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. 8,603,514
`
`
`
`Case IPR2016: Unassigned
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,603,514
`
`
`
`

`
`
`
`PETITIONER’S EXHIBIT LIST
`
`Exhibit No.
`
`Reference
`
`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 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”)
`
`J. Thuro Carstensen, Theory of Pharmaceutical Systems Volume
`II: Heterogenous Systems (1973) (“Theory of Pharmaceutical
`
`
`
`
`
`

`
`
`
`Exhibit No.
`
`Reference
`
`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, 1995)
`
`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
`
`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/
`itsonthetipofyourtongue
`
`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
`
`
`
`
`
`
`
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS
`
`INTRODUCTION ............................................................................... .. 1
`
`BACKGROUND ................................................................................. .. 1
`
`INTRODUCTION ................................................................................. 1
`BACKGROUND ................................................................................... 1
`Brief Overview of the ’514 Patent ........................................................ 1
`
`Brief Overview of the ’5 14 Patent ...................................................... ..l
`
`Brief Overview of the Prosecution History ........................................... 1
`Brief Overview of the Prosecution History ......................................... ..l
`
`GROUNDS FOR STANDING (§ 42.104(a)) ....................................... 8
`GROUNDS FOR STANDING (§ 42.104(a)) ..................................... ..8
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ....................... 8
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ..................... ..8
`Real Party In Interest (§ 42.8(b)(1)) ...................................................... 8
`Real Party In Interest (§ 42.8(b)(l)) .................................................... ..8
`
`Related Proceedings (§ 42.8(b)(2)) ....................................................... 9
`Related Proceedings (§ 42.8(b)(2)) ..................................................... ..9
`
`Lead and Backup Counsel (§ 42.8(b)(3)) ............................................ 10
`Lead and Backup Counsel (§ 42.8(b)(3)) .......................................... ..lO
`
`Service Information (§ 42.8(b)(4)) ...................................................... 11
`Service Information (§ 42.8(b)(4)) .................................................... ..ll
`
`LEVEL OF ORDINARY SKILL IN THE ART .............................. ..l2
`
`THE CHALLENGED CLAIMS OF THE ’5 14 PATENT ............... .. 13
`
`
`
`
`I.
`II.
`
`II.
`
`I.
`
`II.
`II.
`III.
`III.
`
`A.
`
`A.
`
`B.
`B.
`
`A.
`A.
`
`B.
`B.
`
`C.
`C.
`
`D.
`D.
`
`V.
`
`VI.
`
`VII.
`
`VIII.
`
`A.
`A.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IV.
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IV.
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(b)) ................................... 11
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(b)) ................................. ..ll
`V.
`LEVEL OF ORDINARY SKILL IN THE ART ................................ 12
`VI.
`THE CHALLENGED CLAIMS OF THE ’514 PATENT ................. 13
`VII.
`CLAIM CONSTRUCTION ................................................................ 14
`VIII.
`TECHNOLOGY TUTORIAL ............................................................. 16
`Polymers .............................................................................................. 16
`Polymers ............................................................................................ ..l6
`
`CLAIM CONSTRUCTION .............................................................. ..14
`
`TECHNOLOGY TUTORIAL ........................................................... ..l6
`
`B.
`
`B.
`
`C.
`C.
`
`Particles ............................................................................................... 18
`
`Particles ............................................................................................. .. 18
`
`Role of Viscosity ................................................................................. 19
`Role of Viscosity ............................................................................... ..l9
`
`D. Drying of Suspensions ........................................................................ 22
`D.
`Drying of Suspensions ...................................................................... ..22
`
`E.
`E.
`
`F.
`
`F.
`
`Role of Uniformity in Drug Formations ............................................. 22
`Role of Uniformity in Drug Formations ........................................... ..22
`
`Films .................................................................................................... 24
`
`Films .................................................................................................. ..24
`
`
`
`
`
`

`
`
`
`G.
`
`Flavoring of Pharmaceutical Formulations ......................................... 24
`
`IX.
`
`SCOPE AND CONTENT OF THE PRIOR ART .............................. 25
`A. WO 00/42992 (“Chen”) (Ex. 1005) .................................................... 25
`
`B. U.S. Patent No. 7,067,116 (“Bess”) (Ex. 1004) .................................. 26
`
`C. WO 1998/026780 (“Cremer”) (Ex. 1006) ........................................... 27
`
`DETAILED EXPLANATION OF THE GROUNDS FOR
`X.
`UNPATENTABILITY............................................................................................. 27
`A. Ground 1: The Challenged Claims of the ‘514 Patent are Invalid as
`
`Obvious Over Bess in View of Chen .................................................. 27
`
`(a)
`
`The Dependent Claims Are Obvious Over Bess in View of
`
`Chen
`
`42
`
`B. Ground 2: The Challenged Claims Of The ‘514 Patent Are Invalid As
`
`Obvious Over Chen in View of Cremer .............................................. 44
`
`(a)
`
`(b)
`
`Claim Chart: Chen in view of Cremer .................................. 45
`
`The Dependent Claims Are Invalid as Obvious Over Chen
`
`in View of Cremer ......................................................................................... 50
`
`XI.
`
`CONCLUSION ................................................................................... 51
`
`
`
`
`
`
`
`
`
`

`
`
`
`I.
`
`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 USA, 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.
`
`II. BACKGROUND
`
`A. 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
`
`rapidlydissolving, 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, Panyam Decl. at ¶¶ 10-21, 32, 34.)
`
`Brief Overview of the Prosecution History
`
`B.
`The application that matured into the ’514 patent was filed July 10, 2007 as
`
`
`
`

`
`
`
`Application No. 11/775,484 (“‘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 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, 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
`
`-2-
`
`

`
`
`
`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, 2010 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
`
`-3-
`
`

`
`
`
`burden of 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
`
`-4-
`
`

`
`
`
`Examiner issued a non-final rejection of all the claims over the same references
`
`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
`
`-5-
`
`

`
`
`
`under 35 U.S.C. § 1.132 of B. Arlie Bogue dated March 13, 2013
`demonstrating the uniformity of the Applicants’ drug delivery
`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 Reeexam, Ex. 1007 at 5-6.)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:
`
`
`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 patent in an office
`
`action on September 3, 2003.
`
`-6-
`
`

`
`
`
`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.
`
`
`
`(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
`
`-7-
`
`

`
`
`
`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.)
`
`II. GROUNDS FOR STANDING (§ 42.104(a))
`Petitioner certifies under 37 C.F.R. § 42.104(a) that the ’514 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 ‘514 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
`
`timely filed on December 3, 2015.
`
`III. 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”).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
`
`-8-
`
`

`
`
`
`B. 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
`
`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
`
`1-14-cv-00422
`
`DED
`
`1-13-cv-02003
`
`DED
`
`
`turn is owned by IVAX LLC, which is owned by Teva Pharmaceuticals USA, Inc.
`
`-9-
`
`

`
`
`
`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
`
`
`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.
`
`C. 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
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
`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
`(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
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`
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`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
`New York, NY 10018
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
`rcerwinski@goodwinprocter.com
`
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`Service Information (§ 42.8(b)(4))
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`D.
`Please direct all correspondence to counsel at the contact information above.
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`Petitioner consents to service by electronic mail.
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`IV. STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`IDENTIFICATION OF THE CHALLENGE (§ 42.104(b))
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`Petitioner challenges claims 1-3, 9, 15, 62-65, 69-73, and 75 of the ’514
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`patent (“the Challenged Claims”), and requests review of those claims under 35
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`U.S.C. § 311 and AIA § 6. Petitioner challenges these claims on the following
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`grounds:
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`Ground
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`Claims
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`Description
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`1
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`2
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`1-3, 9, 15, 62-65, 69-73, and 75
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`Obvious under §103 over
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`Bess3 in view of Chen4
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`1-3, 9, 15, 62-65, 69-73, and 75
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`Obvious under §103 over
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`Chen in view of Cremer5
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`To support these grounds of unpatentability, this Petition is accompanied by the
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`declaration of Dr. Jaynath Panyam (“Panyam Decl.,” Ex. 1003).
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`
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`The Grounds raised in this petition are meaningfully distinct. Ground 1
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`presents obviousness of claims 1-3, 9, 15, 62-65, 69-73, and 75 based upon Bess in
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`view of Chen. Ground 2 differs from Ground 1 in asserting obviousness of claims
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`1-3, 9, 15, 62-65, 69-73, and 75 based upon Chen in view of Cremer. This ground
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`is not cumulative of Ground 1 as Bess teaches a hydrated polymer gel film and
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`Cremer teaches a film with a mucoadhesive layer that includes a water-soluble,
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`film forming polymer.
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`V. LEVEL OF ORDINARY SKILL IN THE ART
` A person of ordinary skill in the art related to the ’514 patent would have a
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`Masters Degree, Ph.D., or their equivalent in pharmaceutics or pharmaceutical
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`3 Ex. 1004.
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`4 Ex. 1005.
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`5 Ex. 1006, WO 1998026780 to Cremer.
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`sciences or a related field, and several years of experience in developing and
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`formulating dosage forms for drugs. (See Ex. 1003, Panyam Decl. at ¶ 29.)
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`VI. THE CHALLENGED CLAIMS OF THE ’514 PATENT
`Petitioner challenges claims 1-3, 9, 15, 62- 65, 69-73, and 75 of the ’514
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`patent. Independent claims 1 and 62 are illustrative:
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`1. A drug delivery composition comprising:
`(i) 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;
`(ii) a particulate active substantially uniformly stationed in the matrix;
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`and
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`(iii) 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.
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`62. A drug delivery composition comprising:
`(i) a cast film comprising a flowable water-soluble or water swellable
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`
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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;
`(ii) a particulate active substantially uniformly stationed in the matrix;
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`and
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`(iii) a taste-masking agent selected from the group consisting of
`flavors, sweeteners, flavor enhancers, and combinations thereof to provide
`taste-masking of the active;
`wherein the particulate active has 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.
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`(Ex. 1001 at 67:34-56; 73:48-74:9.) Dependent claims 2-3, 9, 15, 63-65, 69-73, and
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`75 of the ‘514 patent relate to particulate size, drug content, taste-masking agents,
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`etc.
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`VII. CLAIM CONSTRUCTION
`A claim subject to Inter Partes Review receives the broadest reasonable
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`construction or interpretation in light of the specification of the patent in which it
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`appears because, among other reasons, the patent owner has an opportunity to
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`amend the claims. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793
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`F.3d 1268 (Fed. Cir. 2015). For purposes of this proceeding only, one claim term
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`warrants a specific construction:
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`
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` “dried without the loss of substantial uniformity” (’514 Patent, Ex. 1001,
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`at claim 1 and 62). In a co-pending litigation, Patent Owner’s expert witness
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`on validity of the ’514 patent, Dr. Langer, testified that the claims were not
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`limited to any particular form of drying, or any particular drying
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`parameters.6 For these reasons, under the broadest reasonable interpretation
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`standard, “dried without the loss of substantial uniformity” should be
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`construed at least as broadly as Patent Owner’s proposed construction in the
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`district court, i.e., “any method of drying.”7
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`6 “Q. Now, the claim -- in none of the claims you looked at specifies parameters for
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`drying, is that correct, it does not specify? A. Not parameters.” (Reckitt Benckiser
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`Pharmaceuticals Inc. v. Watson Laboratories, Inc., CA No. 14-1574-RGA, Trial
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`Tr., Ex. 1010 at 556:10-14.)
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`7 In a copending litigation, under the narrower Phillips v. AWH Corp., 415 F.3d
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`1303, 1316, (Fed. Cir. 2005) claim construction standard, Petitioner has proposed
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`this term should be construed as “dried without employing conventional
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`convection air drying from the top.” (Reckitt Benckiser Inc. et al v. Teva
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`Pharmaceutical USA, Inc., CA. No. 14-01451-RGA, D.I. 91 Ex. A, Ex. 1009 at
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`2.)
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`VIII. TECHNOLOGY TUTORIAL
`A.
`Polymers
`In the pharmaceutical industry, polymers are used for various purposes, such
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`as coating, thickening, binding, controlled release, taste-masking, solubility
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`enhancement and packaging. (Ex. 1008, Physical Pharmacy, 4th ed., 1993, at 557;
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`Ex. 1003, Panyam Decl. at ¶ 38.) A polymer is made of many repeating chemical
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`units which are termed “monomers.” These monomers are polymerized to one
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`another using well-known methods, such as “addition” or “chain reaction”
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`polymerization and “condensation” or “stepwise” techniques. (Id.) Polymers can
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`be depicted by the chemical structure of their monomers. As an example, the
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`structure for polyvinylpyrrolidone is depicted below:
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`(a monomer unit of polyvinylpyrrolidone).
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`
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`In this figure, “n” refers to the number of monomer units that make up the
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`polymer. (Id.)
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`The molecular weight and composition of a polymer may vary depending on
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`the number of monomers or the chemical structures of the monomers. (Ex. 1008.
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`Physical Pharmacy, at 557-558; Ex. 1003, Panyam Decl. at ¶ 43.) These changes
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`result in polymers with different properties, including flexibility, solubility, and/or
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`viscosity. Viscosity can be adjusted by changing the concentration of the polymer
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`and/or using polymers of different average molecular weights. (Ex. 1008, Physical
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`Pharmacy, at 565-566; Ex. 1003, Panyam Decl. at ¶ 43.)
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`Another method of obtaining a polymer composition with different
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`properties such as flexibility, solubility and/or viscosity, is to create a multiple-
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`polymer system using polymers with different properties. (Physical Pharmacy, at
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`565-566 Ex. 1003, Panyam Decl. at ¶ 43.) For example, a single polymer system
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`may contain a highly water-soluble polymer, such as hydroxypropyl
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`methylcellulose, while a two polymer system may contain both a water-soluble
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`polymer, such as hydroxypropyl methylcellulose, and a water-insoluble polymer,
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`such as ethylcellulose.8 (Id.)
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`8 Some examples of water-soluble polymers include methylcellulose,
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`hydroxypropyl methylcellulose, hydroxypropylcellulsoe, polyethylene glycol
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`(PEG), polyvinyl pyrrolidone (PVP), carboxymethyl cellulose, cellulose acetate
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`phthalate and sodium carboxymethylcellulose. (Id.) Some examples of water-
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`insoluble polymers include ethyl cellulose, starch, carboxymethyl starch, and
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`cross-linked povidone. These water-insoluble polymers can absorb water and are
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`typically used for their gelling or thickening properties. (Id.) Gums that are
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`Other polymers are well known for their use as taste-masking agents in drug
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`formulations. These include acrylic polymers, such as a butyl methacrylate/(2-
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`dimethylaminoethyl), methacrylate/methyl methacrylate copolymer and
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`polyvinylacetal diethylaminoacetate. (See, e.g., Ex. 100_, U. S. Pat. No. 6,221,402,
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`entitled “Rapidly releasing and taste-masking pharmaceutical dosage form,” at
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`4:24-41.)
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`Some polymers are well known for use in film compositions, including cast
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`films. These include polyethylene oxide, which is water-swellable, and hydrophilic
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`cellu