`Tedd W. Van Buskirk
`908.518.6341
`tvanbuskirk@lernerdavid.com
`
`
`February 28, 2018
`
` (Electronically Filed)
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P O Box 1450
`Alexandria, VA 22313-1450
`
`Inter Partes Review IPR2018-00717 (U.S. Patent No. 9,492,393)
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`Dear Patent Trial and Appeal Board:
`
`This transmittal letter identifies Exhibits 1001-1068, being filed concurrently with
`the present Petition for Inter Partes Review. Pursuant to 37 C.F.R. § 42.6(e)(4)(ii), the
`Certificate of Service attached to the end of the Petition for Inter Partes Review filed
`herewith, incorporates Exhibits 1001-1068, as listed below:
`Exhibit # Reference
`U.S. Patent No. 9,492,393 (“the ’393 Patent”)
`
`1001
`U.S. Patent No. 1,479,293 (“the ’293 Patent”)
`1002
`
`Finding of Facts and Conclusion of Law, Purdue Pharma L.P. et al. v. Amneal
`1003
`
`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 IPR2016-01413 (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-oxycontin/
`
`1004
`1005
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`1006
`1007
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`1008
`1009
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`1010
`1011
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`1012
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 28, 2018
`Page 2
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`1021
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`Exhibit # Reference
`Harriet Ryan et al., ‘You want a description of hell?’ OxyContin’s 12-Hour
`
`1013
`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”)
`Complaint, Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals, LLC,
`No. 17-cv-00210 (D. Del. Mar. 1, 2017), ECF No. 1
`Declaration of Benjamin Oshlack (Exhibit 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. 14/729,660 (“the ’660 Application”)
`Serial No. 14/729,660, Non-Final Office Action, Sept. 11, 2015
`Serial No. 14/729,660, Amendment, December 11, 2015
`Declaration of Richard O. Mannion Under C.F.R. § 1.132, Mar. 27, 2015
`Serial No. 14/729,660, Supplemental Amendment, Feb. 16, 2016
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`1031
`1032
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`1034
`1035
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 28, 2018
`Page 3
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`Exhibit # Reference
`Serial No. 14/729,660, Final Rejection, Apr. 8, 2016
`
`1038
`Serial No. 14/729,660, Amendment After Final, June 3, 2016
`1039
`
`Serial No. 14/729,660, Notice of Allowance, June 29, 2016
`1040
`
`Mai et al., Effects of cold extrusion and heat treatment on the mechanical
`1041
`
`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
`OxyContin, Physician’s Desk Reference 2569-74 (53rd ed. 1999)
`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. 13/726,324 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
`U.S. Patent No. 9,492,392 (“the ’392 Patent”)
`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)
`Final Written Decision, Amneal v. Purdue, IPR2016-01028 (P.T.A.B. Nov. 8,
`2016), Paper No. 47
`Intentionally omitted
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`5335633_1.docx
`KASHIV 7.1R-005
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 28, 2018
`Page 4
`
`Exhibit # Reference
`Physicochemical properties and mechanism of drug release from ethyl cellulose
`
`1060
`matrix tablets prepared by direct compression and hot-melt extrusion, 269
`International Journal of Pharmaceutics (2004) 269, 509-522, at 515, Table 1
`(“Crowley”)
`U.S. Publication No. 2005/0233062 (“Hossainy”)
`U.S. Patent No. 5,160,743 (“Edgren”)
`US 2007/0190142 (“Breitenbach”)
`Orange Book on MS CONTIN
`Orange Book on ORAMORPH SR
`Orange Book on OPANA ER
`PDR MS CONTIN 2005
`PDR ORAMORPH SR 2005
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`1061
`1062
`1063
`1064
`1065
`1066
`1067
`1068
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`Respectfully submitted,
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`
`Tedd W. Van Buskirk
`Registration No. 46,282
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`
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`TVB/dmf
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`5335633_1.docx
`KASHIV 7.1R-005
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`