Paper No. 1
`Filed: May 31, 2016
`
`
`
`Filed on behalf of Dr. Reddy’s Laboratories, Ltd.
`and Dr. Reddy’s Laboratories, Inc.
`
`By:
`
`Jeffery B. Arnold
`jarnold@cantorcolburn.com
`Cantor Colburn LLP
`1180 Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`Telephone: (404) 607-9991
`Facsimile: (404) 607-9981
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`INDIVIOR UK LIMITED,
`Patent Owner.
`
`
`
`
`Patent No. 8,475,832
`Issue Date: July 2, 2013
`Title: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
`Inter Partes Review No. IPR2016-XXXXX
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,475,832
`
`
`Filed: May 31, 2016
`
`
`
`Filed on behalf of Dr. Reddy’s Laboratories, Ltd.
`and Dr. Reddy’s Laboratories, Inc.
`
`By:
`
`Jeffery B. Arnold
`jarnold@cantorcolburn.com
`Cantor Colburn LLP
`1180 Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`Telephone: (404) 607-9991
`Facsimile: (404) 607-9981
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`INDIVIOR UK LIMITED,
`Patent Owner.
`
`
`
`
`Patent No. 8,475,832
`Issue Date: July 2, 2013
`Title: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
`Inter Partes Review No. IPR2016-XXXXX
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,475,832
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`II.
`
`V.
`
`INTRODUCTION ........................................................................................... 1
`BACKGROUND ............................................................................................. 1
`A.
`Brief Overview of the ’832 Patent ........................................................ 1
`B.
`Brief Overview of the Prosecution History ........................................... 3
`III. GROUNDS FOR STANDING (§ 42.104(A)) ................................................ 6
`IV. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ................................... 6
`A.
`Real Party-in-Interest (§ 42.8(b)(1) ....................................................... 6
`B.
`Related Proceedings (§ 42.8(b)(2)) ....................................................... 6
`C.
`Lead and Backup Counsel (§ 42.8(b)(3)) ............................................10
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(B)) ........................11
`VI. LEVEL OF ORDINARY SKILL IN THE ART ...........................................13
`VII. THE CHALLENGED CLAIMS OF THE ’832 PATENT ............................13
`VIII. CLAIM CONSTRUCTION ..........................................................................15
`IX. SCOPE AND CONTENT OF THE PRIOR ART .........................................15
`A. WO2008/040534 (“LabTec”) (Ex. 1007) ...........................................15
`B. WO 2008/025791 (“Oksche”) (Ex. 1005) ...........................................16
`C.
`U.S. Patent No. 7,357,891 (“Yang”) (Ex. 1006) .................................16
`Suboxone® Sublingual Tablets (Label and SBOA, Exs. 1008
`D.
`and 1009) .............................................................................................17
`U.S. Patent Publication 2005/0085440 (“Birch”) (Ex. 1004) .............22
`The ’055 Publication (Ex. 1010) .........................................................23
`
`E.
`F.
`
`
`
`-i-
`
`
`
`B.
`
`X. DETAILED EXPLANATION OF THE GROUNDS FOR
`UNPATENTABILITY ..................................................................................24
`A. Ground 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 .........................24
`1.
`The film dosage limitations ......................................................24
`2.
`The buffer and pH range limitations .........................................27
`Ground 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 .......39
`Ground 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 .........................40
`1.
`The film dosage limitations ......................................................40
`2.
`The buffer and pH range limitations. ........................................43
`D. Ground 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 ............49
`XI. CONCLUSION ..............................................................................................50
`
`
`
`C.
`
`
`
`-ii-
`
`
`
`PETITIONERS’ EXHIBIT LIST
`
`Reference
`U.S. Patent No. 8,475,832 (filed August 7, 2009) (“’832 patent”)
`
`File History, U.S. Patent No. 8,475,832
`
`Expert Declaration of Metin Çelik, Ph.D., Relating to U.S. Patent
`No. 8,475,832 (“Çelik Decl.”)
`
`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®
`sublingual tablets (“EMEA”)
`
`J.P. Cassidy et al., Controlled Buccal Delivery of Buprenorphine,
`25 J. Controlled Release 21 (1993)
`
`Rex M. C. Dawson et al., Data for Biochemical Research (3d ed.
`1986)
`
`Domenic A. Ciraulo et al., Pharmacokinetics and
`Pharmacodynamics of Multiple Sublingual Buprenorphine Tablets
`-iii-
`
`Exhibit No.
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`
`
`
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`in Dose-Escelation Trials, 46 J. Clinical Pharmacology 179 (2006)
`
`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. No. 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 Marlene Bobka (“Bobka Decl.”)
`
`Parkhurst A. Shore et al., The Gastric Secretion of Drugs: A pH
`Partition Hypothesis, 119 J. Pharmacology Exp. Ther. 361 (1957)
`
`Curriculum Vitae of Metin Çelik, Ph.D.
`
`List of Materials Considered by Metin Çelik, Ph.D.
`
`The Theory and Practice of Industrial Pharmacy (L. Lachman,
`Ph.D.) (1986)
`
`
`
`-iv-
`
`
`
`1028
`
`1029
`
`1030
`
`Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson
`Laboratories, Inc. et al., No. 13-cv-0167-RGA P.I. 1, Complaint
`Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson
`Laboratories, Inc. et al., No. 13-cv-0167-RGA, P.I. 403, JOINT
`PROPOSED FINDINGS OF FACT
`Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson
`Laboratories, Inc. et al., No. 13-cv-0167-RGA, Proposed Joint
`Pretrial Order Exhibit 1, Joint Statements of Admitted Facts
`
`
`
`-v-
`
`
`
`I.
`
`
`
`INTRODUCTION
`
`Under 35 U.S.C. § 311, § 6 of the Leahy-Smith America Invents Act
`
`(“AIA”), and 37 C.F.R. Part 42, Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`
`Laboratories, Inc., (collectively, “Petitioner”) respectfully request Inter Partes
`
`Review of claims 1-7 and 9-12 of U.S. Patent No. 8,475,832 (“’832 patent”; Ex.
`
`1001), which is currently assigned to Indivior UK Limited (“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
`
`
`
`-1-
`
`
`
`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 Suboxone® 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 bioequivalence to the Suboxone® tablet. (Id.
`
`at 11:50–61.) It is notable that the alleged invention of the challenged claims has
`
`
`
`-2-
`
`
`
`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,
`
`Examples 1-8).
`
`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). 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
`
`
`
`-3-
`
`
`
`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
`
`
`
`-4-
`
`
`
`Amendment and Response, at 7.) Applicants failed to mention to the examiner that
`
`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.)
`
`
`
`-5-
`
`
`
`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 challenging the claims of the ’832 patent on the
`
`grounds identified herein.
`
`IV. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A. Real Party-in-Interest (§ 42.8(b)(1)
`
`The real parties-in-interest are Dr. Reddy’s Laboratories, Ltd. and Dr.
`
`Reddy’s Laboratories, Inc. (collectively, “Petitioner”).
`
`B. Related Proceedings (§ 42.8(b)(2))
`
`The following proceedings may affect or be affected by a decision in this
`
`proceeding:
`
`
`
`-6-
`
`
`
`Related Proceeding
`Reckitt Benckiser Pharmaceuticals Inc. v.
`Par Pharmaceutical, Inc. et al.
`
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Watson Laboratories, Inc. et al.
`Reckitt Benckiser Pharmaceuticals Inc. v.
`Alvogen Pine Brook, Inc.et al.
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Par Pharmaceutical, Inc. et al.
`Reckitt Benckiser Pharmaceuticals Inc. v.
`Teva Pharmaceuticals USA, Inc.
`Reckitt Benckiser Pharmaceuticals Inc.
`et al. v Par Pharmaceutical Inc. et al.
`Reckitt Benckiser Pharmaceuticals Inc.
`et al. v. Watson Laboratories Inc. et al.
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Alvogen Pine Brook, Inc.
`Indivior Inc. et al v. Mylan Technologies
`Inc. et al.
`Indivior Inc. et al v. Sandoz Inc.
`RGA Indivior Inc. et al. v. Teva
`Pharmaceuticals USA, Inc.
`Indivior Inc. et al v. Mylan Technologies
`
`Jurisdiction
`Case No.
`1:13-cv-01461-RGA U.S. District
`Court District of
`Delaware
`(Wilmington)
`(“DED”)
`1:13-cv-01674-RGA DED
`
`1:13-cv-02003-RGA DED
`
`1:14-cv-00422-RGA DED
`
`1:14-cv-01451-RGA DED
`
`1:14-cv-01573-RGA DED
`
`1:14-cv-01574-RGA DED
`
`1:15-cv-00477-RGA DED
`
`1:15-cv-01016-RGA DED
`
`1:15-cv-01051-RGA DED
`1:16-cv-00178-RGA DED
`
`1:15-cv-00209-IMK United States
`
`
`
`-7-
`
`
`
`Inc. et al.
`
`BioDelivery Sciences International, Inc.
`v. Reckitt Benckiser Pharmaceuticals
`Inc.
`BioDelivery Sciences International, Inc.
`v. Reckitt Benckiser Pharmaceuticals Inc.
`Teva Pharmaceuticals USA, Inc. v.
`Indivior UK Limited
`
`
`District
`Court/Northern
`District of West
`Virginia
`(Clarksburg)
`USPTO/PTAB
`
`IPR2014-00325
`
`IPR2014-00998
`
`UPSTO/PTAB
`
`IPR2016-00280
`
`UPSTO/PTAB
`
`The following administrative proceedings may affect or be affected by a
`
`decision in this proceeding:
`
`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 is the subject of three 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.
`
`
`
`-8-
`
`
`
`In the BDSI IPR, the Board instituted review of claims 15-19 as
`
`unpatentable over LabTec1 alone, and LabTec in view of Yang2 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.
`
`In the IPR2014-00998 proceeding, the petitioner challenged claims 15-19 as
`
`unpatentable over Oksche3 (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
`
`exercised its discretion under 35 U.S.C. § 325(d) to deny the Petition without
`
`reaching the merits. (Id. at 2).
`
`IPR2016-00280 (“280 IPR”) is currently pending and is awaiting institution.
`
`The Patent and Trial Appeal Board assigned a filing date of December 3, 2015 to
`
`
`1 Ex. 1007, WO 2008/040534, published April 10, 2008, to Applicant LabTec
`GmbH (“LabTec”).
`2 Ex. 1006, U.S. Patent No. 7,357,891, published December 23, 2004 and issued
`April 15, 2008, to Yang et al. (“Yang”).
`3 Ex. 1005, WO 2008/025791, published March 6, 2008, to Applicant Euro-
`Celtique S.A. (“Oksche”).
`
`
`
`-9-
`
`
`
`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.
`
`C. Lead and Backup Counsel (§ 42.8(b)(3))
`
`Lead Counsel
`Jeffery B. Arnold
`USPTO Reg. No. 39,540
`Cantor Colburn LLP
`1180 Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`Telephone: (404) 607-9991
`Facsimile: (404) 607 9981
`jarnold@cantorcolburn.com
`
`
`Back-Up Counsel
`Leslie-Anne Maxwell, Ph.D.
`USPTO Reg. No. 44,778
`Cantor Colburn LLP
`20 Church Street, 22nd Floor
`Hartford, Connecticut 06103
`Telephone: (860) 286-2929
`Facsimile: (860) 286-0115
`amaxwell@cantorcolburn.com
`
`Peter R. Hagerty
`USPTO Reg. No. 42,618
`Cantor Colburn LLP
`1180 Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`Telephone: (404) 607-9991
`Facsimile: (404) 607-9981
`
`
`
`-10-
`
`
`
`phagerty@cantorcolburn.com
`
`Andrew C. Ryan
`USPTO Reg. No. 43,070
`Cantor Colburn LLP
`20 Church Street, 22nd Floor
`Hartford, Connecticut 06103
`Telephone: (860) 286-2929
`Facsimile: (860) 286-0115
`ryan@cantorcolburn.com
`
`
`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
`
`2
`
`Description
`Claims
`1-2, 4-7, and 9-10 Obvious under § 103 over LabTec in view of Yang,
`the Suboxone® 2002 Label,4 SBOA,5 and Birch6
`Obvious under § 103 over LabTec in view of Yang,
`the Suboxone® 2002 Label, SBOA, Birch, and the
`
`3, 11, and 12
`
`
`4 Ex. 1008, Suboxone® 2002 Label.
`5 Ex. 1009, Suboxone® Tablet Summary Basis of Approval (“SBOA”).
`6 Ex. 1004, U.S. Patent Publication No. 2005/0085440, published April 21, 2005
`(“Birch”).
`
`
`
`-11-
`
`
`
`3
`
`4
`
`
`
`’055 publication7
`1-2,4-7, and 9-10 Obvious under § 103 over Oksche in view of Yang,
`the Suboxone® 2002 Label, SBOA, and Birch
`Obvious under § 103 over Oksche in view of Yang,
`the Suboxone® 2002 Label, SBOA, Birch, and the
`’055 publication
`
`3, 11, and 12
`
`In support of these grounds of unpatentability, this Petition is accompanied
`
`by the declaration of Dr. Metin Çelik (“Çelik Decl.,” Ex. 1003).
`
`The Grounds raised in this Petition are meaningfully distinct. Ground 1
`
`presents obviousness of claims 1-2, 4-7, and 9-10 based upon a combination of
`
`LabTec in view of Yang, the Suboxone® 2002 Label, SBOA, and Birch. Ground 3
`
`differs from Ground 1 in asserting obviousness of claims 1-2, 4-7, and 9-10 based
`
`upon the combination of Oksche in View of Yang, the Suboxone® 2002 Label,
`
`SBOA, and Birch. This ground is not cumulative of Ground 1. LabTec explicitly
`
`identifies and explains the criticality of pH on the absorption of buprenorphine and
`
`naloxone through mucosal membranes, a teaching that applicants claimed was
`
`lacking in Oksche. Oksche teaches a mucoadhesive film, which Patent Owner
`
`
`7 Ex. 1010, U.S. Patent Application Publication No. 2005/0037055 (“the ’055
`publication”).
`
`
`
`-12-
`
`
`
`asserted was not disclosed in LabTec.8 Thus, LabTec and Oksche each recite
`
`distinct and noncumulative teachings relevant to the ’832 patent claims.
`
`Nor are Grounds 2 and 4 cumulative of Grounds 1 and 3. Both assert
`
`obviousness of dependent claims 3, 11-12 in further view of the ’055 publication.
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART
`
`A person of ordinary skill in the art (“POSA”) would include a person who
`
`has a degree in the pharmaceutical sciences, chemistry, or a related field, and
`
`several years of practical experience in pharmaceutical formulation and processing,
`
`namely, a Ph.D. and 2-3 years of such experience; or a master’s degree and 4-5
`
`years of such experience; or a bachelor’s degree and 6-7 years of such experience
`
`(See Çelik Decl., Ex. 1003 at ¶ 35.)
`
`VII. THE CHALLENGED CLAIMS OF THE ’832 PATENT
`
`Petitioner challenges claims 1-7 and 9-12. Independent claims 1 and 9
`
`provide:
`
`Claim 1: A film dosage composition comprising:
`
`8 In the BDSI IPR, Patent Owner incorrectly urged that the ’832 patent claims are
`limited to mucoadhesive films and mucosal absorption of active ingredients, and
`that LabTec purportedly failed to teach a mucoadhesive film. The Board ultimately
`found that the petitioner established that LabTec’s teachings nevertheless
`anticipated the challenged claims. (See, e.g., BDSI IPR, Paper 17 at 20.) The
`challenged claims here, like the challenged claims in the BDSI IPR, are not limited
`to mucoadhesive films or mucosal absorption of active ingredients. To the extent
`that the Board finds otherwise, Oksche teaches a mucoadhesive film, and the
`Patent Owner has not asserted otherwise.
`-13-
`
`
`
`
`
`A polymeric carrier matrix;
`A therapeutically effective amount of buprenorphine or a
`pharmaceutically acceptable salt thereof;
`A therapeutically effective amount of naloxone or a
`pharmaceutically acceptable salt thereof; and
`A buffer in an amount to provide a local pH for said
`composition of a value sufficient to optimize absorption of said
`buprenorphine, wherein said local pH is from about 3 to about 3.5 in
`the presence of saliva.
`Claim 9: A method of treating narcotic dependence of a user,
`comprising the steps of:
`providing a composition comprising:
`A polymeric carrier matrix;
`A therapeutically effective amount of buprenorphine or a
`pharmaceutically acceptable salt thereof;
`A therapeutically effective amount of naloxone or a
`pharmaceutically acceptable salt thereof; and
`A buffer in an amount to provide a local pH of about 3 to about
`3.5 for said composition of a value sufficient to optimize absorption of
`said buprenorphine and also sufficient to inhibit absorption of said
`naloxone; and
`administering said composition to the oral cavity of a user.
`(Ex. 1001 at 23:58-67; 24:25-39.) The dependent claims are directed to
`
`pharmacokinetic parameters, specific compositions of polymers, buffers, dosage
`
`strengths, etc.
`
`
`
`-14-
`
`
`
`VIII. CLAIM CONSTRUCTION
`
`A claim subject to Inter Partes Review receives the broadest reasonable
`
`construction or interpretation in light of the specification of the patent in which it
`
`appears because, among other reasons, the patent owner has an opportunity to
`
`amend the claims. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793
`
`F.3d 1268, 1275-79 (Fed. Cir. 2015). For purposes of this proceeding only, no
`
`claim term warrants a specific construction.
`
`IX. SCOPE AND CONTENT OF THE PRIOR ART
`
`A. WO2008/040534 (“LabTec”) (Ex. 1007)
`
`LabTec qualifies as prior art because it published on April 10, 2008, over
`
`one year prior to the earliest priority date claimed in the ’832 patent. LabTec was
`
`not considered by the Office during prosecution of the ’832 patent.
`
`LabTec discloses the use of an orally-disintegrating film dosage form for
`
`delivering buprenorphine and naloxone that is bioequivalent to Suboxone® tablets.
`
`(Ex. 1007, LabTec, at 2-3, 22; see also BDSI IPR, Paper 43 at 13.) Labtec’s film
`
`can be formulated to include pharmaceutical active agents, a film-forming agent,
`
`and other ingredients. (Ex. 1007, LabTec, at 13-14.) LabTec also discloses the
`
`necessary pharmacokinetic profile to achieve bioequivalence between the film and
`
`an existing product, such as the Suboxone® tablet. (Id. at 4-5, 13, 22; BDSI IPR,
`
`Paper 43 at 14.) LabTec teaches that to make a film bioequivalent to a tablet, the
`
`
`
`-15-
`
`
`
`film product should “follow[] the same metabolic and bioabsorption pathways as
`
`the innovator’s [tablet] product, to ensure that the dosage form achieves the proven
`
`clinical efficacy of the innovator [tablet] product.” (Ex. 1007, LabTec, at 2.)
`
`B. WO 2008/025791 (“Oksche”) (Ex. 1005)
`
`Oksche was filed on August 29, 2007 (published on March 6, 2008) and is
`
`prior art to the ’832 patent. Oksche discloses that one can make an orally-
`
`disintegrating film dosage form containing buprenorphine and naloxone. (Ex.
`
`1005, Oksche at 17.) Oksche expressly referenced Suboxone® tablets, (id. at 3, 6,
`
`21), and disclosed the target Cmax and AUC0-48 for buprenorphine that would be
`
`necessary to make a film bioequivalent to those tablets, as well as methods for
`
`making that film. (Id. at 9.) The disclosed dosage forms contain at least one matrix-
`
`forming polymer. (Id. at 17.) Oksche reports that the disclosed film dosage forms
`
`can be made to release buprenorphine rapidly—in less than 3 minutes—upon
`
`sublingual administration. (Id. at 4, 17-18.) The films may also contain pH
`
`modifiers. (Id. at 15.)
`
`C. U.S. Patent No. 7,357,891 (“Yang”) (Ex. 1006)
`
`Yang was published on August 15, 2008, and is prior art to the ’832 patent.
`
`Yang “relates to rapidly dissolving films and methods of their preparation.” (Ex.
`
`1006, Yang at 1:27-28.)
`
`
`
`-16-
`
`
`
`Yang teaches methods for making ingestible films using the same polymers
`
`and ingredients disclosed in the ’832 patent. (Id. at 14:56-15:5.) In fact, the ’832
`
`patent admits that the processes set forth in Yang are suitable for creating an
`
`embodiment of the ’832 patent. (Ex. 1001 at 15:29-37.)
`
`D.
`
`Suboxone® Sublingual Tablets (Label and SBOA, Exs. 1008 and
`1009)
`
`The Suboxone® tablet 2002 label (“Suboxone® 2002 Label”) identifies
`
`
`
`Suboxone® as a tablet containing buprenorphine hydrochloride and naloxone
`
`hydrochloride and, inter alia, excipients such as a citric acid/sodium citrate buffer
`
`system. (Ex. 1008, at 8.) The drug was approved by FDA on October 8, 2002 and
`
`indicated to treat opioid dependence. (Id. at 7.) The tablets have been available on
`
`the market in the United States since approval.
`
`The pharmacokinetic profile of Suboxone® sublingual tablets was published
`
`in the prior art. (See, e.g., Ex. 1011, EMEA Study Report; Ex. 1009, Tablet
`
`Summary Basis of Approval (“SBOA”).) It was also known that under the
`
`conditions provided by the tablets at the site of administration in the mouth,
`
`buprenorphine absorbed transmucosally, avoiding the first-pass effect, while
`
`naloxone was not significantly absorbed, either transmucosally or through the GI
`
`tract. (Ex. 1003, Çelik Decl. at ¶ 75, 83.)
`
`
`
`-17-
`
`
`
`The Suboxone® 2002 Label (Ex. 1008) and the SBOA (Ex. 1009) are prior
`
`art printed publications in accordance with 35 U.S.C. § 311(b).9 In the Declaration
`
`by Marlene Bobka (“Bobka Decl.”), Ms. Marlene Bobka testifies that she is the
`
`president of FOI Services, Inc. (“FOI”). (Ex. 1023, Bobka Decl., at ¶ 1) Since
`
`1975, FOI has facilitated the flow of information under the Freedom of
`
`Information Act (“FOIA”) to its customers. (Id.) FOI specializes in Food & Drug
`
`Administration (“FDA”) information and provides access to a private library of
`
`over 150,000 FDA documents in all categories of products regulated by the
`
`agency. (Id.) Ms. Bobka testifies that on October 18, 2002, FOI submitted a FOIA
`
`request to the FDA, seeking the complete Drug Approval Package for New Drug
`
`Applications (“NDA”) 020732 and 020733 for Subtutex® (Buprenorphine HCl)
`
`and Suboxone® (Buprenorphine HCl & Naloxone HCl Dihydrate) Tablets. (Id. at ¶
`
`3) Ms. Bobka further testifies that FOI received the complete Drug Approval
`
`Package from the FDA on November 17, 2004, and made this package available to
`
`the public to purchase in December of 2004. (Id. at ¶ 4) Ms. Bobka testifies that
`
`Petitioner’s Exhibit 1008 is a true and correct copy of the approved label as it
`
`exists in the Drug Approval Package. (Id. at ¶ 5). Moreover, Ms. Bobka testifies
`
`that Exhibit 1008 was available to the public for purchase from FOI no later than
`
`
`9 The Suboxone® 2002 Label (Ex. 1008) and the SBOA (Ex. 1009) are exhibits in
`IPR2016-00280 and are respectively identified by the same exhibit numbers.
`
`
`
`-18-
`
`
`
`December of 2004. (Id.) Ms. Bobka also testifies that Petitioner’s Exhibit 2009 is a
`
`true and correct copy of an excerpt of the Drug Approval Package that forms the
`
`Summary Basis of Approval for NDAs 020732 and 020733. (Id. at ¶ 6) Exhibit
`
`1009 was available to the public for purchase from FOI no later than December of
`
`2004. (Id.)
`
`In Mylan Pharm. Inc. v. Yeda Research & Dev. Co. Ltd.,
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