Case 1:14-cv-01451-RGA Document 91 Filed 11/17/15 Page 1 of 2 PageID #: 2153
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA. No. 14-01451-RGA
`
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`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`v.
`TEVA PHARMACEUTICALS USA, INC.,
`
`Plaintiffs,
`
`Defendant.
`
`JOINT CLAIM CONSTRUCTION STATEMENT
`
`The parties hereby submit the attached Joint Claim Construction Chart, which sets forth:
`
`(i) the disputed claim terms; (ii) the parties’ respective proposed constructions for the disputed
`
`claim terms; and (iii) the intrinsic evidence on which each party will rely to support its respective
`
`proposed constructions and/or to rebut the opposing party’s proposed constructions. In addition
`
`to the materials disclosed in the Joint Claim Construction Chart, each party reserves the right to
`
`rely on other portions of the specifications and prosecution histories of the patents-in-suit during
`
`claim construction briefing and argument. A copy of the Joint Claim Construction Chart is
`
`attached as Exhibit A. Copies of United States Patent Nos. 8,017,150 (“the ’150 patent”),
`
`8,475,832 (“the ’832 patent”), and 8,603,514 (“the ’514 patent) and those portions of their
`
`prosecution histories cited by the parties are attached as Exhibits B- and organized as follows:
`
`Exhibit B
`
`U.S. Patent No. 8,017,150
`
`Exhibit C
`
`U.S. Patent No. 8,475,832
`
`Exhibit D
`
`U.S. Patent No. 8,603,514
`
`Exhibit E
`
`’514 Patent File History, December 9, 2010 Amendment and Response
`Pursuant to 37 C.F.R. §1.111 at 10-20
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91 Filed 11/17/15 Page 2 of 2 PageID #: 2154
`
`Exhibit F
`
`’514 Patent File History, April 4, 2011 Amendment and Response
`Pursuant to 37 C.F.R. §1.116
`
`Exhibit G
`
`’832 Patent File History, September 9, 2009 IDS
`
`Exhibit H
`
`’832 Patent File History, February 29, 2012 Amendment and Response
`
`Exhibit I
`
`Exhibit J
`
`Exhibit K
`
`’832 Patent File History, October 22, 2012 Amendment and Response
`After Final Office Action
`
`’832 Patent File History, April 30, 2013 Amendment and Response with
`Request for Continued Examination
`
`’588 Patent Reexamination, Decision on Appeal, Reexamination
`Application No. 95/001,753 (Reexamination of U.S. Patent No.
`7,824,588)
`
`Respectfully submitted,
`
`/s/ Daniel M. Attaway
`Mary W. Bourke (#2356)
`Dana K. Severance (#4869)
`Daniel M. Attaway (#5130)
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4320
`(302) 252-4330 (Fax)
`mbourke@wcsr.com
`dseverance@wcsr.com
`dattaway@wcsr.com
`
`Counsel for Plaintiffs
`
`Dated: November 17, 2015
`
`/s/David M. Fry
`John W. Shaw
`Karen E. Keller
`David M. Fry
`SHAW KELLER LLP
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`dfry@shawkeller.com
`
`Counsel for Defendant Teva Pharmaceuticals
`USA, Inc.
`
`2
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-1 Filed 11/17/15 Page 1 of 6 PageID #: 2155
`
`EXHIBIT A
`JOINT CLAIM CONSTRUCTION CHART
`
`Disputed Claim Terms, Proposed Constructions, and Citations to Intrinsic Evidence
`
`The parties reserve the right to rely on any intrinsic evidence cited for a term, regardless of which party provided the same and
`
`the right to further amend these charts as necessary. The parties further reserve the right to rely on any figures, tables, examples, or
`
`any reference incorporated by reference in cited portions of the patents-in-suit or the respective file histories, even if not explicitly
`
`referred to herein.
`
`Term/Phrase
`
`1.
`
`“a taste-masking agent
`coated or intimately
`associated with said
`particulate [active]”
`
`(’514 cls. 1 and 28)
`
`Defendants’ Proposed
`Construction
`The taste masking agent
`is coated on,
`or in contact with, the
`particles of
`active ingredient.
`
`Defendants’ Intrinsic
`Evidence
`’514 Patent: 4:27-30;
`5:64-66; 6:11-12; 6:21-
`26; 6:29-36; 6:49-52;
`7:13-22; 9:16-36; 14-4-
`21; 14-25-51; 15:6-16:3;
`16:63-17:3; 17:32-39;
`38:21-39:60.
`
`Prosecution of ’514
`Patent: December 9,
`2010 Amendment and
`Response Pursuant to 37
`C.F.R. §1.111 at 10-20
`(Ex. E).
`
`Plaintiffs’
`Intrinsic Evidence
`Ex. D (’514 Patent)
`passim where
`referencing “taste-
`masking”; see, e.g.,
`at:
`5:43-49
`5:55-59
`6:11-12
`9:37-41
`16:31-39
`38:23-39:60
`54:1-10
`62:1-6, 19-25, 44-46
`70:37-39
`
`Plaintiffs’ Proposed
`Construction
`The Court previously
`construed “taste-
`masking of the active”
`as having its plain and
`ordinary meaning.
`Plaintiffs do not believe
`further, separate
`construction of this
`term by the Court is
`necessary in this case.
`If the Court determines
`to further construe the
`term, the plain and
`ordinary meaning is a
`taste-masking agent
`sufficiently surrounding
`the particulate active,
`
`1
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-1 Filed 11/17/15 Page 2 of 6 PageID #: 2156
`
`Term/Phrase
`
`2. “said matrix has a
`viscosity sufficient to aid
`in substantially
`maintaining non-self-
`aggregating uniformity
`of the active in the
`matrix”
`
`(’514 cls. 1, 16, 28, 48,
`58 and 62)
`
`3. Plaintiffs’ proposed
`term: “dried without
`loss of substantial
`uniformity”
`
`Defendants’ proposed
`term: “dried without the
`loss of substantial
`uniformity”
`
`Plaintiffs’ Proposed
`Construction
`e.g., by being dissolved
`and homogenously
`distributed.
`
`The Court previously
`construed “viscosity
`sufficient to aid in
`substantially
`maintaining non-self
`aggregating uniformity
`of the active in the
`matrix” as “viscosity
`sufficient to provide
`little to no aggregation
`of the active within the
`film.” Plaintiffs do not
`believe further
`construction of this
`term by the Court is
`necessary in this case.
`
`The Court previously
`construed “capable of
`being dried without loss
`of substantial
`uniformity” as “the film
`matrix is capable of
`being dried such that
`individual dosage units
`do not vary by more
`than 10% from the
`
`Plaintiffs’
`Intrinsic Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Intrinsic
`Evidence
`
`Indefinite.
`
`Ex. D (’514 Patent),
`see, e.g., at:
`2:27-46
`8:56-64
`11:35-37
`18:4-5
`36:55-61
`37:14-18
`54:11-15
`
`Decision on Appeal,
`Reexamination
`Application No.
`95/001,753
`(Reexamination of U.S.
`Patent No. 7,824,588)
`(Ex. K) at 9-10, 16, 18-
`19.
`
`Ex. D (’514 Patent),
`see, e.g., at:
`2:27-46
`11:35-37
`18:4-5
`36:55-61
`37:14-18
`54:11-15
`
`2
`
`Dried without employing
`conventional convection
`air drying
`from the top.
`
`’514 Patent: 2:60-62;
`3:1-34; 4:48-57; 8:56-64;
`9:4-9; 22:27-67; 23:4-20;
`25:27-31; 28:51-29:1;
`30:37-44,61-62; 31:59-
`32:12; 52:26-50
`
`Prosecution of ’514
`Patent: December 9,
`2010 Amendment and
`Response Pursuant to 37
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-1 Filed 11/17/15 Page 3 of 6 PageID #: 2157
`
`Term/Phrase
`
`(’514 cls. 28 and 62)
`
`4.
`
`“wherein said local pH
`is from about 3 to about
`3.5 in the presence of
`saliva”
`
`(’832 cls. 1 and 9)
`
`Teva’s proposed term:
`“about 3 to about 3.5”
`
`Plaintiffs’ Proposed
`Construction
`intended amount of
`active for that dosage
`unit.” Plaintiffs do not
`believe further, separate
`construction of this
`term by the Court is
`necessary in this case.
`
`The Court previously
`construed “provide a
`local pH for said
`composition of a value
`sufficient to optimize
`absorption of said
`buprenorphine, wherein
`said local pH is from
`about 3 to about 3.5 in
`the presence of saliva”
`as “provide a local pH
`for the composition
`sufficient to optimize
`absorption of said
`buprenorphine wherein
`said local pH is about 3
`to about 3.5 in the
`presence of saliva in the
`mouth, where local pH
`refers to the pH of the
`region of the carrier
`matrix immediately
`surrounding the active
`
`Plaintiffs’
`Intrinsic Evidence
`
`Defendants’ Proposed
`Construction
`
`Greater than 2.95 and
`less than 3.54.
`
`Ex. C (’832 Patent),
`see, e.g., at:
`3:14-21
`3:27-32
`3:35-38
`3:42-47
`3:48-50
`11:44-61
`12:26-36
`13:5-7
`15:51-52
`17:51-18:16
`18:35-41
`18:49
`19:3-22
`20:4-9
`20:18-20
`21:19-21
`21:35-44
`22:20-22
`23:1-23:55
`23:64-67
`24:33-37
`
`3
`
`Defendants’ Intrinsic
`Evidence
`C.F.R. §1.111 at 10-20
`(Ex. E); April 4, 2011
`Amendment and
`Response Pursuant to 37
`C.F.R. §1.116 (Ex. F) at
`12-21.
`
`’832 Patent: 11:53-57;
`12:26-36; 13:5-7; 15:51-
`52; 18:11-15; 21:38-44;
`23:1-1.
`
`Prosecution of ’832
`Patent: September 9,
`2009 IDS (Ex. G);
`February 29, 2012
`Amendment and
`Response (Ex. H) at 2-5,
`7-13; October 22, 2012
`Amendment and
`Response After Final
`Office Action (Ex. I) at
`7-10; April 30, 2013
`Amendment and
`Response with Request
`for Continued
`Examination (Ex. J) at 2-
`3 and 5-10.
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-1 Filed 11/17/15 Page 4 of 6 PageID #: 2158
`
`Plaintiffs’
`Intrinsic Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Intrinsic
`Evidence
`
`Term/Phrase
`
`Plaintiffs’ Proposed
`Construction
`agent as the matrix
`hydrates and/or
`dissolves, for example,
`in the mouth of the
`user.” Plaintiffs do not
`believe further, separate
`construction of this
`term by the Court is
`necessary in this case.
`
`To the extent that
`further construction is
`necessary, these terms
`should be construed to
`mean “wherein said
`local pH is above 2.5
`and below 4.0.”
`
`5.
`
`“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%
`
`This term means “at
`least one water-soluble
`polymer component
`consisting of
`polyethylene oxide and
`optionally hydrophilic
`cellulosic polymer,
`wherein the
`polyethylene oxide is in
`an amount of greater
`than 75% of the
`polymer component
`and there may be up to
`
`Ex. B (’150 Patent),
`see, e.g., at:
`Abstract
`1:34-36
`4:27-33
`17:27-42
`17:52-18:5
`47:60-48:33
`49:10-17
`50:6-33
`57:39-45
`
`“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%
`
`’150 Patent: 15:43-56,
`17:27-29
`
`4
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-1 Filed 11/17/15 Page 5 of 6 PageID #: 2159
`
`Term/Phrase
`
`hydrophilic
`cellulosic polymer”
`
`(’150 cl. 1)
`
`Plaintiffs’ Proposed
`Construction
`25% hydrophilic
`cellulosic polymer in
`the polymer
`component.”
`
`Plaintiffs’
`Intrinsic Evidence
`
`Defendants’ Proposed
`Construction
`hydrophilic
`cellulosic polymer”
`
`Defendants’ Intrinsic
`Evidence
`
`’150 Patent: 15:43-56,
`17:27-29
`
`6.
`
`“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”
`
`(’150 cl. 10)
`7. Defendants’ proposed
`term:
`“A film dosage
`composition”
`(‘832 patent, claim 1)
`
`This term means “at
`least one water-soluble
`polymer component
`consisting 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. B (’150 Patent),
`see, e.g., at:
`Abstract
`1:34-36
`4:47-53
`17:27-42
`17:52-18:5
`47:60-48:33
`49:10-17
`50:6-33
`58:32-38
`
`This term has its plain
`and ordinary meaning,
`and limits the claims.
`
`Ex C (’832 Patent)
`passim; see, e.g., at:
`1:6-15
`1:65-3:2
`4:46-60
`6:60-7:3
`15:60-67
`
`5
`
`“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”
`
`This term in the
`preamble is non-
`limiting.
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-1 Filed 11/17/15 Page 6 of 6 PageID #: 2160
`
`Term/Phrase
`
`Plaintiffs’ Proposed
`Construction
`
`Plaintiffs’
`Intrinsic Evidence
`23:57-67
`4:46-60
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Intrinsic
`Evidence
`
`Agreed Upon Constructions:
`
`1. “a hydrophilic cellulosic polymer”(’150 Patent, cls. 1 and 10): a polymer made from cellulose that is hydrophilic.
`
`2. “molecular weight” (‘150 patent, claims 1, 10): The Court previously construed “molecular weight” as “average molecular
`weight.”1
`
`1 Consistent with the Court’s claim construction ruling in the Watson/ Par cases, Teva expressly reserves the right to argue that this
`term is indefinite at a later stage in the proceeding.
`
`6
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 1 of 66 PageID #: 2161
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 1 of 66 Page|D #: 2161
`
`EXHIBIT B
`
`EXHIBIT B
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 2 of 66 PageID #: 2162
`
`US008017150B2
`
`(12) Ulllted States Patent
`Yang et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,017,150 B2
`Sep. 13, 2011
`
`(54) POLYETHYLENE OXIDE-BASED FILMS AND
`DRUG DELIVERY SYSTEMS MADE
`THEREFROM
`
`(75) Inventors: Robert K. Yang, Flushing, NY (US);
`-
`-
`.
`glcharEC1\;IF“lsZ’I<MCLean’
`)’
`(
`any -
`yefs’ mgSPOI't’
`Joseph M. FlllSZ, washlngton, DC (US)
`
`(73) Assignee: MonoSol RX, LLC, Portage, IN (US)
`
`( * ) Notice:
`
`Subject' to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 364 days.
`
`.
`(21) APPI'NO" 12/107’389
`.
`_
`(22) Flled-
`
`APr-221 2008
`
`(65)
`
`Prior Publication Data
`
`US 2008/0260809 A1
`
`001. 23, 2008
`
`Related US. Application Data
`_
`_
`
`_
`
`_
`
`_
`
`(60) Division of application No. 10/856,176, ?led on May
`28, 2004, noW Pat. No. 7,666,337, Which is a
`continuation-in-part
`of
`application
`No.
`PCT/US02/032575, ?led on Oct. 11, 2.002, and a
`contmuatron-m-part
`of
`application
`No.
`PCT/US02/32594, ?led on Oct. 11, 2002, and a
`continuation-in-part
`of
`application
`No.
`PCT/US02/ 32542, ?led on Oct. 11, 2002.
`(60) Provisional application No. 60/473,902, ?led on May
`28, 2003, provisional application No. 60/414,276,
`?led on Sep. 27, 2002, provisional application No.
`60/371,940, ?led on Apr. 11, 2002.
`
`(51) Int- 0-
`(2006.01)
`A61K 9/14
`(52) U.S.Cl. ...... .. 424/484;424/486;424/488;424/434;
`424/435
`
`(58) Field of Classi?cation Search ................ .. 424/434,
`424/435, 436, 443, 484
`See application ?le for complete search history.
`
`(56)
`
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`
`(Continued)
`
`Primary Examiner * Gina C Yu
`(74) Attorney, Agenz, or Firm i Hoffmann & Baron, LLP
`
`(57)
`
`ABSTRACT
`
`The invention relates to the ?lm products and methods of their
`preparation that demonstrate a non-self-aggregating uniform
`heterogeneity. Desirably, the ?lms disintegrate in Water and
`may be formed by a controlled drying process, or other pro
`cess that maintains the required uniformity of the ?lm. The
`?lms contain a polymer component, Which includes polyeth
`ylene oxide optionally blended With hydrophilic cellulosic
`polymers. Desirably, the ?lms also contain a pharmaceutical
`and/or cosmetic active agent With no more than a 10% vari
`ance of the active agent pharmaceutical and/ or cosmetic
`active agent per unit area of the ?lm.
`
`18 Claims, 34 Drawing Sheets
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 3 of 66 PageID #: 2163
`
`US 8,017,150 B2
`Page 2
`
`US. PATENT DOCUMENTS
`.
`3,2252% 2
`Z132; g’lvqtalge .th
`46753009 A
`6/1987 Hgllmesnell a1.
`4,695,465 A
`9/1987 Kigasawa et al.
`12%;:
`ligab‘gigilgal
`4,713,243 A 12/1987 Schiraldietal.
`4,722,761 A
`2/1988 Cartmelletal.
`4,740,365 A
`4/l988 Yukimatsu et al.
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`’
`’
`~
`4,777,046 A 10/1988 IWakPmetaL
`4,789,667 A 12/1988 Maku.” ‘ital
`122%???
`$323 231111.11?‘ a1
`Ram/093 E
`“M989 $522113? et'al
`4876092 A “M989 Mizobuchietéll‘
`4,876,970 A “M989 Bolduc
`4’880’4l6 A ll/l989 Horiuchiet a1
`’
`’
`'
`3,232,323‘:
`13333 gg?fgteglal
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`6/1991 Friedman et a1.
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`9/1994 Heiber et a1.
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`2/1995 Staab
`5,411,945 A
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`lg/lhnomlya et 31'
`eyers
`,
`,
`5,455,043 A 10/1995 Fischel-Ghodsian
`5,462,749 A 10/1995 Rencher
`5,472,704 A 12/1995 Sanms et a1‘
`5,518,902 A
`5/1996 ()Zaki et a1,
`5,567,431 A 10/1996 Vert et a1,
`5,620,757 A
`4/ 1997 Ninorniya et al.
`5,629,003 A
`5/1997 HOISUIl?IlIl et 31~
`2,638,233 2 12%; 511411 _etk{11~t~~~1~ ~~~~~~~~~~~~~~ ~- 424/473
`5,700,479 A 12/1997 Lundgren
`
`6/1998 Heiber etal.
`5,766,620 A
`9/l998 Tapolsky et al.
`5,800,832 A
`9/1999 Zerbe et a1.
`5,948,430 A
`#000 Mogmey etall'
`6’072’100 A
`11588? gg?fgtgt‘ltla'
`213%; $1
`5/2001 Zerbe etal.
`6,231,957 B1
`$88} éhaglgettall'
`253322;‘ 3}
`4/2002 Rzrlfaitaal'
`6’375’963 B1
`l
`120002
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`'
`6’488’963 Bl
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`° "my eta‘
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`2003/0069263 A1
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`2007/0087036 A1
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`
`DE
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`WO
`WO
`WO
`WO
`
`4/1976
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`3630603 (32
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`19646392 A1
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`0219762 A1
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`0241178 B1
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`0259749 B1
`7/1988
`0273069 B1
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`0452446 B1
`11/1992
`0514691 B1
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`0598606 A1
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`2/1995
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`7/1995
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`9/1997
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`7/2000
`0042992
`9/2001
`0170194 A1
`0191721 A2 12/2001
`03030882 A1
`4/2003
`03030883 A1
`4/2003
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`11/2005
`2008011194 A2
`V2008
`
`OTHER PUBLICATIONS
`XP-002298l05; Polyethylenglykole; Internet: wwwroemppcom;
`sep'zo’zoo‘"
`.
`.
`.
`Repka et .31.; In?uence of V1tam1n E. TPGS on the propert1es of
`hydroph1l1c ?lmsproducedbyhot-melteXtruslon;Internat1onalJour
`nal ofPharmaceut1cs;vol. 202, pp. 63-70; 2000.
`Repkaetal;Bioadhesivepropertiesofhydroxypropylcellulosetopi
`cal ?lms produced by hot-melt extrusion; Journal of Controlled
`Release; vol. 70; pp. 341-351; 2001.
`International Search Report for PCT?JS2004/0l7076.
`* cited by examiner
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 4 of 66 PageID #: 2164
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 1 0134
`
`US 8,017,150 B2
`
`70
`l/ 74
`
`12
`
`14
`
`FIG. 1
`
`10
`
`70J
`
`FIG. 5
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 5 of 66 PageID #: 2165
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 2 0134
`
`US 8,017,150 B2
`
`20
`
`f_/
`
`24
`
`54'
`
`36
`40
`
`0
`
`/\-/ 48
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 6 of 66 PageID #: 2166
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 3 0134
`
`US 8,017,150 B2
`
`44
`
`42
`
`sol-L172 i ‘Tl-:60
`
`21‘ /5IL
`A \56
`
`54\
`
`W50
`
`~52
`
`FIG. 7
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 7 of 66 PageID #: 2167
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 4 0134
`
`US 8,017,150 B2
`
`
`
`9 29C 0mm.
`
`
`
`m 292 umw,
`
`w .01
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 8 of 66 PageID #: 2168
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 5 0134
`
`US 8,017,150 B2
`
`1052.
`
`FIG. 9
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 9 of 66 PageID #: 2169
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 6 0134
`
`US 8,017,150 B2
`
`700
`
`FIG. 10
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 10 of 66 PageID #: 2170
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 7 0134
`
`US 8,017,150 B2
`
`FIG. 11
`
`100
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 11 of 66 PageID #: 2171
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 8 0134
`
`US 8,017,150 B2
`
`FIG. 12
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 12 of 66 PageID #: 2172
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 9 0134
`
`US 8,017,150 B2
`
`770
`
`100
`
`FIG. 13
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 13 of 66 PageID #: 2173
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 10 0134
`
`US 8,017,150 B2
`
`100
`
`FIG. 14
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 14 of 66 PageID #: 2174
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 11 0134
`
`US 8,017,150 B2
`
`110
`
`100
`
`FIG. 15
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 15 of 66 PageID #: 2175
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 12 0134
`
`US 8,017,150 B2
`
`//
`
`710
`
`FIG. 16
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 16 of 66 PageID #: 2176
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 13 0134
`
`US 8,017,150 B2
`
`200
`
`FIG. 17
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 17 of 66 PageID #: 2177
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 14 0134
`
`US 8,017,150 B2
`
`500
`
`FIG. 18
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 18 of 66 PageID #: 2178
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 15 0134
`
`US 8,017,150 B2
`
`500
`
`FIG. 19
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 19 of 66 PageID #: 2179
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 16 0134
`
`US 8,017,150 B2
`
`500
`
`FIG. 20
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 20 of 66 PageID #: 2180
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 17 0134
`
`US 8,017,150 B2
`
`500
`
`FIG. 21
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 21 of 66 PageID #: 2181
`
`US. Patent
`
`Sep. 13, 2011
`
`Sheet 18 0134
`
`US 8,017,150 B2
`
`500
`
`FIG. 22
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 22 of 66 PageID #: 2182
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 22 of 66 Page|D #: 2182
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 19 of 34
`
`US 8,017,150 B2
`
`500
`
`FIG. 23
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 23 of 66 PageID #: 2183
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 23 of 66 Page|D #: 2183
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 20 of 34
`
`US 8,017,150 B2
`
`500
`
`FIG. 24
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 24 of 66 PageID #: 2184
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 24 of 66 Page|D #: 2184
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 21 of 34
`
`US 8,017,150 B2
`
`500
`
`FIG. 25
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 25 of 66 PageID #: 2185
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 25 of 66 Page|D #: 2185
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 22 of 34
`
`US 8,017,150 B2
`
`FIG. 26
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 26 of 66 PageID #: 2186
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 26 of 66 Page|D #: 2186
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 23 of 34
`
`US 8,017,150 B2
`
`FIG. 27
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 27 of 66 PageID #: 2187
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 27 of 66 Page|D #: 2187
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 24 of 34
`
`US 8,017,150 B2
`
`500
`
`FIG. 28
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 28 of 66 PageID #: 2188
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 28 of 66 Page|D #: 2188
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 25 of 34
`
`US 8,017,150 B2
`
`500
`
`FIG. 29
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 29 of 66 PageID #: 2189
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 29 of 66 Page|D #: 2189
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 26 of 34
`
`US 8,017,150 B2
`
`500
`
`FIG. 30
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 30 of 66 PageID #: 2190
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 30 of 66 Page|D #: 2190
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 27 of 34
`
`US 8,017,150 B2
`
`500
`
`FIG. 31
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 31 of 66 PageID #: 2191191
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`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 32 of 66 PageID #: 2192
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 32 of 66 Page|D #: 2192
`
`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 29 of 34
`
`US 8,017,150 B2
`
`
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`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1009
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

`
`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 33 of 66 PageID #: 2193
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 33 of 66 Page|D #: 2193
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`Sep. 13, 2011
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`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 34 of 66 PageID #: 2194
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 34 of 66 Page|D #: 2194
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`U.S. Patent
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`Sep. 13, 2011
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`Sheet 31 of 34
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`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 35 of 66 PageID #: 2195
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 35 of 66 Page|D #: 2195
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`U.S. Patent
`
`Sep. 13, 2011
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`Sheet 32 of 34
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`US 8,017,150 B2
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`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 36 of 66 PageID #: 2196
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 36 of 66 Page|D #: 2196
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`U.S. Patent
`
`Sep. 13, 2011
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`Sheet 33 of 34
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`Case 1:14-cv-01451-RGA Document 91-2 Filed 11/17/15 Page 37 of 66 PageID #: 2197
`Case 1:14—cv—O1451—RGA Document 91-2 Filed 11/17/15 Page 37 of 66 Page|D #: 2197
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`U.S. Patent
`
`Sep. 13, 2011
`
`Sheet 34 of 34
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`US 8,017,150 B2
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