throbber

`
`
`
`
`
`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

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket