent”)
`Patent Owners’ Resp. to Petition for Inter Partes Review Under 35
`U.S.C. § 313 and 37 C.F.R. § 42.107, Amneal v. Purdue,
`IPR2016-01027 (P.T.A.B. Feb. 8, 2017)
`U.S. Patent No. 9,060,976 (“the ’976 Patent”)
`Patent Owners’ Resp. to Petition for Inter Partes Review Under 35
`U.S.C. § 313 and 37 C.F.R. § 42.107, Amneal v. Purdue
`IPR20016-01413 (P.T.A.B. Apr. 10, 2017)
`U.S. Patent No. 9,034,376
`Finding of Facts and Conclusion of Law, Purdue Pharma
`L.P. et al. v. Teva Pharms. USA, Inc., No. 11-cv-2037, 11-cv-5083
`(S.D.N.Y. Jan. 14, 2014) (“SDNY II”), aff’d 2014-1306, -1307 (Fed.
`Cir. Feb. 1, 2016)
`U.S. Patent No. 8,114,383 (“the ’383 Patent”)
`Patrick Radden Keefe, The Family that Built an Empire of Pain, The
`New Yorker, Oct. 30, 2017
`Christopher Glazek, The Secretive Family Making Billions from the
`Opioid Crisis (Oct. 16, 2017),
`http://www.esquire.com/news-politics/a12775932/sackler-family-oxy
`contin/
`Harriet Ryan et al., ‘You want a description of hell?’ OxyContin’s
`12-Hour Problem (May 5, 2016),
`http://www.latimes.com/projects/oxycontin-part1/
`Harriet Ryan et al., More than 1 million OxyContin pills ended up in
`the hands of criminals and addicts. What the drugmaker knew
`(July 10, 2016),
`http://www.latimes.com/projects/la-me-oxycontin-part2/
`Harriet Ryan et al., OxyContin goes global ____ “We’re only just
`getting started” (Dec. 18, 2016),
`http://www.latimes.com/projects/la-me-oxycontin-part3/
`U.S. Patent No. 5,508,042 (“Oshlack 1”)
`U.S. Patent Publication No. 2003/0068375 (“Wright”)
`
`1013
`
`1014
`
`1015
`
`1016
`1017
`
`
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petitioner’s Updated Exhibit List
`
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`Exhibit # Reference
`Complaint, Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals,
`1018
`LLC, No. 17-cv-00210 (D. Del. Mar. 1, 2017), ECF No. 1
`Declaration of Benjamin Oshlack (Ex. 2097 in IPR2016-01027
`and -01028)
`Complaint, Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals,
`LLC, No. 15-cv-01152 (D. Del. Dec. 15, 2015, ECF No. 1)
`Complaint, Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals,
`LLC, No. 17-cv-01421 (D. Del. Oct. 10, 2017, ECF No. 1)
`Complaint, Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals,
`LLC, No. 18-cv-00051 (D. Del. Jan. 3, 2018, ECF No. 1)
`Complaint, Purdue Pharma L.P. et al. v. Kashiv Pharma, LLC,
`No. 18-cv-00052 (D. Del. Jan. 3, 2018, ECF No. 1)
`U.S. Publication No. 2005/0031546 (“Bartholomaus”)
`U.S. Patent No. 6,488,963 (“McGinity”)
`U.S. Publication No. 2004/0170680 (“Oshlack 2”)
`U.S. Patent No. 5,273,758 (“Royce”)
`Antonio Moroni & Isaac Ghebre-Sellassie, Application of
`Poly(Oxyethylene) Homopolymers in Sustained Release Solid
`Formulations, 21(12) Drug Development & Industrial Pharmacy
`(1995), at 1411-28 (“Moroni”)
`Zezhi J. Shao et al., Effects of Formulation Variables and
`Post-compression Curing on Drug Release from a New
`Sustained-Release Matrix Material: Polyvinylacetate-Povidone, 6(2)
`Pharmaceutical Development & Technology (2001), at 247-54
`(“Shao”)
`Declaration of Hossein Omidian, Ph.D. (“Omidian Declaration”)
`Curriculum Vitae of Hossein Omidian, PhD
`U.S. Provisional Application No. 60/840,244
`U.S. Patent Application No. 14/729,634 (“the ’634 Application”)
`Serial No. 14/729,634, Non-Final Office Action, August 27, 2015
`Serial No. 14/729,634, Amendment, November 18, 2015
`Declaration of Richard O. Mannion Under C.F.R. § 1.132, March 27,
`2015
`Serial No. 14/729,634, Supplemental Amendment, February 16, 2016
`Serial No. 14/729,634, Final Office Action, May 24, 2016
`Serial No. 14/729,634, Amendment After Final, June 3, 2016
`Serial No. 14/729,634, Notice of Allowability
`
`1024
`1025
`1026
`1027
`1028
`
`1029
`
`1030
`1031
`1032
`1033
`1034
`1035
`1036
`
`1037
`1038
`1039
`1040
`
`
`
`
`2
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petitioner’s Updated Exhibit List
`
`
`1042
`
`1043
`
`1044
`1045
`1046
`1047
`1048
`1049
`
`1050
`
`Exhibit # Reference
`1041 Mai et al., Effects of cold extrusion and heat treatment on the
`mechanical properties of polypropylene, 15(86) Matériaux et
`Constructions (1982), at 99-106
`Hatim S. AlKhatib et al., Effects of Thermal Curing Conditions on
`Drug Release from Polyvinyl Acetate-Polyvinyl Pyrrolidone
`Matrices, 11(1) AAPS PharmSciTech (Mar. 2010), at 253-66
`Patience Mpofu et al., Temperature influence of nonionic
`polyethylene oxide and anionic polyacrylamide on flocculation and
`dewatering behavior of kaolinite dispersions, 271 J. of Colloid &
`Interface Sci. (Mar. 2004), at 145-56
`1999 PDR - OxyContin
`Dow 2002 product catalog
`Dow 2004 product catalog
`Handbook of pharmaceutical excipients
`U.S. Pub. No. 2004/0037883 (“Zhou”)
`A. Apicella et al., Poly(ethylene oxide) (PEO) and different
`molecular weight PEO blends monolithic devices for drug release
`14(2) Biomaterials (1993), at 83-90
`Omelczuk et al., The influence of thermal treatment on the
`physical-mechanical and dissolution properties of tablets containing
`poly(DL-lactic acid Pharmaceutical Research, Vol. 10, No. 4 (1993)
`U.S. Patent No. 5,639,476 (“Oshlack 3”)
`Kurt H. Bauer et al., Coated Pharmaceutical Dosage Forms,
`Scientific Publishers Stuffgart (1998), at 86-87
`Serial No. 14/729,634 Suppl. Prelim. Amendment, Jan. 23, 2013
`Decision, Institution of Inter Partes Review 37 C.F.R. § 42.108,
`Amneal v. Purdue, IPR2016-01027 (P.T.A.B. Nov. 9, 2016), Paper
`No. 13
`Final Written Decision, Amneal v. Purdue, IPR2016-01028 (P.T.A.B.
`Nov. 8, 2016), Paper No. 47
`Final Written Decision, Amneal v. Purdue, IPR2016-01027 (P.T.A.B.
`Nov. 8, 2016), Paper No. 48
`Johannes Bartholomäus, PhD et al., New Abuse Deterrent
`Formulation (ADF) Technology for Immediate-Release Opioids,
`Abuse Deterrent Technology, 13(8) Drug Development & Delivery
`(October 2013)
`Intentionally left blank
`
`1051
`1052
`
`1053
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`
`
`
`3
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petitioner’s Updated Exhibit List
`
`
`Exhibit # Reference
`Intentionally left blank
`1059
`Physicochemical properties and mechanism of drug release from
`1060
`ethyl cellulose matrix tablets prepared by direct compression and
`hot-melt extrusion, 269 International Journal of Pharmaceutics
`(2004) 269, 509-522 (“Crowley”)
`U.S. Publication No. 2005/0233062 (“Hossainy”)
`U.S. Patent No. 5,160,753 (“Edgren”)
`US 2007/0190142 (“Breitenbach”)
`Intentionally left blank
`Intentionally left blank
`Intentionally left blank
`Intentionally left blank
`Intentionally left blank
`Intentionally left blank
`Amneal Pharmaceuticals, Inc. Form S-1, May 9, 2018
`
`1061
`1062
`1063
`1064
`1065
`1066
`1067
`1068
`1069
`1070
`
`
`Respectively submitted,
`
`Dated:
`
`July 10, 2018
`
`
`
`
`
`
`
`5523961_1.docx
`
`By: s/ Tedd Van Buskirk /
`Tedd W. Van Buskirk
`Reg. No. 46,282
`
`
`
`
`
`
`
`4
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`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petitioner’s Updated Exhibit List
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies
`that a copy of
`
`the
`
`foregoing
`
`PETITIONER’S UPDATED EXHIBIT LIST was served on July 10, 2018, as
`
`follows.
`
`VIA E-MAIL
`Gasper J. LaRosa, Esq. (gjlarosa@jonesday.com)
`Kelsey I. Nix, Esq. (knix@jonesday.com)
`Pablo D. Hendler, Esq. (phendler@jonesday.com)
`Kenneth S. Canfeld, Esq. (kcanfield@jonesday.com)
`Sarah A. Geers, Esq. (sgeers@jonesday.com)
`Christopher J. Harnett, Esq. (charnett@jonesday.com)
`Lisamarie LoGiudice, Esq. (llogiudice@jonesday.com)
`
`
`
`
`
`
`Dated:
`
`July 10, 2018
`
`
`
`
`
`By: s/ Tedd Van Buskirk /
`Tedd W. Van Buskirk
`Reg. No. 46,282
`
`
`
`5523961_1.docx
`
`
`
`
`