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
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA. No. 14-01451-RGA
`
`)
`)
`)
`
`))
`
`)
`)
`
`))
`
`)
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
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