IPR2018-00717
`Patent No. 9,492,393
`Petition for Inter Partes Review
`Attorney Docket No. KASHIV 7.1R-005
`
`
`
`
`
`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.
`
`Patent No. 9,492,393 to McKenna et al.
`Issue Date: November 15, 2016
`Title: TAMPER RESISTANT DOSAGE FORMS
`____________________________
`
`Inter Partes Review No. IPR2018-00717
`__________________________________________________________________
`
`PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 9,492,393
`
`
`

`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ................................................................................... iii
`
`EXHIBIT LIST ........................................................................................................ iv
`
`TABLE OF ABBREVIATIONS ........................................................................... viii
`
`I.
`
`II.
`
`OVERVIEW .................................................................................................... 1
`
`REQUIREMENTS FOR PETITION
`FOR INTER PARTES REVIEW ...................................................................... 3
`
`A. Notice Of Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) .............. 4
`
`B. Notice Of Related Matters (37 C.F.R. § 42.8(b)(2)) ................................ 4
`
`C. Designation Of Lead And Backup
`Counsel (37 C.F.R. § 42.8(b)(3)) .............................................................. 5
`
`D. Notice Of Service Information (37 C.F.R. § 42.8(b)(4)) .......................... 6
`
`E. Grounds For Standing (37 C.F.R. § 42.104(a)) ........................................ 6
`
`III.
`
`IDENTIFICATION OF THE CLAIMS
`BEING CHALLENGED (37 C.F.R. § 104(B)) .............................................. 6
`
`IV. SUMMARY OF THE ARGUMENT .............................................................. 7
`
`V.
`
`SUMMARY OF THE ’393 PATENT ............................................................. 9
`
`VI. PERTINENT PROSECUTION
`HISTORY OF THE ’393 PATENT ..............................................................11
`
`VII. PURDUE DID NOT DEMONSTRATE AN UNEXPECTED
`DENSITY DECREASE OR A SUPERIOR RESULT .................................13
`
`A. The Mannion Declaration And ’393 Patent
`Examples Do Not Establish A Density Decrease To POSAs .................13
`
`B. Density Is Not A Superior Result ...........................................................16
`
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`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`C. Purdue’s Evidence Is Not Commensurate
`With The Scope Of The Claims ..............................................................18
`
`VIII. PERSON OF ORDINARY SKILL IN THE ART ........................................19
`
`IX. CLAIM CONSTRUCTION ..........................................................................20
`
`A. “Compression Shaped” And “Compression” .........................................20
`
`B. “Air Cured” And “Curing” .....................................................................20
`
`C. “Optionally” ............................................................................................21
`
`D. “Total Combined Weight Of Said High
`And Low Molecular Weight PEO” .........................................................21
`
`E. “Selected From The Group Consisting Of
`4,000,000; 7,000,000; And A Combination Thereof” ............................22
`
`F. Product-By-Process Limitations .............................................................23
`
`X.
`
`TECHNICAL BACKGROUND AND STATE OF THE ART ....................24
`
`XI. THE CHALLENGED CLAIMS ARE
`OBVIOUS OVER THE PRIOR ART ...........................................................26
`
`A. Legal Background ...................................................................................27
`
`B. Ground 1: Oshlack 1 (Ex. 1016) In View Of
`Bartholomaus (Ex. 1024), McGinity (Ex. 1025),
`And Oshlack 2 (Ex. 1026) ........................................................................29
`
`C. Ground 2: The Challenged Claims Are Obvious
`Over Wright (Ex. 1017) In View Of Royce (Ex. 1027),
`Moroni (Ex. 1028), And Shao (Ex. 1029) .................................................43
`
`XII. CLAIMS CHART ..........................................................................................54
`
`XIII. SECONDARY CONSIDERATIONS ...........................................................60
`
`XIV. CONCLUSION ..............................................................................................63
`
`
`
`
`
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`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`TABLE OF AUTHORITIES
`
` PAGE(S)
`
`CASES
`Alcon Research, LTD. v. Apotex Inc.,
`687 F.3d 1362 (Fed. Cir. 2012) ......................................................................... 28
`In re Aller,
`220 F.2d 454 (C.C.P.A. 1955) ...................................................................... 27, 29
`Asyst Techs., Inc. v. Emtrak, Inc.,
`544 F.3d 1310 (Fed. Cir. 2008) ........................................................................... 2
`In re Baxter Travenol Labs,
`952 F.2d 388 (Fed. Cir. 1991) ........................................................................... 13
`Cadence Pharms., Inc. v. Exela PharmSci Inc.,
`780 F.3d 1364 (Fed. Cir. 2015) ......................................................................... 21
`Cuozzo Speed Techs., L.L.C. v. Lee,
`136 S. Ct. 2131 (2016) ...................................................................................... 20
`In re DBC,
`545 F.3d 1373 (Fed. Cir. 2008) ......................................................................... 62
`Galderma Labs., L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) ....................................................................... 17, 1
`Hoffmann La. Roche, Inc. v. Apotex Inc.,
`748 F.3d 1326 (Fed. Cir. 2014) ......................................................................... 60
`In re Geisler,
`116 F.3d 1465 (Fed. Cir. 1997) ......................................................................... 28
`In re Harris,
`409 F.3d 1339 (Fed. Cir. 2005) ......................................................................... 17
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ......................................................................... 29
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) ......................................................................... 62
`
`
`
`
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`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .................................................................................... 27, 28
`Merck & Cie v. Gnosis S.p.A.,
`808 F.3d 829 (Fed. Cir. 2015) ........................................................................... 27
`In re Merck & Co.,
`800 F.2d 1091 (Fed. Cir. 1986) ........................................................................... 1
`Merck & Co. v. Teva Pharms. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) ........................................................................... 3
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) ......................................................................... 19
`Newell Cos. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ........................................................................... 60
`In re Nordt Dev. Co., LLC,
`No. 2017-1445, 2018 U.S. App. LEXIS 3039
`(Fed. Cir. Feb. 8, 2018) ........................................................................................ 23
`Ohio Willow Wood Co. v. Alps S., L.L.C.,
`735 F.3d 1333 (Fed. Cir. 2013) ........................................................................... 1
`Par Pharm., Inc. v. TWi Pharms., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) ......................................................................... 28
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) ......................................................................... 60
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) .......................................................................................... 28
`In re Soni,
`54 F.3d 746 (Fed. Cir. 1995) ....................................................................... 16, 61
`Steadymed Ltd. v. United Therapeutics Corp.,
`IPR2016-00006, Paper 82, Final Written Decision (Mar. 31, 2017) .................. 16
`In re Thorpe,
`777 F.2d 695 (Fed. Cir. 1985) ........................................................................... 24
`
`
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`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`In re Tiffin,
`448 F.2d 791 (1971) .......................................................................................... 18
`Titanium Metals Corp. v. Banner,
`778 F.2d 775 (Fed. Cir. 1985) ........................................................................... 28
`In re Wertheim,
`541 F.2d 257 (1976) .......................................................................................... 28
`
`STATUES, RULES & OTHER AUTHORITIES
`35 U.S.C. § 103(a) .................................................................................................. 27
`37 C.F.R. § 42.100(b) .............................................................................................. 20
`37 C.F.R. § 42.104(b)(4) .......................................................................................... 27
`
`
`
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`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`EXHIBIT LIST
`
`1004
`1005
`
`1006
`1007
`
`1008
`1009
`
`1010
`1011
`
`1012
`
`1013
`
`1014
`
`Exhibit # Reference
`U.S. Patent No. 9,492,393 (“the ’393 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
`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-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”)
`
`1015
`
`1016
`
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`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`1019
`
`1020
`
`1021
`
`1022
`
`Exhibit # Reference
`U.S. Patent Publication No. 2003/0068375 (“Wright”)
`1017
`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 (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
`Serial No. 14/729,660, Final Rejection, Apr. 8, 2016
`Serial No. 14/729,660, Amendment After Final, June 3, 2016
`
`1030
`1031
`1032
`1033
`1034
`1035
`1036
`
`1023
`
`1024
`1025
`1026
`1027
`1028
`
`1029
`
`1037
`1038
`1039
`
`vii
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`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`1042
`
`1043
`
`1044
`1045
`1046
`1047
`1048
`1049
`
`Exhibit # Reference
`Serial No. 14/729,660, Notice of Allowance, June 29, 2016
`1040
`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
`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)
`
`1050
`
`1051
`1052
`
`1053
`1054
`
`1055
`1056
`
`1057
`
`viii
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`

`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`1059
`1060
`
`Exhibit # Reference
`Final Written Decision, Amneal v. Purdue, IPR2016-01028 (P.T.A.B.
`1058
`Nov. 8, 2016), Paper No. 47
`Intentionally omitted
`Physicochemical properties and mechanism of drug release from
`ethyl cellulose 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”)
`1061
`U.S. Patent No. 5,160,743 (“Edgren”)
`1062
`US 2007/0190142 (“Breitenbach”)
`1063
`1064 MS CONTIN, Approved Drug Products with Therapeutic
`Equivalence Evaluations (“Orange Book”), 3-299 (38th ed. 2018)
`ORAMORPH SR, Approved Drug Products with Therapeutic
`Equivalence Evaluations (“Orange Book”), 6-258 (38th ed. 2018)
`OPANA ER, Approved Drug Products with Therapeutic Equivalence
`Evaluations (“Orange Book”), 6-277 (38th ed. 2018)
`1067 MS CONTIN, Physician’s Desk Reference 2807-2809 (59th ed. 2005)
`ORAMORPH SR Physician’s Desk Reference 404-406 (59th ed.
`1068
`2005)
`
`1065
`
`1066
`
`ix
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`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`Pursuant to 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42, Kashiv Pharma, LLC
`
`(“Kashiv” or “Petitioner”) petitions for Inter Partes Review (“IPR”) seeking
`
`cancellation of claims 1-3, 5, 7-8, 11-13, 15, 18-21, 25, 27, 29 (the “challenged
`
`claims”) of the ’393 Patent (Ex. 1001), which according to USPTO records is
`
`assigned to Purdue.
`
`I.
`
`OVERVIEW
`Opioids have been given to patients to treat pain for centuries. Oxycodone is
`
`one such opioid analgesic. It was invented about 100 years ago (Ex. 1002) and has
`
`been given for pain ever since. Extended release opioids, including oxycodone are
`
`also well known.
`
`The FDA approved Purdue’s MS CONTIN (“CONTIN” meaning
`
`“continuous”)
`
`in
`
`the
`
`late 1980s ____ an extended release morphine sulfate
`
`formulation given twice-a-day to treat pain. (Exs. 1064; 1067.) ORAMORPH SR
`
`is a second morphine sulfate tablet approved in 2001 given to patients 2 to 3 times
`
`a day. (Exs. 1065; 1068.) Opana ER, an extended release tablet containing
`
`oxymorphone given every 12 hours, was FDA approved in June 2006. (Ex. 1066.)
`
`And original OxyContin ____ an extended release oxycodone tablet administered
`
`twice-a-day to patients in pain ____ was approved in 1995. (Ex. 1005, at 6-7.) So
`
`
`
`
`
`

`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`twice-a-day administration of opioids to patients in pain, even oxycodone, was
`
`well known before the August 2006 filing date of the ’393 Patent.
`
`Even the patent literature disclosed twice-daily administration of oxycodone
`
`for treating pain. Purdue has admitted that twice-a-day extended release tablets
`
`containing therapeutic amounts of oxycodone are disclosed in U.S. 5,508,042.
`
`(Exs. 1016 Examples 3, 4, cls. 1, 2; 1019 ¶ 6.) Purdue’s later-filed Wright family
`
`also disclosed and claimed twice-daily extended release oxycodone tablets, and
`
`Purdue acknowledged that this family also covers commercial OxyContin.
`
`(Exs. 1017 ¶¶ [0026], [0041], [0063], [0189]; 1004 cls. 1, 2, 8, 12; 1006 cl. 1; 1008
`
`cls. 1, 11, 18-19.) Finally, Bartholomeus, owned by Grünenthal GmbH, discloses
`
`twice-daily oxycodone. (Exs. 1024¶¶ [0016], [0101], [0136]-[0138], Example 6;
`
`Ex. 1009 73-74.) Clearly, treating patients in pain by administering oxycodone
`
`twice daily was well known.
`
`And yet claim 1 of the ’393 Patent purports to cover that exact method, “[a]
`
`method of treating pain comprising administering to a patient in need thereof a
`
`pharmaceutical tablet comprising:…said tablet provides a dosage form for
`
`twice-daily extended release administration of oxycodone or a pharmaceutically
`
`acceptable salt thereof.” (Ex. 1001 cl. 1.)
`
`The sole difference ____ and it is an obvious difference as explained
`
`herein ____ between this claimed method and those that came before resides in the
`
`2
`
`

`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`specific construction of the claimed tablet and the method steps used to produce it.
`
`But, by 2006, wasn’t it obvious to use any tablet capable of delivering a
`
`therapeutic dose of oxycodone twice-daily in that same treatment method?
`
`Otherwise, what is the difference between the ’393 Patent and Purdue’s U.S. Patent
`
`No. 9,492,392, which claims, almost word for word, the very tablet “used” in the
`
`method claimed in the ’393 Patent? (Compare Exs. 1001 cl. 1 and 1055 cl. 1.) If
`
`Purdue has already been rewarded for that tablet formulation ____ a tablet which is
`
`also obvious for the reasons explained in IPR IPR2018-00625, filed February 27,
`
`2018, and the method of its use is disclosed in the art or obvious from it, these
`
`claims cannot stand. Here, the tablet is not patentable, it adds nothing unobvious to
`
`the claimed method, and the method is known. The challenged claims are therefore
`
`obvious under 35 U.S.C. § 103(a).
`
`II. REQUIREMENTS FOR PETITION FOR INTER PARTES REVIEW
`Pursuant to 37 C.F.R. § 42.22(a), the information presented establishes a
`
`reasonable likelihood that Petitioner will prevail with respect to at least one of the
`
`claims challenged herein. Accordingly, Petitioner requests institution of an IPR
`
`and cancellation of the challenged claims 1-3, 5, 7-8, 11-13, 15, 18-21, 25, 27,
`
`and 29 of the ’393 Patent. The text of claim 1 is included in the claim chart in
`
`Part XII below.
`
`3
`
`

`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`A. Notice Of Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`Petitioner is the real party-in-interest for this proceeding.
`
`B. Notice Of Related Matters (37 C.F.R. § 42.8(b)(2))
`The ’393 Patent and U.S. Patent No. 9,492,392 are asserted in a civil action
`
`pending in the United States District Court for the District of Delaware captioned
`
`Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, 17-cv-00210, filed
`
`March 1, 2017. (Ex. 1018.) Amneal has filed a motion under Fed. R. Civ. P. 25(c)
`
`in that proceeding to substitute Kashiv for itself.
`
`Seven family members of the ’393 Patent (U.S. Patent Nos. 8,808,741;
`
`8,894,987; 8,894,988; 9,763,933; 9,763,886; 9,770,416; and 9,775,808) are
`
`asserted against Petitioner and/or Amneal in civil actions pending in the United
`
`States District Court for the District of Delaware captioned Purdue Pharma
`
`L.P. et al. v. Amneal Pharmaceuticals LLC, 15-cv-01152, 17-cv-01421, and
`
`18-cv-00051 (Exs. 1020, 1021, 1022) and Purdue Pharma L.P. et al. v. Kashiv
`
`Pharma, LLC 18-cv-00052 (Ex. 1023).
`
`Petitioner has also filed IPR No. IPR2018-00625 seeking cancellation of the
`
`corresponding claims of U.S. Patent No. 9,492,392, which is another member of
`
`this patent family.
`
`The Board (Judges Green, Paulraj, and Harlow) has already considered
`
`Purdue patents directed to OxyContin in IPR2016-01027 and -01028, where the
`
`4
`
`

`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`Board held U.S. Patent No. 9,060,976 invalid, and in IPR2016-01412 and -01413
`
`regarding U.S. Patent No. 9,034,376, where Final Written Decisions are presently
`
`under seal. The ’976 and ’376 Patents are not family members but contain related
`
`subject matter and are prior art cited herein.
`
`C. Designation Of Lead And Backup Counsel (37 C.F.R. § 42.8(b)(3))
`Pursuant to 37 C.F.R. §§ 42.8(b)(3), 42.8(b)(4), and 42.10(a), Petitioner
`
`provides the following designation of Lead and Back-Up counsel:
`
`Lead Counsel:
`Tedd W. Van Buskirk
`(Reg. No. 46,282)
`tvanbuskirk@lernerdavid.com
`litigation@lernerdavid.com
`Lerner, David, Littenberg,
` Krumholz & Mentlik, LLP
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.654.5000
`Fax: 908.654.7866
`
`
`
`
`Backup Counsel:
`Michael H. Teschner
`(Reg. No. 32,862)
`MTeschner.ipr@ldlkm.com
`litigation@lernerdavid.com
`Lerner, David, Littenberg,
` Krumholz & Mentlik, LLP
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.654.5000
`Fax: 908.654.7866
`Nichole M. Valeyko
`(Reg. No. 55,832)
`nvaleyko@lernerdavid.com
`litigation@lernerdavid.com
`Lerner, David, Littenberg,
` Krumholz & Mentlik, LLP
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.654.5000
`Fax: 908.654.7866
`MFuller.ipr@ldlkm.com
`litigation@lernerdavid.com
`Lerner, David, Littenberg,
` Krumholz & Mentlik, LLP
`
`5
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`

`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.654.5000
`Fax: 908.654.7866
`D. Notice Of Service Information (37 C.F.R. § 42.8(b)(4))
`Please address all correspondence to the lead and backup counsel at the
`
`address shown above. Petitioner consents to electronic service by e-mail at the
`
`above-listed e-mail addresses.
`
`E. Grounds For Standing (37 C.F.R. § 42.104(a))
`Petitioner certifies that the ’393 Patent is available for IPR and that
`
`Petitioner is not barred or estopped from requesting IPR of its challenged claims.
`
`The fee for this Petition has been paid. The Office is hereby authorized to charge
`
`any fee deficiencies, or credit any overpayments, to Deposit Account No. 12-1095
`
`in connection with this Petition.
`
`III.
`
`IDENTIFICATION OF THE CLAIMS
`BEING CHALLENGED (37 C.F.R. § 104(b))
`The Board should find the challenged claims unpatentable on the following
`
`grounds:
`
`Ground
`1
`
`35 U.S.C.
`103(a)
`
`Claims
`All challenged
`claims
`
`References
`Oshlack 1
`(Ex. 1016) in view
`of Bartholomaus
`(Ex. 1024);
`McGinity
`(Ex. 1025), and
`Oshlack 2
`(Ex. 1026)
`
`6
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`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`Ground
`2
`
`35 U.S.C.
`103(a)
`
`Claims
`All challenged
`claims
`
`References
`Wright (Ex. 1017)
`in view of Royce
`(Ex. 1027), Moroni
`(Ex. 1028), and
`Shao (Ex. 1029)
`A copy of each reference is filed herewith. The grounds for unpatentability
`
`are supported by the Declaration of Hossein Omidian, Ph.D. (Ex. 1030).
`
`IV. SUMMARY OF THE ARGUMENT
`The challenged claims are obvious over Oshlack 1 (Ex. 1016) in view of
`
`Bartholomaus (Ex. 1024), McGinity (Ex. 1025) and Oshlack 2 (Ex. 1026)
`
`(Ground 1) or our Wright (Ex. 1017) in view of Royce (Ex. 1027), Moroni
`
`(Ex. 1028) and Shao (Ex. 1029) (Ground 2). Purdue acknowledged that Oshlack 1
`
`covered original OxyContin. (Exs. 1007 at 27 1019 ¶ 6.) “Original OxyContin®,
`
`approved in 1995…was a powerful pain medicine designed to deliver oxycodone
`
`API slowly over an extended period of
`
`time
`
`to provide patients
`
`in
`
`moderate-to-severe pain with 12 hours of relief per dose.” (Exs. 1005, at 6-7, 37;
`
`1007,
`
`at 4;
`
`1019
`
`¶ 6.) And Oshlack 1
`
`expressly
`
`taught ____ indeed
`
`claimed ____ twice-daily administration of 10-160 mg of oxycodone in an extended
`
`release formulation for the treatment of pain. (Ex. 1016, cls. 1, 2.)
`
`Purdue also acknowledged that there was a problem with this original
`
`formulation ____ it was susceptible to abuse. (Exs. 1005, at 4, 7; 1007, at 4; 1019
`
`¶ 12; 1017 ¶ [0041]; 1024 ¶¶ [0002]-[0003].) Purdue also argued that when trying
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`7
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`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`to provide abuse deterrence, “the POSA’s lead formulation would have been
`
`original OxyContin®.” (Exs. 1005, at 37, see also id at 4 (“Rather, a POSA would
`
`have started with the original OxyContin® formulation.”); 1007, at 37.) Indeed,
`
`according to Purdue, “[a] POSA confronting the problem of original OxyContin®
`
`abuse would have had the goal of maintaining its advantages ____ its strength,
`
`duration, and known dosage ____ and adding abuse deterrence.” (Exs. 1005, at 37;
`
`1007, at 37.)
`
`A POSA would have been motivated to do just what Purdue taught, begun
`
`with original OxyContin and sought to modify it to provide abuse deterrence.
`
`Barholomaus (Ex. 1024) and Wright (Ex. 1017), both taught using a PEO matrix to
`
`produce a tablet that could provide twice-daily administration of conventional
`
`doses of oxycodone, and provided abuse deterrence ____ the very strength, duration
`
`and abuse deterrence goals identified by Purdue. And a POSA would certainly look
`
`to these solutions. Not only is it obvious to swap in one extended-release
`
`technology for another without specific motive to do so, but the references meet
`
`exactly the goals that Purdue itself identified. Moreover, one of these solutions
`
`came from Purdue itself (Ex. 1017 ¶ [0063]), and the other was licensed by Purdue
`
`(Ex. 1009, at 73-74). If a POSA was going to look for solutions, those posed by
`
`Purdue would certainly be on the short list.
`
`8
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`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`
`As for the other recitations of the claims, all dealing with the specifics of the
`
`dosage form, they are disclosed and/or obvious from the combination of references
`
`described in the grounds and the claims chart. And as will be explained in further
`
`detail below, neither the “unexpected” results that Purdue so vehemently advocated
`
`during prosecution nor OxyContin’s commercial success is sufficient to overcome
`
`obviousness here.
`
`V.
`
`SUMMARY OF THE ’393 PATENT
`The ’393 Patent (Ex. 1001)1 issued on November 15, 2016, from U.S.
`
`Application Serial No. 14/729,660 (“the ’660 Application”) (Ex. 1033), filed on
`
`June 3, 2015. The ’393 Patent is a continuation of several earlier family members
`
`all claiming the benefit of U.S. Provisional Application No. 60/840,244, filed
`
`August 25, 2006 (“the Provisional Application”). (Ex. 1032.) Accordingly, the
`
`earliest possible effective filing date for the ’393 Patent is August 25, 2006.
`
`The ’393 Patent claims a method of treating pain by administering to a
`
`patient in need thereof a pharmaceutical tablet for twice-daily administration that
`
`includes a compression-shaped matrix, which is subsequently heated to at least
`
`62ºC for at least five minutes to “cure.” “Curing” is performed without
`
`compression. The tablet includes PEO having a molecular weight of 4,000,000;
`
`
`1 Title 35 as it existed before adoption of the AIA is applicable here.
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`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`7,000,000; or combinations thereof, in an amount of at least 79% or 65% by weight
`
`of the tablet. (Exs. 1001 cl. 1.)
`
`While the claims are silent on abuse deterrence, the specification of the
`
`’393 Patent discloses tamper-resistant dosage forms that include opioid analgesics
`
`and suggests that there is a need in the art to provide resistance to crushing and
`
`dissolution in solvent while maintaining extended-release properties. (Exs. 1001,
`
`1:23-41; 1030 ¶ 14.) In some disclosed embodiments, the dosage form is resistant
`
`to alcohol extraction and dose dumping. (Exs. 1001, 1:54-58; 1030 ¶ 16.) In others,
`
`the dosage form can be flattened without breaking. (Exs. 1001, 1:59-64; 1030
`
`¶ 16.)
`
`The specification discusses the process for creating these tablets, which
`
`includes a “curing” step. Curing is described in various ways, e.g., at least partially
`
`melting the PEO, as subjecting the formulation to elevated temperatures and
`
`heating the PEO to its softening temperature. (Ex. 1001, 17:42-66.) The
`
`specification describes various curing temperature devices that may be used are
`
`described. (Exs. 1001, 18:41-19:67; 1030 ¶¶ 17, 21.)
`
`The specification includes numerous examples, two of which were relied
`
`upon by Purdue and the Examiner in allowing the patent. Example 13 describes the
`
`density of oxycodone formulations made using curing without compression.
`
`(Ex. 1001, 70:10-77:66.) Example 22’s tablets, which were produced using
`
`10
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`

`

`IPR2018-00717 (Patent No. 9,492,393)
`Petition for Inter Partes Review
`
`simultaneous heat and compression. (Id. 128:59-130:15.) Through Examples 13
`
`and 22, Purdue asserted that different density behavior occurs if a tablet is cured
`
`with or without compression. Example 14 describes five formulations and
`
`compares the densities of uncured and cured tablets. (Exs. 1001 Table 14.6,
`
`95:40-55;1030 ¶ 22.)
`
`VI. PERTINENT PROSECUTION HISTORY OF THE ’393 PATENT
`The ’393 Patent was filed under 37 C.F.R. § 1.102(e). A non-final rejection
`
`was mailed on September 11, 2015 (Ex. 1034). In that rejection, the Examiner
`
`found the majority of the claims anticipated by Bartholomaus’s teaching of a tablet
`
`inc