`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
`v.
`
`PURDUE PHARMA L.P.,
`THE P.F. LABORATORIES, INC., and
`PURDUE PHARMACEUTICALS L.P.
`Patent Owners
`____________________
`Case IPR2016-01413
`U.S. Patent No. 9,034,376
`____________________
`
`PATENT OWNERS’ RESPONSE TO PETITION FOR INTER PARTES
`REVIEW UNDER 37 C.F.R. § 42.120
`
`
`KASHIV1007
`IPR of Patent No. 9,492,392
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`Case IPR2016-01413 for
`U.S. Patent No. 9,034,376
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`TABLE OF CONTENTS
`
`D.
`
`B.
`C.
`
`Table of Authorities ................................................................................................. iii
`Exhibit List ............................................................................................................... vi
`Table of Abbreviations........................................................................................... xiv
`I.
`Introduction ...................................................................................................... 1
`II.
`Background ...................................................................................................... 2
`There Was a Long-Felt Need For a Solution to the Problem of
`A.
`Opioid Abuse at the Time of the Inventions ......................................... 2
`Abuse-Deterrent OxyContin® ............................................................... 4
`The ’376 Patent ..................................................................................... 6
`1.
`The ’376 Patent Specification ..................................................... 7
`2.
`The ’534 Provisional Application ............................................... 8
`3.
`Pertinent Prosecution History of the ’376 Patent ....................... 8
`The References Cited by Amneal Do Not Teach or Suggest the
`Claimed Inventions.............................................................................. 11
`1.
`Royce......................................................................................... 11
`2. McGinity ................................................................................... 14
`3.
`Hoffmeister ............................................................................... 16
`4.
`Joshi........................................................................................... 18
`5.
`PDR-1999 .................................................................................. 26
`Person of Ordinary Skill in the Art ................................................................ 27
`III.
`IV. Claim Construction ........................................................................................ 27
`“gelling agent in an effective amount to impart a viscosity” .............. 27
`A.
`“subjected to tampering [by dissolution]” ........................................... 29
`B.
`V. Amneal’s Unpatentability Grounds Fail ........................................................ 31
`Legal Standard ..................................................................................... 31
`A.
`Amneal’s Obviousness Ground Fails .................................................. 33
`B.
`1.
`A POSA Would Not Have Started With Royce To Arrive at
`
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`2.
`3.
`
`the Claimed Inventions ............................................................. 35
`Joshi Is Not Prior Art ................................................................ 37
`Even if Joshi Is Viewed as Prior Art, McGinity,
`Hoffmeister, Joshi, and PDR-1999 Do Not Suggest
`Modifying Royce To Practice the Claimed Inventions ............ 39
`A POSA Would Not Have Had a Reasonable Expectation
`of Successfully Practicing the Claimed Inventions .................. 51
`Amneal’s References Fail to Disclose the Viscosity
`Elements .................................................................................... 54
`VI. Conclusion ..................................................................................................... 58
`
`
`
`4.
`
`5.
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`TABLE OF AUTHORITIES
`
`Page
`
`
`
`
`
`CASES
`
`Application of Mercier, 515 F.2d 1161 (C.C.P.A. 1975) ........................................ 32
`
`Ariad Pharms., Inc. v. Eli Lilly and Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) .......................................................... 19
`
`Ariosa Diagnositcs Inc. v. Illumina, Inc.,
`IPR2014-01093, Paper No. 69 (Jan. 7, 2016) ..................................................... 20
`
`Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc.,
`796 F.2d 443 (Fed. Cir. 1986) ...................................................................... 32, 39
`
`CAE Screenplates Inc. v. Heinrich Fielder GMBH & Co. KG,
`224 F.3d 1308 (Fed. Cir. 2000) .......................................................................... 28
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .................................................................... 31, 42
`
`Dynamic Drinkware LLC v. National Graphics, Inc.,
`800 F.3d 1377 (Fed. Cir. 2015) .................................................................... 20, 32
`
`Epcon Gas Sys., Inc. v. Bauer Compressors, Inc.,
`90 F. App’x 540 (Fed. Cir. 2004) ....................................................................... 28
`
`Ex Parte Yamaguchi,
`88 USPQ2d 1606 (BPAI 2008) .......................................................................... 20
`
`In re Eaton,
`545 F. App’x 994 (Fed. Cir. 2013) ..................................................................... 27
`
`In re Giacomini,
`612 F.3d 1380 (Fed. Cir. 2010) .......................................................................... 20
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`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................................ 32
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`U.S. Patent No. 9,034,376
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`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) .......................................................................... 49
`
`In re OxyContin Antitrust Litig.,
`No. 04-md-1603, 2014 WL 2198590 (S.D.N.Y. May 27, 2014) ....................... 30
`
`In re Wesslau,
`353 F.2d 238 (C.C.P.A. 1965) ............................................................................ 32
`
`InTouch Techs., Inc. v. VGO Comm’s.,
`751 F.3d 1327 (Fed. Cir. 2014) ............................................................................ 1
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................ 31, 33, 50
`
`Leo Pharm. Products, Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) .................................................................... 31, 42
`
`Moore N. Am., Inc. v. Poser Business Forms, Inc.,
`No. 99-cv-570, 2000 WL 1481001 (D. Del. Sept. 29, 2000) ............................. 28
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 50
`
`Panduit Corp. v. Dennison Mfg. Co.,
`810 F.2d 1561 (Fed. Cir. 1987) .......................................................................... 32
`
`Perfect Surgical Techniques v. Olympus America, Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) .............................................................. 22, 23, 24
`
`Personal Web Technologies, LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ...................................................................... 33, 34
`
`Playtex Prod., Inc. v. Procter & Gamble Co.,
`400 F.3d 901 (Fed. Cir. 2005) ............................................................................ 28
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`REG Synthetic Fuels, LLC v. Neste Oil Oyj,
`841 F.3d 954 (Fed. Cir. 2016) ............................................................................ 21
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`Unigene Labs., Inc. v. Apotex Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .............................................................. 31, 37, 49
`
`ViiV Healthcare UK Ltd. v. Lupin Ltd.,
`6 F. Supp. 3d 461 (D. Del. 2013) ........................................................................ 49
`
`Yamanouchi Pharm. Co. v. Danbury Pharmacal, Inc.,
`231 F.3d 1339 (Fed. Cir. 2000) .......................................................................... 51
`
`STATUTES
`
`35 U.S.C. § 102 ............................................................................................ 19, 21, 37
`
`35 U.S.C. § 103 ........................................................................................................ 50
`
`35 U.S.C. § 120 ........................................................................................................ 19
`
`35 U.S.C. § 316 .................................................................................................. 20, 32
`
`REGULATIONS
`
`37 C.F.R. § 42.65 ..................................................................................................... 32
`
`37 C.F.R. § 42.108 ................................................................................................... 32
`
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`
`Exhibit No. Description
`
`EXHIBIT LIST
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`File history of ’134 application, IDS, August 14, 2014
`
`File history of ’134 application, List of References Considered by
`Examiner, October 2, 2014
`
`File history of ’134 application, IDS, January 6, 2015
`
`File history of ’134 application, List of References Considered by
`Examiner, March 23, 2015
`
`File history of 14/728,601, PTO, Notice of Allowance and Examiner-
`Initiated Interview Summary, March 10, 2016, including references cited
`therein
`
`File History of 14/733,659, PTO, Notice of Allowance and Examiner-
`Initiated Interview Summary, August 1, 2016, including references cited
`therein
`
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`
`Cicero et al., A tale of 2 ADFs: differences in the effectiveness of abuse-
`deterrent formulations of oxymorphone and oxycodone extended-release
`drugs, PAIN 157 (2016), 1232–38
`
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`2011.
`
`2012.
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`2013.
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`2014.
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`2015.
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`2016.
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`U.S. Patent No. 9,034,376
`
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` downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM332288.pdf
`(last visited August 11, 2016)
`
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`Products Covered by New Drug Application 20553 Were Withdrawn
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`
`Levina et al., The Influence of Excipients on Drug Release from
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`
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`
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`
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`
`PolyOxTM Water-Soluble Resins, Dow Chemical (March 2002)
`
`Letter from National Association of Attorneys General to FDA, March 11,
`2013
`
`Scheirs et al., Characterizing the solid-state thermal oxidation of
`poly(ethylene oxide) powder, POLYMER 32:11 (1991), 2014-19
`
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`Labeling (Draft Guidance), FDA (Jan. 2013)
`
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`Creating Safer Opioids, FDA VOICE (April 16, 2013)
`
`2023.
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`
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`
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`(last accessed Aug. 10, 2016)
`
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`
`Excerpts of trial transcript from In re OxyContin Antitrust Litigation, 04-
`md-1603 (SHS) (Sept. 23-24, 2013) (Sellers, Weingarten)
`
`Excerpt of trial transcript from Purdue Pharma L.P. et al. v. Amneal
`Pharmaceuticals, LLC, 13-cv-03372-SHS (July 14, 2014) (Oshlack)
`
`Excerpt of trial transcript from Purdue Pharma L.P. et al. v. Amneal
`Pharmaceuticals, LLC, 13-cv-03372-SHS (July 18, 2014) (Maurin)
`
`Excerpts of trial exhibit from Purdue Pharma L.P. et al. v. Amneal
`Pharmaceuticals, LLC, 13-cv-03372-SHS (PTX-4315) containing
`designations of deposition testimony accepted into evidence at trial
`(Breder, Wright)
`
`Hu et al., The Properties of HPMC:PEO Extended Release Hydrophilic
`Matrices and their Response to Ionic Environments, PHARM RES.
`(published online Sept. 15, 2016)
`
`Petition for Inter Partes Review of U.S. Patent No. 9,060,976, IPR2016-
`01027, Paper 2 (May 11, 2016)
`
`Addendum of Agreed Constructions (submitted as part of Plaintiffs’
`Opening Claim Construction Brief), Purdue Pharma L.P. v. Amneal
`Pharms LLC, C.A. No. 15-1152 (D. Del. Sept. 23, 2016), ECF No. 66
`
`U.S. Patent No. 6,228,863
`
`U.S. Patent No. 6,696,088
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`U.S. Patent No. 8,652,497
`
`U.S. Patent No. 5,266,331
`
`U.S. Patent No. 5,656,295
`
`U.S. Patent No. 7,141,250
`
`Declaration of Anthony Palmieri III, Ph.D. in Support of Petition for Inter
`Partes Review of Claim 1 of U.S. Patent No. 9,060,976, IPR2016-01027,
`Exhibit 1009 (May 3, 2016)
`
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`
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`27, 2004
`
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`Litigation, 04-md-1603 (SHS)
`
`Excerpt of trial transcript from In re OxyContin Antitrust Litigation, 04-
`md-1603 (SHS) (Sept. 23, 2013) (Zhang, Feng)
`
`(Intentionally omitted)
`
`Approved Drug Products with Therapeutic Equivalence Evaluations, 21st
`Ed. (2001)
`
`(Intentionally omitted)
`
`(Intentionally omitted)
`
`(Intentionally omitted)
`
`Deposition of Anthony Palmieri III, Ph.D. with errata, for IPR2016-01027
`and IPR2016-01028 (January 13, 2017)
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`2052.
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`exhibit; January 13, 2017)
`
`Handwritten Calculation Notes of Anthony Palmieri III, Ph.D. (Palmieri
`deposition exhibit; March 21, 2017)
`
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`
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`PHARMACOLOGY TO CLINICAL APPLICATION (2003), 127-150
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`
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`
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`
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`
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`
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`
`(Intentionally omitted)
`
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`
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`
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`OxyContin—Public Session (Sept. 24, 2009), available at
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`
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`
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`only]
`
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`only]
`
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`only]
`
`Excerpts from Purdue Pharma L.P. Notebook No. 495 [Board and Parties
`only]
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`Email from R. Paradiso to P. Strassburger et al. (Apr. 25, 2001), with
`attachment [Board and Parties only]
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`
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`
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`(OxyContin) on Opioid Abuse-Related Outcomes in the Postmarketing
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`286
`
`Declaration of Robert J. Paradiso
`
`U.S. Provisional Patent Application No. 60/310,514
`
`Email from B. Oshlack to R. Paradiso and C. Davidson (May 21, 2001),
`with attachment [Board and Parties only]
`
`Email from R. Paradiso to P. Strassburger (June 1, 2001)
`
`Email from P. Strassburger to R. Paradiso (June 18, 2001)
`
`Email from R. Paradiso to P. Strassburger (June 18, 2001)
`
`Draft patent application (July 2, 2001) [Board and Parties only]
`
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`[Board and Parties only]
`
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`01027, Paper 13 (Nov. 11, 2016)
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`
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`2101.
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`2102.
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`2103.
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`2104.
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`2105.
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`TABLE OF ABBREVIATIONS
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`Abbreviation
`
`Explanation
`
`’134 [application]
`
`U.S. Patent Application No. 14/460,134
`
`’534 [application]
`
`U.S. Provisional Application No. 60/310,534 (Ex. 1026)
`
`’088 [patent]
`
`’376 [patent]
`
`’888 [patent]
`
`’976 [patent]
`
`Amneal
`
`API
`
`Bastin
`
`CPDD
`
`CPDD Paper
`
`Doyon
`
`FDA
`
`Hoffmeister
`
`HPE-3rd
`
`U.S. Patent No. 6,696,088 (Ex. 2036)
`
`U.S. Patent No. 9,034,376 (Ex. 1001)
`
`U.S. Patent No. 8,337,888
`
`U.S. Patent No. 9,060,976
`
`Amneal Pharmaceuticals, LLC (petitioner)
`
`active pharmaceutical ingredient
`
`International Publication No. WO 95/20947 (Ex. 1015)
`
`Committee/College on Problems of Drug Dependence
`
`Zacny et al., College on Problems of Drug Dependence
`taskforce on prescription opioid non-medical use and abuse:
`position statement, DRUG AND ALCOHOL DEPENDENCE 69
`(2003) 215-232 (Ex. 2009)
`
`U.S. Patent No. 5,283,065 (Ex. 1036)
`
`U.S. Food and Drug Administration
`
`U.S. Patent No. 4,070,494 (Ex. 1010)
`
`Kibbe, Handbook of Pharmaceutical Excipients (3rd ed.)
`(2000)
`
`HPMC
`
`hydroxymethylcellulose
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`IDS
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`Joshi
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`Information Disclosure Statement
`
`U.S. Patent Publication No. US 2002/0187192 (Ex. 1014)
`
`Joshi provisional
`
`U.S. Provisional Patent Application No. 60/287,509 (Ex.
`1013)
`
`McGinity
`
`Mr. Oshlack
`
`Oshlack
`
`WO 97/49384 (Ex. 1024)
`
`Benjamin Oshlack
`
`U.S. Patent No. 5,508,042 (Ex. 1009)
`
`original OxyContin®
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`the first FDA-approved formulation of Purdue’s OxyContin®,
`approved in 1995 and lacking abuse-deterrent features
`
`OxyContin®
`
`PDR-1997
`
`PDR-1999
`
`PEO
`
`Pet.
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`POSA
`
`PTO
`
`Purdue
`
`Royce
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`SDNY
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`abuse-deterrent formulation of Purdue’s OxyContin®
`approved by the FDA in 2010
`
`Physician’s Desk Reference (51st ed.) (1997) (Ex. 2027)
`
`Physician’s Desk Reference (53rd ed.) (1999) (Ex. 1016)
`
`polyethylene oxide
`
`Amneal’s present Petition for Inter Partes Review
`
`person of ordinary skill in the art
`
`U.S. Patent and Trademark Office
`
`Purdue Pharma L.P., The P.F. Laboratories, Inc., and Purdue
`Pharmaceuticals L.P. (owners of the ’376 patent)
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`U.S. Patent No. 5,273,758 (Ex. 1022)
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`U.S. District Court for the Southern District of New York
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`SDNY decision
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`Findings of Fact and Conclusions of Law, Purdue Pharma
`L.P. v. Amneal Pharms., LLC, No. 13-3372 (SHS), slip op.
`(S.D.N.Y. April 8, 2015) regarding the ’888 patent (Ex. 1005)
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`I.
`
`INTRODUCTION
`
`Amneal petitions for review of claims 1-13 and 16-19 of the ’376 patent on a
`
`single ground, which rests on a combination of five references—Royce in view of
`
`McGinity, Hoffmeister, Joshi, and PDR-1999. None of these references says
`
`anything about how to use gelling in any extended-release formulation to achieve
`
`abuse deterrence, let alone teaches the specific claimed combinations. Amneal
`
`focuses on specific disclosures in the five references selected based on hindsight—
`
`while ignoring other disclosures and the full scope of the prior art.
`
`The Federal Circuit’s finding in InTouch Technologies, Inc. v. VGO
`
`Communications, Inc. is applicable here:
`
`[The challenger’s expert’s] testimony was nothing more
`than impermissible hindsight; she opined that all the
`elements of the claims disparately existed in the prior art,
`but failed to provide the glue to combine these
`references. While she opined that the references were
`like separate pieces of a simple jigsaw puzzle, she did not
`explain what reason or motivation one of ordinary skill in
`the art at the time of the invention would have had to
`place these pieces together.
`
`751 F.3d 1327, 1348-49 (Fed. Cir. 2014). Amneal failed to satisfy its burden of
`
`explaining why one of skill in the art would have been motivated to combine
`
`particular portions of Royce, McGinity, Hoffmeister, Joshi, and PDR-1999 in the
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`way the claimed inventions do, while ignoring other parts that teach away or lead
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`to the use of different excipients.
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`A POSA, reading the prior art in view of the problem at issue, the abuse of
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`original OxyContin®, would not have looked to Royce or McGinity for abuse
`
`deterrence because they are silent on that subject. Recognizing this, Amneal relies
`
`on portions of Joshi and Hoffmeister for teaching these elements of the challenged
`
`claims. Joshi is not prior art to the challenged claims for the reasons discussed
`
`below, and Amneal cannot meet its burden of demonstrating obviousness without
`
`the benefit of Joshi. In fact, Amneal’s expert, Dr. Palmieri, admitted that he did
`
`not evaluate the obviousness of the challenged claims without the benefit of Joshi.
`
`Finally, a POSA would not have looked to Joshi or Hoffmeister because they are
`
`directed to immediate-release formulations, and Joshi is further directed to central-
`
`nervous-system stimulants, not oxycodone, a central-nervous-system depressant.
`
`Accordingly, Amneal’s petition should be denied.
`
`II. BACKGROUND
`
`A.
`
`There Was a Long-Felt Need For a Solution to the Problem of
`Opioid Abuse at the Time of the Inventions
`
`Oxycodone belongs to the opioid class of drugs, which have been abused for
`
`more than a century. (Ex. 1005 at 28; Ex. 2078 at 8-9; Ex. 2054 ¶ 42.) Opioid
`
`abuse continued to escalate, particularly in the 1990s. By the early 2000s, opioid
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`abuse had surged to create a national health crisis. (Ex. 2009 at 217-18; Ex. 2011
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`at 5.)
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`Against this backdrop, Purdue and others sought to develop improved
`
`formulations to deter abuse while still delivering effective pain treatment to
`
`patients over an extended period of time. Researchers at the time generally
`
`employed “[t]wo main strategies.” (Ex. 2009 at 224; Ex. 2001 ¶ 106.) One
`
`strategy was to include in the formulation an antagonist, i.e., a counteracting drug
`
`substance to be released and to block the opioid’s effects upon abuse of the
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`formulation. (Ex. 2009 at 224-25.) The second strategy was to use an extended-
`
`release profile, which original OxyContin® was already using. (Id. at 224;
`
`Ex. 1016 at 2572 (“Delayed absorption, as provided by [original] OxyContin
`
`tablets, is believed to reduce the abuse liability of a drug.”); Ex. 2054 ¶ 45; Ex.
`
`2060 at 244; Ex. 2059 at 688.)
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`When Purdue began its project for abuse-deterrent OxyContin®, the goal was
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`to deter abuse while preserving the drug’s efficacy for legitimate users. (Ex. 2081
`
`¶ 17; Ex. 2092 ¶ 14.) Any potential approach needed to avoid a substantial change
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`in the drug’s release profile. (Ex. 2081 ¶ 17; Ex. 2092 ¶ 14.) Purdue’s scientists
`
`evaluated a variety of different strategies for several years before selecting a
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`counter-intuitive strategy not disclosed in the prior art. This strategy involved
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`combining the API with two gelling agents to prevent the crushed tablet from
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`being drawn into a syringe or snorted.
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`B. Abuse-Deterrent OxyContin®
`Original OxyContin®, approved in 1995, was a groundbreaking treatment for
`
`patients suffering from chronic pain. (Ex. 2001 ¶ 30; Ex. 2054 ¶ 41.) It 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. (Ex. 1016 at 2573; Ex. 1018 at 2.) But many of the
`
`features that made it so effective, including its strength, duration, and dosage, also
`
`made it attractive to abusers. (See Ex. 1007 ¶ 14; Ex. 2001 ¶ 31.)
`
`The science of abuse-deterrent formulations was in its nascent stages at the
`
`time of the inventions. (Ex. 2054 ¶ 46; see Ex. 2081 ¶¶ 13, 20-21; Ex. 2092 ¶¶ 9,
`
`14-15.) The literature contained no discussion of any formulation that could
`
`effectively reduce patterns of abuse. Purdue was at the forefront of this work,
`
`developing the epidemiological studies and ultimately the formulations that
`
`changed the marketplace. (Ex. 2054 ¶¶ 44-53; see generally Exs. 2081, 2092.)
`
`Benjamin Oshlack led the team that developed the original OxyContin®
`
`product. (Ex. 2081 ¶ 6.) He was one of the leading experts in the world in the area
`
`of controlled-release dosage forms at the time of the inventions of the ’376 patent.
`
`He started work on developing abuse-deterrent dosage forms in 1996, when Purdue
`
`was investigating ways to deter abuse of immediate-release hydrocodone. (Ex.
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`2054 ¶ 46; Ex. 2081¶ 11.) Purdue’s formulation development team spent many
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`millions of dollars and countless hours over the next five years investigating
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`different approaches to the problem of abuse. (Ex. 2054 ¶ 46; Ex. 2081 ¶¶ 11, 13;
`
`Ex. 2092 ¶ 11.) Purdue’s development of an abuse-deterrent oxycodone product
`
`started with modifying the original OxyContin® product. In particular, Purdue
`
`investigated antagonist combination products in the form of beads, pellets, layers,
`
`including sequestered and un-sequestered technologies. (Ex. 2054 ¶ 48; Ex. 2081
`
`¶¶ 14-15; Ex. 2092 ¶ 12; Ex. 2086 at 10.)
`
`A critical point in the development was in 1998, when Dr. Curtis Wright
`
`joined Purdue as Executive Director of Medical Research. (Ex. 2092 ¶ 5.) Dr.
`
`Wright was a medical doctor who had more than 20 years of experience studying
`
`the problem of opioid abuse. (Ex. 2092 ¶¶ 2-5.) Dr. Wright’s unique experience,
`
`in combination with brainstorming with the other inventors, provided the insight
`
`that led to the inventions of the ’376 patent: preventing abuse by making
`
`formulations viscous when subjected to typical methods of tampering. (Ex. 2029
`
`at 7-9 (49:4-51:13); Ex. 2031 at 2-3, 6-8; Ex. 2054 ¶¶ 50, 52-53; Ex. 2081 ¶¶ 18-
`
`20; Ex. 2092 ¶¶ 16-18.)
`
`In 2001, the inventors of the ’376 patent led the Purdue team that developed
`
`a unique in vitro testing method used to evaluate the abuse-deterrent potential of
`
`various gelling agents and formulations. (Ex. 2054 ¶ 52; Ex. 2081 ¶¶ 19, 22-23;
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`Ex. 2092 ¶¶ 17, 19; Exs. 2087-2090.) Mr. Oshlack and his team used this testing
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