`
`Filed on behalf of Dr. Reddy’s Laboratories, Ltd.
`and Dr. Reddy’s Laboratories, Inc.
`
`By:
`
`Jeffery B. Arnold
`jarnold@cantorcolburn.co
`m 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
`
`TEVA PHARMACEUTICALS USA INC.,DR. REDDY’S
`LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`
`Petitioner
`v.Petitione
`
`rs, v.
`
`MONOSOL RX, LLC, Patent OwnerU.S.
`
`Patent No. 8,017,150 Issue Date: September 13, 2011
`Title: POLYETHYLENE OXIDE-BASED FILMS AND DRUG
`DELIVERY SYSTEMS MADE THEREFROM
`CaseInter Partes Review No. IPR2016: Unassigned-XXXXX
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT
`NO. 8,017,150
`
`MonoSol2002-0001
`
`Dr. Reddys v. MonoSol
`IPR2016-01112
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION
`
`BACKGROUND
`
`Brief Overview of the ’150 Patent
`
`Brief Overview of the Prosecution History
`
`GROUNDS FOR STANDING 37 C.F.R. § 42.104(a)
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`Real Party-In-Interest (§ 42.8(b)(1))
`
`Related Proceedings (§ 42.8(b)(2))
`
`Lead and Backup Counsel (§ 42.8(b)(3))
`
`Service Information (§ 42.8(b)(4))
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(b))
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`THE CHALLENGED CLAIMS OF THE ’150 PATENT
`
`CLAIM CONSTRUCTION
`
`THE ‘150 PATENT PRIORITY DATE
`
`SCOPE AND CONTENT OF THE PRIOR ART
`
`The Prior Art as of May 28, 2003
`
`WO 2000/042992 (“Chen”) (Ex. 1021)
`
`U.S. Patent No. 4,713,243 (“Schiraldi”) (Ex. 1004)
`
`U.S. Application Pub. No. 2002/0147201 (“Chen II”)
`(Ex. 1049)
`
`
`
`-ii--ii-
`
`8
`
`8
`
`8
`
`9
`
`11
`
`12
`
`12
`
`12
`
`14
`
`15
`
`15
`
`16
`
`17
`
`18
`
`20
`
`23
`
`23
`
`23
`
`25
`
`26
`
`MonoSol2002-0002
`
`
`
`U.S. Patent No. 6,322,811 (“Verma”) (Ex. 1005)
`
`U.S. Patent No. 5,656,296 (“Khan”) (Ex. 1046)
`
`The Prior Art as of April 22, 2008
`
`U.S. Patent App. No. 2005/0037055 (“Yang”) (Ex. 1006)
`
`DETAILED EXPLANATION OF THE GROUNDS FOR
`UNPATENTABILITY
`
`Ground 1: Claims 1, 3-5, 7-10, And 12-14, and 16-18 Are Obvious
`Over Chen In View Of Schiraldi And Claims 6 and 15 Are
`Obvious Over Chen In View Of Schiraldi And Additionally
`In View Of Chen II
`
`Claim Chart: Chen in view of Schiraldi
`
`Ground 2: Claims 1, 4-5, 8, 10, 13-14, and 17 Are Obvious
`Over Schiraldi in View of Verma
`
`Claim Chart: Schiraldi in View of Verma
`
`Ground 3: Claims 6-7, 9, 15-16, and 18 Are Obvious Over
`Schiraldi in View of Verma and Khan
`
`Ground 4: Claims 1, 4-10, and 13-18 Are Obvious Over Yang
`
`Claim Chart: Yang
`
`CONCLUSION
`
`27
`
`28
`
`28
`
`28
`
`30
`
`30
`
`33
`
`39
`
`42
`
`49
`
`50
`
`51
`
`58
`
`-iii-
`
`MonoSol2002-0003
`
`
`
`PETITIONER’S EXHIBIT LIST
`
`Reference
`U.S. Patent No. 8,017,150 (filed Apr. 22, 2008)
`File History, U.S. Patent No. 8,017,150
`Expert Declaration of Nandita DasRussell J. Mumper, Ph.D. In
`Support of Petition for
`Inter Partes Review of U.S. Patent No. 8,017,150
`U.S. Patent No. 4,713,243 (filed June 16, 1986) (“Schiraldi”)
`U.S. Patent No. 6,322,811 (issued November 27, 2001) (“Verma”)
`U.S. Patent Application Pub. No. US 2005/0037055 (published
`February 17, 2005) (“Yang”)
`
`[Intentionally Left Blank]
`E.W. Flick, Water-Soluble Resins – An Industrial Guide (2nd ed.
`1991) (“Flick”)
`
`Joint Claim Construction Chart, Reckitt Benckiser Pharmaceuticals
`Inc. v. Teva Pharmaceuticals USA, Inc., CA No. 14-1451-RGA
`(November 17, 2015), D.I. 91
`
`U.S. Provisional Application No. 60/328,868
`U.S. Provisional Application No. 60/473,902
`[Intentionally Left Blank]
`Proposed Joint Pre-Trial Order, Reckitt Benckiser
`Pharmaceuticals, Inc. v. Watson Laboratories, Inc., C.A. No.
`13-cv-0167-RGA, D.I. 347
`
`Reckitt Benckiser Pharmaceuticals Inc. et al v. Watson
`Laboratories, Inc et al, CA No. 13-1674-RGA, D.I. 364 (“Proposed
`[Intentionally Left Blank]
`
`Exhibit No.
`1001
`1002
`1003
`
`1004
`1005
`1006
`
`1007
`1008
`
`1009
`
`1010
`1011
`1012
`1013
`
`1014
`
`1015
`
`Exhibit No.
`
`Reference
`
`- 4-
`
`MonoSol2002-0004
`
`
`
`1016
`
`1017
`1018
`
`1019
`
`1020
`1021
`1022
`
`1023
`1024
`1025
`1026
`
`1027
`
`1028
`
`1029
`
`Trial Transcript, Reckitt Benckiser Inc. v. Watson Labs., Inc., CA
`No. 14-1574-RGA (Nov. 3-4, 2015) (“Trial Tr.”)
`
`U.S. App. No. 10/856,176
`Anders & H.P. Merkle, Evaluation of Laminated
`R.
`Muco-Adhesive Patches for Buccal Drug Delivery, 49 Int’l J.
`Pharmaceutics 231 (1989) (“Anders”)
`
`Viralkumar F. Patel et al., Advances in Oral Transmucosal Drug
`Delivery, 153 J. Controlled Release 106 (2011)
`
`U.S. Patent No. 5,948,430 (filed August 1, 1997) (“Zerbe”)
`WO 00/42992 (published July 27, 2000) (“Chen I”)
`Guo & Zerbe, Water-Soluble Film for Oral Administration, 13th
`International Symposium on Controlled Release of Bioactive
`Materials, 227 (1997) (“Guo”)
`
`EP No. 0,090,560 (published May 3, 1989) (“Mitra”)
`U.S. Patent No. 4,849,246 (issued July 18, 1989) (“Schmidt”)
`U.S. Patent No. 6,552,024 (filed November 5, 1999) (“Chen
`Le Person et al., Near Infrared Drying of Pharmaceutical
`S.
`Thin Films: Experimental Analysis of Internal Mass Transport, 37
`Chemical Engineering & Processing 257 (1998) (“Le Person”)
`
`Gary DeGrande et al., Specialized Oral Mucosal Drug Delivery
`Systems, in Oral Mucosal Drug Delivery (James Swarbrick, ed.,
`1995)
`
`Apicella et al., Poly(ethylene oxide) (PEO) and
`A.
`Different Molecular Weight PEO Blends Monolithic
`Devices for Drug Release, 14(2) Biomaterials 83 (1993)
`(“Apicella”)
`Hans P. Merkle et al., Mucoadhesive Buccal Patches for Peptide
`Delivery, in Bioadhesive Drug Delivery Systems (Vincent Lenaerts
`& Robert Gurny, eds., 1990)
`
`- 5-
`
`MonoSol2002-0005
`
`
`
`Exhibit No.
`
`Reference
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`1039
`1040
`1041
`
`& Robert Gurny, eds., 1990)
`Remington’s Pharmaceutical Sciences (Alfonso R. Gennaro,
`ed.,17th ed. 1985)
`
`C.S. Fuller et al., Interactions in poly(ethylene oxide)—
`hydroxypropyl methylcellulose blends, 42 Polymer 9583 (2001)
`(“Fuller”)
`
`J.P. Cassidy et al., Controlled buccal delivery of buprenorphine,
`25 Journal of Controlled Release 21 (1993) (“Cassidy”)
`
`Jian-Hwa Guo & K. M. Cooklock, Bioadhesive Polymer Buccal
`Patches for Buprenorphine Controlled Delivery: Solubility
`Consideration, 21(17) Drug Dev. & Indus. Pharmacy 2013 (1995)
`(“Guo & Cooklock”)
`
`Gordon L. Amidon et al., A Theoretical Basis for a
`Biopharmaceutic Drug Classification: The Correlation of in Vitro
`Drug Product Dissolution and in Vivo Bioavailability, 12(3)
`Pharmaceutical Res. 413 (1995) (“Amidon”)
`
`Marilyn N. Martinez & Gordon L. Amidon, A Mechanistic
`Approach to Understanding the Factors Affecting Drug
`Absorption: A Review of Fundamentals, 42 J. Clinical
`Pharmacology 620 (2002) (“Martinez”)
`
`Robert O. Ebewele, Polymer Science and Technology (2000)
`(“Polymer Science and Technology”)
`
`Philip E. Slade, Jr., Polymer Molecular Weights (in two parts),
`Part I (1975)
`
`G.S. Misra, Introductory Polymer Chemistry (1993)
`Textbook of Polymer Science (2nd ed. 1971)
`WO 2000/02955 (published January 20, 2000) (“Wang”)
`U.S. Patent No. 6,562,375 (filed August 1, 2000) (“Sako”)
`- 6-
`
`MonoSol2002-0006
`
`
`
`1042
`
`Exhi
`bit
`
`1043
`1044
`1045
`
`1046
`1047
`1048
`1049
`
`ReferenceMichael A. Repka & James W. McGinity, Influence
`
`Michael A. Repka & James W. McGinity, Influence of Vitamin E
`TPGS on the Properties of Hydrophilic Films Produced by Hot-
`U.S. Patent No. 4,764,378 (filed February 10, 1986) (“Keith”)
`U.S. Patent No. 5,273,758 (filed Apr. 13, 1992) (“Royce”)
`U.S. Patent No. 4,284,534 (filed October 24, 1980) (“’534
`patent”)
`
`U.S. Patent No. 5,656,296 (filed August 12, 1997) (“Khan”)
`Curriculum Vitae of Nandita DasRussell J. Mumper, Ph.D.
`List of Materials Consideredconsidered by Nandita DasRussell J.
`US Patent Application Pub. No. 2002/00147201, published
`Oct. 10, 2002. (“Chen II”)
`
`- 7-
`
`MonoSol2002-0007
`
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION
`
`BACKGROUND
`
`Brief Overview of the ’150 Patent
`
`Brief Overview of the Prosecution History
`
`GROUNDS FOR STANDING 37 C.F.R. § 42.104(A)
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`Real Party In Interest (§ 42.8(b)(1))
`
`Related Proceedings (§ 42.8(b)(2))
`
`Lead and Backup Counsel (§ 42.8(b)(3))
`
`Service Information (§ 42.8(b)(4))
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(B))
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`THE CHALLENGED CLAIMS OF THE ’150 PATENT
`
`CLAIM CONSTRUCTION
`
`THE ’150 PATENT PRIORITY DATE
`
`SCOPE AND CONTENT OF THE PRIOR ART
`
`The Prior Art as of May 28, 2003
`The Prior Art as of April 22, 2008
`
`Page
`
`1
`
`1
`
`1
`
`2
`
`4
`
`5
`
`5
`
`5
`
`6
`
`8
`
`8
`
`9
`
`9
`
`11
`
`13
`
`16
`
`16
`19
`
`DETAILED EXPLAINATION OF THE GROUNDS FOR UNPATENTABILITY21
`i- 8
`
`MonoSol2002-0008
`
`
`
`GROUND 1: CLAIMS 1, 4-5, 8, 10, 13-14, AND 17 ARE OBVIOUS
`OVER SCHIRALDI IN VIEW OF VERMA
`
`GROUND 2: CLAIMS 6-7, 9, 15-16 AND 18 ARE OBVIOUS OVER
`SCHIRALDI IN VIEW OF VERMA AND KHAN
`
`21
`
`31
`
`GROUND 3: CLAIMS 1, 4-10, AND 13-18 ARE OBVIOUS OVER YANG.
`
`33
`
`CONCLUSION
`
`Cases
`
`TABLE OF AUTHORITIES
`
`41
`
`Page(s)
`
`Reckitt Benckiser Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals
`USA, Inc., Case No. 1-14-cv-01451 (D.
`Del.)..............................................................4, 6, 11
`
`Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson Laboratories,
`Inc. et al.
`Case No. 13-cv-0167 (D. Del.) ...........................................................6, 14, 15,
`34
`
`Statutes
`
`35 U.S.C. § 102(b) .............................................................................................16,
`20
`
`35 U.S.C. § 311 ......................................................................................................1,
`
`8 O
`
`ther Authorities
`
`37 C.F.R. § 42.6(e)
`
`37 C.F.R. § 42.8
`
`37 C.F.R. § 42.104(a)
`
`37 C.F.R. § 42.100(b)
`
`M.P.E.P. § 2163
`
`i- 9
`
`1
`
`5
`
`4
`
`11
`
`33
`
`MonoSol2002-0009
`
`
`
`INTRODUCTION
`
`Pursuant to 35 U.S.C. § 311, § 6 of the Leahy-Smith America Invents Act
`
`(“AIA”), and 37 C.F.R. Part 42, Teva Pharmaceuticals USADr. Reddy’s
`
`Laboratories, Ltd. and Dr.
`
`Reddy’s Laboratories, Inc. (“Tevacollectively – “Dr. Reddy’s” or “Petitioner”)
`
`respectfully requests inter partes reviewInter Partes Review of claims 1, 43-10,
`
`and 1312-18 of U.S. Patent 8,017,150 (“the ’150 patent”), which is currently
`
`assigned to MonoSol RX, LLC (“Patent Owner”). This petition and supporting
`
`exhibits demonstrate that claims 1, 43-10, and 1312-18 of the ’150 patent are
`
`unpatentable over the prior art and should be canceled.
`
`BACKGROUND
`
`Brief Overview of the ’150 Patent
`
`The ’150 patent is entitled “Polyethylene Oxide-based Films and Drug
`
`Delivery Systems Made Therefrom.” The ’150 patent is directed to a uniform,
`
`mucosally-adhesive, water-soluble, dissolving film product for delivering an active
`
`pharmaceutical ingredient and methods for preparing such film products. (Ex. 1001
`
`at Abstract.) It discloses the application of well-known methods for forming uniform
`
`film products along with well-known compositions for such film products, such as
`
`the use of both low and high molecular weight polyethylene oxide (“PEO”) for
`
`adjusting various properties of the finished film product. (Id.)
`
`i-10
`
`MonoSol2002-0010
`
`
`
`Brief Overview of the Prosecution History
`
`The ’150 patent was filed on April 22, 2008, as U.S. Patent Application No.
`
`12/107,389 (“the ’389 application”), and is a divisional of U.S. Patent Application
`
`No. 10/856,176, which was filed on May 28, 2004 (now U.S. Patent No.
`
`7,666,337), which is a continuation-in-part of PCT Application No.
`
`PCT/US02/032575, filed on Oct. 11, 2002, and a continuation-in-part of PCT
`
`Application No. PCT/US02/32594, filed on Oct. 11, 2002, and a continuation-in-
`
`part of PCT Application No. PCT/US02/32542, filed on Oct. 11, 2002. The ’150
`
`patent issued on September 13, 2011.
`
`During prosecution, the Examiner rejected certain claims as obvious over
`
`Schiraldi11 in view of Flick2.2. Among other things, Schiraldi disclosed polymers
`
`having molecular weights “above 100,000 and preferably above 3,000,000.” (Ex.
`
`1002, Non-Final Rejection, April 29, 2010, at 3.)
`
`In response, the Applicants argued that Schiraldi failed to teach a claimed
`
`combination of molecular weights. (Ex. 1002, Response to Office Action, July 29,
`
`2010, at 2-3.) Applicants also argued that they had “discovered that the particular
`
`1 Ex. 1004, U.S. Patent No. 4,713,243 (“Schiraldi”).
`2 Ex. 1008, E.W. Flick, Water-Soluble Resins – An Industrial Guide (2nd ed. 1991)
`
`(“Flick”). combination of molecular weights and polymers claimed provides a
`
`suitable release profile for an opiate.” (Id.) Finally, the Applicants emphasized that
`-11
`
`MonoSol2002-0011
`
`
`
`“[t]he
`
`1Ex. 1004, U.S. Patent No. 4,713,243 (“Schiraldi”).
`2 Ex. 1008, E.W. Flick, Water-Soluble Resins – An Industrial Guide (2nd ed.
`1991) (“Flick”).
`
`-12
`
`MonoSol2002-0012
`
`
`
`claims recite a particular combination of polymers, having a particular molecular
`
`weight, in a particular ratio. . . .
`
`This is not a matter of simply testing different
`
`molecular weights, or simply testing different ratios.” (Id. at 4.4).
`
`On October 13, 2010, the Examiner issued a Final Office Action maintaining
`
`the rejection of claims 1-18 as obvious in view of Schiraldi. The Examiner found
`
`that “[i]t would have been obvious to one of ordinary skill in the art at the time of
`
`the present invention to modify the Schiraldi film product by using polyethylene
`
`oxide resins of different molecular weight and varying the weight ratio of
`
`polyethylene oxide:hydrophilic cellulosic polymer [“HPC”] as motivated by the
`
`combined teachings of Schiraldi and Flick.” (Ex. 1002, Final Office Action dated
`
`October 13, 2010 at 4.) Such motivation, the Examiner correctly reasoned, is found
`
`in Schiraldi because it teaches that various types of film products may be
`
`formulated by varying the polymer weight ratio, and by choosing and blending
`
`different polymers.
`
`(Id.) In response, Applicants reiterated the same arguments
`
`presented in their July 2010 remarks, admitting that “Schiraldi does disclose the
`
`general combination of a hydroxypropyl cellulose and a homopolymer of ethylene
`
`oxide,” (Ex. 1002, Response to Office Action dated December 13, 2010, at 2),
`
`butarguing argued that Schiraldi did not disclose the particular claimed molecular
`
`weight combination.
`
`The Examiner maintained the rejection in an Advisory Action (Ex. 1002,
`
`-10-
`
`MonoSol2002-0013
`
`
`
`Advisory Action dated December 28, 2010, at 2.) Applicants filed a Notice of
`
`Appeal and requested a Pre-Brief Appeal Conference, maintaining their earlier
`
`argument and further alleging that Applicants “unexpectedly discovered that the
`
`particular combination of molecular weights and polymers claimed provides a
`
`suitable release profile for an opiate, and still provides a suitable dosage form.” (Ex.
`
`1002, Pre-Brief Appeal Conference Request dated January 13, 2011, at 2 (emphasis
`
`in original).) On February 8, 2011, a decision in the Pre-Brief Appeal Conference
`
`indicated the claims under consideration were allowable. (Ex. 1002, Pre-Brief
`
`Appeal Conference Decision dated February 8, 2011.)
`
`GROUNDS FOR STANDING 37 C.F.R. § 42.104(aA)
`
`Petitioner certifies pursuantPursuant to 37 C.F.R. § 42.104(a), Petitioner
`
`hereby certifies that the ’150 patent is available for inter partes review and that the
`
`Petitioner is not barred or estopped from requesting inter partes review challenging
`
`the claims of the ’150 patent on the grounds identified in this Petition. Petitioner
`
`was served with a complaint asserting the ’150 patent on December 3, 2014 in
`
`Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, et al v. Teva
`
`Pharmaceuticals USA, Inc., Civil Action 14-1451 (D. Del.). This petition isherein.
`
`timely filed on December 3, 2015.
`
`-11-
`
`MonoSol2002-0014
`
`
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`Real Party -In -Interest (§ 42.8(b)(1))
`
`The real partyparties-in-interest is Teva Pharmaceuticals USA Inc. (“Tevaare
`Dr. Reddy’s Laboratories, Ltd. and Dr.
`
`Reddy’s Laboratories, Inc. (collectively – “Dr. Reddy’s” or “Petitioner”).3
`
`Related Proceedings (§ 42.8(b)(2))
`
`The following proceedings may affect or be affected by a decision in this
`
`proceeding:
`
`Name
`
`Number
`
`District
`
`Indivior Inc. et al v. Sandoz Inc.
`
`1-15-cv-01051
`
`DED
`
`Indivior Inc. et al v. Mylan Technologies Inc.
`
`et al
`
`Indivior Inc. et al v. Mylan Technologies Inc.
`
`et al
`
`1-15-cv-00209 WVND
`
`1-15-cv-01016
`
`DED
`
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v.
`
`Alvogen Pine Brook, Inc.
`
`1-15-cv-00477
`
`DED
`
`3 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.
`
`-12-
`
`MonoSol2002-0015
`
`
`
`Related Proceeding
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Par Pharmaceutical, Inc. et al.
`
`Reckitt Benckiser Pharmaceuticals
`Inc.
`
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Alvogen Pine Brook, Inc.et al.
`Reckitt Benckiser Pharmaceuticals
`Inc.
`
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Teva Pharmaceuticals USA, Inc.
`Reckitt Benckiser Pharmaceuticals
`Inc. et al. v Par Pharmaceutical Inc. et
`Related Proceeding
`Reckitt Benckiser Pharmaceuticals
`Inc. et al. v. Watson Laboratories Inc.
`Reckitt Benckiser Pharmaceuticals
`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.
`
`Case No.
`Jurisdiction
`1:13-cv-01461-RGA U.S. District
`Court District
`of Delaware
`(Wilmington)
`(“DED”)
`DED
`
`1:13-cv-01674-RGA
`
`1:13-cv-02003-RGA DED
`
`1:14-cv-00422-RGA
`
`DED
`
`1:14-cv-01451-RGA
`
`DED
`
`1:14-cv-01573-RGA DED
`
`Jurisdiction
`Case No.
`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
`
`-13-
`
`MonoSol2002-0016
`
`
`
`Indivior Inc. et al v. Mylan
`Technologies Inc. et al.
`
`1:15-cv-00209-IMK
`
`BioDelivery Sciences International,
`Inc.
`v.
`
`Reckitt Benckiser
`
`BioDelivery Sciences International,
`Inc.
`v.
`
`Reckitt Benckiser
`
`BioDelivery Sciences International,
`Inc.
`v.
`
`Reckitt Benckiser
`
`United States
`District
`Court/Northern
`District of West
`Virginia
`(Clarksburg)
`USPTO/PTAB
`
`IPR2014-00325
`
`IPR2014-00998
`
`USPTO/PTAB
`
`IPR2016-00280
`
`USPTO/PTAB
`
`-14-
`
`MonoSol2002-0017
`
`
`
`Reckitt Benckiser Pharmaceuticals Inc. et al.
`
`v.
`
`Teva Pharmaceuticals USA, Inc.
`
`1-14-cv-01451
`
`DED
`
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v.
`
`Par Pharmaceutical, Inc. et al
`
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v.
`
`Alvogen Pine Brook Inc.
`
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v.
`
`Watson Laboratories Inc., et al.
`
`1-14-cv-00422
`
`DED
`
`1-13-cv-02003
`
`DED
`
`1-13-cv-01674
`
`DED
`
`Reckitt Benckiser Pharmaceuticals, Inc. et al
`
`v.
`
`Par Pharmaceutical, Inc. et al
`
`1-13-cv-01461
`
`DED
`
`Petitioner is not aware of anyThe following administrative proceedings may affect or
`be affected by a decision in this proceeding.: The ’150 patent has been the subject of
`one Inter Partes Review: IPR20015- 00282 (“282 IPR”) initiated by Teva
`Pharmaceuticals USA, Inc. The Patent Trial and appeal Board denied institution
`of the Inter Partes Review of the 282 IPR for being time-barred under 35 U.S.C. §
`315(b) with reaching the merits. (IPR2016- 00282, Paper 19 at 14.)
`Lead and Backup Counsel (§ 42.8(b)(3))
`
`Lead Counsel
`
`Backup Counsel
`
`-15-
`
`MonoSol2002-0018
`
`
`
`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
`
`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
`
`-16-
`
`MonoSol2002-0019
`
`
`
`Lead Counsel
`Elizabeth Holland (Reg. No. 47,657)
`GOODWIN PROCTER LLP
`
`The New York Times Building
`
`Backup Counsel
`Eleanor M. Yost (Reg. No.
`58,013)Atlanta, Georgia 30309
`J. Coy Stull
`Telephone: (404) 607-9991
`Facsimile: (404) 607-9981
`phagerty@cantorcolburn.com
`
`Andrew C. Ryan
`USPTO Reg. No.
`43,070
`Cantor Colburn LLP
`20 Church Street, 22nd Floor
`Hartford, Connecticut 06103
`
`620 Eighth Avenue New York, NY 10018
`(212) 813-8800 (telephone)
`
`(212) 355-3333 (facsimile) eholland@goodwinprocter.com
`
`-17-
`
`MonoSol2002-0020
`
`
`
`GOODWIN PROCTER LLP
`
`901 New York Avenue NW Washington, DC 20001
`
`(202) 346-4000 (telephone)
`
`(202) 346-4000 (facsimile) eyost@goodwinprocter.com
`
`jstull@goodwinprocter.com
`
`Elaine H. Blais
`
`Robert Frederickson III
`
`(both to seek pro hac vice admission) GOODWIN PROCTER LLP
`
`Exchange Place 53 State Street
`
`Boston, Massachusetts 02109
`
`(617) 570-1000 (telephone)
`
`(617) 523-1231 (facsimile) eblais@goodwinprocter.com
`
`rfrederickson@goodwinprocter.com
`
`Robert V. Cerwinski
`
`(to seek pro hac vice admission)
`
`GOODWIN PROCTER LLP
`
`The New York Times Building 620
`
`Eighth Avenue
`
`-18-
`
`MonoSol2002-0021
`
`
`
`New York, NY 10018
`
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
`
`rcerwinski@goodwinprocter.com
`
`Service Information (§ 42.8(b)(4))
`
`Please direct all correspondence to counsel at the contact information above.
`
`Petitioner consents to service by electronic mail.
`
`STATEMENT OF THE PRECISE RELIEF
`REQUESTED AND IDENTIFICATION OF THE
`CHALLENGE (§ 42.104(bB))
`
`Petitioner challenges claims 1, 43-10, and 1312-18 of the ’150 patent, and
`
`requests review of these claims under 35 U.S.C. § 311 and AIA § 6. Petitioner’s
`
`grounds of challenge are as follows:
`
`Ground
`
`Claims
`
`Description
`
`1, 3-10, 12-18
`
`1, 4-5, 8, 10, 1312-14,
`
`Obvious under § 103 over Chen3 in view of
`Schiraldi, and (claims 6 and 15 only)
`additionally in view Chen II4.
`Obvious under § 103 over Schiraldi in view of
`Verma45.
`
`and 17
`6-7, 9, 15-16, and 18 Obvious under § 103 over Schiraldi in view of
`Verma and Khan56.
`
`1
`
`12
`
`23
`
`-19-
`
`MonoSol2002-0022
`
`
`
`1, 4-10, and 13-18
`
`Obvious under § 103 over Yang67.
`
`34
`
`In support of these grounds of unpatentability, this Petition is accompanied
`
`by the declarationDeclaration of Dr. Nandita Das (“DasRussell J. Mumper
`
`(“Mumper Decl.,” Ex. 1003).
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`A person of ordinary skill would include a person who possesses a Master’s
`
`degree or Ph.D. in pharmaceutical sciences, chemistry, or a related filed, and a
`
`number of years of experience. (Ex. 1003, DasMumper Decl. at ¶ 30.40.)
`
`3 Ex. 1021, Chen.
`4 Ex. 1049, Chen II.
`5 Ex. 1005, Verma.
`6 Ex. 1046, Khan.
`7 Ex. 1006, Yang.
`
`-20-
`
`MonoSol2002-0023
`
`
`
`THE CHALLENGED CLAIMS OF THE ’150 PATENT
`
`Petitioner challenges claims 1, 43-10, and 1312-18. Independent claims 1 and
`
`10 provide:
`
`A mucosally-adhesive water-soluble film product
`comprising: an analgesic opiate pharmaceutical active;
`and
`
`4 Ex. 1005, Verma.
`
`5 Ex. 1046, Khan.
`
`6 Ex. 1006, Yang.
`an analgesic opiate pharmaceutical active; and
`at least one water-soluble polymer component consisting of
`polyethylene oxide in combination with a hydrophilic cellulosic
`polymer; wherein:
`
`the water-soluble polymer component comprises greater than
`75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer;
`the polyethylene oxide comprises one or more low molecular weight
`polyethylene oxides and one or more higher molecular weight
`polyethylene oxides, the molecular weight of the low molecular weight
`polyethylene oxide being in the range 100,000 to 300,000 and the
`molecular weight of the higher molecular weight polyethylene oxide
`being in the range 600,000 to 900,000; and the polyethylene oxide of
`low molecular weight comprises about 60% or more in the polymer
`component.
`A mucosally-adhesive water-soluble film product
`
`10.
`
`-21-
`
`MonoSol2002-0024
`
`
`
`comprising: an analgesic opiate pharmaceutical active; and
`at least one water-soluble polymer component consisting of
`polyethylene oxide in combination with a hydrophilic cellulosic
`polymer; wherein:
`
`-22-
`
`MonoSol2002-0025
`
`
`
`the water-soluble polymer component comprises the hydrophilic cellulosic
`polymer in a ratio of up to about 4:1 with the polyethylene oxide; the polyethylene
`oxide comprises one or more low molecular weight polyethylene oxides and one or
`more higher molecular weight polyethylene oxides, the molecular weight of the low
`molecular weight polyethylene oxide being in the range 100,000 to 300,000 and the
`molecular weight of the higher molecular weight polyethylene oxide being in the
`range 600,000 to 900,000; and the polyethylene oxide of low molecular weight
`comprises about 60% or more in the polymer component.
`(Ex. 1001 at claims 1 and 10.) Dependent claims 4-9 and 13-18 of the ’150
`
`patent relate to the addition of other pharmaceutical actives, sweeteners, flavors and
`
`buffers to the formulation.
`
`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).
`
`For purposes of this proceeding only, two claim terms warrant a specific
`
`construction:
`
`“at least one water-soluble polymer component consisting of
`polyethylene oxide in combination with a hydrophilic cellulosic
`
`-23-
`
`MonoSol2002-0026
`
`
`
`polymer… up to 25% hydrophilic cellulosic polymer” In a district
`court case involving the ’150 patent, Reckitt Benckiser
`Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA, Inc., Case
`No. 1-14-cv-01451 (D. Del.), Patent Owner proffered the following
`construction of the claim term to the district court: “at least one water-
`soluble polymer component consisting of polyethylene oxide and
`optionally hydrophilic cellulosic polymer.” (Ex. 1009, Joint Claim
`Construction Chart, at 5 (emphasis added).).8 In other words,
`Patent Owner urged that hydrophilic cellulosic polymer is not a
`limitation of the claims.
`Petitioner requests that the Board
`construe this term at least as broadly as the definition proffered
`by the Patent Owner to the district court.
`optionally hydrophilic cellulosic polymer.” (Ex. 1009, Joint Claim
`
`Construction Chart, at 5 (emphasis added).).7 In other words, Patent
`
`Owner urged that hydrophilic cellulosic polymer is not a limitation of
`
`the claims. Petitioner requests that the Board construe this term at
`
`least as broadly as the definition proffered by the Patent Owner to the
`
`district court.
`
`“at least one water soluble polymer component consisting of
`polyethylene oxide in combination with a hydrophilic cellulosic
`polymer; wherein: the water-soluble polymer component
`comprises the hydrophilic cellulosic polymer in a ratio of up to
`about 4:1 with the polyethylene oxide” In the district court case
`cited above, Patent Owner proffered the following construction of this
`claim term: “at least one water-soluble polymer component consisting
`-24-
`
`MonoSol2002-0027
`
`
`
`of polyethylene oxide and optionally hydrophilic cellulosic
`polymer, wherein the ratio of hydrophilic cellulosic polymer to
`polyethylene may be up to about 4:1.” (Ex. 1009, Joint Claim
`Construction Chart,
`
`7 Petitioner8 The defendant in that case , Teva Pharmaceuticals USA, Inc.,
`(under the Philips standard) proffered a different construction of this claim term to
`the district court: “at least one watersolublewater-soluble polymer component
`consisting of polyethylene oxide in combination with a hydrophilic cellulosic
`polymer; wherein: the water-soluble polymer component comprises greater than
`75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer” (Ex. 1009,
`Joint Claim Construction Chart at 4-5.)
`
`-25-
`
`MonoSol2002-0028
`
`
`
`of polyethylene oxide and optionally hydrophilic cellulosic polymer, wherein
`the ratio of hydrophilic cellulosic polymer to polyethylene may be up to
`about 4:1.” (Ex. 1009, Joint Claim Construction Chart, at 5 (emphasis
`added).).
`Petitioner requests that the Board construe this term at least as broadly as the
`
`definition proffered by the Patent Owner to the district court.
`
`To the extent that the Board adopts Patent Owner’s construction from the
`
`district court litigation and determines that HPC is not a limitation of the challenged
`
`claims, the claims are entitled to a 2003 priority date (see Section IX, infra). If the
`
`claims are entitled to a 2003 priority date, they are obvious for the reasons
`
`described below in connection with Grounds 11, 2, and 2.3. To the extent that the
`
`Board determines that HPC is a limitation of the challenged claims, though, the
`
`claims are entitled to a 2008 priority date at the earliest (see Section IX, infra), and
`
`are obvious for the reasons described below in Ground 3.4.
`
`THE ‘150 PATENT PRIORITY DATE
`
`In a related litigation, Patent Owner alleged that the ’150 patent is entitled
`
`to a priority date of May 28, 2003 (the filing date of its parent application).89 But
`
`to the extent that the Board construes the challenged claims as requiring (1) a
`
`combination of PEO and HPC, (2) combinations of low and high molecular weight
`
`PEOs, and (3)
`
`60% or greater of the polymer component is low molecular weight PEO, the
`(3)
`IX. THE ’150 PATENT PRIORITY DATE
`26
`
`MonoSol2002-0029
`
`
`
`9Ex. 1013, Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson
`Laboratories, Inc. et al. C.A. No. 13-cv-0167-RGA D.I. 347 (“Joint Pretrial
`Order”), Ex. 2 at 48.
`-20-
`
`IX. THE ’150 PATENT PRIORITY DATE
`27
`
`MonoSol2002-0030
`
`
`
`claims are entitled to only a 2008 priority date910 at the earliest, because none of
`
`the applications in the priority chain leading up tofor the application that matured
`
`into the ’150 patent included a disclosure sufficient to show possession of the
`
`alleged invention of the claims.
`
`The earliest application to which the ’150 patent claims priority is U.S.
`
`Provisional Application No. 60/328,868 (“the ’868 application”), which was filed
`
`on October 12, 2001. (Ex. 1010.) That provisional application, however, discloses
`
`film formulations containing PEG only, and not a mucosally-adhesive, water-
`
`soluble film product comprising a water-soluble polymer component consisting of
`
`PEO in combination with HPC, as required by the challenged claims. (Ex. 1003,
`
`8 Ex. 1013, Reckitt Benckiser Pharmaceuticals, Inc. et al. v. Watson Laboratories,
`
`Inc. et al. C.A. No. 13-cv-0167-RGA D.I. 347 (“Joint Pretrial Order “), Ex. 2 at
`
`48. 9 The filing date of the ’389 application, the application that matured into the
`
`’150Das Decl. at ¶ 44.) Mumper Decl. at ¶ 54.) There is also no disclosure of
`
`combinations of low and high molecular weight PEOs, or any specific percentage
`
`of low molecular weight PEO in the composition. (Id.)
`
`The combination of PEO and HPC was not disclosed until U.S. Provisional
`
`Application No. 60/473,902 (“the ’902 application”), filed on May 28, 2003. But
`
`even in that application, there is no disclosure of a combination of PEO and HPC
`
`-21-
`
`MonoSol2002-0031
`
`
`
`plus a specific percentage of low molecular weight PEO. (Id. at 46.)
`
`It was only
`
`the claims of the ’150 patent itself, as amended during prosecution, that provided
`
`10The filing date of the ’389 application, the application that matured into the
`’150 patent.
`any disclosure of compositions containing PEO and HPC and a polymer component
`
`comprising at least 60% low molecular weight PEO.
`
`(Ex. 1002, April 22, 2008
`
`Claims, at 91.)
`
`In a co-pending litigation in district court, Patent Owner asserted that the
`
`’902 Application disclosed to a person of ordinary skill that the inventors had
`
`possession of the claimed products having about 60% or more of the lower
`
`molecular weight PEO in the polymer component, and referred to the composition
`
`“DW” in Table 22 in the specification of the ‘902 Application for support.
`
`(Ex.1016, Reckitt Benckiser Pharmaceuticals Inc., et al v. Watson Laboratories,
`
`Inc. et al, C.A. No. 13-cv-01674-RGA, November 4, 2015 Tr. Test
`
`661:14-669:18,
`
`688:9-689:12.) This Table shows, in the leftmost column, various film
`
`compositions. (Ex. 1002, April 22, 2008 Specification, at 80.) The top row shows
`
`the various molecular weight of PEO.
`
`(Id.) The right-hand column shows HPC.
`
`(Id.) The composition “DW” has 80%/wt of the 200,000 molecular weight PEO,
`
`and 20%/wt of the 900,000 molecular weight PEO, but does not have any HPC.
`
`(Id.)
`
`-22-
`
`MonoSol2002-0032
`
`
`
`Because Applicants failed to provide a sufficient disclosure of the alleged
`
`invention claimed in the ’150 patent—specifically, the combination of PEO and
`
`HPC, wherein the PEO is composed of both low and high molecular weight PEOs
`
`and wherein the polymer component of the formulation comprises at least 60% low
`
`molecular weight PEO—they are entitled to a priority date no earlier than April 22,
`
`2008.
`
`SCOPE AND CONTENT OF THE PRIOR ART
`
`The Prior Art as of May 28, 2003
`
`1. WO 2000/042992 (“Chen”) (Ex. 1021)
`
`Chen, titled “Compositions and Methods for Mucosal Delivery,”
`
`published July 27, 2000,