11
`
`-.
`
`i
`'.~ ..
`
`IN THE UNITED STATES DISTRICT COURT
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`FOR THE DISTRICT OF DELAWARE
`
`RECKITT BENCKISER
`RECKlTT BENCKlSER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`MONOSOL RX, LLC,
`
`Plaintiffs,
`Plaintiffs,
`
`Civil Action No. 13-1674-RGA
`Civil Action No. 13-1674-RGA
`
`v.
`v.
`
`WATSON LABORATORIES, INC. and
`WATSON LABORATORIES, INC. and
`ACTAVIS LABORATORIES UT, INC.,
`ACTAVIS LABORATORIES UT, INC.,
`
`Defendants.
`Defendants.
`
`RECKITT BENCKISER
`RECKlTT BENCKlSER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`MONOSOL RX,LLC,
`
`Plaintiffs,
`. Plaintiffs,
`
`v.
`v.
`
`
`PAR PHARMACEUTICAL, INC. and PAR PHARMACEUTICAL, INC. and
`INTELGENX TECHNOLOGIES CORP.,
`INTELGENX TECHNOLOGIES CORP.,
`
`Defendants.
`Defendants.
`
`Civil Action No. 14-422-RGA
`Civil Action No. 14-422-RGA
`
`TRIAL OPINION
`TRIAL OPINION
`
`Mary W. Bourke, Esq., Dana K. Severance, Esq., Daniel M. Attaway, Esq., WOMBLE
`Mary W. Bourke, Esq., Dana K. Severance, Esq., Daniel M. Attaway, Esq., WOMBLE
`CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE, attorneys for Plaintiffs.
`CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE, attorneys for Plaintiffs.
`
`Daniel A. Ladow, Esq., James M. Bollinger, Esq., Timothy P. Heaton, Esq., J. Magnus Essunger,
`Daniel A. Ladow, Esq., James M. Bollinger, Esq., Timothy P. Heaton, Esq., J. Magnus Essunger,
`Esq., TROUTMAN SANDERS LLP, New York, NY; Charanjit Brahma, Esq., TROUTMAN
`Esq., TROUTMAN SANDERS LLP, New York, NY; CharanjitBrahma, Esq., TROUTMAN
`
`MonoSol2009-0001
`
`Dr. Reddys v. MonoSol
`IPR2016-01112
`
`

`
`SANDERS LLP, San Francisco, CA; Robert E. Browne, Jr., Esq., TROUTMAN SANDERS
`SANDERS LLP, San Francisco, CA; Robert E. Browne, Jr., Esq., TROUTMAN SANDERS
`LLP, Chicago, IL; Puja Patel Lea, Esq., TROUTMAN SANDERS LLP, Atlanta, GA; Jeffrey B.
`LLP, Chicago, IL; Puja Patel Lea, Esq., TROUTMAN SANDERS LLP, Atlanta, GA; Jeffrey B.
`Elikan, Esq., Jeffr~y Lerner, Esq., Erica N. Andersen, Esq., Ashley M. Kwon, Esq.,
`Elikan, Esq., Jeffr~y Lerner, Esq., Erica N. Andersen, Esq., Ashley M. Kwon, Esq.,
`COVINGTON & BURLING LLP, Washington, DC, attorneys for Plaintiffs Reckitt Benckiser
`COVINGTON & BURLING LLP, Washington, DC, attorneys for Plaintiffs Reckitt Benckiser
`Pharmaceuticals Inc. and RB Pharmaceuticals Limited.
`Pharmaceuticals Inc. and RB Pharmaceuticals Limited.
`
`James F. Hibey, Esq., Timothy C. Bickham, Esq., STEPTOE & JOHNSON LLP, Washington,
`James F. Hibey, Esq., Timothy C. Bickham, Esq., STEPTOE & JOHNSON LLP, Washington,
`DC; David L. Hecht, Esq., Cassandra A. Adams, Esq., STEPTOE & JOHNSON LLP, New
`DC; David L. Hecht, Esq., Cassandra A. Adams, Esq., STEPTOE & JOHNSON LLP, New
`York, NY, attorneys for Plaintiff MonoSol Rx, LLC.
`York, NY, attorneys for PlaintiffMonoSol Rx, LLC.
`
`John C. Phillips, Jr., Esq., Megan C. Haney, Esq., PHILLIPS, GOLDMAN & SPENCE, P.A.,
`John C. Phillips, Jr., Esq., Megan C. Haney, Esq., PHILLIPS, GOLDMAN & SPENCE, P .A.,
`Wilmington, DE; George C. Lombardi, Esq., Michael K. Nutter, Esq., Tyler G. Johannes, Esq.,
`Wilmington, DE; George C. Lombardi, Esq., Michael K. Nutter, Esq:, Tyler G. Johannes, Esq.,
`WINSTON & STRAWN LLP, Chicago, IL; Stephen Smerek, Esq., David P. Dalke, .Esq., Ashlea
`WINSTON & STRAWN LLP, Chicago, IL; Stephen Smerek,Esq., David P. Dalke, Esq., Ashlea
`P. Raymond, Esq., WINSTON & STRAWN LLP, Los Angeles, CA; MelindaK. Lackey, Esq.,
`P. Raymond, Esq., WINSTON & STRAWN LLP, Los Angeles, CA; Melinda K. Lackey, Esq.,
`Donald Mahoney, III, Esq., WINSTON & STRAWN LLP, Houston, TX, attorneys for
`Donald Mahoney, III, Esq., WINSTON & STRAWN LLP, Houston, TX, attorneys for
`Defendants Watson Laboratories, Inc. and Actavis Laboratories UT, Inc.
`Defendants Watson Laboratories, Inc. and Actavis Laboratories UT, Inc.
`
`Steven J. Fineman, Esq., Katharine Lester Mowery, Esq., RICHARDS, LAYTON & FINGER,
`Steven J. Fineman, Esq., Katharine Lester Mowery, Esq., RICHARDS, LAYTON & FINGER,
`P.A., Wilmington, DE; Daniel G. Brown, Esq., LATHAM & WATKINS LLP, New York, NY;
`P.A., Wilmington, DE; Daniel G. Brown, Esq., LATHAM & WATKINS LLP, New York, NY;
`James K. Lynch, Esq., LATHAM & WATKINS LLP, San Francisco, CA; Terry Keaniey, Esq.,
`James K. Lynch, Esq., LATHAM & WATKINS LLP, San Francisco, CA; Terry Kearney, Esq.,
`LATHAM & WATKINS LLP, Menlo Park, CA; Jennifer Koh, Esq., B .. Thomas Watson, Esq.,
`LATHAM & WATKINS LLP, Menlo Park, CA; Jennifer Koh, Esq., B .. Thomas Watson, Esq.,
`LATHAM & WATKINS LLP, San Diego, CA; Emily C. Melvin, Esq., Brenda L. Danek, Esq.,
`LATHAM & WATKINS LLP, San Diego, CA; Emily C. Melvin, Esq., Brenda L. Danek, Esq.,
`LATHAM & WATKINS LLP, Chicago, IL, .attorneys for Defendants Par Pharmaceutical, Inc.
`LATHAM & WATKINS LLP, Chicago, IL, attorneys for Defendants Par Pharmaceutical, Inc.
`and IntelGenx Technologies Corp.
`and IntelGenx Technologies Corp.
`
`June 3-, 2016
`
`JuneJ__, 2016
`
`2
`2
`
`MonoSol2009-0002
`
`

`
`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, and
`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, and
`
`MonoSol Rx, LLC (collectively, "Reckitt") brought this suit against Defendants Watson
`MonoSol Rx, LLC (collectively, "Reckitt") brought this suit against Defendants Watson
`
`Laboratories, Inc. and Actavis Laboratories UT, Inc. (collectively, "Watson") (D.I. 1, 11, 287) 1
`Laboratories, Inc. and Actavis Laboratories UT, Inc. (collectively, "Watson") (D.l. 1, 11,287)1
`
`and Defendants Par Pharmaceutical, Inc. and IntelGenx Technologies Corporation (collectively,
`and Defendants Par Pharmaceutical, Inc. and IntelGenx Technologies Corporation (collectively,
`
`"Par") (C.A. No. 14-422 D.l. 1,9, 14; D.l. 80) alleging infringement of U.S. Patent Nos.
`"Par") (C.A. No. 14-422 D.I. 1, 9, 14; D.I. 80) alleging infringement of U.S. Patent Nos.
`
`8,475,832 (''the '832 patent"); 8,603,514 ("the '514 patent"); and 8,017,150 (''the '150 patent");
`8,475,832 (''the '832 patent"); 8,603,514 ("the '514 patent"); and 8,017,150 ("the '150 patent")~
`
`Reckitt's suits against Watson and Par were consolidated for all pretrial proceedings. (D.l. 66;
`Reckitt' s suits against Watson and Par were consolidated for all pretrial proceedings. (D .I. 66;
`
`C.A. No. 14-422 D.I. 19). The Court held a four day bench trial. (D.I. 414, 415, 416, 417).2 On
`C.A. No. 14-422 D.l. 19). The Court held a four day bench trial. (D.l. 414, 415,416,417).2 On
`
`November 3-4, 2015, the parties addressed the validity of the '150 and '514 patents and
`November 3-4,2015, the parties addressed the validity of the '150 and '514 patents and
`
`infringement of the '150 patent by Watson (D.I. 414, 415). On December 17-18,2015, the
`infringement of the '150 patent by Watson (D.I. 414, 415). On December 17-18, 2015, the
`
`parties addressed the validity of the '832 patent, infringement of the '150 patent by Par, and
`parties addressed the validity of the '832 patent, infringement of the' 150 patent by Par, and
`
`infringement of the '832 and '514 patents by Watson and Par (D.l. 416, 417). The parties filed
`infringement of the '832 and '514 patents by Watson and Par (D.I. 416, 417). The parties filed
`
`post-trial briefing (D.l. 396, 397, 406, 407, 408, 410, 411) and proposed findings offact (D.l.
`-post-trial briefing (D.I. 396, 397, 406, 407, 408, 410, 411) and proposed findings of fact (D.I.
`
`400).3 Having considered the documentary evidence and testimony, the Court makes the
`400V Having considered the documentary evidence and testimony, the Court makes the
`
`following findings offact and conclusions of law pursuant to Federal Rule of Civil Procedure
`following findings of fact and conclusions oflaw pursuant to Federal Rule of Civil Procedure
`
`52(a).
`52(a).
`
`" are to the docket in C.A. No. 13-1674 unless otherwise noted.
`1 Citations to "D.I.
`"are to the docket in C.A. No. 13-1674 unless otherwise noted.
`1 Citations to "D.l.
`2 Although the official transcript is filed in four parts (D.l. 414,415, 416, 417), citations to the transcript herein are
`2 Although the official transcript is filed in four parts (D.I. 414, 415, 416, 417), citations to the transcript herein are
`generally cited as "Tr."
`generally cited as "Tr."
`3 Reckitt also submitted a notice of supplemental authority on March 28, 2016 (D.I. 424), informing the Court of the
`3 Reckitt also submitted a notice of supplemental authority on March 28,2016 (D.I. 424), informing the Court of the
`final written decisions of the Patent Trial and Appeal Board in inter partes review proceedings of a patent related to
`final written decisions of the Patent Trial and Appeal Board in inter partes review proceedings of a patent related to
`the '514 patent.
`the '514 patent.
`
`3
`3
`
`MonoSol2009-0003
`
`

`
`I.
`I.
`
`BACKGROUND
`BACKGROUND
`
`A.
`A.
`
`Overview
`Overview
`
`Plaintiff Reckitt Benckiser Pharmaceuticals is the holder of approved New Drug
`PlaintiffReckitt Benckiser Pharmaceuticals is the holder of approved New Drug
`
`Application ("NDA") No. 22-410 for Suboxone® sublingual film, which is indicated for
`Application ("NDA") No. 22-410 for Suboxone® sublingual film, which is indicated for
`
`maintenance treatment of opioid dependence. (D.I. 353-1 at if'il 10, 16). The active ingredients
`maintenance treatment ofopioid dependence. (D.I. 353-1 at~ 10,16). The active ingredients
`
`of Suboxone® sublingual film are buprenorphine hydrochloride and naloxone hydrochloride.
`of Suboxone® sublingual film are buprenorphine hydrochloride and naloxone hydrochloride.
`
`(Id. at if 17). Buprenorphine is an opioid. (Tr. 1292:7-11; DFF137).4 Naloxone is an opioid
`(Id. at ~ 17). Buprenorphine is an opioid. (Tr. 1292:7-11; DFF137).4 Naloxone is an opioid
`
`antagonist that prevents the action of opioids like buprenorphine when delivered simultaneously
`antagonist that prevents the action of opioids like buprenorphine when delivered simultaneously
`
`I
`
`to the bloodstream of a user. (Tr. 1293:3-17, 1474:9-14). Suboxone® sublingual film includes
`to the bloodstream of a user. (Tr. 1293:3-17, 1474:9-14). Suboxone® sublingual film includes
`
`both buprenorphine and naloxone to prevent unintended diversion of the product for abuse. (Tr.
`both buprenorphine and naloxone to prevent unintended diversion of the product for abuse. (Tr.
`
`1474:9-14).
`1474:9-14).
`
`Suboxone® sublingual film is available in four dosage strengths (buprenorphine
`Suboxone® sublingual film is available in four dosage strengths (buprenorphine
`
`hydrochloride/naloxone hydrochloride): 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg.
`hydrochloride/naloxone hydrochloride): 2 mg/0.5 mg, 4 mgll mg, 8 mg/2 mg, and 12 mg/3 mg.
`
`(D.I. 353-1 at if 17). Plaintiff RB Pharmaceuticals Limited is the assignee of the '832 patent,
`(D.I. 353-1 at ~ 17). PlaintiffRB Pharmaceuticals Limited is the assignee of the '832 patent,
`
`entitled "Sublingual and Buccal Film Compositions." (Id. atif 24; '832 patent, (54) & (73)).
`entitled "Sublingual and Buccal Film Compositions." (Id. at~ 24; '832 patent, (54) & (73)).
`
`PlaintiffMonoSol Rx, LLC is the assignee of the '514 patent, entitled "Uniform Films for Rapid
`Plaintiff Mono Sol Rx, LLC is the assignee of the '514 patent, entitled "Uniform Films for Rapid
`
`Dissolve Dosage Form Incorporating Taste-Masking Compositions," and the '150 patent,
`Dissolve Dosage Form Incorporating Taste-Masking Compositions," and the '150 patent,
`
`entitled "Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom." (D.I.
`entitled "Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom." (D.L
`
`353-1 at ifil 28, 32; '514 patent, (54) & (73); '150 patent, (54) & (73)). Plaintiff Reckitt
`353-1 at ~~ 28,32; '514 patent, (54) & (73); '150 patent, (54) & (73)). PlaintiffReckitt
`
`Benckiser Pharmaceuticals is an exclusive licensee of the '832, '514, and '150 patents. (D.I.
`Benckiser Pharmaceuticals is an exclusive licensee of the '832, '514, and '150 patents. (D.I.
`
`353-1 at W 25,29,33). The '832, '514, and '150 patents are listed in the Food and Drug
`353-1 at ifil 25, 29, 33). The '832, '514, and '150 patents are listed in the Food and Drug
`
`4 Citations to "PFF," "DFF," "DPRF," and "DWRF" herein are to the Corrected Joint Proposed Findings of Fact and
`4 Citations to "PFF," "DFF," "DPRF," and "DWRF" herein are to the Corrected Joint Proposed Findings of Fact and
`related responses filed at D.I. 400.
`related responses filed at D.l. 400.
`
`4
`4
`
`MonoSol2009-0004
`
`

`
`Administration's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the
`Administration's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the
`
`"Orange Book") entry for Suboxone® sublingual film. (Id. at if 34).
`"Orange Book") entry for Suboxone® sublingual film. (Id. at ~ 34).
`
`Watson and Par each filed Abbreviated New Drug Applications ("ANDAs") seeking
`Watson and Par each filed Abbreviated New Drug Applications ("ANDAs") seeking
`
`FDA approval to market generic versions of the 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12
`FDA approval to market generic versions of the 2 mg/O.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12
`
`mg/3 mg dosage strengths ofSuboxone® sublingual film prior to the expiration of the '832,
`mg/3 mg dosage strengths of Suboxone® sub lingual film prior to the expiration of the '832,
`
`'514, and '150 patents. (Id. at iii! 42, 45, 118). Watson seeks approval for its ANDA Product
`'514, and '150 patents. (Id. at ~~ 42,45, 118). Watson seeks approval for its ANDA Product
`
`through ANDA Nos. 204383 and 207087.5 (Id. at'~~ 43,45). Par seeks approval for its ANDA
`through ANDA Nos. 204383 and 207087.5 (Id. atifif 43, 45). Par seeks approval for its ANDA
`
`Product through ANDA No. 205854. (Id. at if 118). Watson's ANDAs and Par's ANDA contain
`Product through ANDA No. 205854. (ld. at ~ 118). Watson's ANDAs and Par's ANDA contain
`
`Paragraph IV certifications alleging that the '832, '514, and '150 patents are invalid,
`Paragraph IV certifications alleging that the '832, '514, and '150 patents are invalid,
`
`unenforceable, and/or will not be infringed by the manufacture, use, or sale of the generic
`unenforceable, and/or will not be infringed by the manufacture, use, or sale of the generic
`
`products proposed in the ANDAs. (Id. at iii! 43, 44, 46, 119). Reckitt received notices of
`products proposed in the ANDAs. (ld. at ~~ 43,44,46, 119). Reckitt received notices of
`
`Watson's and Par's Paragraph IV certifications and initiated the present litigation. (Id.; D.L 1,
`Watson's and Par's Paragraph IV certifications and initiated the present litigation. (Id.; D.I. 1,
`
`11, 80, 287).
`11, 80, 287).
`
`B.
`B.
`
`Asserted Patents
`Asserted Patents
`
`1.
`I.
`
`'832 Patent
`'832 Patent
`
`The '832 patent is directed to pharmaceutical film compositions and formulations that
`The '832 patent is directed to pharmaceutical film compositions and formulations that
`
`contain buprenorphine and naloxone. ('832 patent, 23:58-25:6). Reckitt asserts independent
`contain buprenorphine and naloxone. ('832 patent, 23:58-25:6). Reckitt asserts independent
`
`claims 1 and 15 and dependent claims 3, 6, and 16-19 against Watson and Par. (PFF21). The
`claims 1 and 15 and dependent claims 3, 6, and 16-19 against Watson and Par. (PFF21). The
`
`'832 patent issued on July 2, 2013. ('832 patent, (45)). The asserted claims of the '832 patent
`'832 patent issued on July 2,2013. ('832 patent, (45)). The asserted claims ofthe '832 patent
`
`are entitled to a priority date of August 7, 2009. (D.L 353-1 at ~ 120).
`are entitled to a priority date of August 7, 2009. (D.I. 353-1 at if 120).
`
`Claim 1 of the '832 patent reads:
`Claim 1 of the '832 patent reads:
`
`A film dosage composition comprising:
`A film dosage composition comprising:
`
`5 "Watson's ANDA Product" and "Par's ANDA Product" refer to the parties' respective proposed generic drug
`5 "Watson's ANDA Product" and "Par's ANDA Product" refer to the parties' respective proposed generic drug
`fonnrnations.
`formulations.
`
`5
`5
`
`MonoSol2009-0005
`
`

`
`a. A polymeric carrier matrix;
`a. A polymeric carrier matrix;
`
`b. A therapeutically effective amount of buprenorphine or a pharmaceutically
`b. A therapeutically effective amount of buprenorphine or a pharmaceutically
`acceptable salt thereof;
`acceptable salt thereof;
`
`c. A therapeutically effective amount of naloxone or a pharmaceutically acceptable
`c. A therapeutically effective amount of naloxone or a pharmaceutically acceptable
`salt thereof; and
`salt thereof; and
`
`d. A buffer in an amount to provide a local pH for said composition of a value
`d. A buffer in an amount to provide a local pH for said composition of a value
`sufficient to optimize absorption of said buprenorphine, wherein said local pH is
`sufficient to optimize absorption of said buprenorphine, wherein said local pH is
`from about 3 to about 3 .5 in the presence of saliva.
`from about 3 to about 3.5 in the presence of saliva.
`
`('832 patent, 23:58-67).
`('832 patent, 23:58-67).
`
`Claim 15 of the '832 patent reads:
`Claim 15 of the '832 patent reads:
`
`An orally dissolving film formulation comprising buprenorphine and naloxone,
`An orally dissolving film formulation comprising buprenorphine and naloxone,
`wherein said formulation provides an in vivo plasma profile having a Cmax of
`wherein said formulation provides an in vivo plasma profile having a Cmax of
`between about 0.624 ng/ml and about 5.638 ng/ml for buprenorphine and an in vivo
`between about 0.624 ng/ml and about 5.638 ng/ml forbuprenorphine and an in vivo
`plasma profile having a Cmax of between about 41.04 pg/ml to about 323. 7 5 pg/ml
`plasma profile having a Cmax of between about 41.04 pg/ml to about 323.75 pg/ml
`for naloxone.
`for naloxone.
`
`(Id. at 24:56-61).
`(Id. at 24:56-61).
`
`2.
`2.
`
`'514 Patent
`'514 Patent
`
`The '514 patent is directed to pharmaceutical film compositions that achieve certain
`The '514 patent is directed to pharmaceutical film compositions that achieve certain
`
`levels of active ingredient content uniformity. ('514 patent, (57)). Reckitt asserts independent
`levels of active ingredient content uniformity. ('514 patent, (57)). Reckitt asserts independent
`
`claim 62 and dependent claims 64, 65, 69, and 73 against Watson and Par. (PFF19). The '514
`claim 62 and dependent claims 64, 65, 69, and 73 against Watson and Par. (PFFI9). The '514
`
`patent issued on December 10, 2013. ('514 patent, (45)). The asserted claims of the '514 patent
`patent issued on December 10, 2013. ('514 patent, (45)). The asserted claims of the '514 patent
`
`are entitled to a priority date of September 27, 2002. (D.I. 353-1 at if 121).
`are entitled to a priority date of September 27,2002. (D.L 353-1 at,-r 121).
`
`Claim 62 of the '514 patent reads:
`Claim 62 of the '514 patent reads:
`
`A drug delivery composition comprising:
`A drug delivery composition comprising:
`
`(i) a cast film comprising a flowable water-soluble or water swellable film-forming
`(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
`matrix comprising one or more substantially water soluble or water swellable
`polymers; and a desired amount of at least one active;
`polymers; and a desired amount of at least one active;
`
`wherein said matrix has a viscosity sufficient to aid in substantially maintaining
`wherein said matrix has a viscosity sufficient to aid in substantially maintaining
`non-self-aggregating uniformity of the active in the matrix;
`non-self-aggregating uniformity of the active in the matrix;
`
`6
`6
`
`MonoSol2009-0006
`
`

`
`(ii) a particulate active substantially unifonnly stationed in the matrix; and
`(ii) a particulate active substantially uniformly stationed in the matrix; and
`
`(iii) a taste-masking agent selected from the group consisting of flavors, sweeteners,
`(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;
`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
`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
`flowable water-soluble or water swellable film-fonning matrix is capable of being
`dried without loss of substantial uniformity in the stationing of said particulate
`dried without loss of substantial unifonnity in the stationing of said particulate
`active therein; and
`active therein; and
`
`wherein the uniformity subsequent to casting and drying of the matrix is measured
`wherein the unifonnity subsequent to casting and drying of the matrix is measured
`by substantially equally sized individual unit doses which do not vary by more than
`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.
`10% of said desired amount of said at least one active.
`
`('514 patent, 73:48-74:10).
`('514 patent, 73:48-74:10).
`
`3.
`3.
`
`'150 Patent
`'150Patent
`
`The '150 patent is directed to pharmaceutical film products comprising, among other
`The '150 patent is directed to pharmaceutical film products comprising, among other
`
`things, certain amounts of specific polymers, including polyethylene oxides. ('150 patent, (57)).
`things, certain amounts of specific polymers, including polyethylene oxides. (' 150 patent, (57)).
`
`Reckitt asserts independent claim 1 and dependent claim 4 against Watson. (PFF23). Reckitt
`Reckitt asserts independent claim I and dependent claim 4 against Watson. (PFF23). Reckitt
`
`asserts independent claim 10 and dependent claim 13 against Par. (PFF25). The' 150 patent
`asserts independent claim 10 and dependent claim 13 against Par. (PFF25). The '150 patent
`
`issued on September 13,2011. ('150 patent, (45)). The parties stipulated that, for purposes of
`issued on September 13, 2011. (' 150 patent, (45)). The parties stipulated that, for purposes of
`
`the present case, the asserted claims of the '150 patent are entitled to a priority date no earlier
`the present case, the asserted claims of the '150 patent are entitled to a priority date no earlier
`
`than May 28, 2003. (D.I. 353-1 at ii 122).
`than May 28,2003. (D.1. 353-1 at ~ 122).
`
`Claim 1 of the '150 patent reads:
`Claim 1 of the '150 patent reads:
`
`A mucosally-adhesive water-soluble film product comprising:
`A mucosally-adhesive water-soluble film product comprising:
`
`an analgesic opiate pharmaceutical active; and
`an analgesic opiate pharmaceutical active; and
`
`at least one water-soluble polymer component consisting of polyethylene oxide in
`at least one water-soluble polymer component consisting of polyethylene oxide in
`combination with a hydrophilic cellulosic polymer;
`combination with a hydrophilic cellulosic polymer;
`
`wherein:
`wherein:
`
`the water-soluble polymer component comprises greater than 75% polyethylene
`the water-soluble polymer component comprises greater than 75% polyethylene
`oxide and up to 25% hydrophilic cellulosic polymer;
`oxide and up to 25% hydrophilic cellulosic polymer;
`
`7
`7
`
`MonoSol2009-0007
`
`

`
`the polyethylene oxide comprises one or more low molecular weight polyethylene
`the polyethylene oxide comprises one or more low molecular weight polyethylene
`oxides and one or more higher molecular weight polyethylene oxides, the molecular
`oxides and one or more higher molecular weight polyethylene oxides, the molecular
`weight ofthe low molecular weight polyethylene oxide being in the range 100,000
`weight of the low molecular weight polyethylene oxide being in the range 100,000
`to 300,000 and the molecular weight of the higher molecular weight polyethylene
`to 300,000 and the molecular weight of the higher molecular weight polyethylene
`oxide being in the range 600,000 to 900,000; and
`oxide being in the range 600,000 to 900,000; and
`
`the polyethylene oxide of low molecular weight comprises about 60% or more in
`the polyethylene oxide of low molecular weight comprises about 60% or more in
`the polymer component.
`the polymer component.
`
`('150 patent, 57:36-54).
`('150 patent, 57:36-54).
`
`Claim 10 of the' 150 patent reads:
`Claim 10 of the '150 patent reads:
`
`A mucosally-adhesive water-soluble film product comprising:
`A mucosally-adhesive water-soluble film product comprising:
`
`an analgesic opiate pharmaceutical active; and
`an analgesic opiate pharmaceutical active; and
`
`at least one water-soluble polymer component consisting of polyethylene oxide in
`at least one water-soluble polymer component consisting of polyethylene oxide in
`combination with a hydrophilic cellulosic polymer;
`combination with a hydrophilic cellulosic polymer;
`
`wherein:
`wherein:
`
`the water-soluble polymer component comprises the hydrophilic cellulosic polymer
`the water-soluble polymer component comprises the hydrophilic cellulosic polymer
`in a ratio of up to about 4: 1 with the polyethylene oxide;.
`in a ratio of up to about 4: 1 ~th the polyethylene oxide;.
`
`the polyethylene oxide comprises one or more low molecular weight polyethylene
`the polyethylene oxide comprises one or more low molecular weight polyethylene
`oxides and one or more higher molecular weight polyethylene oxides, the molecular
`oxides and one or more higher molecular weight polyethylene oxides, the molecular
`weight of the low molecular weight polyethylene oxide being in the range 100,000
`weight of the low molecular weight polyethylene oxide being in the range 100,000
`to 300,000 and the molecular weight of the higher molecular weight polyethylene
`to 300,000 and the molecular weight of the higher molecular weight polyethylene
`oxide being in the range 600,000 to 900,000; and
`oxide being in the range 600,000 to 900,000; and
`
`the polyethylene oxide of low molecular weight comprises about 60% or more in
`the polyethylene oxide of low molecular weight comprises about 60% or more in
`the polymer component.
`the polymer component.
`
`(ld. at 58 :28-46).
`(Id. at 58:28-46).
`
`II.
`II.
`
`LEGAL STANDARDS
`LEGAL STANDARDS
`
`A.
`A.
`
`Infringement
`Infringement
`
`A patent is infringed when a person "without authority makes, uses, offers to sell, or sells
`A patent is infringed when a person "without authority makes, uses, offers to sell, or sells
`
`any patented invention, within the United States ... during the term of the patent .... " 35
`any patented invention, within the United States ... during the term of the patent .... " 35
`
`8
`8
`
`MonoSol2009-0008
`
`

`
`U.S.C. § 271(a). A two-step analysis is employed in making an infringement determination. See
`U.S.C. § 271(a). A two-step analysis is employed in making an infringement determination. See
`
`Markman v. Westview Instruments, Inc., 52 F.3d 967,976 (Fed. Cir. 1995) (en banc), aff'd, 517
`Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en bane), afj"d, 517
`
`U.S. 370 (1996). First, the court must construe the asserted claims to ascertain their meaning and
`U.S. 370 (1996). First, the court must construe the asserted claims to ascertain their meaning and
`
`scope. See id. The trier dffact must then compare the properly construed claims with the
`scope. See id. The trier of fact must then compare the properly construed claims with the
`
`accused infringing product. See id. This second step is a question of fact. Bai v. L & L Wings,
`accused infringing product. See id. This second step is a question of fact. Bai v. L & L Wings,
`
`Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).
`Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).
`
`"Literal infringement of a claim exists when every limitation recited in the claim is found
`"Literal infringement of a claim exists when every limitation recited in the claim is found
`
`in the accused device." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir. 1998). "If
`in the accused device." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Crr. 1998). "If
`
`any claim limitation is absent from the accused device, there is no literal infringement as a matter
`any claim limitation is absent from the accused device, there is no literal infringement as a matter
`
`oflaw." Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). If an
`oflaw." Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). If an
`
`accused product does not infringe an independent claim, it also does not infringe any claim
`accused product does not infringe an independent claim, it also does not infringe any claim
`
`depending thereon. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir.
`depending thereon. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir.
`
`1989). However, "[ o ]ne may infringe an independent claim and not infringe a claim dependent
`1989). However, "[0 ]ne may infringe an independent claim and not infringe a claim dependent
`
`on that claim." Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352,1359 (Fed. Cir. 2007)
`on that claim." Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, ·1359 (Fed. Cir. 2007)
`
`(internal quotation marks omitted). A product that does not literally infringe a patent claim may
`(internal quotation marks omitted). A product that does not literally infringe a patent claim may
`
`still infringe under the doctrine of equivalents if the differences between an individual limitation
`still infringe under the doctrine of equivalents if the differences between an individual limitation
`
`of the claimed invention and an element of the accused product are insubstantial. See Warner(cid:173)
`of the claimed invention and an element of the accused product are insubstantial. See Warner(cid:173)
`
`Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17,39-40 (1997). The patent owner has the
`Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39-40 (1997). The patent owner has the
`
`burden of proving infringement by a preponderance of the evidence. See SmithKline
`burden of proving infringement by a preponderance of the evidence. See SmithKline
`
`Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878,889 (Fed. Cir. 1988).
`Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988).
`
`B.
`B.
`
`Anticipation
`Anticipation
`
`A patent claim is invalid as anticipated under 35 U.S.C. § 102 if "within the four corners
`A patent claim is invalid as anticipated under 35 U.S.C. § 102 if"within the four comers
`
`of a single, prior art document ... every element of the claimed invention [is described], either
`of a single, prior art document ... every element of the claimed invention [is described], either
`
`9
`9
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`MonoSol2009-0009
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`

`
`expressly or inherently, such that a person of ordinary skill in the art could practice the invention
`expressly or inherently, such that a person of ordinary skill in the art could practice the invention
`
`without undue experimentation." Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed.
`without undue experimentation." Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed.
`
`Cir. 2009) (alterations in original) (internal quotation marks omitted). As with infringement, the
`Cir. 2009) (alterations in original) (internal quotation marks omitted). As with infringement, the
`
`court construes the claims and compares them against the prior art. See Enzo Biochem, Inc. v.
`court construes the claims and compares them against the prior art. See Enzo Biochem, Inc. v.
`
`Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir. 2010). "[T]he accused infringer must show by
`Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir.201O). "[T]he accused infringer must show by
`
`clear and convincing evidence that a single prior art reference discloses each and every element
`clear and convincing evidence that a single prior art reference discloses each and every element
`
`of a claimed invention." Silicon Graphics, Inc. v. AT! Techs., Inc., 607 F.3d 784, 796 (Fed. Cir .
`of a claimed invention." Silicon Graphics, Inc. v. ATI Techs., Inc., 607 F.3d 784, 796 (Fed. Cir.
`
`. 2010). "A claimed invention cannot be anticipated by a prior art reference ifthe allegedly
`2010). "A claimed invention cannot be anticipated by a prior art reference if the allegedly
`
`anticipatory disclosures cited as prior art are not enabled .... [A disclosure] is not truly prior art[]
`anticipatory disclosures cited as prior ar