`
`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. 8,603,514 Issue Date: December 10, 2013 Title:
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE
`FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS Inter Partes Review No.
`IPR2016-XXXXX
`
`Case IPR2016: Unassigned
`
`MonoSol2002-0001
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 1/116
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,603,514
`
`MonoSol2002-0002
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 2/116
`
`
`
`PETITIONER’S EXHIBIT LISTTABLE OF CONTENTS
`
`INTRODUCTION
`
`BACKGROUND
`
`Brief Overview of the ‘514 Patent
`
`Brief Overview of the Prosecution History
`
`GROUNDS FOR STANDING
`
`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 ‘514 PATENT
`
`CLAIM CONSTRUCTION
`
`TECHNOLOGY TUTORIAL
`
`Polymers
`
`Particles
`
`Role of Viscosity
`
`Drying of Suspensions
`
`Role of Uniformity in Drug Formulations
`
`-i-
`
`Page
`1
`
`1
`
`1
`
`1
`
`8
`
`8
`
`8
`
`8
`
`10
`
`11
`
`11
`
`12
`
`13
`
`14
`
`15
`
`15
`
`18
`
`18
`
`21
`
`22
`
`MonoSol2002-0003
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`
`
`
`Films
`
`Flavoring of Pharmaceutical Formulations
`
`SCOPE AND CONTENT OF THE PRIOR ART
`
`WO 00/42992 (“Chen”) (Ex. 1005)
`
`U.S. Patent No. 7,067,116 (“Bess”) (Ex. 1004)
`
`CA 2,274,910 (“Cremer”) (Ex. 1006)
`
`DETAILED EXPLANATION OF THE GROUNDS FOR
`UNPATENTABILITY
`
`Ground 1: The Challenged Claims of the ‘514 Patent are
`Invalid Under 35 U.S.C. § 103(a) as Being Obvious Over
`Bess
`in View of Chen
`
`Claim Chart: Bess in View of Chen
`
`Ground 2: The Challenged Claims of the ‘514 Patent are
`Invalid Under 35 U.S.C. § 103(a) as Being Obvious Over
`Chen
`in View of Cremer
`
`Claim Chart: Chen in View of Cremer
`
`CONCLUSION
`
`23
`
`23
`
`24
`
`24
`
`25
`
`26
`
`27
`
`27
`
`39
`
`50
`
`52
`
`62
`
`-ii-
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`MonoSol2002-0004
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`
`
`PETITIONERS’ EXHIBIT LIST
`
`Exhibit No.
`
`Reference
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`U.S. Patent No. 8,603,514 (filed July 10, 2007)
`
`File History, U.S. Patent No. 8,603,514
`
`Expert Declaration of Metin Çelik, Ph.D., Relating to U.S.
`Patent No. 8,603,514
`
`U.S. Patent No. 7,067,116 (filed Mar. 23, 2000) (“Bess”)
`
`WO 00/42992 (published July 27, 2000) (“Chen”)
`
`CA 2,274,910 (published June 25, 1998) (“Cremer”)
`
`File History of Reexam No. 95/002,170
`
`Alfred Martin, Physical Pharmacy (4th ed. 1993) (“Physical
`Pharmacy”)
`[Intentionally Left Blank]
`
`Trial Transcript, Reckitt Benckiser Inc. v. Watson Labs., Inc.,
`CA No. 14-1574-RGA (Nov. 3-4, 2015) (“Trial Tr.”)
`
`U.S. Patent No. 6,221,402 (issued April 24, 2001)
`
`C.S. Fuller et al., Interactions in poly(ethylene oxide)—
`hydroxypropyl methylcellulose blends, 42 Polymer 9583 (2001)
`
`Leon Lachman et al, The Theory and Practice of Industrial
`Pharmacy (1986) (“The Theory and Practice of Industrial
`Pharmacy”)
`Thuro Carstensen, Theory of Pharmaceutical Systems
`J.
`Volume II: Heterogenous Systems (1973) (“Theory of
`Pharmaceutical Systems”)
`
`-iii-
`
`MonoSol2002-0005
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`
`
`
`Exhibit No.
`
`Reference
`
`Exhibit No.
`
`Reference
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`Exhibit No.
`
`U.S. Patent No. 8,603,514 (filed July 10, 2007)
`
`File History, U.S. Patent No. 8,603,514
`
`Expert Declaration of Jayanth Panyam, Ph.D., Relating to U.S.
`Patent No. 8,603,514
`
`U.S. Patent No. 7,067,116 (filed Mar. 23, 2000) (“Bess”)
`
`WO 00/42992 (published July 27, 2000) (“Chen”)
`
`CA 2,274,910 (published June 25, 1998) (“Cremer”)
`
`File History of Reexam No. 95/002,170
`
`Alfred Martin, Physical Pharmacy (4th ed. 1993) (“Physical
`Pharmacy”)
`
`Joint Claim Construction Chart, Reckitt Benckiser Inc. et al v.
`Teva Pharmaceutical USA, Inc., CA. No. 14-01451-RGA (Nov.
`17, 2015), D.I. 91
`
`Trial Transcript, Reckitt Benckiser Inc. v. Watson Labs., Inc.,
`CA No. 14-1574-RGA (Nov. 3-4, 2015) (“Trial Tr.”)
`
`U.S. Patent No. 6,221,402 (issued April 24, 2001)
`
`C.S. Fuller et al., Interactions in poly(ethylene oxide)—
`hydroxypropyl methylcellulose blends, 42 Polymer 9583 (2001)
`
`Leon Lachman et al, The Theory and Practice of Industrial
`Pharmacy (1986) (“The Theory and Practice of Industrial
`Pharmacy”)
`
`Thuro Carstensen, Theory of Pharmaceutical Systems
`J.
`Volume II: Heterogenous Systems (1973) (“Theory of
`Reference
`
`-iv-
`
`MonoSol2002-0006
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
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`
`
`
`Systems”)
`Remington’s Pharmaceutical Sciences (Alfonso R. Gennaro, ed.,
`18th ed., 1990)
`
`Mixing in the Process Industries (N. Harnby et al., eds., 2nd ed.,
`1997)
`
`Sevim Kaya & Ahmet Kaya, Microwave drying effects on
`properties of whey protein isolate edible films, 43 Journal of Food
`Engineering 91 (2000)
`
`X.Z. Shu et al., Novel pH-sensitive citrate cross-linked chitosan
`film for drug controlled release, 212 International Journal of
`Pharmaceutics 19 (2001)
`
`T.J. Bowser & L.R. Wilhelm, Modeling Simultaneous Shrinkage
`and Heat and Mass Transfer of a Thin, Nonporous Film During
`Drying, Vol. 60 No. 4 Journal of Food Science 753 (Nov. 4,
`
`U.S. Patent No. 6,596,298 (filed September 14, 1999)
`
`U.S. Patent No. 6,099,865 (filed June 11, 1999)
`
`U.S. Patent No. 5,166,233 (filed January 31, 1990)
`
`Jian-Hwa Guo & Horst Zerbe, Water Soluble Film for Oral
`Administration, The 24th International Symposium on Controlled
`Release of Bioactive Materials 227 (1997) (“Guo”)
`
`J.P. Cassidy et al., Controlled buccal delivery of buprenorphine,
`25 Journal of Controlled Release 21 (1993)
`
`U.S. Patent No. 4,849,246 (issued July 18, 1989)
`
`U.S. Patent No. 5,393,528 (filed June 1, 1993)
`
`U.S. Patent No. 5,948,430 (filed August 1, 1997) (“Zerbe”)
`
`U.S. Patent No. 5,629,003 (filed September 2, 1994)
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`Exhibit No.
`
`Reference
`
`-iv-
`
`MonoSol2002-0007
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 7/116
`
`
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`EP No. 0,090,560 (published May 3, 1989) (“Mitra”)
`
`Remington’s Pharmaceutical Sciences (John E. Hoover ed., 15th
`ed. 1975)
`
`Arlene Weintraub, It's On The Tip Of Your Tongue, Bloomberg
`(July 30, 2006),
`http://www.bloomberg.com/bw/stories/20060730/
`
`U.S. Patent No. 6,552,024 (filed Nov. 5, 1999)
`
`WO 2001/70194 (published September 27, 2001)
`
`1034
`
`Curriculum Vitae of Jayanth Panyam, Ph.D.
`
`1035
`
`1037
`
`1038
`
`1039
`
`Materials Considered by Jayanth Panyam, Ph.D.
`
`Decision on Appeal Regarding U.S. Patent 7,666,337, Appeal
`2014-00893
`
`Decision on Appeal Regarding U.S. Patent 7,824,588, Appeal
`2014-000547
`
`Decision on Appeal Regarding U.S. Patent 7,897,080, Appeal
`2014-007671
`
`-iv-
`
`MonoSol2002-0008
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`
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`II.
`III.
`
`A.
`
`B.
`
`A.
`
`B.
`
`C.
`
`D.
`
`INTRODUCTION
`BACKGROUND
`Brief Overview of the ’514 Patent
`
`Brief Overview of the Prosecution History
`
`GROUNDS FOR STANDING (§ 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))
`
`IV.
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(b))
`V.
`LEVEL OF ORDINARY SKILL IN THE ART
`VI.
`THE CHALLENGED CLAIMS OF THE ’514 PATENT
`VII.
`CLAIM CONSTRUCTION
`VIII.
`TECHNOLOGY TUTORIAL
`Polymers
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`Particles
`
`Role of Viscosity
`
`Drying of Suspensions
`
`Role of Uniformity in Drug Formations
`
`Films
`
`-v-
`
`1
`1
`1
`
`1
`
`8
`8
`8
`
`9
`
`10
`
`11
`
`11
`12
`13
`14
`16
`16
`
`18
`
`19
`
`22
`
`22
`
`24
`
`MonoSol2002-0009
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`Dr. Reddy's v. MonoSol, IPR2017-01582
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`
`
`G.
`
`Flavoring of Pharmaceutical Formulations
`
`IX.
`
`A.
`
`B.
`
`SCOPE AND CONTENT OF THE PRIOR ART
`WO 00/42992 (“Chen”) (Ex. 1005)
`
`U.S. Patent No. 7,067,116 (“Bess”) (Ex. 1004)
`
`C. WO 1998/026780 (“Cremer”) (Ex. 1006)
`
`24
`
`25
`25
`
`26
`
`27
`
`DETAILED EXPLANATION OF THE GROUNDS FOR
`X.
`27
`UNPATENTABILITY.
`Ground 1: The Challenged Claims of the ‘514 Patent are Invalid as Obvious
`
`Over Bess in View of Chen
`
`27
`
`The Dependent Claims Are Obvious Over Bess in View of Chen
`
`42
`
`Ground 2: The Challenged Claims Of The ‘514 Patent Are Invalid As Obvious
`
`Over Chen in View of Cremer
`
`Claim Chart: Chen in view of Cremer
`
`44
`
` 45
`
`The Dependent Claims Are Invalid as Obvious Over Chen in View of
`
`Cremer
`
`50
`
`CONCLUSION
`XI.
`Exhibit No.
`
`Reference
`
`51
`
`1029
`
`1030
`
`EP No. 0,090,560 (published May 3, 1989) (“Mitra”)
`
`Appellant’s Appeal Brief Regarding U.S. Patent 7,824,588,
`Reexamination Control 95/001,753
`
`-v-
`
`MonoSol2002-0010
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 10/116
`
`
`
`1031
`
`1032
`
`1033
`
`Arlene Weintraub, It's On The Tip Of Your Tongue, Bloomberg
`(July 30, 2006),
`http://www.bloomberg.com/bw/stories/20060730/
`
`U.S. Patent No. 6,552,024 (filed Nov. 5, 1999)
`
`WO 2001/70194 (published September 27, 2001)
`
`1034
`
`Curriculum Vitae of Metin Çelik, Ph.D.
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`Materials Considered by Metin Çelik, Ph.D.
`
`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
`Decision on Appeal Regarding U.S. Patent 7,666,337, Appeal
`2014- 00893
`
`Decision on Appeal Regarding U.S. Patent 7,824,588, Appeal
`2014- 000547
`
`Decision on Appeal Regarding U.S. Patent 7,897,080, Appeal
`2014- 007671
`
`Patent Owner’s Preliminary Response in IPR2016-00281 of
`U.S. Patent 8,603,514
`
`-v-
`
`MonoSol2002-0011
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`Dr. Reddy's v. MonoSol, IPR2017-01582
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`
`
`INTRODUCTION
`
`Under 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. (“Petitioner”)
`
`respectfully requests inter partes review of claims 1-3, 9, 15, 62- 65, 69-73, and 75
`
`of U.S. Patent No. 8,603,514 (“the ’514 patent”),
`
`which is assigned to Monosol RX, LLC (“Monosol” or “Patent Owner”). This
`
`petition and supporting exhibits demonstrate there is a reasonable likelihood that
`
`claims 1-3, 9, 15, 62-65, 69-73, and 75 of the ’514 patent are unpatentable over
`
`the prior art and should be canceled.
`
`BACKGROUND
`
`Brief Overview of the ’‘514 Patent
`
`The ’514 patent is entitled “Uniform Films for Rapid Dissolve Dosage Form
`
`Incorporating Taste-Masking Compositions.” (Ex. 1001.) The patent is directed to
`
`rapidlydissolvingrapidly dissolving, thin-film drug delivery compositions for the
`
`oral administration of active pharmaceutical components. (Id. at Abstract.) In
`
`general, the patent describes the manufacture of uniform pharmaceutical film drug
`
`products using techniques and ingredients that were well known to those of
`
`ordinary skill in the art.. (See Ex. 1003, PanyamMetin Çelik Decl. at ¶¶ 10-21, 32,
`
`34.26-37, 48-49.)
`
`Brief Overview of the Prosecution History
`- 1
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`
`
`The application that matured into the ’514 patent was filed July 10, 2007 as
`
`Application No. 11/775,484 (“the ‘484 application”) and claims priority to several
`
`applications. (Exs. 1001, 1002.) The ’514 patent issued on December 10, 2013, and
`
`names Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as
`
`inventors. (Id.) The ’‘484 application is a continuation-in-part of application No.
`
`10/768,809 (“the ‘809 application”), filed on January 30, 2004 and published on
`
`December 23, 2004. The ’‘809 application is a continuation-in-part of applications
`
`Nos.
`
`PCT/US02/32575 (“the ‘575 PCT application”); PCT/US02/32594 (“the ’‘594 PCT
`
`application”); and PCT/US02/32542 (“the ’‘542 PCT application”), all filed on
`
`October 11, 2002. The ’‘809 application issued as U.S. Patent No. 7,357,891. The
`
`’‘484 application is also a continuation-in-part of application No. 10/856,176 (“the
`
`’‘176 application”), filed on May 28, 2004 and published on February 17, 2005,
`
`which itself is a continuation-in-part of the ’‘809 application. The ’‘176 application
`
`issued as U.S. Patent No. 7,666,337.
`
`The ’‘514 patent also claims priority to provisional applications Nos.
`
`60/328,868 (“the ’‘868 application”), filed on October 12, 2001; 60/386,937 (“the
`
`’‘937 application”), filed on June 7, 2002; 60/414,276 ( “the ’‘276 application”),
`
`filed
`
`on September 27, 2002; 60/443,741 (“the ’‘741 application”), filed on January 30,
`
`- 2
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`
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`2003; and 60/473,902 (“the ’902 application”), filed on May 28, 2003.
`
`On September 9, 2010, the Examiner rejected many of the claims in the ’‘484
`
`- 3
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`MonoSol2002-0014
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`application as anticipated under 35 U.S.C. §102(e) by U.S. Patent 7,067,116 (Ex.
`
`1004, “Bess”). (Ex. 1002, ’514 File History, September 9, 20102010, Non-Final
`
`Rejection at 3-6.) The Examiner stated that Bess “discloses fast dissolving orally
`
`consumable solid film [sic] containing a taste masking agent and a
`
`pharmaceutically active agent . . .” (Id. at 4.) The Examiner also rejected the
`
`majority of the claims as obvious, under §103, over Ex. 1005, WO2000/42992
`
`(“Chen”) in view of U.S. Patent No. 5,653,993 (“Ghanta”). (Id. at 6-8.) According
`
`to the Examiner, “Chen discloses a water-soluble hydrocolloid; mucosal surface
`
`coated forming film, having an effective dose of an active agent.” (Id. at 6.) The
`
`Examiner also stated that active agents “can be encapsulated in a material that is
`
`different than the hydrocolloid. Encapsulation is additionally utilized to achieve
`
`masking of taste of active agents that are bitter.” (Id. at 7.) On December 9, 2010,
`
`Applicants amended several claims to recite the limitation: “wherein the uniformity
`
`is determined by the composition having a variation of drug content of less than
`
`10% per film unit.” (’514 File History, Ex. 1002, December 9, 2010 Amendment
`
`and Response at 2-9.) Applicants also argued that none of the cited references
`
`taught films where the dosing is uniform. (Id. at 11-17.) On February 2, 2011, the
`
`Examiner issued a Final Rejection of all the claims, maintained the previous
`
`rejections, and asserted that Applicants had the burden of
`
`- 4
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`
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`showing that the prior art did not achieve uniformity. (’514 File History, Ex. 1002,
`
`February 2, 2011 Final Rejection at 2-10.) The Examiner suggested that “Applicant
`
`provide evidence that the film does not have a different drug variation than that
`
`claims [sic] in the instant claims.” (Id. at 12.) On April 4, 2011, Applicants
`
`submitted an Amendment After Final Rejection. Applicants amended several
`
`claims, including by adding a limitation that the matrix have “a viscosity sufficient
`
`to aid in substantially maintaining non- self- aggregating uniformity of the active in
`
`the matrix.” (’‘514 File History, Ex. 1002, April 4, 2011 Amendment and Response
`
`at 2, 5.) Applicants argued that none of the cited prior art demonstrated uniformity.
`
`(Id. at 12-18.) Applicants further argued that because Bess uses “‘conventional’
`
`drying techniques, i.e. air- dried or dried under warm air[,] . . . [u]niform
`
`distribution of actives within the final film would not be expected with Bess’s
`
`process.” (Id. at 15.) Applicants again asserted that Chen merely mixes the taste
`
`modifying agents without recognizing the problems of attaining uniformity and
`
`asserted that Chen does not disclose “using the specific controlled, bottom-drying
`
`methods presently claimed.” (Id. at 17-18.) On June 1, 2011, Applicants filed a
`
`Request for Continued Examination, in which they incorporated their previous
`
`amendments. (’‘514 File History, Ex. 1002, June 1, 2011 Request for Continued
`
`Examination at 1-2.) On June 19, 2012, the Examiner issued a non-final rejection of
`
`all the claims over the same references
`
`- 5
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`MonoSol2002-0016
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`
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`discussed above. (‘514 File History, June 19, 2012 Non-Final Rejection, Ex. 1002
`
`at 2-13.) On December 19, 2012, Applicants responded with minor amendments to
`
`the claims and largely reiterated their previous argument that the burden was on the
`
`Examiner to demonstrate inherency. (Id., December 19, 2012 Amendment and
`
`Response at 1-16.) On March 13, 2013, the Examiner issued a Final Rejection.
`
`(Id., March 13, 2013 Final Rejection at 2-10.) However, the Examiner indicated
`
`that certain claims would be allowed if written in independent form. (Id. at 2.) The
`
`Examiner maintained the rejection over Bess and the rejection over the
`
`combination of Chen and Ghanta, again reiterating that the burden was on
`
`Applicants to show the lack of uniformity in these references. (Id. at 2-10.) On
`
`May 10, 2013, Applicants filed a Response After Final Action.
`
`Applicants added new claims and amended other claims, which eventually became
`
`the final, issued claims. (Id., May 10, 2013 Amendment and Response After Final
`
`Action at 2-19.) Applicants referenced a May 1, 2013 interview in which they
`
`persuaded the Examiner that Bess and Chen did not obtain uniform formulations.
`
`(Id., May 10, 2013 Amendment and Response After Final Action at 20-21.) In the
`
`Interview Summary, Applicants stated:
`
`During the Interview, 2 exhibits were discussed: 1) the Declaration
`under 35 U.S.C. § 1.132 of B. Arlie Bogue dated March 13, 2013
`demonstrating the uniformity of the Applicants’ drug delivery
`
`- 6
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`
`
`compositions both within single lots and across lots and 2) a sheet
`based on Figure 5 of the Chen reference demonstrating that Chen’s
`compositions vary by greater than 10% from a desired amount of
`active. . . . The Bogue declaration was submitted in Reexamination
`No. 95/002,170.
`(Id.) The Bogue Declaration was not filed in the ’‘484 file history, but there are
`
`three substantially similar declarations found in the File History of Reexam No.
`
`95/002,170 (the “‘170 Reexam”). (See ’170 ReeexamReexam, Ex. 1007 at
`
`5-6.)1 1
`
`On June 14, 2013, the Examiner issued a Notice of Allowance. (‘514 File
`
`History, Ex. 1002, June 14, 2013 Notice of Allowance at 1-4.) On June 18, 2013,
`
`Applicants filed an Amendment after Notice of Allowance, correcting the
`
`dependencies of the to-be issued claims. (Id., June 18, 2013 Amendment After
`
`Notice of Allowance at 2-16.) Applicants also offered a “detailed interview
`
`summary.” (Id. at 18-20.) There, Applicants stated:
`
`As shown in Figure 5 of Chen, which shows the release profiles of
`four actives from exemplary films, in many instances the amount of
`active released from Chen’s films is greater than 110% of the
`expected amount.
`
`1 Reexam No. 95/002,170 was a reexamination of U.S. Patent No. 7,897,080 (“the
`‘080 patent”), involving some of the same prior art as the prosecution of the ‘514
`patent, including Chen (Ex. 1005). It was filed September 10, 2012. It terminated
`in the amendment or cancellation of several claims of the ’808‘080 patent in an
`- 7
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`MonoSol2002-0018
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`
`
`office action on September 3, 2003.
`
`- 8
`
`MonoSol2002-0019
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`Dr. Reddy's v. MonoSol, IPR2017-01582
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`
`
`
`As shown in Figure 5 of Chen, which shows the release profiles of four
`actives from exemplary films, in many instances the amount of active released
`from Chen’s films is greater than 110% of the expected
`amount.
`
`- 9
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`MonoSol2002-0020
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`
`
`(Id. at 18-19.) Applicants also argued that Bess “is devoid of any teaching of
`
`the active content uniformity of its compositions.” (Id. at 19.)
`
`On August 1, 2013, Applicants also briefly summarized the May 1, 2013
`
`interview. Applicants’ summary states:
`
`Applicants presented arguments regarding the teachings of Bess [Bess] and
`Chen. After reviewing Figure 5 of Chen and the Declaration, it was
`determined that neither Bess nor Chen inherently result in a film having a
`uniformity in which the individual dosage unit does not vary by more than
`10% of the desired amount of the active. All pending claims appear
`allowable over the prior art.
`(Id. at 1.) The claims under consideration ultimately issued. (Ex. 1002, November
`
`20, 2013 Issue Notification at 1.)
`
`- 10
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`MonoSol2002-0021
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`
`
`
`GROUNDS FOR STANDING (§ 42.104(a))
`
`Petitioner certifies underPursuant to 37 C.F.R. § 42.104(a), Petitioner
`
`hereby certifies that the ’514 patent is available for inter partesInter Partes
`
`review and that the Petitioner is not barred or estopped from requesting inter
`
`partesInter Partes review challenging the claims of the ’514 patent on the
`
`grounds identified in this Petition. Petitioner was served with a complaint
`
`asserting
`
`the ‘514 patent on December 3, 2014
`
`in Reckitt Benckiser
`
`Pharmaceuticals, Inc., RB Pharmaceuticals Limited, et al vherein.
`
`Teva Pharmaceuticals USA, Inc., Civil Action 14-1451 (D. Del.). This petition is
`
`timely filed on December 3, 2015.
`
`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. (“Dr.
`
`Reddy’s” or “Petitioner”).2
`
`2 Teva is an indirect, wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.
`
`Teva is owned by 1) Orvet UK, which in turn is owned by Teva Pharmaceuticals
`
`Europe B.V., which in turn is owned by Teva Pharmaceutical Industries Ltd. and 2)
`
`Teva Pharmaceutical Holdings Coöperatieve U.A., which in
`
`Related Proceedings (§ 42.8(b)(2))
`
`- 11
`
`MonoSol2002-0022
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`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 22/116
`
`
`
`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
`
`- 12
`
`MonoSol2002-0023
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 23/116
`
`
`
`1-15-cv-00209
`
`WVND Indivior Inc. et al v. Mylan Technologies Inc. et al
`
`- 13
`
`MonoSol2002-0024
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 24/116
`
`
`
`DED
`1-15-cv-01016
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v.
`
`Alvogen Pine Brook, Inc.
`
`- 14
`
`MonoSol2002-0025
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 25/116
`
`
`
`1-15-cv-00477
`
`DED
`
`Reckitt Benckiser Pharmaceuticals Inc. et al.
`
`v.
`
`Teva Pharmaceuticals USA, Inc.
`
`- 15
`
`MonoSol2002-0026
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 26/116
`
`
`
`1-14-cv-01451
`
`DED
`
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v.
`
`Par Pharmaceutical, Inc. et al
`
`- 16
`
`MonoSol2002-0027
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 27/116
`
`
`
`1-14-cv-00422
`
`DED
`
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v.
`
`Alvogen Pine Brook Inc
`
`- 17
`
`MonoSol2002-0028
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 28/116
`
`
`
`1-13-cv-02003
`
`DED
`
`turn is owned by IVAX LLC, which is owned by Teva Pharmaceuticals USA, Inc.
`Reckitt Benckiser Pharmaceuticals Inc. et al
`
`v. Watson Laboratories Inc., et al.
`
`- 18
`
`MonoSol2002-0029
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 29/116
`
`
`
`1-13-cv-01674
`
`DED
`
`Reckitt Benckiser Pharmaceuticals, Inc. et al
`
`v.
`
`Par Pharmaceutical, Inc. et al
`
`- 19
`
`MonoSol2002-0030
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 30/116
`
`
`
`DED
`1-13-cv-01461
`Related Proceeding
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Par Pharmaceutical, Inc. et al.
`
`Reckitt Benckiser Pharmaceuticals Inc.
`Watson Laboratories, Inc. et al.
`v.
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Alvogen Pine Brook, Inc.et al.
`Reckitt Benckiser Pharmaceuticals Inc.
`Par Pharmaceutical, Inc. et al.
`v.
`Reckitt Benckiser Pharmaceuticals Inc.
`v. Teva Pharmaceuticals USA, Inc.
`Reckitt Benckiser Pharmaceuticals
`Inc. et al. v Par Pharmaceutical Inc. et
`Reckitt Benckiser Pharmaceuticals
`Inc. et al. v. Watson Laboratories Inc.
`Reckitt Benckiser Pharmaceuticals Inc.
`Alvogen Pine Brook, Inc.
`v.
`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.
`1-13-cv-01461-RGA
`
`Jurisdiction
`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
`
`- 20
`
`MonoSol2002-0031
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 31/116
`
`
`
`Indivior Inc. et al v. Mylan Technologies
`Inc. et al.
`
`1-15-cv-00209-IMK
`
`United States
`District
`Court/Northern
`District of West
`Virginia
`(Clarksburg)
`USPTO/PTAB
`
`BioDelivery Sciences International, Inc.
`v.Reckitt Benckiser Pharmaceuticals
`BioDelivery Sciences International, Inc.
`v.Reckitt Benckiser Pharmaceuticals
`Teva Pharmaceuticals USA, Inc. v.
`
`IPR2014-00325
`
`IPR2014-00998
`
`UPSTO/PTAB
`
`IPR2016-00280
`
`UPSTO/PTAB
`
`- 21
`
`MonoSol2002-0032
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 32/116
`
`
`
`Indivior UK Limited
`
`The following administrative proceedings may affect or be affected by a
`
`decision in this proceeding: Petitioner is aware of at least one currently-pending
`
`U.S. patent application that claims the benefit of the ’‘514 Patent: U.S. Patent
`
`Application Serial No. 14/572,173 filed on December 16, 2014, which is pending.
`
`Lead and Backup Counsel (§ 42.8(b)(3))
`
`Lead Counsel
`Elizabeth Holland
`(Reg. No. 47,657)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`813-8800 (telephone)
`(212)
`355-3333 (facsimile)
`(212)
`eholland@goodwinprocter.com
`
`Backup Counsel
`Eleanor M. Yost
`(Reg. No. 58,013)
`J. Coy Stull
`(Reg. No. 62,599)
`GOODWIN PROCTER LLP
`901 New York Avenue NW
`Washington, DC 20001
`346-4000 (telephone)
`(202)
`346-4000 (facsimile)
`(202)
`eyost@goodwinprocter.com
`jstull@goodwinprocter.com
`
`Elaine H. Blais
`Robert Frederickson III
`(both to seek pro hac vice admission)
`GOODWIN PROCTER LLP
`Exchange Place
`
`Lead Counsel
`
`Back-Up Counsel
`
`- 22
`
`MonoSol2002-0033
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 33/116
`
`
`
`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
`2050
`Atlanta, Georgia 30309
`
`- 23
`
`MonoSol2002-0034
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
`MONOSOL EX. 2002 - 34/116
`
`
`
`53 State Street Boston,
`Massachusetts 02109Facsimile:
`(404) 607-9981
`phagerty@cantorcolburn.com
`(617) 570-1000 (telephone)
`(617) 523-1231 (facsimile)
`eblais@goodwinprocter.com
`rfrederickson@goodwinprocter.c
`om
`
`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
`
`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))
`
`Please direct all correspondence to counsel at the contact information above.
`- 11-
`
`MonoSol2002-0035
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
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`
`
`
`Petitioner consents to service by electronic mail.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`AND IDENTIFICATION OF THE CHALLENGE (§ 42.104(b))
`
`Petitioner challenges claims 1-3, 9, 15, 62-65, 69-73, and 75 of the ’514
`
`patent (“the Challenged Claims”), and requests review of those claims under 35
`
`U.S.C. § 311 and AIA § 6. Petitioner challenges these claims on the following
`
`grounds:
`
`- 12-
`
`MonoSol2002-0036
`
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`
`
`
`Ground
`
`Claims
`
`Description
`
`1
`
`2
`
`1-3, 9, 15, 62-65, 69-73,73 and
`75
`
`1-3, 9, 15, 62-65, 69-73,73 and
`75
`
`Obvious under §103 over Bess32 in
`view of Chen43
`Obvious under §103 over Chen
`in view of Cremer54
`
`To support these grounds of unpatentability, this Petition is accompanied by
`
`the declaration of Dr. Jaynath PanyamMetin Çelik (“PanyamÇelik Decl.,” Ex.
`
`1003).
`
`The Grounds raised in this petition are meaningfully distinct. Ground 1
`
`presents obviousness of claims 1-3, 9, 15, 62-65, 69-73, and 75 based upon Bess in
`
`view of Chen. Ground 2 differs from Ground 1 in asserting obviousness of claims
`
`1-3, 9, 15, 62-65, 69-73, and 75 based upon Chen in view of Cremer. This ground
`
`is not cumulative of Ground 1 as Bess teaches a hydrated polymer gel film and
`
`Cremer teaches a film with a mucoadhesive layer that includes a water-soluble, film
`
`forming polymer.
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`A person of ordinary skill in the art related to the ’514 patent would have a
`
`MastersMaster’s Degree, Ph.D., or their equivalent in pharmaceutics or
`
`pharmaceutical
`
`3 Ex. 1004.
`
`- 13-
`
`MonoSol2002-0037
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`
`
`
`4 Ex. 1005.
`5 Ex. 1006, WO 1998026780 to Cremer. sciences or a related field, and several years
`
`of experience in developing and formulating dosage forms for drugs. (See Ex. 1003,
`
`PanyamÇelik Decl. at ¶ 29.)45.)
`
`2 Ex. 1004
`3 Ex. 1005
`4 Ex. 1006
`
`- 14-
`
`MonoSol2002-0038
`
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`
`
`
`THE CHALLENGED CLAIMS OF THE ’‘514 PATENT
`
`Petitioner challenges claims 1-3, 9, 15, 62- 65, 69-73,73 and 75 of the
`
`’‘514 patent. Independent claims 1 and 62 are illustrative:
`
`A drug delivery composition comprising:
`a cast film comprising a flowable water-soluble or water
`swellable film-forming matrix comprising one or more substantially
`water soluble or water swellable polymers; and a desired amount of at
`least one active; wherein said matrix has a viscosity sufficient to aid in
`substantially maintaining non-self-aggregating uniformity of the active
`in the matrix;
`a particulate active substantially uniformly stationed in the
`matrix; and
`
`and
`
`- 15-
`
`MonoSol2002-0039
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
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`
`
`
`a taste-masking agent coated or intimately associated with said
`particulate to provide taste-masking of the active;
`a taste-masking agent coated or intimately associated with
`said particulate to provide taste-masking of the active; wherein
`the combined particulate and taste-masking agent have a particle size
`of 200 microns or less and said flowable water-soluble or water
`swellable film-forming matrix is capable of being dried without loss
`of substantial uniformity in the stationing of said particulate active
`therein; and wherein the uniformity subsequent to casting and drying
`of the matrix is measured by substantially equally sized individual
`unit doses which do not vary by more than 10% of said desired
`amount of said at least one active.
`A drug delivery composition comprising:
`a cast film comprising a flowable water-soluble or water
`swellable film-forming matrix comprising one or more
`substantially
`
`- 16-
`
`MonoSol2002-0040
`
`Dr. Reddy's v. MonoSol, IPR2017-01582
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`
`
`
`film-forming matrix comprising one or more substantially water soluble or
`water swellable polymers; and a desired amount of at least one active;
`wherein said matrix has a viscosity sufficient to aid in substantially
`maintaining non-self-aggregating uniformity of the active in the matrix;
`a parti