`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COLLEGIUM PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P.,
`AND THE P.F. LABORATORIES INC.,
`Patent Owner.
`
`
`Case PGR2018-00048
`U.S. Patent No: 9,693,961
`
`
`
`
`
`AMENDED PETITION FOR POST-GRANT REVIEW OF
`U.S. PATENT NO. 9,693,961
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`INTRODUCTION ................................................................................ 1
`
`II.
`
`GROUNDS FOR STANDING ............................................................. 3
`
`III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ........................ 4
`
`A.
`
`Real Party-in Interest (§ 42.8(b)(1)) ........................................... 4
`
`B.
`
`C.
`
`Related Matters (§ 42.8(b)(2)) ................................................... 4
`
`Lead and Back-Up Counsel (§ 42.8(b)(3)) ................................ 5
`
`D.
`
`Service Information (§ 42.8(b)(4)) ............................................. 6
`
`IV.
`
`IDENTIFICATION OF CHALLENGED CLAIMS AND PRECISE
`RELIEF SOUGHT................................................................................ 6
`
`V. OPIATE ABUSE AND METHODS OF ABUSE DETERRENCE .... 6
`
`VI. SUMMARY OF THE ʼ961 PATENT DISCLOSURE AND THE
`ALLEGED INVENTIONS ................................................................. 11
`
`VII. CLAIM CONSTRUCTION UNDER 37 C.F.R. § 42.104(B)(3) ....... 17
`
`VIII. LEVEL OF ORDINARY SKILL IN THE ART ................................ 21
`
`IX. APPLICATIONS IN THE PRIORITY CHAIN OF THE ʼ961
`PATENT ............................................................................................. 21
`
`X.
`
`THE CHALLENGED CLAIMS ARE ELIGIBLE FOR PGR ........... 24
`
`A. A Patent is Eligible for PGR if it Cannot Properly Claim
`Priority to a Parent Application Predating March 16, 2013 ..... 25
`
`B.
`
`The Related Applications do not Provide Written Description
`Support for the Full Scope of the Challenged Claims ............. 26
`
`1.
`
`The ʼ534 Provisional does not Provide Written
`Description Support for the Full Scope of the Challenged
`Claims ............................................................................ 28
`
`
`
`i
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`a.
`
`b.
`
`The inventors were not in possession of the full
`scope of “abuse deterrent dosage forms” ............ 28
`
`The claimed dosage form is the result of
`impermissible “picking and choosing” from the
`specification of the ʼ534 Provisional ................... 33
`
`2.
`
`The NP Related Applications do not Provide Written
`Description Support for the Full Scope of the Challenged
`Claims ............................................................................ 39
`
`C.
`
`The Related Applications do not Enable the Full Scope of the
`Challenged Claims ................................................................... 40
`
`1.
`
`The ʼ534 Provisional does not Enable the Full Scope of
`the Challenged Claims. .................................................. 42
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`The Challenged Claims are exceedingly broad ... 43
`
`The ʼ534 Provisional contains no working
`examples of any purported embodiment of the
`ʼ961 patent ........................................................... 46
`
`The ʼ534 Provisional Provides no direction or
`guidance ............................................................... 47
`
`The art is unpredictable and the claims of the ʼ961
`patent likely encompass numerous inoperative
`formulations ......................................................... 50
`
`Nature of the invention and state of the art inform
`the quantity of experimentation necessary to
`enable the full scope of the claims of the ʼ961
`patent .................................................................... 56
`
`2.
`
`The NP Related Applications do not Enable the Full
`Scope of the Challenged Claims .................................... 65
`
`XI.
`
`IT IS MORE LIKELY THAN NOT THAT THE CHALLENGED
`CLAIMS ARE UNPATENTABLE. .................................................. 67
`
`A. Ground 1: The Challenged Claims Lack Written Description
`Support ..................................................................................... 67
`
`ii
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`B. Ground 2: The Challenged Claims Lack Enablement Support 68
`
`C.
`
`Ground 3: The Challenged Claims are Indefinite .................... 69
`
`D. Ground 4: The Challenged Claims are Anticipated ................. 70
`
`XII. CONCLUSION ................................................................................... 85
`
`XIII. CERTIFICATE OF COMPLIANCE ................................................. 85
`
`XIV. PAYMENT OF FEES ........................................................................ 87
`
`
`
`
`
`iii
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Acorda Therapeutics Inc. v. Apotex Inc.,
`No. 07-4937, 2011 U.S. Dist. LEXIS 102875
`(D.N.J. Sept. 6, 2011) ................................................................................... 50, 64
`
`Alza Corp. v. Andrx Pharms., LLC,
`603 F.3d 935 (Fed. Cir. 2010) ...................................................................... 44, 57
`
`Amgen Inc. v. Sanofi,
`872 F.3d 1367 (Fed. Cir. 2017) .......................................................................... 53
`
`Amneal Pharms., LLC v. Purdue Pharma L.P.,
`IPR2016-01027, Paper 48 (P.T.A.B. Nov. 8, 2017) ............................................. 5
`
`Amneal Pharms. LLC v. Purdue Pharma L.P.,
`IPR2016-01412, Paper 9 (P.T.A.B. Feb. 14, 2017) .............................................. 5
`
`Anascape, Ltd. v. Nintendo of Am., Inc.,
`601 F.3d 1333 (Fed. Cir. 2010) .............................................................. 27, 32, 33
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) .......................................................................... 30
`
`Atlas Powder Co. v. E.I. du Pont De Nemours & Co.,
`750 F.2d 1569 (Fed. Cir. 1984) .................................................................... 42, 56
`
`Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc.,
`501 F.3d 1274 (Fed. Cir. 2007) .................................................................... 46, 47
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) .......................................................................... 21
`
`Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc.,
`291 F.3d 1317 (Fed. Cir. 2002) .......................................................................... 29
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (1016) ........................................................................................ 17
`
`
`
`iv
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`Enercon GmbH v. ITC,
`151 F.3d 1376 (Fed. Cir. 1998) .......................................................................... 18
`
`Enzo BioChem, Inc. v. Calgene, Inc.,
`188 F.3d 1362 (Fed. Cir. 1999) ..................................................42, 50, 63, 64, 65
`
`Forest Labs., Inc. v. Teva Pharm. USA, Inc.,
`Nos. 2016-2550, 2016-2553, 2017 U.S. App. LEXIS 24877
`(Fed. Cir. Dec. 11, 2017) .............................................................................. 70, 71
`
`Genentech, Inc. v. Novo Nordisk A/S,
`108 F.3d 1361 (Fed. Cir. 1997) .......................................................................... 57
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) .................................................................... 27, 32
`
`Grünenthal GmBH v. Antecip Bioventures II LLC,
`PGR2017-00008, Paper 7 (P.T.A.B. July 7, 2017) ............................................ 26
`
`Hyatt v. Dudas,
`492 F.3d 1365 (Fed. Cir. 2007) .................................................................... 33, 34
`
`ICU Medical, Inc. v. Alaris Medical Systems, Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) .......................................................................... 31
`
`In re Fisher,
`427 F.2d 833 (C.C.P.A. 1970) ............................................................................ 50
`
`In re Jennings,
`30 C.C.P.A. 887 (C.C.P.A. 1943) ....................................................................... 70
`
`In re NTP, Inc.,
`654 F.3d 1268 (Fed. Cir. 2011) .......................................................................... 27
`
`In re OxyContin Antitrust Litigation,
`No. 04-Md-1603, 2015 U.S. Dist. LEXIS 45967
`(S.D.N.Y. Apr. 8, 2015),
`aff’d, No. 2015-1654 (Fed. Cir. Apr. 8, 2016) .................................................... 4
`
`In re Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) ............................................................................ 38
`
`v
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988) ............................................................................ 41
`
`Inguran, LLC v. Premium Genetics (UK) Ltd.,
`PGR2015-00017, Paper 8 (P.T.A.B. Dec. 22, 2015) .......................................... 26
`
`Invitrogen Corp. v. Clontech Labs., Inc.,
`429 F.3d 1052 (Fed. Cir. 2005) .......................................................................... 41
`
`Minerva Surgical, Inc. v. Hologic, Inc.,
`PGR2017-00002, Paper 8 (P.T.A.B. May 10, 2017) ......................................... 26
`
`Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc.,
`166 F.3d 1190 (Fed Cir. 1999) ..................................................................... 41, 43
`
`Novozymes A/S v. Dupont Nutrition Biosciences APS,
`723 F.3d 1336 (Fed. Cir. 2013) .................................................................... 38, 39
`
`Pharmaceutical Resources, Inc. v. Roxane Labs., Inc.,
`253 F. App’x 26 (Fed. Cir. 2007) ....................................................................... 64
`
`Purdue Pharma L.P. et al. v. Collegium Pharmaceutical, Inc.,
`1-15-cv-13099 (D. Mass., filed Aug. 6. 2015) ..................................................... 4
`
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) .................................................................... 28, 33
`
`Purdue Pharma L.P. v. Recro Tech., LLC,
`694 F. App’x 794 (Fed. Cir. 2017) ..................................................................... 39
`
`Regents of the Univ. of Cal. v. Eli Lilly & Co.,
`119 F.3d 1559 (Fed. Cir. 1997) .......................................................................... 28
`
`Schering Corp. v. Geneva Pharms., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003) .................................................................... 71, 72
`
`Trintec Indus., Inc. v. Top-USA Corp.,
`295 F.3d 1292 (Fed. Cir. 2002) .......................................................................... 75
`
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) .......................................................................... 29
`
`vi
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`US Endodontics, LLC v. Gold Standard Instruments, LLC,
`PGR2015-00019, Paper 54 (P.T.A.B. Dec. 28, 2016) .................................. 25, 26
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .................................................................... 27, 39
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................ 18
`
`Statutes
`
`35 U.S.C. § 102 ........................................................................................................ 85
`
`35 U.S.C. § 112 ...................................................................................... 25, 26, 41, 85
`
`35 U.S.C. § 321(c) ..................................................................................................... 4
`
`Other Authorities
`
`37 C.F.R. § 42.202(a) ................................................................................................. 4
`
`37 C.F.R. § 42.204(a) ................................................................................................. 3
`
`M.P.E.P. § 211.01(b)................................................................................................ 30
`
`
`
`
`
`vii
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`Exhibit No.
`
`Ex. 1001
`Ex. 1002
`Ex. 1003
`Ex. 1004
`Ex. 1005
`Ex. 1006
`
`Ex. 1007
`Ex. 1008
`Ex. 1009
`Ex. 1010
`Ex. 1011
`Ex. 1012
`
`Ex. 1013
`
`Ex. 1014
`
`Ex. 1015
`
`Ex. 1016
`Ex. 1017
`
`Ex. 1018
`
`Ex. 1019
`
`TABLE OF EXHIBITS1
`
`Document Name
`
`U.S. Patent 9,693,961 to Wright et al.
`Declaration of Walter G. Chambliss, Ph.D.
`Curriculum Vitae of Walter G. Chambliss, Ph.D
`U.S. Application No. 15/015,722 to Wright et al.
`Provisional Application No. 60/310,534 to Wright et al.
`U.S. Application No. 10/214,412, published as US
`2003/0068375 (Abandoned)
`U.S. Application No. 12/262,015, issued as U.S. 8,389,007
`U.S. Application No. 13/765,368, issued as U.S. 9,040,084
`U.S. Application No. 13/890,874, issued as U.S. 9,308,170
`U.S. Application No. 13/946,418, issued as U.S. 8,999,961
`U.S. Application No. 14/638,685, issued as U.S. 9,867,783
`Preliminary Amendment filed June 2, 2015 in Application
`14/728,601 to Wright et al.
`Office Action in Application 14/728,601 to Wright et al.,
`dated August 5, 2015
`F. R. Gusterson et al., Letter, “Analgesia in Terminal
`Malignant Disease”, British Medical Journal (July 7, 1979)
`NDA 7337/S24, Percodan Final Printed Labeling (January
`1989)
`U.S. Patent 5,468,744 to Raffa et al.
`The United States Pharmacopeia, The National Formulary,
`USP 23/NF 18 (1994)
`E. Bourret et al., “Rheological Behaviour of Saturated
`Polyglycolysed Glycerides”, 46 J. Pharm. Pharmacol. 538
`(1994)
`W. Sutananta et al., “An Investigation into the Effect of
`Preparation Conditions on the Structure and Mechanical
`Properties of Pharmaceutical Glyceride Bases”, 110 Int. J.
`of Pharmaceutics 75 (1994)
`
`
`1 Unless otherwise noted, all exhibits are cited by their original page, column, or
`
`paragraph numbers.
`
`viii
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`Exhibit No.
`
`Ex. 1020
`Ex. 1021
`Ex. 1022
`Ex. 1023
`Ex. 1024
`Ex. 1025
`
`Ex. 1026
`
`Ex. 1027
`
`Ex. 1028
`
`Ex. 1029
`Ex. 1030
`Ex. 1031
`Ex. 1032
`
`Ex. 1033
`Ex. 1034
`Ex. 1035
`
`Ex. 1036
`Ex. 1037
`Ex. 1038
`
`Ex. 1039
`Ex. 1040
`Ex. 1041
`
`Ex. 1042
`
`Document Name
`
`U.S. Patent No. 6,248,363 to Patel et al.
`International Publication Number WO 96/36330 to Lin
`U.S. Patent No. 6,225,444 to Shashoua
`U.S. Patent No. 4,882,167 to Jang
`U.S. Patent No. 6,120,751 to Unger
`K. Harvey et al., “Parenteral Lipid Emulsions in Guinea
`Pigs Differentially Influence Plasma and Tissue Levels of
`Fatty Acids, Squalene, Cholesterol, and Phytosterols”, 49(8)
`Lipids 777 (2014)
`C. Shacky et al., “A Comparative Study of Eicosapentainoic
`Acid Metabolism by Human Platelets in vivo and in vitro”,
`26 J. of Lipid Research 457 (1985)
`A. Kibbe ed., Handbook of Pharmaceutical Excipients (3rd
`Ed. 2000)
`International Publication No. WO 00/38649 to DuFour
`(Certified Translation)
`UK Patent Application GB 2 162 061 A to Bardhan
`U.S. Patent 4,175,119 to Porter
`OxyContin® Label 2001
`Declaration under 37 C.F.R. 1.132, submitted in Application
`No. 14/946,275 to Rariy et al.
`J. Sprowls, Ph.D., Prescription Pharmacy (2nd Ed. 1970)
`U.S. Patent 3,184,386 to Stephenson
`L. Lachman et al., The Theory and Practice of Industrial
`Pharmacy (3rd ed. 1986)
`U.S. Patent 5,656,295 to Oshlack et al.
`Left intentionally blank
`Master Batch Record, Oxycodone DETERx™, Batch
`Production Record #Oxy-10152008 (FILED UNDER
`SEAL)
`U.S. Patent 3,980,766 to Shaw et al.
`U.S. Patent 6,309,668 to Bastin et al.
`US 2004/0010000 to Ayer et al.
`
`Provisional Application 60/376470 to Ayer et al.
`
`ix
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`Exhibit No.
`
`Ex. 1043
`
`Ex. 1044
`
`Ex. 1045
`Ex. 1046
`
`Ex. 1047
`Ex. 1048
`
`Ex. 1049
`
`Ex. 1050
`
`Ex. 1051
`
`Ex. 1052
`
`Ex. 1053
`
`Ex. 1054
`
`Ex. 1055
`Ex. 1056
`Ex. 1057
`
`Ex. 1058
`
`Ex. 1059
`Ex. 1060
`
`Document Name
`
`U.S. Patent Application Publication No. 2015/0164835 to
`King et al.
`U.S. Patent Application Publication No. 2014/0271835 to
`Wengner
`U.S. Patent 8,569,228 to Jenkins et al.
`U.S. Patent Application Publication No. 2011/0142943 to
`Rariy et al.
`Declaration of Todd Scungio
`Collegium Pharmaceutical Study: Intravenous Abuse
`Comparison of Oxycodone DETERx™ Versus
`OxyContin™ (FILED UNDER SEAL)
`Complaint, Purdue Pharma L.P. et al., v. Collegium
`Pharmaceutical, Inc., 17-cv-11814 [Dkt 1]
`Order Granting Consolidation, Purdue Pharma, L.P. et al. v.
`Collegium Pharmaceutical, Inc., 15-cv-13099 [Dkt 152]
`Joint Claim Construction and Prehearing Statement, Purdue
`Pharma, L.P. et al. v. Collegium Pharmaceutical, Inc., 15-
`cv-13099 [Dkt 116]
`A. Gennaro ed., Remington: The Science and Practice of
`Pharmacy (20th ed. 2000)
`E. Cone et al., “An Iterative Model for in vitro Laboratory
`Assessment of Tamper Deterrent Formulations”, 131 Drug
`and Alcohol Dependence 100 (2013)
`FDA, Abuse-Deterrent Opioids - Evaluation and Labeling:
`Guidance for Industry (April 2015)
`U.S. Patent No. 6,228,863 to Palermo et al.
`Left intentionally blank
`Department of Justice, National Drug Intelligence Center,
`Information Bulletin, “OxyContin Diversion and Abuse”
`(January 2001)
`Plaintiffs’ Opening Claim Construction Brief, Purdue
`Pharma L.P. et al. v. Collegium Pharmaceutical, Inc., 15-
`cv-13099 [Dkt 99] (Redacted version filed in district court)
`U.S. Patent 8,652,497 to Sackler
`S. Passik et al., “Psychiatric and Pain Characteristics of
`Prescription Drug Abusers Entering Drug Rehabilitation”,
`20:2 J. of Pain & Palliative Care Pharmacotherapy 5 (2006)
`
`x
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`Exhibit No.
`
`Ex. 1061
`Ex. 1062
`Ex. 1063
`Ex. 1064
`
`Ex. 1065
`
`Ex. 1066
`Ex. 1067
`Ex. 1068
`
`Ex. 1069
`
`Ex. 1070
`
`Ex. 1071
`
`
`
`Document Name
`
`U.S. Patent 5,545,628 to Deboeck et al.
`U.S. Patent 6,468,559 to Chen et al.
`Bulletin Technique Gattefossé Report (1988)
`S. Harris et al., “Abuse Potential, Pharmacokinetics,
`Pharmacodynamics, and Safety of Intranasally
`Administered Crushed Oxycodone HCl Abuse-Deterrent
`Controlled-Release Tablets in Recreational Opioid Users”,
`54(4) J. of Clinical Pharmacology 468 (2013)
`B. Lara-Hernandez et al., “Effect of Stearic Acid on the
`Properties of Metronidazole/Methocel K4M Floating
`Matrices”, 45(3) Brazilian J. of Pharm. Scis. 497 (2009)
`Left Intentionally Blank
`B. Alberts et al., Essential Cell Biology (2nd ed. 2004)
`C. Smith et al., “Oral and Oropharyngeal Perceptions of
`Fluid Viscosity Across the Age Span”, Dysphagia (2006)
`Rowe et al. eds., Handbook of Pharmaceutical Excipients
`(7th ed. 2012)
`Y. Zhang et al., “Effect of Processing Methods and Heat
`Treatment on the Formation of Wax Matrix Tablets for
`Sustained Drug Release”, 6(2) Pharm. Dev. and Tech. 131
`(2001)
`I. Ghebre-Sellassie ed., Pharmaceutical Pelletization
`Technology (1989)
`
`xi
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`I.
`
`INTRODUCTION
`
`Petitioner Collegium Pharmaceutical, Inc. (“Collegium”) respectfully
`
`requests post-grant review (“PGR”) of claims 1-17 of U.S. Patent No. 9,693,961
`
`(“the ʼ961 patent”). The ’961 patent is the seventh application in the priority chain,
`
`filed some fifteen years after the original provisional application on August 6,
`
`2001. The ʼ961 patent represents a blatant attempt by Patent Owner (“Purdue”) to
`
`ignore the alleged invention disclosed in the parent specifications and instead seeks
`
`to obtain extremely broad claims in hopes of covering subject matter actually
`
`developed and invented by Collegium. Not surprisingly, Purdue’s gambit led to
`
`claims that lack written description and enablement; and therefore, the ʼ961 patent
`
`is not entitled to claim priority to the provisional application in the alleged priority
`
`chain. Because of this, as explained below, the effective filing date of the ʼ961
`
`patent is February 4, 2016 (“Effective Filing Date”), and thus the ʼ961 patent is
`
`eligible for PGR. The claims are also invalid as indefinite, and, as of the Effective
`
`Filing Date, anticipated by Collegium’s invention disclosed in its own patent
`
`application.
`
`The technology at issue relates to the problem of prescription drug abuse,
`
`including abuse of opioid pharmaceutical dosage forms. Purdue’s application
`
`disclosed a controlled release opiate drug product that was modified by the
`
`inclusion of an “aversive agent” intended to deter abuse. The specification
`
`
`
`1
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`describes that aversive agents include a bittering agent, an irritant, or a gelling
`
`agent. Purdue consistently claimed this purported “aversive agent” invention
`
`through six prior applications, but the ’961 patent claims a much broader purported
`
`invention: any “abuse deterrent dosage form.” In other words, the claims of the
`
`ʼ961 patent purport to encompass both aversive agents and other, non-aversive
`
`agent methods of making an abuse deterrent dosage form—for example, a dye,
`
`emetic or purgative, precipitant, or visual indicator—that are not disclosed in the
`
`specification of the ʼ961 patent.
`
`To conjure up the claims of the ’961 patent, Purdue also had to cherry-pick
`
`from laundry lists of ingredients included in its original application. The claims
`
`recite oxycodone, polyglycolyzed glycerides (“PGG”), fatty acids, carnauba wax,
`
`and beeswax, which, when combined, purportedly release oxycodone over time
`
`and deter abuse. But the claims of the ʼ961 patent describe the “controlled release”
`
`and “abuse deterrent” limitations in functional, if not simply aspirational, terms.
`
`The specification neither exemplifies such a claimed dosage form, nor gives any
`
`guidance as to the specific selections from among these ingredient classes, nor the
`
`relative amounts that might make a successful dosage form with controlled release
`
`and abuse deterrent functions. Indeed, even under a conservative estimate by
`
`Collegium’s expert witness, Dr. Walter Chambliss, the claims of the ʼ961 patent
`
`encompass upwards of one million unique combinations of the claimed
`
`2
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`pharmaceutical ingredients, which would have taken at least 1200 hours of
`
`experimentation—if success could be achieved at all—to enable the full scope of
`
`even the narrowest claims. As such, and with zero disclosed examples in the ʼ961
`
`patent, the claims are not described or enabled.
`
`In 2001, Purdue had possession of, at most, a dosage form that implemented
`
`the use of an aversive agent to deter abuse. Purdue should not be permitted to
`
`improperly expand the scope of its purported invention beyond that described in or
`
`enabled by the specification of the ʼ961 patent. The ʼ961 patent is invalid for lack
`
`of written description, lack of enablement, indefiniteness, and anticipation.
`
`Accordingly, Collegium seeks cancellation of claims 1-17 of the ʼ961 patent.
`
`II. GROUNDS FOR STANDING
`
`Collegium certifies that, under 37 C.F.R. § 42.204(a), the ʼ961 patent is
`
`available for PGR and that Collegium in not barred or estopped from requesting
`
`review of the ʼ961 patent. The application underlying the ʼ961 patent, Application
`
`No. 15/015,722 (“the ʼ722 Application”), was filed on February 4, 2016. (See Ex-
`
`1001, at [22].) The ʼ722 Application claims priority to Provisional Application No.
`
`60/310,534 (“the ʼ534 Provisional”), which filed on August 6, 2001. (Id. at [60].)
`
`But as discussed below in Section X, neither the ʼ534 Provisional, nor any other
`
`application in the priority chain, provides written description support or enables the
`
`claims of the ʼ961 patent. As a result, the effective filing date of the ʼ961 patent is
`
`3
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`the filing date of the ʼ722 Application, which is after March 16, 2013. Moreover,
`
`the ʼ961 patent issued less than nine months ago, on July 4, 2017. (Id. at [45].)
`
`Therefore, the claims of the ʼ961 patent are eligible for PGR. See 35 U.S.C.
`
`§ 321(c); 37 C.F.R. § 42.202(a).
`
`III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A. Real Party-in Interest (§ 42.8(b)(1))
`
`The real party-in-interest for petitioner is Collegium Pharmaceutical, Inc.
`
`The ’961 patent is assigned on its face to Purdue Pharma L.P., The P.F.
`
`Laboratories, Inc., and Purdue Pharmaceuticals L.P.
`
`B. Related Matters (§ 42.8(b)(2))
`
`The ʼ961 patent is asserted against Collegium in a civil action pending in the
`
`United States District Court for the District of Massachusetts and captioned as
`
`Purdue Pharma L.P. et al. v. Collegium Pharmaceutical, Inc., 1-17-cv-11814, filed
`
`September 21, 2017. (Ex-1049.) On December 13, 2017, Civil Action No. 1-17-cv-
`
`11814 was consolidated, for case management and discovery purposes only, with
`
`pending litigation captioned as Purdue Pharma L.P. et al. v. Collegium
`
`Pharmaceutical, Inc., 1-15-cv-13099 (D. Mass., filed Aug. 6. 2015). (Ex-1050.)
`
`The ʼ961 patent issued from the same non-provisional application—No.
`
`10/214,412—as U.S. Patent Nos. 8,337,888 (“the ʼ888 patent”); 9,060,976 (“the
`
`ʼ976 patent”); and the 9,034,376 (“the ʼ376 patent”). Certain claims of the ʼ888
`
`4
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`patent were previously found invalid as obvious and indefinite. See In re
`
`OxyContin Antitrust Litig., No. 04-Md-1603, 2015 U.S. Dist. LEXIS 45967, at *53
`
`(S.D.N.Y. Apr. 8, 2015), aff’d, No. 2015-1654 (Fed. Cir. Apr. 8, 2016). Similarly,
`
`claim 1 of the ʼ976 patent has been adjudicated invalid as obvious. See Amneal
`
`Pharms., LLC v. Purdue Pharma L.P., IPR2016-01027, Paper 48 at 43 (P.T.A.B.
`
`Nov. 8, 2017). Finally, inter partes review has been instituted for claims 1-13 and
`
`16-19 of the ʼ376 patent. See Amneal Pharms. LLC v. Purdue Pharma L.P.,
`
`IPR2016-01412, Paper 9 (P.T.A.B. Feb. 14, 2017). A decision on the patentability
`
`of the ʼ376 patent has not yet issued.
`
`C.
`
`Lead and Back-Up Counsel (§ 42.8(b)(3))
`
`Lead Counsel
`Cyrus A. Morton (Reg. No. 44,954)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email: CMorton@RobinsKaplan.com
`
`Additional Back-Up Counsel
`Jake M. Holdreith
`(pro hac vice motion to follow)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email:
`JHoldreith@RobinsKaplan.com
`
`Back-Up Counsel
`Christopher A. Pinahs (Reg. No. 76,375)
`Kelsey J. Thorkelson (Reg. No. 73,130)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email: CPinahs@RobinsKaplan.com
` KThorkelson@RobinsKaplan.com
`Additional Back-Up Counsel
`Oren D. Langer
`(pro hac vice motion to follow)
`ROBINS KAPLAN LLP
`399 Park Avenue, Suite 3600
`New York, NY 10022
`Phone: 212.980.7400
`Fax: 212.980.7499
`Email: OLanger@RobinsKaplan.com
`
`5
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`D.
`
`Service Information (§ 42.8(b)(4))
`
`Please direct all correspondence to lead and back-up counsel at the above
`
`addresses. Collegium consents to electronic service at the above-identified email
`
`addresses.
`
`IV.
`
`IDENTIFICATION OF CHALLENGED CLAIMS AND PRECISE
`RELIEF SOUGHT
`
`Collegium respectfully requests PGR of claims 1-17—i.e., all issued
`
`claims—of the ʼ961 patent (the “Challenged Claims”). It is more likely than not
`
`that the Challenged Claims are unpatentable as described below. Accordingly,
`
`cancellation of all of the Challenged Claims should occur.
`
`Ground Claims
`
`Statutory Basis
`
`1
`
`2
`
`3
`
`4
`
`1-17
`
`35 U.S.C. § 112 (written description)
`
`1-17
`
`35 U.S.C. § 112 (enablement)
`
`1-17
`
`35 U.S.C. § 112 (indefiniteness)
`
`1-17
`
`35 U.S.C. § 102 (anticipation)
`
`
`V. OPIATE ABUSE AND METHODS OF ABUSE DETERRENCE
`
`The ʼ961 patent description is generally directed to opiate drugs and their
`
`abuse. “The opium group of narcotic drugs are among the most powerfully acting
`
`and clinically useful drugs . . . .” (Ex-1052 at 1445.) As a medicinal drug, opium
`
`and its related alkaloids have been known and used for centuries. (Id.) Opiates are
`
`6
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`compounds derived from or chemically related to active compounds obtained from
`
`the opium poppy. (Id.; Ex-1002, ¶ 39.)
`
`It has been known for decades that the use of opiates can lead to tolerance
`
`and physical dependence, resulting in dose escalation and excessive use. (Ex-1052
`
`at 1445.) One opioid analgesic subject to extensive reports of “[d]iversion and
`
`abuse” includes oxycodone, which is sold under the brand name OxyContin®. (Ex-
`
`1057 at 1.) Indeed, in January 2001, prior to the filing of the ʼ534 Provisional, the
`
`U.S. Department of Justice characterized OxyContin® abuse as “a major problem”
`
`that “ha[d] increased in recent years.” (Ex-1057 at 1-2; Ex-1002, ¶ 28.) It was also
`
`known that abusers tampered with OxyContin® by destroying the extended release
`
`properties of the dosage form, thereby liberating most, if not all, of the oxycodone
`
`active pharmaceutical ingredient (“API”). (Ex-1057 at 1-2; Ex-1002, ¶ 28) Typical
`
`routes of abuse include crushing and snorting; crushing, dissolving and injecting;
`
`and chewing and swallowing. (Ex-1057 at 1-2; Ex-1060 at Abstract; see also Ex-
`
`1002, ¶ 28.)
`
`By 2001, several abuse deterrent dosage forms had been developed. (Ex-
`
`1002, ¶¶ 29-34.) For example, the specification of the ʼ961 patent purports to
`
`describe the use of aversive agents, including a bittering agent, irritant, or gelling
`
`agent that provide an unpleasant taste, burning or irritating effect, or a gel-like
`
`7
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`quality, respectively, upon tampering of the dosage form. (Ex-1001 at 2:62-3:38;
`
`Ex-1002, ¶ 29.)
`
`Other abuse deterrent dosage forms not mentioned in the ʼ961 patent were
`
`also known by 2001. For instance, the art described the use of a dye, which
`
`“provides a noticeable color” that “makes the act of abuse visible to the abuser and
`
`to others such that the abuser is less likely to inhale, inject and/or swallow the
`
`tampered dosage form.” (Ex-1005 at 3; Ex-1028 at 3:3-12; 7:1-9; see also Ex-
`
`1002, ¶ 30.)
`
`Deterring abuse by combining an opioid agonist with an opioid antagonist
`
`was also known by 2001. (Ex-1002, ¶ 31.) For example, U.S. Patent No.
`
`6,228,863, which is cited in the specification of the ʼ961 patent (Ex-1001 at 2:4-6),
`
`combined an analgesically effective amount of an opioid agonist together with an
`
`opioid antagonist into an oral dosage form. (Ex-1055 at 11:60-12:3.) More
`
`particularly, agonist/antagonist dosage forms can be abuse deterrent because the
`
`“opioid antagonists . . . block or reverse all of the effect of opioid agonists” upon
`
`tampering of the dosage form. (Id. at 2:56-57.)
`
`A purgative or emetic was another abuse deterrent dosage form known in the
`
`art by 2001. (Ex-1002, ¶ 32.) For example, UK Patent Application GB2162061
`
`disclosed compositions comprising a drug subject to abuse in combination with a
`
`purgative (also known in the art as a laxative) such as bisacodyl, or an emetic such
`
`8
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`as ammonium carbonate. (Ex 1029, at Abstract, 1:125–2:33.) Similarly, U.S.
`
`Patent No. 4,175,119 taught combining a drug subject to abuse, including
`
`oxycodone, with an emetic. (Ex-1030, Abstract, 2:13-36, 3:50-63.)
`
`The use of a precipitant to make an abuse deterrent dosage form was also
`
`known by 2001. (Ex-1002, ¶ 33.) For example, U.S Patent No. 3,980,766 (“Shaw”)
`
`describes the use of an excipient in the dosage form to induce precipitation of a
`
`major portion of a drug of abuse when the dosage form is added to water in
`
`preparation of injection. (Ex-1039 at 2:59-3:68.) More specifically, the abuse
`
`deterrent dosage form in Shaw comprises at least one pH control or salt forming
`
`component that precipitates the API when the dosage form is added to water. (Id.)
`
`The use of various visual indicators were also known by 2001. (Ex-1002,
`
`¶ 34.) For example, WO0038649 discloses the use of a colorant, an effervescent
`
`that causes the dosage form to float, and insoluble particles, which all indicate
`
`when a dosage form containing a drug subject to abuse, such as oxycodone, has
`
`been manipulated. (Ex-1028, at 1:10-23, 3:3–37.)
`
`As discussed herein, as of the filing date of the ʼ534 Provisional, a person of
`
`ordinary skill in the art (“POSA”) would have been aware of at least seven
`
`different ways to make an “abuse deterrent dosage form” utilizing a sole active
`
`9
`
`
`
`PGR2018-00048
`Patent: 9,693,961
`
`agent,2 including a bittering agent, an irritant, a gelling agent, a dye, emetic or
`
`purgative, preci