IPR2018-00625
`Patent No. 9,492,392
`Petition for Inter Partes Review
`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.
`
`Patent No. 9,492,392 to McKenna et al.
`Issue Date: November 15, 2016
`Title: TAMPER RESISTANT DOSAGE FORMS
`____________________________
`
`Inter Partes Review No. IPR2018-00625
`__________________________________________________________________
`
`PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 9,492,392
`
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ................................................................................... iv
`
`EXHIBIT LIST ....................................................................................................... vii
`
`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)) ............................................................................ 3
`
`B. Notice Of Related Matters (37 C.F.R. § 42.8(b)(2)) ................................ 3
`
`C. Designation Of Lead And Backup
`Counsel (37 C.F.R. § 42.8(b)(3)) .............................................................. 4
`
`D. Notice Of Service Information (37 C.F.R. § 42.8(b)(4)) .......................... 5
`
`E. Grounds For Standing (37 C.F.R. § 42.104(a)) ........................................ 5
`
`III.
`
`IDENTIFICATION OF THE CLAIMS
`BEING CHALLENGED (37 C.F.R. § 104(B)) .............................................. 6
`
`IV. SUMMARY OF THE ARGUMENT .............................................................. 6
`
`V.
`
`SUMMARY OF THE ’392 PATENT ............................................................. 9
`
`VI. PERTINENT PROSECUTION
`HISTORY OF THE ’392 PATENT ..............................................................10
`
`VII. PURDUE DID NOT DEMONSTRATE AN UNEXPECTED
`DENSITY DECREASE OR A SUPERIOR RESULT .................................12
`
`A. Purdue’s Data Would Not Establish
`A Density Decrease To A POSA ............................................................12
`
`B. Density Is Not A Superior Result ...........................................................16
`
`i
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`
`C. Purdue’s Evidence Is Not Commensurate
`With The Scope Of The Claims ..............................................................17
`
`VIII. PERSON OF SKILL IN THE ART ..............................................................18
`
`IX. CLAIM CONSTRUCTION ..........................................................................19
`
`A. “Compression Shaped” And “Compression” .........................................19
`
`B. “Air Cured” And “Curing” .....................................................................20
`
`C. “Optionally” ............................................................................................20
`
`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 .............................................................22
`
`X.
`
`TECHNICAL BACKGROUND AND STATE OF THE ART ....................23
`
`XI. THE CHALLENGED CLAIMS ARE
`OBVIOUS OVER THE PRIOR ART ...........................................................25
`
`A. Legal Background ...................................................................................26
`
`B. Ground 1: The Challenged Claims Are Obvious
`Over Bartholomaus (Ex. 1024) In View Of McGinity
`(Ex. 1025), Oshlack 2 (Ex. 1026), And Oshlack 1 (Ex. 1016) ....................28
`
`1.
`
`Independent Claim 1 Is Obvious......................................................29
`
`1. The Dependent Claims Are Also Obvious ......................................35
`
`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) .................................................41
`
`1.
`
`Independent Claim 1 Is Obvious......................................................41
`
`2. The Dependent Claims Are Also Obvious ......................................48
`
`ii
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`
`D. Ground 3: Oshlack 1 (Ex. 1016) In View Of
`Bartholomaus (Ex. 1024), McGinity (Ex. 1025),
`And Oshlack 2 (Ex. 1026) ......................................................................52
`
`XII. CLAIM CHART ............................................................................................54
`
`XIII. SECONDARY CONSIDERATIONS ...........................................................60
`
`XIV. CONCLUSION ..............................................................................................63
`
`
`
`
`
`iii
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`
`TABLE OF AUTHORITIES
`
` PAGE(S)
`
`CASES
`Alcon Research, LTD. v. Apotex Inc.,
`687 F.3d 1362 (Fed. Cir. 2012) ......................................................................... 27
`In re Aller,
`220 F.2d 454 (C.C.P.A. 1955) ...................................................................... 26, 28
`Asyst Techs., Inc. v. Emtrak, Inc.,
`544 F.3d 1310 (Fed. Cir. 2008) ......................................................................... 62
`In re Baxter Travenol, Labs.,
`952 F.2d 389392 (Fed. Cir. 1991) ..................................................................... 13
`Cadence Pharms., Inc. v. Exela PharmSci Inc.,
`780 F.3d 1364 (Fed. Cir. 2015) ......................................................................... 20
`Cuozzo Speed Techs., L.L.C. v. Lee,
`136 S. Ct. 2131 (2016) ................................................................................ 19, 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) ..................................................................... 16, 61
`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) ......................................................................... 27
`In re Harris,
`409 F.3d 1339 (Fed. Cir. 2005) ......................................................................... 17
`In re Thorpe,
`777 F.2d 695 (Fed. Cir. 1985) ........................................................................... 23
`In re Tiffin,
`448 F.2d 791 (1971) .......................................................................................... 17
`
`
`iv
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ......................................................................... 28
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) ......................................................................... 62
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .................................................................................... 26, 27
`Merck & Cie v. Gnosis S.p.A.,
`808 F.3d 829 (Fed. Cir. 2015) ........................................................................... 26
`Merck & Co.,
`800 F.2d 1091 (Fed. Cir. 1986) ......................................................................... 61
`In re Merck & Co. v. Teva Pharms. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) ................................................................... 61, 63
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) ......................................................................... 18
`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) ......................................................................... 61
`Par Pharm., Inc. v. TWi Pharms., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) ......................................................................... 27
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) ......................................................................... 60
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) .......................................................................................... 27
`In re Soni,
`54 F.3d 746 (Fed. Cir. 1995) ....................................................................... 16, 61
`
`
`v
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`Steadymed Ltd. v. United Therapeutics Corp.,
`IPR2016-00006, Paper 82, Final Written Decision (Mar. 31, 2017) .................. 16
`Titanium Metals Corp. v. Banner,
`778 F.2d 775 (Fed. Cir. 1985) ........................................................................... 27
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ........................................................................... 27
`
`STATUTES, RULES & OTHER AUTHORITIES
`
`35 U.S.C. § 103(a) .................................................................................................. 26
`
`37 C.F.R. § 42.100(b) .............................................................................................. 19
`37 C.F.R. § 42.104(b)(4) ......................................................................................... 26
`
`
`
`
`
`vi
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`
`EXHIBIT LIST
`
`1004
`1005
`
`1006
`1007
`
`1008
`1009
`
`1010
`1011
`
`1012
`
`1013
`
`1014
`
`Exhibit # Reference
`U.S. Patent No. 9,492,392 (“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”)
`
`1015
`
`1016
`
`vii
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`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 (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
`
`1030
`1031
`1032
`1033
`1034
`1035
`1036
`
`1023
`
`1024
`1025
`1026
`1027
`1028
`
`1029
`
`1037
`1038
`1039
`
`viii
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`
`1042
`
`1043
`
`1044
`1045
`1046
`1047
`1048
`1049
`
`Exhibit # Reference
`Serial No. 14/729,634, Notice of Allowability
`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
`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)
`
`1050
`
`1051
`1052
`
`1053
`1054
`
`1055
`
`1056
`
`1057
`
`ix
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`
`Exhibit # Reference
`Intentionally left blank
`1058
`1059
`Intentionally left blank
`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”)
`
`1061
`1062
`1063
`
`x
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`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, 11-12, 14, 17-20, 24-25, and 27-28 (the
`
`“challenged claims”) of the ’392 Patent (Ex. 1001), which according to USPTO
`
`records is assigned to Purdue.
`
`I.
`
`OVERVIEW
`The ’392 Patent claims twice-a-day extended release oxycodone tablets
`
`formed by compression followed by “curing.” The Examiner properly rejected
`
`these claims for being nothing more than the product of ordinary skill based on
`
`what was known in the art. She later allowed them in view of testing purporting to
`
`show a supposedly unexpected decrease in tablet density as a result of “curing.”
`
`But that testing actually establishes nothing. The Examiner had it right the first
`
`time.
`
`Purdue likes to tell the story of OxyContin® as if it created a “wonder drug.”
`
`In actuality, Purdue merely incorporated existing extended release technology into
`
`a tablet containing oxycodone ____ a drug discovered in the early 1900s (Ex. 1002.)
`
`Purdue’s “standard” yarn tells of original OxyContin’s introduction and eminent
`
`demise by the FDA because of the growing epidemic of opioid abuse that was (and
`
`still is) plaguing this country. But original OxyContin was reborn as reformulated
`
`
`
`
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`OxyContin®, allegedly providing both abuse deterrence and extended release.
`
`(Exs. 1003, at 28-31; 1009 ¶¶ 6, 12.) This story may sound familiar ____ Purdue has
`
`told it before. (Exs. 1005, at 6-10, 1006 Abstract, 1:16-50, 2:64-3:5, cl. 1; 1007,
`
`at 4-8; 1009, at 66-74.)
`
`Purdue glosses over its marketing tactics, which some have credited for both
`
`OxyContin’s success and creating the opioid crisis. (Exs. 1011-1015.) Purdue also
`
`glosses over the fact that extended release oxycodone technologies, and even abuse
`
`deterrence, were already known. Indeed, Purdue admits that twice-a-day extended
`
`release oxycodone tablets are known from Purdue’s U.S. Patent No. 5,508,042.
`
`(Ex. 1009 ¶¶ 6, 12.) Purdue separately discloses and claims oxycodone tablets
`
`using polyethylene oxide (“PEO”) for both extended release and abuse deterrence.
`
`(Exs. 1017 ¶¶ [0049], [0150]; 1004 cls. 1, 2, 8, 12; 1006 cl. 1; 1008 cl. 1.) And
`
`Purdue was not alone. Grunenthal discloses an abuse-proofed controlled-release
`
`tablet that comprises high molecular weight PEO and oxycodone. (Ex. 1024
`
`Abstract, Example 6, cls. 1, 2, 4, 6, 8.) And its tablet can be produced by
`
`press-forming with subsequent exposure to heat. (Id. cls. 1, 2, 4-6, 9, 10, 29.)
`
`So the tale of the ’392 Patent is not the discovery of using PEO to produce a
`
`twice-daily oxycodone tablet having abuse deterrent properties ____ that was clearly
`
`known. And it is not the discovery of advantages coming from compressing a
`
`tablet followed by curing ____ that too was known. As for Purdue’s allegedly
`
`2
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`unexpected density decrease ____ it
`
`is,
`
`to borrow a
`
`literary phrase from
`
`Shakespeare’s Macbeth, a tale full of sound and fury, signifying nothing. Purdue’s
`
`data does not support any conclusion, and even to Purdue the result was not
`
`superior. Petitioner will demonstrate that the claims of the ’392 Patent are 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 of the ’392 Patent. The text of challenged
`
`claim 1 is included in the claim chart in Part XII below.
`
`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 ’392 Patent and U.S. Patent No. 9,492,393 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.
`
`3
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`
`Seven family members of the ’392 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).
`
`The Board (Judges Green, Paulraj, and Harlow) has already considered
`
`Purdue patents directed to OxyContin in IPR2016-01027 and -01028, where the
`
`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
`
`Backup Counsel:
`Michael H. Teschner
`(Reg. No. 32,862)
`MTeschner.ipr@ldlkm.com
`litigation@lernerdavid.com
`Lerner, David, Littenberg,
` Krumholz & Mentlik, LLP
`
`4
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.654.5000
`Fax: 908.654.7866
`Maegan A. Fuller
`(Reg. No. 71,596)
`MFuller.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
`
`
`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
`
`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 ’392 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.
`
`5
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`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
`
`2
`
`3
`
`References
`Bartholomaus
`(Ex. 1024) in view
`of McGinity
`(Ex. 1025),
`Oshlack 2
`(Ex. 1026), and
`Oshlack 1
`(Ex. 1016)
`Wright (Ex. 1017)
`in view of Royce
`(Ex. 1027), Moroni
`(Ex. 1028), and
`Shao (Ex. 1029)
`Oshlack 1
`(Ex. 1016) in view
`of Bartholomaus
`(Ex. 1029),
`McGinity
`(Ex. 1025, and
`Oshlack 2
`(Ex. 1026).
`A copy of each reference is filed herewith. The grounds for unpatentability
`
`103(a)
`
`103(a)
`
`All challenged
`claims
`
`
`All challenged
`claims
`
`are supported by the Declaration of Hossein Omidian, Ph.D. (Ex. 1030).
`
`IV. SUMMARY OF THE ARGUMENT
`The art of Ground 1 (Bartholomaus (Ex. 1024) in view of McGinity
`
`(Ex. 1025), Oshlack 2 (Ex. 1026), and Oshlack 1 (Ex. 1016)), renders
`
`the
`
`6
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`challenged claims obvious largely for the reasons explained by the Examiner in
`
`rejecting the claims over Bartholomaus during prosecution. This combination
`
`teaches a compressed and cured extended-release twice-daily tablet of oxycodone
`
`having, or rendering obvious, the claimed amounts of high molecular weight PEO
`
`and oxycodone. In allowing these claims, the Examiner and Purdue mistook
`
`Bartholomaus’s teaching of heating with compression as the “curing” step. But
`
`Bartholomaus actually teaches curing after compression by heating previously-
`
`compressed tablets to at least the softening temperature of the PEO, without further
`
`compression. (Ex. 1024 ¶¶ [0065], [0067].) And Bartholomaus in combination
`
`with McGinity, Oshlack 1, and/or Oshlack 2 teaches PEO in amounts up to
`
`99.99 wt.% of the tablet, and at least 5 wt% oxycodone. (Ex. 1030 ¶¶ 44-46, 68-79,
`
`86-90, 117-148.)
`
`In Ground 2, the challenged claims are shown to be obvious over Wright
`
`(Ex. 1017) in view of Royce (Ex. 1027), Moroni (Ex. 1028), and Shao (Ex. 1029).
`
`Wright discloses twice-a-day extended-release oxycodone/PEO tablets. Wright’s
`
`tablets could be formed by curing after compression. Wright in combination with
`
`Royce (Ex. 1027) and Moroni (Ex. 1028) provide specific reason to use PEO
`
`having a molecular weight in the range claimed and provides a reasonable
`
`expectation that doing so would result in an extended-release, abuse-deterrent
`
`oxycodone formulation. And Shao, along with Wright, teaches a POSA to expect
`
`7
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`improved physical properties and/or stabilized extended release (Exs. 1017
`
`¶ [0143]; 1029, at 250, 253; 1030 ¶¶ 80-85, 91-94, 149-172).
`
`Ground 3 relies on the art as discussed in Ground 1, but starts the analysis
`
`differently. Purdue has admitted in, inter alia, past IPRs, that Oshlack 1 (Ex. 1016)
`
`disclosed Purdue’s original OxyContin formulation; approved in 1995 for
`
`twice-daily administration to patients to treat pain. Purdue acknowledged that there
`
`was an abuse problem with this formulation and argued that any solution would
`
`start with Oshlack 1, providing the same release and strength, while also providing
`
`abuse deterrence. (Ex. 1030 ¶¶ 44-46.)
`
`Petitioner does not agree that Oshlack 1 is the only place to start an analysis.
`
`But it is one logical place. Purdue identified a problem and market need, suggested
`
`a starting point for solutions, and set out criteria success. That solution came from
`
`Purdue. Both the Wright family, which is owned by Purdue, and the Bartholomaus
`
`family, which Purdue had
`
`rights
`
`to
`
`(see Ex. 1009, at 73-74), offered
`
`abuse-deterrent formulations for twice-daily tablets of oxycodone that meet
`
`Purdue’s own criteria. To avoid redundancy, Petitioner has elected to base this
`
`ground on the combination of references as explained in detail in Ground 1.
`
`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 based on these grounds.
`
`8
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`V.
`
`SUMMARY OF THE ’392 PATENT
`The ’392 Patent (Ex. 1001)1 issued on November 15, 2016, from U.S.
`
`Application Serial No. 14/729,634 (“the ’634 Application”) (Ex. 1033), filed on
`
`June 3, 2015. The ’392 Patent is a continuation of several 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 ’392 Patent is August 25, 2006.
`
`The ’392 Patent claims a cured, shaped 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; 7,000,000; or combinations thereof, in an amount of at least 79% or
`
`65% by weight of the tablet. The tablet may optionally include low molecular
`
`weight PEO in the matrix, a coating, and a second air-cured matrix that includes a
`
`low molecular weight PEO. (Exs. 1001, cl. 1; 1030 ¶ 15.)
`
`The ’392 Patent discloses tamper-resistant dosage forms that include opioid
`
`analgesics and suggests that such tablets should be resistant to crushing and
`
`dissolution
`
`in solvent while maintaining
`
`its extended-release properties.
`
`
`1 Title 35 as it existed before adoption of the AIA is applicable here.
`
`9
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`(Exs. 1001, 1:23-41; 1030 ¶ 14.) In some embodiments, the dosage form is
`
`resistant to alcohol extraction and dose dumping. (Exs. 1001, 1:56-58; 1030 ¶ 16.)
`
`In other embodiments, the dosage form can be flattened without breaking.
`
`(Exs. 1001, 1:63-65; 1030 ¶ 16.)
`
`The specification discusses the process for creating the 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.) Various useful
`
`temperatures and devices are described. (Exs. 1001, 18:41-19:67; 1030 ¶ 17.)
`
`The specification includes numerous examples, two of which were relied
`
`upon by Purdue and the Examiner in allowing the patent. Example 13 describes
`
`oxycodone formulations made using curing without compression. (Ex. 1001,
`
`70:15-81:13.) Example 22’s tablets were produced using simultaneous heat and
`
`compression. (Id. 133:60-135:15.) 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, 99:58-100:11; 1030 ¶ 22.)
`
`VI. PERTINENT PROSECUTION HISTORY OF THE ’392 PATENT
`The ’392 Patent was filed under 37 C.F.R. § 1.102(e) on June 3, 2015, as the
`
`’634 Application. (Ex. 1033.) A nonfinal rejection was mailed on August 27, 2015.
`
`10
`
`

`

`IPR2018-00625 (Patent No. 9,492,392)
`Petition for Inter Partes Review
`
`(Ex. 1034.) In that rejection, the Examiner found the pending claims anticipated by
`
`Bartholomaus’s teaching of a tablet including PEO of MW 7,000,000 and
`
`oxycodone. (Id. at 4-7.) Similarly, the Examiner rejected the claims as obvious
`
`over Bartholoma