Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 1 of 61 PageID #: 17301
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`Plaintiffs,
`
`Civil Action No. 13-1674-RGA
`
`v.
`
`WATSON LABORATORIES, INC. and
`ACTAVIS LABORATORIES UT, INC.,
`
`Defendants.
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`
`PAR PHARMACEUTICAL, INC. and
`INTELGENX TECHNOLOGIES CORP.,
`
`Defendants.
`
`Civil Action No. 14-422-RGA
`
`TRIAL OPINION
`
`Mary W. Bourke, Esq., Dana K. Severance, Esq., Daniel M. Attaway, Esq., WOMBLE
`CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE, attorneys for Plaintiffs.
`
`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
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 001
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 2 of 61 PageID #: 17302
`
`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., Jeffr~y 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. Bickham, Esq., STEPTOE & JOHNSON LLP, Washington,
`DC; David L. Hecht, Esq., Cassandra A. Adams, Esq., STEPTOE & JOHNSON LLP, New
`York, NY, attorneys for Plaintiff MonoSol Rx, LLC.
`
`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.,
`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.,
`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, 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, 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.
`
`JuneJ__, 2016
`
`2
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 002
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 3 of 61 PageID #: 17303
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, and
`
`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
`
`and Defendants Par Pharmaceutical, Inc. and IntelGenx Technologies Corporation (collectively,
`
`"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");
`
`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
`
`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
`
`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.I. 416, 417). The parties filed
`
`-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
`
`following findings of fact and conclusions oflaw pursuant to Federal Rule of Civil Procedure
`
`52(a).
`
`1 Citations to "D.I.
`"are to the docket in C.A. No. 13-1674 unless otherwise noted.
`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."
`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
`the '514 patent.
`
`3
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 003
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 4 of 61 PageID #: 17304
`
`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 if'il 10, 16). The active ingredients
`
`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
`
`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
`
`both buprenorphine and naloxone to prevent unintended diversion of the product for abuse. (Tr.
`
`1474:9-14).
`
`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.
`
`(D.I. 353-1 at if 17). Plaintiff RB Pharmaceuticals Limited is the assignee of the '832 patent,
`
`entitled "Sublingual and Buccal Film Compositions." (Id. atif 24; '832 patent, (54) & (73)).
`
`PlaintiffMonoSol 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,
`
`entitled "Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom." (D.I.
`
`353-1 at ifil 28, 32; '514 patent, (54) & (73); '150 patent, (54) & (73)). Plaintiff Reckitt
`
`Benckiser Pharmaceuticals is an exclusive licensee of the '832, '514, and '150 patents. (D.I.
`
`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
`related responses filed at D.I. 400.
`
`4
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 004
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 5 of 61 PageID #: 17305
`
`Administration's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the
`
`"Orange Book") entry for Suboxone® sublingual film. (Id. at if 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/1 mg, 8 mg/2 mg, and 12
`
`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
`
`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
`
`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
`
`products proposed in the ANDAs. (Id. at iii! 43, 44, 46, 119). Reckitt received notices of
`
`Watson's and Par's Paragraph IV certifications and initiated the present litigation. (Id.; D.I. 1,
`
`11, 80, 287).
`
`B.
`
`Asserted Patents
`
`I.
`
`'832 Patent
`
`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. ('832 patent, (45)). The asserted claims of the '832 patent
`
`are entitled to a priority date of August 7, 2009. (D.I. 353-1 at if 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.
`
`5
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 005
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 6 of 61 PageID #: 17306
`
`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.
`
`('832 patent, 23:58-67).
`
`Claim 15 of the '832 patent reads:
`
`An orally dissolving film formulation 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 of between about 41.04 pg/ml to about 323. 7 5 pg/ml
`for naloxone.
`
`(Id. at 24:56-61).
`
`2.
`
`'514 Patent
`
`The '514 patent is directed to pharmaceutical film compositions that achieve certain
`
`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
`
`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).
`
`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;
`
`6
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 006
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 7 of 61 PageID #: 17307
`
`(ii) a particulate active substantially uniformly stationed in the matrix; and
`
`(iii) a taste-masking agent selected from the group consisting of flavors, sweeteners,
`flavor enhancers, and combinations thereof to provide taste-masking of the active;
`
`wherein the particulate active has a particle size of 200 microns or less and said
`flowable water-soluble or water swellable film-forming matrix is capable of being
`dried without loss of substantial uniformity in the stationing of said particulate
`active therein; and
`
`wherein the uniformity subsequent to casting and drying of the matrix is measured
`by substantially equally sized individual unit doses which do not vary by more than
`10% of said desired amount of said at least one active.
`
`('514 patent, 73:48-74:10).
`
`3.
`
`'150Patent
`
`The '150 patent is directed to pharmaceutical film products comprising, among other
`
`things, certain amounts of specific polymers, including polyethylene oxides. (' 150 patent, (57)).
`
`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
`
`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
`
`than May 28, 2003. (D.I. 353-1 at ii 122).
`
`Claim 1 of the '150 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
`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;
`
`7
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 007
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 8 of 61 PageID #: 17308
`
`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.
`
`('150 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-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;.
`
`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
`
`8
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 008
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 9 of 61 PageID #: 17309
`
`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 bane), afj"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. Bai v. L & L Wings,
`
`Inc., 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." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir. 1998). "If
`
`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
`
`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 infringe a claim dependent
`
`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
`
`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)
`
`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
`
`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 comers
`
`of a single, prior art document ... every element of the claimed invention [is described], either
`
`9
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 009
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 10 of 61 PageID #: 17310
`
`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.
`
`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 infringer 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. AT! Techs., Inc., 607 F.3d 784, 796 (Fed. Cir .
`
`. 2010). "A claimed invention cannot be anticipated by a prior art reference ifthe 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 art to reduce the disclosed invention to
`
`practice." Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354 (Fed. Cir. 2003).
`
`"Enablement is a question oflaw." 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 Labs., Inc. v. Ivax Pharm., Inc., 438 F. Supp. 2d 479, 487
`
`n.3 (D. Del. 2006), aff'd, 501 F.3d 1263 (Fed. Cir. 2007).
`
`C.
`
`Obviousness
`
`A patent claim is invalid as obvious under 35 U.S.C. § 103 "ifthe 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'l Co. v.
`
`Teleflex Inc., 550 U.S. 398, 406-07 (2007). "Under§ 103, the scope and content of the prior art
`
`are to be determined; differences between the prior art and the claims at issue are to be
`
`10
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 010
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 11 of 61 PageID #: 17311
`
`ascertained; and the level of ordinary skill in the pertinent art resolved." KSR, 550 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 Extended-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 results, and copying,
`
`among others. Graham v. John Deere Co. of Kansas 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'l 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 subject matter which the applicant regards as his invention." 35 U.S.C.
`
`§ 112, ·ir 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 of the public, e.g._, competitors of
`
`the patent owner, can determine whether or not they infringe." All Dental Prodx, LLC v.
`
`Advantage Dental Prods., 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
`
`11
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 011
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 12 of 61 PageID #: 17312
`
`·'
`
`his invention, [a court] must hold that claim invalid under§ 112, paragraph 2." Allen Eng'g
`
`·Corp. v. Bartell 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
`
`I.
`
`Findings of Fact
`
`1. A person of ordinary skill in the art with respect to the '832 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. 6
`
`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.
`
`3. The following are prior art to the '832 patent: (1) the Suboxone® sublingual tablets; (2) PCT
`Publication WO 2008/025791 to Euro-Celtique ("Euro-Celtique"); PCT Publication WO
`2008/040534 to LabTec ("LabTec"); Cassidy et al., "Controlled buccal delivery of
`buprenorphine," Journal of Controlled Release (1993) ("Cassidy"); and U.S. Patent Application
`Publication No. 2005/0085440 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 '832 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 mucosa.
`
`6 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 '514 patent are undisputed. (See
`DFF3 7, PFF466). The necessary qualifications in the context of the '514 patent were stated at trial at a level of
`generality such that they do not seem to materially differ from those relevant to the '832 patent. (See Tr. 315:23-
`316:5). Thus, the finding above is derived from testimony regarding the person of ordinary skill in the art in the
`context of the '514 patent and, if it does not precisely represent the person of ordinary skill 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.
`
`12
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 012
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 13 of 61 PageID #: 17313
`
`5. A person of ordinary skill in the art would have copied the buffer and pH of the Suboxone®
`tablet in creating a film dosage form of buprenorphine and naloxone.
`
`6. A person of ordinary skill in the art would have expected that the lower end of the operative
`pH range of the Suboxone® tablet's sodium citrate and citric acid buffer would achieve the
`targeted selective bioabsorption parameters for buprenorphine and naloxone.
`
`7. Formulating a dosage form to achieve specific pharmacokinetic parameters was routine and
`formulating orally dissolving films was known in the art before the priority date of the '832
`patent.
`
`2.
`
`Conclusions of Law
`
`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" ofbuprenorphine have no standard
`
`meaning and the '832 patent provides no guidance regarding how to determine those limitations
`
`with reasonable certainty. (D.I. 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 term that was not well known in the art. (See, e.g., '832
`
`patent, 23:64-67; see also Tr. 1363:8-18). Testimony at trial indicated that "local pH"
`
`implicates complex dynamics and measurement techniques. (See Tr. 876:2-15, 962:15-964:7,
`
`969:10-19, 1117:15-1118:17, 1364:9-22). Reckitt's expert Dr. Davies testified that "local pH"·
`
`is equivalent to "microenvironmental pH," which was described in the prior art. (Tr. 1469: 14--
`
`1470:7; JTX47 at 1; JTX72 at 1). Defendants' expert Dr. Bley, on the other hand, testified that
`
`the microenvironmental pH that Dr. Davies identified is not "local pH." (Tr. 1364:9-22).
`
`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.
`
`396 at 21). The pH measurements obtained by the experts in this case varied with conditions
`
`13
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 013
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 14 of 61 PageID #: 17314
`
`including volume of solvent, type of solvent, and component concentration. (Tr. 876:7-15,
`
`921:18-922:12, 962:15-964:7, 969:10-19; see DFF229-DFF230, DPRF73).
`
`Reckitt maintains that the local pH limitation does not render claims 1, 3, and 6 indefinite
`
`because the '832 patent expressly defines "local pH" and the Court adopted the definition in its
`
`claim construction. (D.I. 406 at 24). According to Reckitt, the patent defines "local pH" to
`
`mean "the pH of the region of the carrier matrix immediately surrounding the active agent as the
`
`matrix hydrates and/or dissolves, for example, in the mouth of the user." ('832 patent, 3:35-38;
`
`D.I. 406 at 24; PFF800; D.I. 156 at 11). Reckitt's expert Dr. Davies testified that a person of
`
`skill in the art would understand that local pH is measured through an in vitro experiment
`
`simulating in vivo conditions in the mouth, using a volume of water or simulated saliva that
`
`·'
`
`approximates the amount of saliva to which a film would be exposed in the mouth. (Tr.
`
`1470:19-1471 :7). Reckitt maintains that Dr. Davies' testimony is supported by the fact that
`
`Defendants' expert Dr. Bley did in vitro measurements oflocal pH. (D.I. 406 at 24; Tr. 1471 :7-
`
`14; see also PTX183 at 28440 (IntelGenx lab notebook referring to in vitro pH testing as
`
`"[m]easur[ing] pH [of] strips in the mouth using simulated saliva")). Reckitt also maintains that
`
`Dr. Bley' s assertion that the term "local pH" is indefinite is inconsistent with his testimony that a
`
`person of skill in the art would have recognized that the claimed local pH range was disclosed in
`
`the prior art. (D.I. 406 at 24; see Tr. 1332:15-21).
`
`The term "local pH" is indefinite. Reckitt cites the "microenvironmental pH" discussed
`
`in prior art to show how a person of skill in the art would understand "local pH." (PFF801; see
`
`Tr. 1469:23-1470:7; JTX47 at 1; JTX72 at 1). Aside from Dr. Davies' conclusory testimony
`
`that "somebody of ordinary skill would know how to [dissolve], ... in a small volume of water
`
`or simulated saliva so that they can predict or approximate in vivo local pH in the mouth,"
`
`14
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 014
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 15 of 61 PageID #: 17315
`
`Reckitt has not explained how microenvironmental pH correlates to the dissolution pH testing
`
`that the experts have conducted in this case. (Tr. 1471:1-7). The testimony ofDrs. Davies,
`
`Toste, Mcconville, and Michniak-Kohn makes clear that the particular conditions under which
`
`pH is measured can have demonstrable impacts on the resulting pH values. (Tr. 921 :18-922:12,
`
`969:15-970:6, 1117:15-1119:14, 1189:9-1191:6, 1195:3-17, 1280:21-1281 :3; JTX274 at 2-3;
`
`see DFF230-DFF23 l ). 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
`
`measured. The parties' experts vigorously disagree regarding the appropriate conditions for
`
`measuring local pH. (See Tr. 875:13-879:3, 921 :15-922:12; 976:12-9~8:10, 1114:15-1115:21,
`
`1120:14-1122:22, 1191:21-1192:12, 1280:21-1281:3, JTX274 at 2-3; see also PFF196,
`
`PFF284, DFF225).
`
`In Akzo Nobel Coatings, Inc. v. Dow Chemical Co., the Federal Circuit affirmed the
`
`district court's conclusion that "viscosity below 10 Pa.s" did not render claims indefinite
`
`because, although the patent did not indicate the temperature at which viscosity was to be
`
`measured, an expert declaration proved that "[t]he standard practice in analytical chemistry
`
`dictates that if a temperature is not specified for a given measurement, room temperature is
`
`implied." 811F.3d1334, 1344 (Fed. Cir. 2016). Here, there is no evidence as to a standard type
`
`of solvent, volume of solvent, or time at which pH is to be measured. I therefore conclude that
`
`the patent fails to provide persons of ordinary skill with information from which they could
`
`determine the "local pH" of a formulation with reasonable certainty. Claims 1, 3, and 6 of the
`
`'832 patent are indefinite and therefore invalid. 7
`
`7 Defendants also argue that claims 1, 3, and 6 are inde:flliite 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. (D.I.
`396 at 21). The patent describes only a single example of"optimized absorption": absorption bioequivalent to the
`Suboxone® tablet. ('832 patent, 3:15-21; D.I. 396 at 21). Defendants maintain, however, that nothing in the '832
`
`15
`
`Par Pharm., Inc., et al.
`Exhibit 1023
`Page 015
`
`

`

`Case 1:13-cv-01674-RGA Document 446 Filed 06/03/16 Page 16 of 61 PageID #: 17316
`
`b)
`
`Anticipation and Obviousness
`
`Defendants argue that claims 1, 3, and 6 of the '832 patent are invalid for obviousness.
`
`(D.I. 396 at 10). Defendants argue that the '832 patent claims nothing more than films that are
`
`bioequivalent to the prior-art Suboxone® sublingual tablets and that a person of skill in the art
`
`would have copied the tablets' buffer system to make a film bioequivalent to the Suboxone®
`
`tablets with a pH in the claimed range. (Id.). As· a result, Defendants argue, "the claimed
`
`invention is the most routine of pharmaceutical industry tasks: mimicking the pharmacokinetics
`
`of an existing product." (Id. at 9). Reckitt maintains that the claimed "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 t