throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`
`
`TEVA PHARMACEUTICALS USA INC.,
`
`Petitioner
`
`
`
`v.
`
`MONOSOL RX, LLC,
`
`
`
`
`
`Patent Owner
`
`U.S. Patent No. 8,017,150
`
`________________________
`
`Case IPR2016: Unassigned
`________________________
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,017,150
`
`

`
`
`
`PETITIONER EXHIBIT LIST
`
`Exhibit No.
`
`Reference
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`U.S. Patent No. 8,017,150 (filed Apr. 22, 2008)
`
`File History, U.S. Patent No. 8,017,150
`
`Expert Declaration of Nandita Das, 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
`Findings of Fact”)
`
`1015
`
`[Intentionally Left Blank]
`
`
`
`
`
`

`
`
`
`Exhibit No.
`
`Reference
`
`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
`
`R. Anders & H.P. Merkle, Evaluation of Laminated 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 II”)
`
`S. Le Person et al., Near Infrared Drying of Pharmaceutical 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)
`
`A. Apicella et al., Poly(ethylene oxide) (PEO) and 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
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`
`
`
`
`

`
`
`
`Exhibit No.
`
`Reference
`& 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”)
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`
`
`
`
`

`
`
`
`Exhibit No.
`
`Reference
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`Michael A. Repka & James W. McGinity, Influence of Vitamin E
`TPGS on the Properties of Hydrophilic Films Produced by Hot-
`Melt Extrusion, 202 Int’l J. Pharmaceutics 63 (2000) (“Repka”)
`
`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 Das, Ph.D.
`
`List of Materials Considered by Nandita Das, Ph.D.
`
`
`
`
`
`
`
`

`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 1
`
`A.
`
`B.
`
`Brief Overview of the ’150 Patent ........................................................ 1
`
`Brief Overview of the Prosecution History ........................................... 2
`
`III. GROUNDS FOR STANDING 37 C.F.R. § 42.104(A) .................................. 4
`
`IV. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ................................... 5
`
`A.
`
`B.
`
`C.
`
`D.
`
`Real Party In Interest (§ 42.8(b)(1)) ...................................................... 5
`
`Related Proceedings (§ 42.8(b)(2)) ....................................................... 5
`
`Lead and Backup Counsel (§ 42.8(b)(3)) .............................................. 6
`
`Service Information (§ 42.8(b)(4)) ........................................................ 8
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(B)) .......................... 8
`
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART ............................................. 9
`
`VII. THE CHALLENGED CLAIMS OF THE ’150 PATENT .............................. 9
`
`VIII. CLAIM CONSTRUCTION .......................................................................... 11
`
`IX. THE ’150 PATENT PRIORITY DATE ........................................................ 13
`
`X.
`
`SCOPE AND CONTENT OF THE PRIOR ART ......................................... 16
`
`A.
`
`The Prior Art as of May 28, 2003 ....................................................... 16
`
`i
`
`
`
`

`
`
`
`B.
`B.
`
`The Prior Art as of April 22, 2008 ...................................................... 19
`The Prior Art as of April 22, 2008 .................................................... ..19
`
`XI. DETAILED EXPLAINATION OF THE GROUNDS FOR
`UNPATENTABILITY .................................................................................. 21
`
`XI.
`
`DETAILED EXPLAINATION OF THE GROUNDS FOR
`
`UNPATENTABILITY ................................................................................ ..21
`
`A. GROUND 1: CLAIMS 1, 4-5, 8, 10, 13-14, AND 17 ARE OBVIOUS
`A.
`GROUND 1: CLAIMS 1, 4-5, 8, 10, 13-14, AND 17 ARE OBVIOUS
`OVER SCHIRALDI IN VIEW OF VERMA ..................................... 21
`OVER SCHIRALDI IN VIEW OF VERMA ................................... ..21
`
`
`
`
`
`
`
`B.
`B.
`
`C.
`C.
`
`GROUND 2: CLAIMS 6-7, 9, 15-16 AND 18 ARE OBVIOUS
`GROUND 2: CLAIMS 6-7, 9, 15-16 AND 18 ARE OBVIOUS
`OVER SCHIRALDI IN VIEW OF VERMA AND KHAN ............... 31
`
`OVER SCHIRALDI IN VIEW OF VERMA AND KHAN ............. ..31
`
`GROUND 3: CLAIMS 1, 4-10, AND 13-18 ARE OBVIOUS OVER
`GROUND 3: CLAIMS 1, 4-10, AND 13-18 ARE OBVIOUS OVER
`YANG.................................................................................................. 33
`YANG ................................................................................................ ..33
`
`
`XII. CONCLUSION .............................................................................................. 41
`
`XII.
`
`CONCLUSION ............................................................................................ ..41
`
`ii
`
`
`
`
`
`

`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`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
`
`Other Authorities
`
`37 C.F.R. § 42.6(e) ..................................................................................................... 1
`
`37 C.F.R. § 42.8 ......................................................................................................... 5
`
`37 C.F.R. § 42.104(a) ................................................................................................. 4
`
`37 C.F.R. § 42.100(b) .............................................................................................. 11
`
`M.P.E.P. § 2163 ....................................................................................................... 33
`
`iii
`
`
`
`
`
`

`
`I.
`
`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 USA, Inc. (“Teva” or
`
`“Petitioner”) respectfully requests inter partes review of claims 1, 4-10, and 13-18
`
`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, 4-10, and 13-18 of the ’150 patent are unpatentable over
`
`the prior art and should be canceled.
`
`II. BACKGROUND
`
`A. 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.)
`
`1
`
`
`
`

`
`
`
`Brief Overview of the Prosecution History
`
`B.
`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
`
`Schiraldi1 in view of Flick2. 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)
`
`2
`
`(“Flick”).
`
`
`
`

`
`
`
`combination of molecular weights and polymers claimed provides a suitable
`
`release profile for an opiate.” (Id.) Finally, the Applicants emphasized that “[t]he
`
`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.)
`
`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), but
`
`3
`
`
`
`

`
`
`
`arguing that Schiraldi did not disclose the particular claimed molecular weight
`
`combination.
`
`The Examiner maintained the rejection in an Advisory Action (Ex. 1002,
`
`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.)
`
`III. GROUNDS FOR STANDING 37 C.F.R. § 42.104(a)
`
`Petitioner certifies pursuant to 37 C.F.R. § 42.104(a) that the ’150 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 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 is
`
`4
`
`timely filed on December 3, 2015.
`
`
`
`

`
`
`
`IV. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A. Real Party In Interest (§ 42.8(b)(1))
`The real party-in-interest is Teva Pharmaceuticals USA Inc. (“Teva” or
`
`“Petitioner”).3
`
`Related Proceedings (§ 42.8(b)(2))
`
`B.
`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
`
`1-15-cv-00209 WVND
`
`Indivior Inc. et al v. Mylan Technologies Inc.
`
`et al
`
`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.
`
`5
`
`
`
`

`
`
`
`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
`
`1-14-cv-00422
`
`DED
`
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v. Alvogen Pine Brook Inc.
`
`1-13-cv-02003
`
`DED
`
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v. Watson Laboratories Inc., et al.
`
`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 any administrative proceedings may affect or be
`
`affected by a decision in this proceeding.
`
`C. Lead and Backup Counsel (§ 42.8(b)(3))
`
`Lead Counsel
`
`Backup Counsel
`
`Elizabeth Holland
`
`(Reg. No. 47,657)
`
`Eleanor M. Yost
`
`(Reg. No. 58,013)
`
`GOODWIN PROCTER LLP
`
`J. Coy Stull
`
`The New York Times Building
`
`(Reg. No. 62,599)
`
`6
`
`
`
`

`
`
`
`620 Eighth Avenue
`
`GOODWIN PROCTER LLP
`
`New York, NY 10018
`
`901 New York Avenue NW
`
`(212) 813-8800 (telephone)
`
`Washington, DC 20001
`
`(212) 355-3333 (facsimile)
`
`(202) 346-4000 (telephone)
`
`eholland@goodwinprocter.com
`
`(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
`
`7
`
`
`
`

`
`
`
`
`
`Robert V. Cerwinski
`
`(to seek pro hac vice admission)
`
`GOODWIN PROCTER LLP
`
`The New York Times Building
`
`620 Eighth Avenue
`
`New York, NY 10018
`
`(212) 813-8800 (telephone)
`
`(212) 355-3333 (facsimile)
`
`rcerwinski@goodwinprocter.com
`
`
`
`Service Information (§ 42.8(b)(4))
`
`D.
`Please direct all correspondence to counsel at the contact information above.
`
`Petitioner consents to service by electronic mail.
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(b))
`
`Petitioner challenges claims 1, 4-10, and 13-18 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:
`
`8
`
`
`
`

`
`
`
`Ground
`
`Claims
`
`Description
`
`1
`
`1, 4-5, 8, 10, 13-14,
`
`Obvious under § 103 over Schiraldi in view of
`
`and 17
`
`Verma4
`
`2
`
`6-7, 9, 15-16, and 18
`
` Obvious under § 103 over Schiraldi in view of
`
`Verma and Khan5
`
`3
`
`1, 4-10, and 13-18
`
`Obvious under § 103 over Yang6
`
`
`In support of these grounds of unpatentability, this Petition is accompanied by the
`
`declaration of Dr. Nandita Das (“Das Decl.,” Ex. 1003).
`
`VI. 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, Das Decl. at ¶ 30.)
`
`VII. THE CHALLENGED CLAIMS OF THE ’150 PATENT
`
`Petitioner challenges claims 1, 4-10, and 13-18. Independent claims 1 and
`
`10 provide:
`
`1. A mucosally-adhesive water-soluble film product comprising:
`
`4 Ex. 1005, Verma.
`
`9
`
`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.
`10. A mucosally-adhesive water-soluble film product 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:
`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
`
`10
`
`
`
`

`
`
`
`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.
`
`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).
`
`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
`
`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
`
`11
`
`
`
`

`
`
`
`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
`
`
`7 Petitioner (under the Philips standard) proffered a different construction of this
`
`claim term to the district court: “at least one watersoluble 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.)
`
`12
`
`
`
`

`
`
`
`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 1 and 2. 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.
`
`
`
`IX. THE ’150 PATENT PRIORITY DATE
`13
`
`
`
`

`
`
`
`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).8 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 claims are entitled to only a 2008 priority date9 at the earliest, because
`
`none of the applications in the chain leading up to 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 ’150
`
`14
`
`patent.
`
`
`
`

`
`
`
`Das Decl. at ¶ 44.) 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
`
`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
`
`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
`15
`
`
`
`

`
`
`
`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.)
`
`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.
`
`X.
`
`SCOPE AND CONTENT OF THE PRIOR ART
`
`A. The Prior Art as of May 28, 2003
`(i) U.S. Patent No. 4,713,243 (“Schiraldi”) (Ex. 1004)
`Schiraldi, titled “Bioadhesive extruded film for intra-oral drug delivery and
`
`process,” issued December 15, 1987, and is prior art under 35 U.S.C. § 102(b).
`
`Schiraldi discloses a mucosally-adhesive thin film for intra-oral, controlled-release
`
`delivery. (Ex. 1004, Schiraldi at Abstract; see also id. at 2:30-51.) The film
`
`consists of a water soluble or swellable polymer matrix. The matrix, in turn,
`
`consists of hydroxypropyl cellulose (40-95% by weight), a homopolymer of
`
`ethylene oxide (5-60% by weight), a water-insoluble polymer (up to 10% by
`
`weight), a plasticizer (2-10% by weight), and a pharmaceutical active. (Id.)
`
`16
`
`
`
`

`
`
`
`Schiraldi discloses films having, inter alia, PEO, a flavor, and an active10
`
`selected from anesthetics, analgesics, anti-inflammator[ies], or similar agents. (Id.
`
`at 2:38-41, 2:30-51, 3:42-44; Ex. 1003, Das Decl. at ¶ 100.) Schiraldi also
`
`describes films having thicknesses ranging from 1 to 10 mils or 0.025-0.25 mm.
`
`(Ex. 1004, Schiraldi at 2:44-46, 6:33-56 (Example 2); Ex. 1003, Das Decl. at ¶
`
`104.)
`
`Schiraldi’s films include PEO having a molecular weight of at least 100,000
`
`daltons and preferably above 3,000,000 daltons. (Ex. 1004, Schiraldi at 4:24-27;
`
`Ex. 1003, Das Decl. at ¶ 103.) Schiraldi teaches that one can “vary[] the ratios of
`
`the [] polymers” in order to control the adhesive properties of the film. (Ex. 1004,
`
`Schiraldi at 3:25-32; Ex. 1003, Das Decl. at ¶ 103.) Schiraldi also discloses the
`
`design of customized film products, wherein polymers are selected and blended to
`
`achieve “the desired delivery rate, the type of disorder to be treated, the area to be
`
`treated and the medication being administered.” (Ex. 1004, Schiraldi at 3:28-32;
`
`Ex. 1003, Das Decl. at ¶ 106.)
`
`
`10 Schiraldi also teaches person of ordinary skill of the advantages of a film
`
`incorporating an additional pharmaceutical agent. (Ex. 1004, Schiraldi at 8:21-42;
`
`17
`
`Ex. 1003, Das Decl. at ¶ 102.)
`
`
`
`

`
`
`
`In Example 2, Schiraldi discloses an ethylene oxide polymer component of
`
`“59.4%” w/w. (Ex. 1004, Schiraldi at 6:33-56.) In, Example 4, Schiraldi discloses
`
`an “[a]nalgesic [f]ilm” comprising 57% w/w polyethylene oxide (Polyox* WSR-
`
`301) and hydroxypropyl cellulose. (Id. at 7:24-51.) Polyox* WSR-301 is
`
`manufactured by Dow Chemical and has an average molecular weight of 4,000,000
`
`daltons. (Ex.1008, Flick at 4; Ex. 1003 Das Decl. at ¶ 107.)
`
`(ii) U.S. Patent No. 6,322,811 (“Verma”) (Ex. 1005)
`Verma, entitled “Alkylene oxide polymer compositions,” published on
`
`November 27, 2001, and is prior art to the ’150 patent.11
`
`Verma discloses films comprising one or more alkylene oxide polymers
`
`from low and high molecular weight ranges. (Ex. 1005, Verma at Abstract, 3:20-
`
`28; Ex. 1003, Das Decl.at ¶ 125.) Verma also explains that polymer compositions
`
`may optionally contain additional polymers, including, for example, cellulosic
`
`polymers, to achieve desired properties. (Ex. 1005, Verma at 3:20-45; Ex. 1003,
`
`Das Decl. ¶ 125.)
`
`Films described in Verma are flexible, water soluble, and have thicknesses
`
`ranging from about 0.05 to 1 mm (1.97 to 39.4 mils). (Ex. 1005, Verma at 4:41-45;
`
`
`11 Verma’s corresponding PCT application, WO99/40156, published on August 12,
`
`1999 and is § 102(b) art to the ’150 patent.
`
`18
`
`
`
`

`
`
`
`Ex. 1003, Das Decl. ¶ 126.) For example, Table 4 of Verma identifies components
`
`of “Flexible Lip Ribbon Die Extruded Films.” (Ex. 1005, Verma at 11:16-64.)
`
`Film number 8 is composed of two different molecular weights of PEO: 3

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


Or .

Accessing this document will incur an additional charge of $.

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

Accept $ Charge
throbber

Still Working On It

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

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

throbber

A few More Minutes ... Still Working

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

Thank you for your continued patience.

This document could not be displayed.

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

Your account does not support viewing this document.

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

Your account does not support viewing this document.

Set your membership status to view this document.

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

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

Become a Member

One Moment Please

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

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

Your document is on its way!

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

Sealed Document

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

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


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket