throbber
Paper No. 11
`Filed: May 31, 20162
`
`Filed on behalf of Dr. Reddy’s Laboratories, Ltd.
`and Dr. Reddy’s Laboratories, Inc.3
`
`By:
`
`Jeffery B. Arnold4
`jarnold@cantorcolburn.com
`5 Cantor Colburn LLP 1180
`Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`Telephone: (404) 607-9991
`Facsimile: (404) 607-99816
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TEVA PHARMACEUTICALS USA, INC.7
`
`Petitioner8
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,9
`Petitioners,10
`
`v.
`
`RB PHARMACEUTICALS LTD.11
`
`INDIVIOR UK LIMITED, 12Patent OwnerU13.S. 14
`
`Patent No. 8,475,832 Issue Date: July 2, 201315
`Title: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS16
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
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`
`Case17Inter Partes Review No.18 IPR2016: Unassigned19-XXXXX20
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,475,832
`PETITIONER21
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`TABLE OF CONTENTS22
`
`Page23
`
`I.
`24INTRODUCTION
`...........................................................................................125
`
`II.
`26BACKGROUND
`.............................................................................................127
`
`A.
`28Brief Overview of the ’832 Patent
`........................................................129
`
`B.
`30Brief Overview of the Prosecution
`History...........................................331
`
`III.
`32GROUNDS FOR STANDING (§ 42.104(A))
`................................................633
`
`IV.
`34MANDATORY NOTICES UNDER 37 C.F.R. §
`42.8...................................635
`
`A.
`36Real Party-in-Interest (§
`42.8(b)(1).......................................................637
`
`B.
`38Related Proceedings (§ 42.8(b)(2))
`.......................................................639
`
`C.
`40Lead and Backup Counsel (§
`42.8(b)(3))............................................1041
`
`V.
`
`42STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(B)) ........................1143
`
`VI.
`44LEVEL OF ORDINARY SKILL IN THE ART
`...........................................1345
`
`VII.
`46THE CHALLENGED CLAIMS OF THE ’832
`PATENT............................1347
`
`VIII. CLAIM CONSTRUCTION ..........................................................................1548
`
`IX.
`49SCOPE AND CONTENT OF THE PRIOR
`ART.........................................1550
`
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`A.
`51WO2008/040534 (“LabTec”) (Ex. 1007)
`...........................................1552
`
`B.
`53WO 2008/025791 (“Oksche”) (Ex.
`1005)...........................................1654
`
`C.
`55U.S. Patent No. 7,357,891 (“Yang”) (Ex.
`1006).................................1656
`57Suboxone® Sublingual Tablets (Label and SBOA, Exs. 1008 and 1009)58
`.............................................................................................1759
`
`D.
`
`E.
`60U.S. Patent Publication 2005/0085440 (“Birch”) (Ex. 1004)
`.............2261
`
`F.
`62The ’055 Publication (Ex. 1010)
`.........................................................2363
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`X.
`
`64DETAILED EXPLANATION OF THE GROUNDS FOR
`UNPATENTABILITY
`..................................................................................2465
`A.
`
`66Ground 1: Claims 1-2, 4-7, and 9-10 are Invalid Under 35 U.S.C. §
`103(a) as Being Obvious Over LabTec in View of Yang, the Suboxone®
`2002 Label, SBOA, and Birch.........................2467
`
`1.
`68The film dosage limitations
`......................................................2469
`
`2.
`70The buffer and pH range limitations
`.........................................2771
`
`B.
`
`C.
`
`72Ground 2: Claims 3 and 11-12 are Invalid Under 35 U.S.C. § 103(a) as
`Being Obvious Over LabTec in View of Yang, the Suboxone® 2002
`Label, SBOA, Birch, and the ’055 Publication.......3973
`
`74Ground 3: Claims 1-2, 4-7, and 9-10 are Invalid Under 35 U.S.C. §
`103(a) as Being Obvious Over Oksche in View of Yang, Birch, the
`Suboxone® 2002 Label, and SBOA.........................4075
`1.
`76The film dosage limitations
`......................................................4077
`
`2.
`78The buffer and pH range
`limitations.........................................4379
`
`D.
`
`80Ground 4: Claims 3 and 11-12 are Invalid Under 35 U.S.C. § 103(a) as
`Being Obvious Over Oksche in View of Yang, Birch, the Suboxone®
`2002 Label, SBOA, and the ’055 Publication............4981
`
`XI.
`
`82CONCLUSION..............................................................................................50
`83
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`PETITIONERS’84 EXHIBIT LIST
`
`Exhibit No.
`1001
`
`Reference
`U.S. Patent No. 8,475,832 (filed August 7, 2009) (“’832 patent”)85
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`File History, U.S. Patent No. 8,475,832
`
`Expert Declaration of Nandita Das86Metin Çelik87, Ph.D., Relating to
`U.S. Patent
`
`88
`U.S. Patent Application Publication 2005/0085440 (published April
`21, 2005) (“Birch”)
`
`WO 2008/025791 (published March 6, 2008) (“Oksche”)
`
`U.S. Patent No. 7,357,891 (published December 23, 2004) (issued
`April 15, 2008) (“Yang”)
`
`WO 2008/040534 (published April 10, 2008) (“LabTec”)
`
`Suboxone® Label
`
`Suboxone® Tablet Summary Basis of Approval (“SBOA”)
`
`U.S. Patent Application Publication No. 2005/0037055 (“the ’055
`publication”)
`European Medicines Agency Initial Marketing-Authorisation
`Document, Scientific Discussion, Oct. 19, 2006
`for
`Suboxone®89 sublingual tablets (“EMEA”)
`
`J.P. Cassidy et al., Controlled Buccal Delivery of Buprenorphine,
`25
`90
`91
`Rex M. C. Dawson et al., Data for Biochemical Research (3d ed.
`1986)
`
`Domenic A. Ciraulo et al., Pharmacokinetics and
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`Exhibit No.93
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`Reference
`94in
`C. Nora Chiang & Richard L. Hawks, Pharmacokinetics of the
`Combination Tablet of Buprenorphine and Naloxone, 70 Drug &
`Alcohol Dependence S39 (2003)
`
`Campbell et al., The History of the Development of Buprenorphine
`as an Addiction Therapeutic, 1248 Ann. N.Y. Acad. Sc. (Issue:
`Addiction Reviews), 124 (2012) (“Campbell”)
`
`Bullingham et al., Sublingual Buprenorphine Used
`Postoperatively: Clinical Observations and Preliminary
`Pharmacokinetic Analysis,
`12 Br. J. Clinical Pharmacology 117 (1981)
`
`U.S. Patent App. Pub. 96No. US 2010/0087470
`
`U.S. Patent No. 4,582,835
`
`Center for Drug Evaluation and Research, Approval Package for
`App. No. 22-410/S006/S007 (approval date 8/10/12) (“Film
`Approval Package”)
`Encyclopedia of Pharmaceutical Technology, 2nd ed., Vol. I, Drug
`Delivery—Buccal Route (McElnay et al.) (“McElnay”)
`
`U.S. Patent No. 5,288,497 (“Stanley”)
`
`Declaration by Maureen Reitman, SC.D. (“Reitman97Marlene Bobka
`(“Bobka98 Decl.”)
`Parkhurst A. Shore et al., The Gastric Secretion of Drugs: A pH
`Partition Hypothesis, 119 J. Pharmacology Exp. Ther. 361 (1957)
`
`1025
`
`Curriculum Vitae of Nandita Das99Metin Çelik100, Ph.D.
`
`1026
`1027103
`
`List of Materials Considered by Nandita Das101Metin Çelik102, Ph.D.
`The Theory and Practice of Industrial Pharmacy (L. Lachman,104
`Ph.D.) (1986)105
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`1028106
`
`1029109
`
`1030112
`
`Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson107
`Laboratories, Inc. et al., No. 13-cv-0167-RGA P.I. 1, Complaint108
`Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson110
`Laboratories, Inc. et al., No. 13-cv-0167-RGA, P.I. 403, JOINT
`PROPOSED FINDINGS OF FACT111
`Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson113
`Laboratories, Inc. et al., No. 13-cv-0167-RGA, Proposed Joint114
`Pretrial Order Exhibit 1, Joint Statements of Admitted Facts115
`TABLE OF
`CONTENTS116
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`Page117
`
`INTRODUCTION
`I.
`...........................................................................................1118
`BACKGROUND
`II.
`.............................................................................................1119
`Brief Overview of the ’832 Patent
`A.
`........................................................1120
`Brief Overview of the Prosecution
`B.
`History...........................................4121
`GROUNDS FOR STANDING (§ 42.104(a))
`III.
`.................................................6122
`IV. MANDATORY NOTICES UNDER 37 C.F.R. §
`42.8...................................7123
`Real Party124 in125 Interest (§ 42.8(b)(1))
`A.
`......................................................7126
`Related Proceedings (§ 42.8(b)(2))
`B.
`.......................................................7127
`Lead and Backup Counsel (§
`C.
`42.8(b)(3))............................................10128
`Service Information (§
`D.
`42.8(b)(4))......................................................11129
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§
`42.104(b)).........................12130
`LEVEL OF ORDINARY SKILL IN THE ART
`VI.
`...........................................14131
`VII. THE CHALLENGED CLAIMS OF THE ’832
`PATENT............................14132
`VIII. CLAIM CONSTRUCTION
`..........................................................................15133
`SCOPE AND CONTENT OF THE PRIOR
`IX.
`ART.........................................16134
`A. WO2008/040534 (“LabTec”) (Ex. 1007)
`...........................................16135
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`X.
`
`B. WO 2008/025791 (“Oksche”) (Ex.
`1005)...........................................17136
`U.S. Patent No. 7,357,891 (“Yang”) (Ex.
`C.
`1006).................................17137
`Suboxone® Sublingual Tablets (Label and SBOA, Exs. 1008 and
`D.
`1009)....................................................................................................18
`138
`U.S. Patent Publication 2005/0085440 (“Birch”) (Ex. 1004)
`E.
`.............19139
`The ’055 Publication (Ex. 1010)
`F.
`.........................................................20140
`DETAILED EXPLANATION OF THE GROUNDS FOR
`UNPATENTABILITY
`..................................................................................20141
`Ground 1: Claims 1-2, 4-7, and 9-10 are Obvious Over LabTec in View
`A.
`of Yang, the Suboxone® 2002 Label, SBOA, and Birch..........20142
`The film dosage limitations. .....................................................20
`i.
`ii.
`The buffer and pH range limitations.
`........................................24143
`Ground 2: Claims 3 and 11-12 are Obvious Over LabTec in View
`of Yang, the Suboxone® 2002 Label, SBOA, Birch, and the
`’055144
`Publication
`...........................................................................................35145
`Ground 3: Claims 1-2, 4-7, and 9-10 are Obvious Over Oksche
`in146
`View of Yang, Birch, the Suboxone® 2002 Label, and SBOA..........37
`i. The film dosage limitations. .....................................................37 ii.
`The buffer and pH range limitations.147 ........................................39148
`Ground 4: Claims 3 and 11-12 are Obvious Over Oksche in View
`of Yang, Birch, the Suboxone® 2002 Label, SBOA, and the
`’055149
`Publication
`...........................................................................................45150
`XI.
`CONCLUSION..............................................................................................461
`51
`-2-
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`D.
`
`B.
`
`C.
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`TABLE OF AUTHORITIES152
`
`Page(s)153
`
`Cases154
`
`Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson Laboratories,
`Inc. et al.,155
`Civil Action No. 13- 0167 (D. Del.)
`...................................................................19156
`Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, et al v. Teva
`Pharmaceuticals USA, Inc., Civil Action No. 14-1451 (D. Del.)
`......................................................................5157
`
`In re Translogic Tech., Inc., 504 F.3d 1249 (Fed. Cir. 2007)
`..........................................................................16158
`
`Statutes159
`35 U.S.C. § 311 ....................................................................................................1,
`11160
`
`35 U.S.C. § 325(d)
`.....................................................................................................9161
`
`Regulations162
`37 C.F.R. Part
`42........................................................................................................1163
`
`37 C.F.R. § 42.8
`.........................................................................................................6164
`
`37 C.F.R. § 42.100(b)
`..............................................................................................16165
`
`37 C.F.R. §
`42.104(a).................................................................................................5166
`INTRODUCTION
`I.
`
`Under 35 U.S.C. § 311, § 6 of the Leahy-Smith America Invents Act
`
`(“AIA”), and 37 C.F.R. Part 42, Teva Pharmaceuticals USA167Dr. Reddy’s
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`Laboratories, Ltd. and Dr. Reddy’s Laboratories168, Inc., (collectively,
`
`169“Petitioner”) respectfully requests inter partes review170request Inter Partes
`
`Review171 of claims 1-7 and 9-12 of U.S. Patent No. 8,475,832 (“the 172’832
`
`patent”; Ex.
`
`1001), which is currently assigned to RB Pharmaceuticals, Ltd.173Indivior UK
`
`Limited174 (“Patent Owner”). This petition and supporting exhibits demonstrate
`
`that there is a reasonable likelihood that claims 1-7 and 9-12 of the ’832 patent are
`
`unpatentable over the prior art and
`
`should be canceled.
`
`II.
`
`BACKGROUND
`
`A.
`
`Brief Overview of the ’832 Patent
`
`The ’832 patent relates to compositions and methods for treating narcotic
`
`dependence. In general, the patent claims concern an orally-dissolvable film
`
`composition containing buprenorphine and naloxone that produces “optimal”
`
`absorption of buprenorphine, which includes, according to the patent, absorption
`
`that is bioequivalent to Suboxone® tablets. (Ex. 1001, 4:55-58.) Suboxone® tablets
`
`were in the prior art. Like the claimed film, they are
`
`orally-dissolvable formulations containing buprenorphine and naloxone. (Id. at
`
`4:51-55.) Buprenorphine is an opioid that can satisfy an opioid addict’s urge for
`
`narcotics, but does not provide the “high” associated with misuse of opioids. (Id. at
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`1:36-40.) Naloxone blocks the effect of buprenorphine. Unlike buprenorphine, it is
`
`not absorbed orally and thus does not exert an effect when the tablet is used as
`
`intended. Should an abuser attempt to extract and inject buprenorphine from the
`
`tablets, however, the naloxone will also be extracted and will prevent the
`
`buprenorphine from having a narcotic effect. The naloxone thus decreases the
`
`likelihood of diversion and abuse of buprenorphine. (Id. at 1:46-52.) Nevertheless,
`
`according to the inventors of the ’832 patent, the tablet is more susceptible to abuse
`
`than the claimed film because it can purportedly be removed more easily from the
`
`mouth for later extraction of buprenorphine. (Id. at 1:55-62.) More particularly, the
`
`challenged claims concern, inter alia, a composition comprising a polymeric carrier,
`
`buprenorphine, naloxone, and a buffer to “provide for a local pH” from about 3 to
`
`about 3.5 in the presence of saliva. (See infra Section VII.) The ’832 patent states that
`
`controlling the local pH with a buffer in this manner will maximize the absorption of
`
`the buprenorphine while simultaneously minimizing the absorption of the naloxone,
`
`i.e., will produce absorption that is bioequivalent to Subxone175Suboxone176® tablets.
`
`(Ex. 1001, ’832 patent, at 11:26-30.) According to the patent, “it has been
`
`surprisingly discovered” that, at a
`
`local pH level from about 2 to about 4, and most desirably from 3 to 4, the film
`
`composition of the invention achieves bioequivalence1177 to the Suboxone® tablet.
`
`
`-5-
`1 In other words, the alleged invention features the same oral dissolvability, same drug
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`(Id. at 11:50–61.) It is notable that the alleged invention of the challenged claims
`
`has179
`
`
`combination, same strength, same route of delivery, and the same or similar
`pharmacokinetic parameters (such as bioequivalent Cmax and AUC) as the Suboxone®
`-6-
`tablets. (See id. at 15:55-23:11, Examples 1-8.)178
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`the same oral dissolvability, same drug combination, same strength, same route of
`
`delivery, and the same or substantially similar pharmacokinetic parameters, e.g.,
`
`bioequivalent Cmax and AUC, as the Suboxone® tablets. (See id. at 15:55-23:11,180
`Examples 1-8).181
`
`Patent Owner relied upon this buffer and pH range during prosecution as the
`
`alleged novel features of the invention. (See infra Section II.B.) But this buffer is the
`
`same as that used in the Suboxone® tablet to maximize absorption of the
`
`buprenorphine and minimize the absorption of naloxone. Moreover, the buffer was
`
`well-known in the prior art, as was the pH range at which the absorption of
`
`buprenorphine across mucosal membranes would be optimal. (Compare, e.g., Ex.
`1008, Suboxone® 2002 Label at 8 (“Each tablet also contains … citric acid, sodium
`
`citrate”), with Ex. 1001, ’832 patent, at 15:55-16:32, Example 1, 17:49-23:55,
`
`Examples 4-9, 24:19-21, Claim 7.1827183).184 It would have been well-within the skill
`
`of the ordinary artisan to create a film that uses the same buffer as in the tablets, to
`
`provide the same local pH as the tablets, and to produce the same absorption of
`
`buprenorphine as the tablets. Thus, these claimed features cannot confer
`
`patentability.
`
`B.
`
`Brief Overview of the Prosecution History
`
`The application leading to the ’832 patent (U.S. Patent Application No.
`
`12/537,571, hereinafter “’571 application”) was filed on August 7, 2009 and lists
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`Garry L. Myers, Samuel D. Hilbert, Bill J. Boone, B. Arlie Bogue, Pradeep
`
`Sanghvi, and Madhusudan Hariharan as inventors. (’832 patent, Ex. 1001.) The
`
`’571 application initially included 31 claims. (’571 application, Ex. 1002, at 33-
`
`36.) Claims 1, 11, 15, 17, 24, 26, and 27 were independent claims. (Id.) None of
`
`these independent claims recited any pH ranges. (Id.)
`
`Responding to a rejection of claims 1, 4, 5, 7-10, 15, 17, and 20-24, the
`
`applicants amended the claims “to recite a particular local pH value and/or to recite
`
`that the buffer optimizes absorption of buprenorphine while also inhibiting
`
`absorption of the naloxone.” (Ex. 1002, 2/29/12 Amendment and Response, at 7.) In
`
`particular, claim 1 was amended to include a “local pH” of from about 2 to
`
`about 3.5 in the presence of saliva. (Ex. 1002, 2/29/12 Amendment and Response, at
`
`2.) Claim 17 (which issued as independent claim 9) was also amended to include a
`
`“local pH of about 2 to about 3.5.” (Ex. 1002, 2/29/12 Amendment and
`
`Response, at 4 (emphasis in original).)
`
`The alleged invention was intended to provide a maximum blood concentration
`
`(Cmax) that is 80 to 125% of the level provided by a Suboxone® tablet at the same
`
`dosage levels of buprenorphine and naloxone. (Ex. 1002, 2/29/12
`
`Amendment and Response, at 7.) In order to achieve this, applicants “discovered
`
`that the film product should include a buffer that provides a specific buffer
`
`capacity to the film in order to achieve the desired result.” (Ex. 1002, 2/29/12
`
`Amendment and Response, at 7.) Applicants failed to mention to the examiner that
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`the claimed film used the identical buffer (citric acid/sodium citrate) as had been
`
`used in Suboxone® tablets, to produce the same local pH as the tablets.
`
`To distinguish the prior art, the applicants focused on pH, and argued that it
`
`“discovered that at a pH of about 2-3.5, the relative absorptions [of buprenorphine and
`
`naloxone] can be controlled effectively.” (Ex. 1002, 2/29/12 Amendment and
`
`Response, at 12.) Nevertheless, the examiner again rejected the claims.
`
`In an advisory action, the examiner noted that Example 8—on which
`
`applicants relied to show “unexpected” results—only “tested products at a pH of
`
`from 3.0-3.5.” (Ex. 1002, 11/6/12 Advisory Action, at 3(emphasis in original).)
`
`According to the examiner, this was “not sufficient to provide evidence of
`
`unexpected or significant benefits associated with the full scope of the claimed
`
`invention, which recites a ‘local pH of about 2 to about 3.5 in the presence of
`
`saliva.’” (Id. at 3-4 (emphasis in original).) Thus, the examiner determined that
`
`“Applicant’s showing is not commensurate in scope with the claimed invention.”
`
`(Id. at 4.) Eventually, the claims were amended to recite the local pH range of
`
`about 3 to about 3.5 to provide a scope that “is fully and expressly supported by the
`
`experimental results.” (Ex. 1002, 4/30/13 Amendment and Response with Request
`
`for Continued Examination, at 6.)
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`On May 24, 2013, the examiner issued a Notice of Allowability. (Ex. 1002,
`
`5/24/13 Notice of Allowability.) The examiner cited the results of an interview as
`
`the basis on which the claims were allowed. (Id.) At the May 20, 2013 interview,
`
`the examiner “agreed that the prior art does not teach the claimed local pH” based on
`
`applicants’ representation that “the prior art is silent regarding the use of a buffer to
`
`provide a local pH which would achieve optimized absorption of buprenorphine and
`
`naloxone.” (Ex. 1002, 5/20/13 Examiner-Initiated Interview Summary.)
`
`III. GROUNDS FOR STANDING (§ 42.104(A))
`
`Petitioner certifies under 37 C.F.R. § 42.104(a) that the ’832 patent is
`
`available for Inter Partes Review and that Petitioner is not barred or estopped from
`
`requesting Inter Partes Review on the grounds identified in this Petition. Petitioner
`
`was served with a complaint asserting185challenging the claims of186 the ’832 patent
`
`on December 3, 2014 in Reckitt Benckiser Pharmaceuticals, Inc. v. Teva
`
`Pharmaceuticals USA, Inc., No.187the188
`
`1:14-cv-01451-RGA (D. Del. Nov. 17, 2015). This Petition was timely filed on189
`grounds identified herein.190
`December 3, 2015.191
`IV. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A.
`
`Real Party -192in -193Interest (§ 42.8(b)(1))194
`
`The real party-in-interest is Teva Pharmaceuticals USA, Inc. (“Teva”
`
`or195parties-in-interest are Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`
`Laboratories, Inc. (collectively, 196“Petitioner”).2197
`-10-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 20/85
`
`

`
`B.
`
`Related Proceedings (§ 42.8(b)(2))
`
`The following proceedings may affect or be affected by a decision in this
`
`proceeding:
`
`Name198
`
`Number199
`
`District200
`
`Indivior Inc. v. Sandoz Inc.201
`
`1-15-cv-01051202 DED203
`
`Indivior Inc. v. Mylan Technologies Inc.204
`
`1-15-cv-00209205 WVND206
`
`Indivior Inc. v. Mylan Technologies Inc.207
`
`1-15-cv-01016208 DED209
`
`Reckitt Benckiser Pharmaceuticals Inc. v.
`
`Alvogen Pine Brook, Inc.210
`
`Reckitt Benckiser Pharmaceuticals Inc. v.
`
`Teva Pharmaceuticals USA, Inc.213
`
`1-15-cv-00477211 DED212
`
`1-14-cv-01451214 DED215
`
`2 Teva is owned directly or indirectly by: Teva Pharmaceutical Industries Ltd.,
`
`Orvet UK, Teva Pharmaceuticals Europe B.V., Teva Pharmaceutical Holdings
`
`Coöperatieve U.A., and IVAX LLC.216
`
`-11-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 21/85
`
`

`
`Reckitt Benckiser Pharmaceuticals Inc. v.
`Par217
`
`Pharmaceutical, Inc.218
`Reckitt Benckiser Pharmaceuticals Inc. v.
`
`Alvogen Pine Brook, Inc.221
`
`Reckitt Benckiser Pharmaceuticals Inc. v.
`
`Watson Laboratories Inc.224
`
`Reckitt Benckiser Pharmaceuticals, Inc. v.
`
`Par Pharmaceutical, Inc.227
`
`1-14-cv-00422219 DED220
`
`1-13-cv-02003222 DED223
`
`1-13-cv-01674225 DED226
`
`1-13-cv-01461228 DED229
`
`Related Proceeding230
`Reckitt Benckiser Pharmaceuticals Inc.
`v.233
`Par Pharmaceutical, Inc. et al.234
`
`Case No.231
`1:13-cv-01461-RGA23
`5
`
`Jurisdiction232
`U.S. District236
`Court District of
`Delaware
`(Wilmington)
`(“DED”)237
`DED242
`
`Reckitt Benckiser Pharmaceuticals Inc.238
`239Watson Laboratories, Inc. et al.240
`v.
`Reckitt Benckiser Pharmaceuticals Inc.
`v.243
`Alvogen Pine Brook, Inc.et al.244
`Reckitt Benckiser Pharmaceuticals Inc.247
`248Par Pharmaceutical, Inc. et al.249
`v.
`Reckitt Benckiser Pharmaceuticals Inc.
`v.252
`Teva Pharmaceuticals USA, Inc.253
`
`1:13-cv-01674-RGA24
`1
`
`1:13-cv-02003-RGA24
`5
`
`DED246
`
`1:14-cv-00422-RGA25
`0
`
`DED251
`
`1:14-cv-01451-RGA25
`4
`
`DED255
`
`-12-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 22/85
`
`

`
`1:14-cv-01573-RGA25
`8
`
`1:14-cv-01574-RGA26
`2
`
`1:15-cv-00477-RGA26
`7
`
`Reckitt Benckiser Pharmaceuticals Inc.256
`et al. v Par Pharmaceutical Inc. et al.257
`Reckitt Benckiser Pharmaceuticals Inc.260
`et al. v. Watson Laboratories Inc. et al.261
`Reckitt Benckiser Pharmaceuticals Inc.264
`265Alvogen Pine Brook, Inc.266
`v.
`Indivior Inc. et al v. Mylan Technologies269
`Inc. et al.270
`Indivior Inc. et al v. Sandoz Inc.273
`RGA Indivior Inc. et al. v. Teva276
`Pharmaceuticals USA, Inc.277
`Indivior Inc. et al v. Mylan Technologies280 1:15-cv-00209-IMK28
`1
`Inc. et al.283
`
`1:15-cv-01016-RGA27
`1
`
`1:15-cv-01051-RGA27
`4
`1:16-cv-00178-RGA27
`8
`
`DED259
`
`DED263
`
`DED268
`
`DED272
`
`DED275
`DED279
`
`United States282
`District284
`Court/Northern
`District of West
`Virginia
`(Clarksburg)285
`USPTO/PTAB291
`
`BioDelivery Sciences International, Inc.286
`287Reckitt Benckiser
`v.
`Pharmaceuticals288
`Inc.289
`BioDelivery Sciences International, Inc.292
`293Reckitt Benckiser Pharmaceuticals
`v.
`Inc.294
`Teva Pharmaceuticals USA, Inc. v.297
`Indivior UK Limited298
`
`IPR2014-00325290
`
`IPR2014-00998295
`
`UPSTO/PTAB296
`
`IPR2016-00280299
`
`UPSTO/PTAB300
`
`The following administrative proceedings may affect or be affected by a
`
`decision in this proceeding:
`
`-13-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 23/85
`
`

`
`The ’832 patent is part of a family of applications. Petitioner is aware of at
`
`least one currently pending U.S. patent application that claims the benefit of the
`
`’832 patent: U.S. Patent Application Serial No. 14/715,462, filed on May 18, 2015,
`
`which is pending.
`
`The ’832 patent was also301is302 the subject of two303three304 Inter Partes
`
`Reviews: IPR2014-00325 (“the BDSI IPR”) and IPR2014-00998, both initiated by
`
`petitioner Biodelivery Sciences International, Inc. , and IPR2016-00280. Teva
`
`Pharmaceuticals USA, Inc. (“Teva”) is the petitioner in IPR2016-00280.305
`
`-14-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 24/85
`
`

`
`In the BDSI IPR, the Board instituted review of claims 15-19 as unpatentable over
`LabTec33061307 alone, and LabTec in view of Yang43102311 and Birch. (IPR2014-00325,
`Paper 17 at 17, 20.) The Board ultimately found that petitioner established by a
`preponderance of the evidence that claims 15-19 are unpatentable on both instituted
`grounds. (IPR2014-00325, Paper 43 at 27.) That decision is currently on appeal.314
`
`27.) That decision is currently on appeal.315
`In the IPR2014-00998 proceeding, the petitioner challenged claims 15-19 as
`
`unpatentable over Oksche53163317 (referred to in that case as “Euro-Celtique”);
`
`Oksche in view of the European Medicines Agency (EMEA) Study Report on
`
`Suboxone® tablets, 2006 (“EMEA Study Report”)6; Oksche in view of the EMEA
`
`Study
`
`Report and WO 2003/030883; and Oksche in view of the EMEA Study Report and
`
`Yang. (IPR2014-00998, Paper 12 at 5.) In view of the earlier BDSI IPR, the Board
`
`6 Ex. 1011, European Medicines Agency Initial Marketing-Authorisation321
`
`Document, Scientific Discussion, Oct. 19, 2006 for Suboxone sublingual
`
`tablets.322 exercised its discretion under 35 U.S.C. § 325(d) to deny the
`
`Petition without reaching the merits. (Id. at 2).323
`
`IPR2016-00280 (“280 IPR”) is currently pending and is awaiting institution.
`
`
`33081309 Ex. 1007, WO 2008/040534, published April 10, 2008, to Applicant LabTec
`GmbH (“LabTec”).
`43122313 Ex. 1006, U.S. Patent No. 7,357,891, published December 23, 2004 and issued
`April 15, 2008, to Yang et al. (“Yang”).
`-15-
`53183319 Ex. 1005, WO 2008/025791, published March 6, 2008, to Applicant Euro-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 25/85
`
`

`
`The Patent and Trial Appeal Board assigned a filing date of December 3, 2015 to324
`
`
`-16-
`Celtique S.A. (“Oksche”).
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 26/85
`
`

`
`Teva. (See IPR2016-00280, Paper 6 at 1.) Patent Owner filed a motion to change
`
`the filing date to December 4, 2015. (See id., Paper 10 at 1) Patent Owner maintains
`
`it served Teva with a complaint asserting the ’832 patent on December 3, 2014.
`
`(Id.) Patent Owner also asserts that a December 4, 2016 filing date will time-bar
`
`Teva’s petition under 35 U.S.C. § 315. There has been no action on the merits.325
`
`C.
`
`Lead and Backup Counsel (§ 42.8(b)(3))
`
`Lead Counsel326
`Jeffery B. Arnold328
`USPTO Reg. No. 39,540329
`Cantor Colburn LLP330
`1180 Peachtree Street, Suite
`2050331
`Atlanta, Georgia 30309332
`Telephone: (404) 607-9991333
`Facsimile: (404) 607 9981334
`jarnold@cantorcolburn.com
`335
`
`Back-Up Counsel327
`Leslie-Anne Maxwell, Ph.D.336
`USPTO Reg. No. 44,778337
`Cantor Colburn LLP338
`20 Church Street, 22nd Floor339
`Hartford, Connecticut 06103340
`Telephone: (860) 286-2929341
`Facsimile: (860) 286-0115
`342amaxwell@cantorcolburn.c
`om343
`
`Peter R. Hagerty344
`USPTO Reg. No. 42,618345
`Cantor Colburn LLP346
`1180 Peachtree Street, Suite
`2050347
`Atlanta, Georgia 30309348
`Telephone: (404) 607-9991349
`phagerty@cantorcolburn.com351
`
`-17-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 27/85
`
`

`
`Lead
`Counsel354
`Elizabeth Holland356
`
`(Reg. No. 47,657)
`
`GOODWIN PROCTER
`
`LLP357
`
`Andrew C. Ryan352
`USPTO Reg. No. 43,070353
`Backup Counsel355
`
`Eleanor M. Yost361
`
`(Reg. No. 58,013)
`
`J. Coy Stull362
`
`(Reg. No. 62,599)
`
`The New York Times Building358
`
`GOODWIN PROCTER
`
`620 Eighth Avenue New
`
`LLP363
`
`York, NY 10018 (212)
`
`901 New York Avenue NW
`
`813-8800 (telephone) (212)
`
`Washington, DC 20001
`
`355-3333 (facsimile)359
`
`(202) 346-4000 (telephone)
`
`eholland@goodwinprocter.com360
`
`(202) 346-4000 (facsimile)
`
`364eyost@goodwinprocter.co
`
`m 3
`
`65jstull@goodwinprocter.co
`
`m366
`
`Elaine H. Blais367
`
`Exchange Place370Cantor Colburn
`LLP371
`
`53 State Street372
`
`-18-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 28/85
`
`

`
`Boston, Massachusetts 02109
`
`(617) 570-1000 (telephone)
`
`(617) 523-1231 (facsimile)
`
`373eblais@goodwinprocter.com3
`
`74
`
`rfrederickson@goodwinprocter.com375
`
`Robert V. Cerwinski376
`
`(to seek pro hac vice admission)
`
`GOODWIN PROCTER LLP377
`
`The New York Times Building378
`
`620 Eighth Avenue New
`
`York, NY 10018 (212)
`
`813-8800 (telephone) (212)
`
`355-3333
`
`(facsimile)379rcerwinski@goo
`
`dwinprocter.com380
`
`D.
`
`20 Church Street, 22nd Floor381
`Hartford, Connecticut 06103382
`Service Information (§ 42.8(b)(4))383
`Telephone: (860) 286-2929
`Facsimile: (860) 286-0115384
`
`-19-
`
`Dr. Reddy's Labs. v. Indivior UK Ltd, IPR2016-01113
`INDIVIOR EX. 2001 - 29/85
`
`

`
`ryan@cantorcolburn.com385
`Please direct all correspondence to counsel at the contact information above.
`
`Petitioner consents to service by electronic mail.386
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(B))
`
`Petitioner challenges claims 1-7 and 9-12 of the ’832 patent and requests
`
`review of those claims under 35 U.S.C. § 311 and AIA § 6. Petitioner’s grounds of
`
`challenge are as follows:
`
`Ground
`1
`

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