MonoSol 2002-0001
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`Mylan Y 0RQR6RO
`,3570200
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`

`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.
`Elikan, Esq., Jeffiey Lerner, Esq., Erica N. Andersen, Esq., Ashley M. Kwon, Esq.,
`
`COVINGTON & BURLING LLP, Washington, DC, attorneys for Plaintiffs Reckitt Benckiser
`Pharmaceuticals Inc. and RB Pharmaceuticals Limited.
`
`James F. Hibey, Esq., Timothy C. Biekham, Esq., STEPTOE & JOHNSON LLP, Washington,
`
`DC; David L. Hecht, Esq., Cassandra A. Adams, Esq., STEPTOE & JOHNSON LLP, New
`
`York, NY, attorneys for Plaintiff Mono Sol Rx, LLC.
`
`John C. Phillips, Jr., Esq., Megan C. Haney, Esq., PHILLIPS, GOLDMAN & SPENCE, P.A.,
`Wihnington, 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
`P. Raymond, Esq., WINSTON & STRAWN LLP, Los Angeles, CA; Melinda K. Lackey, Esq.,
`Donald Mahoney, III, Esq., WINSTON & STRAWN LLP, Houston, TX, attorneys for
`
`Defendants Watson Laboratories, Inc. and Actavis Laboratories UT, Inc.
`
`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;
`James K. Lynch, E-sq., 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, San Diego, CA; Emily C. Melvin, Esq., Brenda L. Danek, Esq.,
`LATHAM & WATKINS LLP, Chicago, IL, attorneys for Defendants Par Pharmaceutical, Inc.
`and IntelGenx Technologies Corp.
`
`June5_, 2016
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`MonoSol 2002-0002
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`MonoSol 2002-0002
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`wIs,%.sgi)1sTRIc'r JUDGE-:
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, and
`
`MonoSo1 Rx, LLC (collectively, “Reckitt”) brought this suit against Defendants Watson
`
`Laboratories, Inc. and Actavis Laboratories UT, Inc. (collectively, “Watson”) (D.I. 1, 11, 287)]
`
`and Defendants Par Pharmaceutical, Inc. and IntelGenx Technologies Corporation (collectively,
`
`“Par”) (C.A. No. 14-422 D}. 1, 9, 14; D.I. 80) alleging infringement ofU.S. Patent Nos.
`
`8,475,832 (“the ’832 patent” ; 8,603,514 (“the ‘S 14 patent”); and 8,017,150 (“the ’150 patent”)-.
`
`Reckitt’s suits against Watson and Par were consolidated for all pretrial proceedings. (D.I. 66;
`
`No. 14-422 D.I. 19). The Court held a four day bench trial. (D1. 414, 415, 416, 417)? On
`
`November 3-4, 2015, the parties addressed the validity of the ’ 150 and ’5 14 patents and
`
`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
`
`infringement of the ‘S32 and ’5 14 patents by Watson and Par (D.I. 416, 417). The parties filed
`
`post-trial briefing (D.I. 396, 397, 406, 407, 408, 410, 411) and proposed findings offact (D.I.
`
`400) .3 Having considered the documentary evidence and testimony, the Court makes the
`
`following findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure
`
`52(3).
`
`‘ Citations to “ill.
`
`” are to the docket in CA. No. 13-1674 unless otherwise noted.
`
`2 Although the official transcript is filed in four parts (111. 414, 415, 416, 417), citations to the transcript herein are
`generally cited as “Tr?”
`3 Recldtt 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 interpafles review proceedings of a patent related to
`the ‘S 14 patent.
`
`MonoSol 2002-0003
`M0n0S0l 2002-0003
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`I.
`
`BACKGROUND '
`
`A.
`
`Overview
`
`Plaintiff Reckitt Benckiser Pharmaceuticals is the holder of approved New Drug
`
`Application (“NDA”) No. 22-410 for Suboxone® sublingual film, which is indicated for
`
`maintenance treatment of opioid dependence. (D.I. 353-1 at 10, 16). The active ingredients
`
`of Suhoxone® sublingual film are buprenorphine hydro chloride and naloxone hydrochloride.
`
`(Id. at ‘H 17). Buprenorphine is an opioid.
`
`(Tr. 1292:7—11;DFF13'?).4 Naloxone is an opioid
`
`antagonist that prevents the action of opioids like huprenorphine when delivered simultaneously
`
`to the bloodstream of a user. (Tr. 1293:3——1 7, 147-4:9—14). Suboxone® sublingual film includes
`
`both buprenorphine and naloxone to prevent unintended diversion of the product for abuse. (Tr.
`
`1474:9—14).
`
`Suhoxone® sublingual film is available in four dosage strengths (buprenorphine
`
`hydrochloridefnaloxone hydrochloride): 2 mg/0.5 mg, 4 mg/1 mg, 8 mgf2 mg, and 12 mg!3 mg.
`
`(13.1. 353-1 at 1] 17). Plaintiff RB Pharmaceuticals Limited is the assignee of the ‘S32 patent,
`
`entitled “Sublingnal and Buccal Film Compositions.” (Id. at 1] 24; ‘S32 patent, (54) & (73)).
`
`Plaintiff MonoSo1 Rx, LLC is the assignee of the “S14 patent, entitled “Uniform Films for Rapid
`
`Dissolve Dosage Form Incorporating Taste—Masking Compositions,” and the ’ 1 50 patent,
`
`entitled “Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom.” (D.I.
`
`353-1 at1]‘|l 28, 32; ’514 patent, (54) & (73); ‘I50 patent, (54) & (73)). Plaintiff Reckitt
`
`Benckiser Pharmaceuticals is an exclusive licensee of the ‘B32, ’S14,land ’ 150 patents. (D.I.
`
`353-1 at W 25, 29, 33). The ‘$32, ’514, and ’l50 patents are listed in the Food and Drug
`
`4 Citations to “PFF,” “DFF,” “DPRF,” and “DWR.F” herein are to the Corrected Joint Proposed Findings of Fact and
`related responses filed at D.I. 400.
`
`MonoSol 2002-0004
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`M0n0S01 2002-0004
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`4
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`Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations" (the
`
`“Orange Book”) entry for Suboxone® sublingual film. (Id. at 1| 34).
`
`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/l mg, 8 mg/2 mg, and 12
`
`mg/3 mg dosage strengths of Suboxone® sublingual film prior to the expiration of the ’832,
`
`’514, and ’150 patents. (Id. at 1111 42, 45, 118). Watson seeks approval for its ANDA Product
`
`through ANDA Nos. 204383 and 20708725 (Id. at’1|1] 43, 45). Par seeks approval for its ANDA
`
`Product through ANDA No. 205854. (Id. at 1| 118). Watson’s ANDAS and Par’s ANDA contain
`
`Paragraph IV certifications alleging that the ’832, ’5 14, and ’150 patents are invalid,
`
`unenforceable, andfor will not be infringed by the manufacture, use, or sale of the generic
`
`products proposed in the ANDAS.
`
`(Id. at ‘MI 43, 44, 46, 119). Reckitt received notices of
`
`Watsorfs and Par’s Paragraph IV certifications and initiated the present litigation. (Id.; D.I. 1,
`
`11, 80, 287).
`
`B.
`
`Asserted Patents
`
`1.
`
`’83 2 Parent
`
`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
`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.
`
`(‘S32 patent, (45)). The asserted claims of the ’832 patent
`
`are entitled to a priority date of August 7, 2009.
`
`(13.1. 353-1 at 11 120).
`
`Claim 1 of the ’832 patent reads:
`
`A film dosage composition comprising:
`
`5 “Watson’s ANDA Product” and “Par’s ANDA Product" refer to the parties‘ respective proposed generic drug
`formulations.
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`MonoSol 2002-0005
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`MonoS0l 2002-0005
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`a. A polymeric carrier matrix;
`
`b. A therapeutically effective amount of buprenorphine or a pharmaceutically
`acceptable salt thereof;
`
`c. A therapeutically effective amount of naloxone or a pharmaceutically acceptable
`salt thereof; and
`
`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
`from about 3 to about 3.5 in the presence of saliva.
`
`C332 patent, 23:58-67).
`
`Claim 15 of the ’832 patent reads:
`
`An orally dissolving film fonnulation comprising buprenorphine and naloxone,
`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
`plasma profile having a Cmax ofbetween about 41.04 pg/ml to about 323 .75 pg/ml
`for naloxone._
`
`(Id. at 24:56-61).
`
`2.
`
`’514 Patent
`
`' The *5 14 patent is directed to pharmaceutical film compositions that achieve certain
`
`levels of active ingredient content uniformity. (’5 14 patent, (5 7)). Reckitt asserts independent
`
`claim 62 and dependent claims 64, 65, 69, and 73 against Watson and Par. (PFF19). The ‘S14
`
`patent issued on December 10, 2013. (’514 patent, (45)). The asserted claims of the ’5 14 patent
`
`are entitled to a priority date of September 27, 2002.
`
`(D.I. 353-] at 1| 121).
`
`Claim 62 of the ’514 patent reads:
`
`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;
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`MonoSol 2002-0006
`M0n0S01 2002-0006
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`6
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`(ii) a particulate active substantially uniformly stationed in the matrix; and
`
`(iii) a taste-masking agent selected from the group consisting offlavors, 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~fo1'1ning 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.
`
`(’5 14 patent, 'i"3:48—74:10).
`
`3.
`
`I ’150 Parent
`
`The ’150 patent is directed to pharmaceutical film’ products compxising, among other
`
`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
`
`asserts independent claim 10 and dependent claim 13 against Par. (PFF25). The ’ l 50 patent
`
`issued on September 13, 201 1. I (’ 150 patent, (45)). The parties stipulated that, for purposes of
`
`the present case, the asserted claims of the ’l 50 patent are entitled to a priority date no earlier
`
`than May 23, 2003. (D.l. 353-1 at1l122).
`
`I
`
`Claim 1 ofthe ’l 50 patent reads:
`
`A mucosally-adhesive water-soluble film product comprising:
`
`an analgesic opiate pharmaceutical active; and
`
`at least one water-soluble polymer component consisting of polyethylene oxide in
`oombination with a hydrophilic cellulosic polymer;
`
`wherein:
`
`the water—soluble polymer component comprises greater than 75% polyethylene
`oxide and up to 25% hydrophilic cellulosic polymer;
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`MonoSol 2002-0007
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`M0n0S0l 2002-0007
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`the polyethylene oxide comprises one or more low molecular weight polyethylene
`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
`to 300,000 and the molecular weight of the higher molecular weight polyethylene
`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 polymer component.
`
`(’l50 patent, 57:36-54).
`
`Claim 10 of the ’ 150 patent reads:
`
`A mucosally-adhesive water-soluble film product comprising:
`
`an analgesic opiate pharmaceutical active; and
`
`at least one water—so1u‘ole 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;_
`
`the polyethylene oxide comprises one or more low molecular weight polyethylene
`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
`to 300,000 and the molecular weight of the higher molecular weight polyethylene
`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 polymer component.
`
`(Id. at 58:28-46).
`
`II.
`
`LEGAL STANDARDS
`
`A.
`
`Infringement
`
`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
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`MonoSol 2002-0008
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`'M0n0S0l 2002-0008
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`U.S.C. § 271(a). A two—step analysis is employed in making an infringement determination. See
`
`Markmcm v. Westview Instruments, Inc, 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), afi”d, 517
`
`U.S. 370 (1996). First, the court must construe the asserted claims to ascertain their meaning and
`
`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. Bar’ v. L cf: L Wings,
`
`nm, 160 F.3d 1350, 1353 (Fed. Cir. 1998).
`
`“Literal infringement of a claim exists when every limitation recited in the claim is found
`
`in the accused device.” Kuhn v. Gen. Motors Corp, 135 F.3d 1472, 147'?‘ (Fed. Cir. 1998). “If
`
`any claim limitation is absent fiom the accused device, there is no literal infringement as a matter
`
`of law.” Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 124'? (Fed. Cir. 2000). If an
`
`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.
`
`1989). However, “[o]ne may infringe an independent claim and not infi-inge a claim dependent
`
`on that claim.” Monsanto Co. v. Syngento 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
`
`still infringe under the doctrine of equivalents if the difierences between an individual limitation
`
`of the claimed invention and an element ofthe accused product are insubstantial. See Warner-
`
`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. Smiz‘hKline
`
`Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988).
`
`B .
`
`Anticipation
`
`A patent claim is invalid as anticipated under 35 U.S.C. § 102 if “within the four corners
`
`of a single, prior art document .
`
`.
`
`. every element of the claimed invention [is described], either
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`MonoSol 2002-0009
`MonoSol 2002-0009
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`expressly or inherently, such that a person of ordinary skill in the art could practice the invention
`
`without undue experimentation.” Callaway GoJ_TfC0. v. Acushner C0,, 576 F.3d 1331, 1346 (Fed.
`
`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.
`
`Applera Corp, 599 F.3d 1325, 1332 (Fed. Cir. 2010). “[T]he accused infiinger must show by
`
`clear and convincing evidence that a single prior art reference discloses each and every element
`
`of a claimed invention." Silicon Graphics, Inc. v. ATI Techs., Inc., 60'? F.3d 784, 796 (Fed. Cir.
`
`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[]
`
`if that disclosure fails to enable one of skill in the an to reduce the disclosed invention to
`
`practice.” Amgen Inc. v. I-Ioechst Marion Roussel, Inc., 314 F.3d 1313, 1354 (Fed. Cir. 2003).
`
`“Enablement is a question of law.” Id. at 1334. Disclosures in prior art patents are
`
`presumptively enabled absent persuasive contrary evidence. Id. at 1355. “[T]he burden still
`
`rests on the party asserting invalidity to ultimately demonstrate by clear and convincing evidence
`
`that the prior art is enabled.” Forest‘ Lc‘zb.s‘., Inc. v. Ivax Pharm, Inc., 438 F. Supp. 2d 479, 487
`
`11.3 (D. Del. 2006), afl"d, 501 F.3d 1263 (Fed. Cir. 2007).
`
`C.
`
`Obviousness
`
`I
`
`A patent claim is invalid as obvious under 35 U.S.C. § 103 “if the differences between
`the subject matter sought to be patented and the prior art are such that the subject matter as a
`
`whole would have been obvious at the time the invention was made to a person having ordinary
`
`skill in the art to which said subject matter pertains.” 35 U.S.C. § 103; see also KSR Int’! Co. v.
`
`Teleflex Inc, 550 US. 398, 406-07 (2007). “Under § 103, the scope and content of the prior art
`
`are to be determined; difierences between the prior art and the claims at issue are to be
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`MonoSol 2002-0010
`I Mon0Sol 2002-0010
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`10
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`ascertained; and the level of ordinary skill in the pertinent art resolved.” KSR, S50 U.S. at 406
`
`(citations and internal quotation marks omitted).
`
`A court is required to consider secondary considerations, or objective indicia of
`
`nonobviousness, before reaching an obviousness determination, as a “check against hindsight
`
`bias.” See In re Cyclobenzaprine Hydrochloride Extendea'—-Release Capsule Patent Litig., 676
`
`F.3d 1063, 1078-79 (Fed. Cir. 2012). Relevant secondary considerations include commercial
`
`success, long felt but unsolved needs, failure of others, praise, unexpected resuits, and copying,
`
`among others. Graham v. John Deere Co. ofKansas City, 383 U.S. 1, 17-18 (1966); Ruiz v. A.B.
`
`Chance Co., 234 F.3d 654, 662-63 (Fed. Cir. 2000); Tex. Instruments, Inc. v. U.S. Int’! Trade
`
`Comm ’n, 988 F.2d 1165, 1178 (Fed. Cir. 1993).
`
`D.
`
`Indefiniteness
`
`All valid patents must “conclude with one or more claims particularly pointing out and
`
`distinctly claiming the subj ect matter which the applicant regards as his invention.” 35 U-S.C.
`
`§ 112, "|[ 2. The principal justification for the definiteness requirement “is to ensure that the
`
`_ claims are written in such a way that they give notice to the public of the extent of the legal
`
`protection afforded by the patent, so that interested members ofthe public, e.g._, competitors of
`
`the patent owner, can determine whether or not they infringe.” AZ! Dental Prodx, LLC v.
`Advantage Dental Pr0ds., Inc., 309 F.3d -774, 779-80 (Fed. Cir. 2002); see also Nautilus, Inc. v.
`Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014). “[A] patent is invalid for indefiniteness
`
`if its claims, read in light of the specification delineating the patent, and the prosecution history,
`
`fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.”
`
`Nautilus, Inc., 134 S. Ct. at 2124. “Where it would be apparent to one of skill in the art, based
`
`on the specification, that the invention set forth in a claim is not what the patentee regarded as
`
`MonoSol 2002-0011
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`M0n0S0l 2002-0011
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`11
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`his invention, [a court] must hold that claim invalid under § 112, paragraph 2.” Allen Eng ’g
`
`' Corp. v. Bartel! Indus, Inc, 299 F.3d 1336, 1349 (Fed. Cir. 2002). Indefiniteness is a legal
`
`question. Biomedino, LLC v. Waters Techs. Corp., 490 F.3d 946, 949 (Fed. Cir. 2007).
`
`III.
`
`’832 PATENT
`
`A.
`
`Validity
`
`1'.
`
`Findings ofFact
`
`1. A person of ordinary skill in the art with respect to the ‘S32 patent would have a bachelor's
`degree in pharmaceutical science, chemistry, or a related field, and two to five years of relevant
`experience in developing drug formulations. Alternatively, a person of ordinary skill in the art
`could have a master’s degree or Ph.D. and less practical experience.“
`
`2. The conditions under which local pH is measured can have demonstrable impacts on the
`resulting pH values. The ’832 patent does not disclose the volume of solvent that should be used
`to measure local pH in in vitro dissolution tests, the type of solvent that should be used to
`measure local pH in in vitro dissolution tests, or the time point at which local pH should be
`measured in in vitro dissolution tests.
`
`(1) the Suboxone® sublingual tablets; (2) PCT
`3. The following are prior art to the ‘S32 patent:
`Publication W0 2008/025791 to Euro—Celtique (“Euro-Celtique”); PCT Publication W0
`2008;"0405 34 to LabTec (“LabTec”); Cassidy et al., “Controlled buccal delivery of
`buprenorphine,” Journal of Controlled Release (1993) (“Cassidy”); and U.S. Patent Application
`Publication No. 200510085440 to Birch (“Birch”). The European Medicines Agency Initial
`Marketing-Authorisation Document, Scientific Discussion, Oct. 19, 2006 for Suboxone® tablets
`(“European Medicines Agency Document”) is also prior art to the ‘S32 patent.
`
`4. Because the nasal and sublingual mucous membranes are structurally similar, a person of
`skill in the art would expect that the teachings of Birch with respect to absorption of
`buprenorphine across nasal mucosa at acidic pHs would also apply to absorption across
`Sublingual rnucosa.
`
`'5 Although the parties’ experts did not testify at trial as to descriptions of a person of ordinary skill in the art with
`respect to the ’832 patent, they did testify regarding the knowledge and motivations of such a person. No party
`objected to testimony regarding the knowledge and motivations of a person of ordinary skill in the art on the ground
`that the characteristics of such a person had not been established. I therefore take it that there was no dispute about
`the characteristics of the person of ordinary skill in the art in the context of the ’832 patent.
`The characteristics of the person of ordinary skill in the art with respect to the ’S}4 patent are undisputed. (See
`DFF37, PFF466). The necessary qualifications in the context of the *5 14 patent were stated at trial at a level of
`generality such that they do not seem to materially differ from those relevant to the ‘S32 patent. (See Tr. 315:23—
`315:5). Thus, the finding above is derived from testimony regarding the person of ordinary skill in the art in the
`context of the ’5 14 patent and, if it does not precisely represent the person of ordinary slcill in the art with respect to
`the ’832 patent, it is sufficiently similar to permit resolution of the issues raised in the parties’ post-trial briefing.
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`MonoSol 2002-0012
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`M0n0S0l 2002-0012
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`5. A person of ordinary skill in the art would have copied the buffer and pH of the Sl1bOX.0I‘lC®
`tablet in creating a film dosage form of buprenorphine and naloxone.
`
`6. A person of ordinary slcill in the art would have expected that the lower end ofthe operative
`pH range of the Suboxone® tablet’s sodium citrate and citric acid buffer would achieve the
`targeted selective bioahsorption parameters for buprenorphine and naloxone.
`
`7. Formulating a dosage form to achieve specific phannaookinetic parameters was routine and
`formulating orally dissolving films was known in the art before the priority date of the ’832
`
`patent.
`
`2.
`
`Conclusions ofLaw
`
`a)
`
`Indefiniteness
`
`Defendants argue that claims 1, 3, and 6 of the ’832 patent are invalid for indefiniteness
`
`because the terms “local pH” and “optimized absorption” of buprenorphine have no standard
`
`meaning and the ’832 patent provides no guidance regarding how to determine those limitations
`
`with reasonable certainty. (D.l. 396 at 20).
`
`Defendants argue that the ’832 patentees could have defined the claimed pH values as
`
`those measured by dissolution testing, which was well known in the art.
`
`(Id. at 20). Instead, the
`
`’832 patent claims “local pH” ranges, a tenn that was not well known in the art. (See, e.g., ’832
`
`patent, 23:64-67; see aiso Tr. 1363:8»1 8). Testimony at trial indicated that “local pi-I.”
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`implicates complex dynamics and measurement techniques. (See Tr. 876:2~l 5, 962115-964:7,
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`969: 10-19, 1117:} 5-1 1 1 8:17, l364:9—22). Reckitfsiexpert Dr. Davies testified that “local pH” '
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`is equivalent to “nzicroenvironrnental pH,” which was described in the prior art. (Tr. 1469:14-
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`I-170:7; JTX47 at 1; JTX72 at 1). Defendants’ expert Dr. Bley, on the other hand, testified that
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`the microenviromnental pH that Dr. Davies identified is not “local pH.” (Tr. 1364:9—22).
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`Further, Defendants argue, the parties’ attempts to measure local pH in this case demonstrate that
`the patent lacks sufficient information to provide objective boundaries to the claim. (See D.I. _
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`396 at 21). The pH measurements obtained by the experts in this case varied with conditions
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`including volume of solvent, type of solvent, and component concentration.
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`(Tr. 876:7-15,
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`921 :1 8—922:l2, 962:15—964:7, 969: l0—1 9; see DFF229~DFF230, DPRF73).
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`Reckitt maintains that the local pH limitation does not render claims 1, 3, and 6 indefinite
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`because the ’332 patent expressly defines “local pH” and the Court adopted the definition in its
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`claim construction. (D1. 406 at 24). According to Reckitt, the patent defines “local pH” to
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`mean “the pH of the region of the carrier matrix immediately surrounding the active agent as the
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`matrix hydrates andfor dissolves, for example, in the mouth of the user.” (’832 patent, 3:3 5-38;
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`D.I. 406 at 24; PFF800; D.I. 156 at 11). Reckitt’s expert Dr. Davies testified that a person of
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`skill in the art would understand that local pH is measured through an in vitro experiment
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`simulating in vivo conditions in the mouth, using a volume of water or simulated saliva that
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`approximates the amount of saliva to which a film would be exposed in the mouth. (Tr.
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`1470:19—14'?1:7). Reckitt maintains that Dr- Davies’ testimony is supported by the fact that
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`Defendants’ expert Dr. Bley did in vitro measurements of local pH.
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`(D.I. 406 at 24; Tr. 1471 :7-
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`14; see also PTX183 at 28440 (Inte1Genx lab notebook referring to in vitro pH testing as
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`“[m]easur[ing] pH [of] strips in the mouth using simulated sa1iva”)). Reckitt also maintains that
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`Dr. B1ey’s assertion that the term “local pH” is indefinite is inconsistent with
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`testimony that a
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`person of skill in the art would have recognized that the claimed local pH range was disclosed in
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`the priorart. (D.I. 406 at 24; see Tr. 1332:15—2l).
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`The term “local pH” is indefinite. Reckitt cites the “microenvironmental p ” discussed
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`in prior art to show how a person of skill in the art would understand “local pH." (PFF801; see
`Tr. 1469:23Fl=i70:'7; JTX47 at 1; JTX72 at 1). Aside from Dr. Davies’ conclusory testimony
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`that “somebody of ordinary skill would know how to [dissolve], .
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`.
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`. in a small volume of water
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`or simulated saliva so that they can predict or approximate in vivo local pH in the mouth,”
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`Reckitt has not earplained how microenvironmental pl-I correlates to the dissolution pl-I testing
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`that the experts have conducted in this case.
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`(Tr. 1471 :1~7). The testimony of Drs. Davies,
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`Toste, Mcconville, and Michniak-Kohn makes clear that the particular conditions under which
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`pH is measured can have demonstrable impacts on the resulting pH values.
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`(Tr. 921 :1 8—922:12,
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`969:15—970:6, 111'?:15—1 119314, l189:9—1191:6, 1195:3—1'?, 1280:21—1281:3;JTX274 at 2-3;
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`see DFF230-DFF231). Nowhere in the patent is there an explanation of the volume or type of
`solvent to be used to measure local pH or at what point during dissolution the local pH is to be
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`measured. The parties’ experts vigorously disagree regarding the appropriate conditions for
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`measuring local pH. (See Tr. 8'.75:13—879:3, 921 :15—922: 12; 976:12—9'Z8:10, 1114:15—1 115221,
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`I120:l4—1122:22, l191:21—1192:l2, 1280:21—l281:3, JTX274 at 2-3; see also PFF196,
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`PFF284, DFF225).
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`In Akzo Nobel Coatings, Inc. v. Dow Chemical C0,, the Federal Circuit affirmed the
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`district court’s conclusion that “viscosity below 10 Pa.s” did not render claims indefinite
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`because, although the patent did not indicate the-temperature at which viscosity was to be
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`measured, an expert declaration proved that “[t]he standard practice in analytical chemistry
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`dictates that if a temperature is not specified for a given measurement, room temperature is
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`implied.” 811 F.3d 1334, 1344 (Fed. Cir. 2016). Here, there is no evidence as to a standard type
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`of solvent, volume of solvent, or time at which pH is to be measured.
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`1 therefore conclude that
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`the patent fails to provide persons of ordinary skill with information from which they could
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`determine the “local pH” of a formulation with reasonable certainty. Claims 1, 3, and 6 of the
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`’832 patent are indefinite and therefore invalid?
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`7 Defendants also argue that claims 1, 3, and 6 are indefinite because a person of skill in the art would generally be
`unable to determine whether any particular product meets the “sufficient to optimize absorption” limitation. (D1.
`396 at 21). The patent describes only a single example of “optimized absorption”: absorption bioequivalent to the
`SuboxoI1e® tablet. (‘S32 patent, 3 : 15-21; 13.1. 396 at 21). Defendants maintain, however, that nothing in the ’832
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`b)
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`Anticipation and Obviousness
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`Defendants argue that claims 1, 3, and 6 of the ’832 patent are invalid for obviousness.
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`(D.I. 396 at 10). Defendants argue that the ’832 patent claims nothing more than films that are
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`bioequivalent to the prior-art Suboxone® sublingual tablets and that a person of skill in the art
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`would have copied the tablets’ buffer system to make a film bioequivalent to the Suboxone®
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`tablets with a pH in the claimed range.
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`(Id.). Asa result, Defendants argue, “the claimed
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`invention is the most routine of pharmaceutical industry tasks: mimicking the pharmacokinetics
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`of an existing product.” (Id. at 9). Reckitt maintains that the claimed “butter in an amount to
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`provide a local pH for said composition of a value sufficient to optimize absorption of said
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`buprenorphine, wherein said local pH is from about 3 to about 3.5 in the presence of -saliva” is
`inventive and would not have been obvious to persons of skill in the art.
`(See D1. 406 at 19).
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`Defendants’ obviousness argument focuses on five pieces of prior art: (1) the
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`Suboxone® sublingual tablets (JTX239, JTX240; DFF135); (2) PCT Publication W0
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`200&/025791 to Euro—Celtique (“Euro-Celtique”) (JTXl88; DFF145); (3) PCT Publication W0
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`patent indicates that the meaning of “optimized absorption” is limited to absorption bioequivalent to the Suboxone®
`tablet. (D.I. 396 at 21). Thus, “a skilled artisan is unable to determine whether any particular product not having
`bioequivalent absorption meets [the sufficient to optimize absorption] limitation, rendering claims 1, 3, and 6
`indefinite.” (Id.).
`Reckitt argues that the Court’s construction of the “sufficient to optimizie” term “indicates bioequivalent
`absorption as compared to Suboxone tablets.” (D.I. 406 at 24—25 (quoting Dr. McC0nville’s testimony at Tr.
`1 l31:1S—20) (internal quotation marks omitted)). Because the “sufficient to optimize” term means absorption
`hioequivalent to the Suboxone® tablets, according to Reckitt, persons of skill in the art have no difficulty
`understanding and appiying the term.
`(Id. at 25 (citing ’832 patent for explanation of what is considered
`bioeqnivalent to the Suboxone® tablet)).
`The Court’s construction, however, did not equate “sufficicnt to optimize absorption” with absorption
`bioequivalent to that of the Suboxone® tablet. Instead, it indicated that bioequivalent absorption to the Suboxone®
`tablet was one example of optimized absorption. (See D.I. 15 6 at 11-12 (“The term ‘sufiicient to optimize
`absorption of said buprenorphine’ means sufficient to reach an optimum level of buprenorphine absorption that
`includes a bioequivalent absorption as compared to the absorption after administration of Suboxone® tablets.”
`(emphasis added))). Still, Defendants have failed to prove that because “optimized absorption” is not limited to
`bioequivalent absorption, the patent provides insufiicient guidance to persons of skill in that art as to what
`absorption qualifies as “optimized absorption.” The term “sufficient to optimize absorption” therefore does not
`render claims 1, 3, and 6 of-the ’832 patent indefinite.
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`2008/040534 to LabTec (“LabTec”) (JTCl 86; DFF14S); (4) Cassidy et al., “tC)ontro1Ied buccal
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`delivery of buprenorphine,” Journal of Controlled Release (1993) (“Cassidy”) (JTX117;
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`DFF153); and (5) U.S. Patent Application Publication No. 2005!0085440 to Birch (“Birch”)
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`(JTX179; DFF157). In particular, Defendants argue that “[t]he combination of the Suboxone
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`sublingual tablet with EuroCeltique or LabTec in View