`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`RECKITT BENCKISER
`
`PHARMACEUTICALS, INC., RB
`
`PHARMACEUTICALS LIMITED, and
`
`MONOSOL RX, LLC
`
`Plaintiffs,
`
`v.
`
`WATSON LABORATORIES, INC,
`
`
`Defendants.
`
`RECKITT BENCKISER
`
`PHARMACEUTICALS, INC., RB
`
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC
`
`Civil Action No. 13—1674—RGA
`
`Consolidated
`
`Plaintlffsa
`
`V.
`
`Civil Action No. 14-422-RGA
`
`PAR PHARMACEUTICAL, INC., and
`INTELGENX TECHNOLOGIES CORP.
`Defendants.
`
`
`MEMORANDUM OPINION
`
`Daniel A. Ladow (argued), Esq., Troutman Sanders LLP, New York, NY; James M. Bollinger,
`
`Esq., Troutman Sanders LLP, New York, NY; Timothy P. Heaton, Esq., Troutman Sanders LLP,
`
`New York, NY; J. Magnus Essunger, Esq., Troutman Sanders LLP, New York, NY; Timothy C.
`Bickham, Esq. (argued), Steptoe & Johnson LLP, Washington, DC; James F. Hibey, Esq.,
`Steptoe & Johnson LLP, Washington, DC; Houda Morad, Esq., Steptoe & Johnson LLP,
`Washington, DC; Mary W. Bourke, Esq. (argued), Womble Carlyle Sandridge & Rice, LLP,
`Wilmington, DE; Daniel Attaway, Esq., Womble Carlyle Sandridge & Rice, LLP, Wilmington,
`DE; attorneys for plaintiffs.
`
`Daniel G. Brown (argued), Esq., Latham & Watkins LLP, New York, NY; Emily C. Melvin,
`
`Esq., Latham & Watkins LLP, Chicago IL; David P. Dalke (argued), Esq., Winston & Strawn
`
`LLP, Los Angeles, CA; Peter Perkowski, Winston & Strawn LLP, Los Angeles, CA; Steven J.
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`Dr. Reddy's - EX1024
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`Page 1
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`Dr. Reddy's - EX1024
`Page 1
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`Case 1:13-cv-01674-RGA Document 156 Filed 12}12I14 Page 2 of 18 PagelD #: 3233
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`Fineman (argued), Esq., Richards, Layton & Finger, P.A.; John C. Phillips, Jr., Esq., Phillips,
`Goldman & Spence, P.A., Wilmington, DE; attorneys for defendants.
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`December &, 2014
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`Case 1:13-cv-01674-RGA Document 156 Filed 1312114 Page 3 of 18 PagelD #: 3234
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`ANDREWS,
`
`.
`
`.D ST CT JU
`
`:
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`/
`
`Before this Court is the issue of claim construction of disputed terms found in three U.S.
`
`Patents, 8,017,150 (“the ‘150 patent”), 8,475,832 (“the “832 patent”), and 8,603,514 (“the ‘514
`
`patent”).
`
`I. BACKGROUND
`
`Plaintiffs assert that Defendants’ ANDAs infringe the ‘150 patent, the ‘832 patent, and
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`the ‘514 patent. (D.I. 106). The Court has considered the parties’ claim construction briefing
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`(D.I. 106, 107, 108) and held a Markman hearing on December 3, 2014.
`
`II. LEGAL STANDARD
`
`“It is a bedrock principle of patent law that the claims of a patent define the invention to
`
`which the patentee is entitled the right to exclude.” Phillips v. AWH Corp, 415 F.3d 1303, 1312
`
`(Fed. Cir. 2005) (en banc) (internal quotation marks omitted). “‘ [T]here is no magic formula or
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`catechism for conducting claim construction.’ Instead, the court is free to attach the appropriate
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`weight to appropriate sources ‘in light of the statutes and policies that inform patent law.m
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`SofiView LLC v. Apple Inc, 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
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`415 F.3d at 1324). When construing patent claims, a matter of law, a court considers the literal
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`language of the claim, the patent specification, and the prosecution history. Markman v.
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`Westview Instruments, Inc, 52 F.3d 967, 977—80 (Fed. Cir. 1995) (en bane), aff’d, 517 U.S. 370
`
`(1996). Of these sources, “the specification is always highly relevant to the claim construction
`
`analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.”
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`Phillips, 415 F .3d at 1315 (internal quotations and citations omitted).
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`Case 1:13-cv-01674-RGA Document 156 Filed 1312114 Page 4 of 18 PagelD #: 3235
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`Furthermore, “the words of a claim are generally given their ordinary and customary
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`meaning .
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`.
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`. [which is] the meaning that the term would have to a person of ordinary skill in the
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`art in question at the time of the invention, i.e., as of the effective filing date of the patent
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`application.” Phillips, 415 F.3d at 1312—13 (internal citations and quotation marks omitted).
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`“[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the
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`entire patent.” Id. at 1321 (internal quotation marks omitted). “In some cases, the ordinary
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`meaning of claim language as understood by a person of skill in the art may be readily apparent
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`even to lay judges, and claim construction in such cases involves little more than the application
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`of the widely accepted meaning of commonly understood words.” 1d. at 1314 (internal citations
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`omitted).
`
`A court may consider extrinsic evidence, which “consists of all evidence external to the
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`patent and prosecution history, including expert and inventor testimony, dictionaries, and learned
`
`treatises,” in order to assist the court in understanding the underlying technology, the meaning of
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`terms to one skilled in the art and how the invention works. Id. at 13171-19 (internal quotation
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`marks and citations omitted). However, extrinsic evidence is less reliable and less useful in
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`claim construction than the patent and its prosecution history. Id.
`
`Moreover, “[a] claim construction is persuasive, not because it follows a certain rule, but
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`because it defines terms in the context of the whole patent.” Renishaw PLC v. Marposs Societa’
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`per Azionf, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
`
`It follows that “a claim interpretation that
`
`would exclude the inventor’s device is rarely the correct interpretation." 05mm GmbH v. Int ’3
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`Trade Comm ’n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (internal quotation marks and citation
`
`omitted).
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`Case 1:13-cv-01674-RGA Document 156 Filed 1312114 Page 5 of 18 PagelD #: 3236
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`III. CONSTRUCTION OF DISPUTED TERMS
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`A. The ’15!) Patent
`
`Claim 1 of the ‘ 150 patent is representative:
`
`A mucosally-adhesive water-soluble film product comprising:
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`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;
`
`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, claim 1).
`
`1. “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
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`the low molecular weight polyethylene oxide being in the range of 100,000 to 300,000 and the
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`molecular weight of the higher molecular weight polyethylene oxide being in the range of
`
`600,000 to 900,000; and the polyethylene oxide of low molecular weight comprises about 60%
`
`or more in the polymer component” (claims 1, 10)
`
`a. Plaintijfi ’ proposed construction: The plain and ordinary meaning is a
`
`polyethylene oxide component comprising polyethylene oxide within the molecular weight range
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`Case 1:13-cv-01674—RGA Document 156 Filed 1312114 Page 6 of 18 PagelD #: 3237
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`of 600,000 to 900,000 Daltons and at least about 60% polyethylene oxide within the molecular
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`weight range of 100,000 to 300,000 Daltons.
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`b. Defendants ’ proposed construction: The polyethylene oxide comprises (i) one
`
`or more polyethylene oxides having a lower average molecular weight, calculated from the
`
`molecular weights of all the chains in the sample, in the range of 100,000 to 300,000; and (ii)
`
`one or more polyethylene oxides having a higher average molecular weight, calculated from the
`
`molecular weights of all the chains in the sample, in the range of 600,000 to 900,000, and (iii)
`
`the polyethylene Oxide having the lower average molecular weight comprises about 60% or more
`
`by weight but less than 100% by weight in the polymer component. Alternatively, the term
`
`“molecular weight” is indefinite.
`
`c. Court ’3 construction: The polyethylene oxide comprises (i) one or more
`
`polyethylene oxides having a lower average molecular weight in the range of 100,000 to
`
`300,000; and (ii) one or more polyethylene oxides having a higher average molecular weight in
`
`the range of 600,000 to 900,000, and (iii) the polyethylene oxide having the lower average
`
`molecular weight comprises about 60% or more by weight in the polymer component.
`
`Plaintiffs argue that “molecular weight” in this term should be actual molecular weight or
`
`“the sum of the atomic weights of all the atoms in a molecule.” (D.I. 106 at p.8). Defendants
`
`argue that molecular weight must be an average, but that a person of ordinary skill in the art
`
`“would also understand that there are multiple methods of calculating the average value (with
`
`results varying depending on the method used), such that it is necessary to Specify which type of
`
`molecular weight is applicable to a given polymer sample." (Id at p.29) (emphasis in original).
`
`According to Defendants, therefore, because the patent does not provide guidance for calculating
`
`molecular weight of the PEOS, the term molecular weight should be indefinite. (Id).
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`Case 1:13-cv-01674-RGA Document 156 Filed 1312114 Page 7 of 18 PagelD #: 3238
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`The Court finds that “molecular weight” means “average molecular weight," not actual
`
`molecular weight. When the patent describes examples of films that include the blend of
`
`different weight polymers in Table 22 of the patent, it lists percentages of PEOs of different
`
`weights such as 100,000, 200,000, 300,000, and 900,000. (‘150 patent, 50:7-34). When
`
`explaining properties of these different resulting films, the patent refers to the particular weights
`
`listed in Table 22 as “higher molecular weight PEOS” and “lower molecular weight PEOS.”
`
`(See, e. g, ‘ 150 patent, 51:29-38). Defendants’ expert points to the examiner in the ‘150
`
`prosecution history citing a brochure from Union Carbide that describes the average molecular
`
`weight of certain polymer samples using viscosity average. (D.I. 107-5 at 15-16). At the
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`hearing, Defendants noted that common commercial polymers have single molecular weights,
`
`which a person of ordinary skill in the art would understand to be an average weight. (D.I. 147
`
`at 39). Defendants, at the hearing, explained that a person skilled in the art would look at Table
`
`22 of the patent and understand those molecular weight PEOs as the type made by commercial
`
`companies, described with average weights. (DJ. 14'? at 48). The Court agrees. Molecular
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`weight in the patent, therefore, must mean average molecular weight.
`
`Both sides cite to Teva Pharmaceuticals USA. Inc. v. Sandoz Inc, 723 F.3d I363 (Fed.
`
`Cir. 2013) to support their position, but Teva cuts against Plaintiffs’ position. Plaintiffs argue
`
`that the current claim is nearly identical to the “Group 11” claims in Teva, where the court found
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`that molecular weight referred to precise points on a distribution curve, or what the Plaintiffs call
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`actual molecular weight.
`
`(D.I. 106 at p.9). A representative claim from Group II in Teva reads:
`
`“Co-polymer-l having over 75% of its mole fraction within the molecular weight range from
`
`about 2 kDa to about 20 kDa. . .” Teva, 723 F.3d at 1367. Plaintiffs force a comparison to the
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`Group 11 claims, arguing that claim 1 of the ‘150 patent recites 60% of the lower molecular
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`Case 1:13-cv-01674—RGA Document 156 Filed 1312114 Page 8 of 18 PagelD #: 3239
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`weight PEOs falling within the molecular weight boundary of 100,000 to 300,000. (D.I. 106 at
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`p.11). Claim 1, however, describes lower molecular weight PEOS within a certain weight range
`
`and higher molecular weight PEOs within a certain range; the lower molecular weight PEOs then
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`make up at least 60% of the polymer component, which also includes hydrophilic cellulosic
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`polymer. Claim 1 does not say that 60% of the low molecular weight PEOS fall within a 100,000
`
`to 300,000 boundary. Instead, the 60% refers to the composition of the lower weight PEOs in
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`the final polymer component, which in addition to the two PEOs, also includes hydrophilic
`
`cellulosic polymer. In short, Teva does not support Plaintiffs’ position on using actual molecular
`
`weight.
`
`Even though Teva found that another set of claims with “molecular weight” construed as
`
`“average molecular weight” were indefinite because there are several different approaches to
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`calculating average molecular weight, I believe that any indefiniteness arguments about “average
`
`molecular weight” are for another day. Defendants argue that a person skilled in the art would
`
`not kn0w which measure of average weight to use because there is no guidance from the patent
`
`or prosecution history, and therefore “molecular weight” is indefinite. (D.I. 106 at p.34).
`
`Defendants’ expert, however, points to prosecution history of the patent referring to using
`
`viscosity average, for example. (D.I. 107-5 at 15-16).l At a later date, eXperts may provide
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`further guidance on the indefiniteness question.
`
`Defendants argue that the polymer component, comprised of low average molecular
`
`weight P503 and high average weight PEOs, must come from two different sources. (D.I. 106 at
`
`‘ I also note that commercial polyethylene oxide products appear to use average molecular
`weight to describe themselves.
`I would expect persons of ordinary skill in the art to understand
`which method was in use in the commercial products, which might inform any understanding of
`the patent.
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`Case 1:13-cv-01674-RGA Document 156 Filed 1312114 Page 9 of 18 PagelD #: 3240
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`pp.3—6). Plaintiffs respond that only the presences of the required PEOs is relevant; “how they
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`got there (from one bottle or two) is completely irrelevant.” (D.I. 106 at p.16). The Court agrees
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`that the source of the PEOs, whether from one or two bottles, to adopt Plaintiffs’
`
`characterization, is not relevant to the construction. Nonetheless, it is clear from the patent that
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`discrete sets of the low average molecular weight P505 and the high average weight PEOs must
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`be present in the product. For example, the description of the invention in the patent describes
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`19 6B
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`“combining
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`small amounts” of the high molecular weight PEOs with “larger amounts” of the
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`low molecular weight PEOs.
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`(‘ 150 patent, 18:6-28). Therefore, at a minimum, there must be
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`some amount of each PEO. Defendants have voiced concern that Plaintiffs were trying to read
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`the claims such that essentially only lower average molecular weight PEOs would be present in
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`the component, with stray molecules being counted as higher average weight PEOs.2 Whether or
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`not Plaintiffs were trying to read the claims this way, the Court agrees with Defendants that the
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`product cannot be comprised of only low average molecular weight PEOs, or only low average
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`molecular weight PEOs with stray higher average molecular weight PEOs.
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`Defendants propose that the construction include an upper limit for the lower average
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`molecular weight polyethylene oxides that is “less than 100%” of the weight of the polymer
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`component. (D1. 106 at pp.6—7). Defendants are concerned that Plaintiffs proposed construction
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`would allow a product comprised of 100% of the low molecular weight PEO but 0% of the high
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`molecular weight PEO. (Id. at p.7). While the Court will not adopt the Defendant’s upper limit
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`requirement in its construction of the terms (as the construction already requires the presence of
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`2 In the briefing, Defendants argue that “[b]ecause of the way PEOs are synthesized, a single
`source of PEO may randomly include some finite number of individual PEO molecules that
`happen to fall within each of the claimed molecular weight ranges.“ (D.l. 106 at p.5)(citations
`omitted).
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`Page 9
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112l14 Page 10 of 18 PagelD #: 3241
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`some higher average molecular weight PEOS), it seems clear that the product cannot contain only
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`the low molecular weight PEOs. Indeed, Plaintiffs agreed to this point in the Markman hearing.
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`(13.1. 147 at 31-32).
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`2. “molecular weight” (claims 1, 10)
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`a. Plaintiffs ’ proposed construction: The plain and ordinary meaning is the sum
`
`of the atomic weights of all the atoms in a molecule.
`
`b. Defendants ’ proposed construction: Average molecular weight calculated from
`
`the moleCular weights of all the chains in the sample. Alternatively, the term “molecular weight”
`
`is indefinite.
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`c. Cour: ’5 construction: Average molecular weight
`
`The court has provided its reasoning for construing “molecular weight” as “average
`
`molecular weight” above.
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`B. The ‘832 Patent
`
`Claim 1 of the ‘832 patent is representative:
`
`A film dosage composition comprising:
`
`a. A polymeric carrier matrix;
`
`I). A therapeutically effective amount of buprenorphine or a
`pharmaceutically acceptable salt thereof;
`
`0. 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.
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`10
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112t14 Page 11 of 18 PagelD #: 3242
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`(‘832 patent, claim 1).
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`1. “provide a local pH for said composition of a value sufficient to optimize absorption
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`of said buprenorphine, wherein said local pH is from about 3 to about 3.5 in the presence of
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`saliva” (claim 1)
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`a. Plaintiffs ’ proposed construction: The composition contains one or more
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`components that provide a local pH sufficient to Optimize absorption of said buprenorphine
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`wherein said local pH is about 3 to 3.5 in the presence of saliva, where local pH refers to the pH
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`of the region of the carrier matrix immediately surrounding the active agent as the matrix
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`hydrates and/or dissolves, for example, in the mouth of the user. The term “sufficient to
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`optimize absorption of said buprenorphine” means sufficient to reach an optimum level of
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`buprenorphine absorption that includes a bioequivalent absorption as compared to the absorption
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`after administration of Suboxone® tablets.
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`b. Defendants ’ proposed construction: Control the pH of the region of the carrier
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`matrix immediately surrounding the active agent as the matrix hydrates andfor dissolves such
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`that said pH is about 3 to about 3.5 in the mouth.
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`c. Court ’3 construction: provide a local pH for the composition sufficient to
`
`optimize absorption of said buprenorphine wherein said local pH is about 3 to about 3.5 in the
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`presence of saliva in the mouth, where local pH refers to the pH of the region of the carrier
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`matrix immediately surrounding the active agent as the matrix hydrates and/or dissolves, for
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`example, in the mouth of the user. The term “sufficient to optimize absorption of said
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`buprenorphine” means sufficient to reach an Optimum level of buprenorphine absorptiOn that
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`11
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112l14 Page 12 of 18 PagelD #: 3243
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`includes a bioequivalent absorption as compared to the absorption after administration of
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`Suboxone® tablets.
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`Both parties at the Markman hearing agreed to construing the term to read “in the
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`presence of saliva in the mouth.” (D.I. 147 at 69-70).3 Two disputes remain: 1) the construction
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`of “provide a local pH” and 2) the relevance of “. . .sufficient to optimize absorption of said
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`buprenorphine wherein said local pH is. . .”
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`The Court agrees with Plaintiffs that the construction of “provide a local pH” is “provide
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`a local pH,“ not Defendants’ proposal of “control the pH of the region. .
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`Defendants argue that
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`a buffer must provide a local pH “sufficient to optimize absorption of said buprenorphine,”
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`which cannot be done only in a “fleeting moment,” something that the language “provide,” rather
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`than “control,” allows. (DJ. 106 at p.45). The Court disagrees. There is no compelling reason
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`to change “provide” to “control,” when “provide” is the language used by the claim. The
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`interchangeable use of “provide” and “control” in the specification does not mean “provide”
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`means “control” any more than it means that “control” means “provide.”
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`The Court further agrees with Plaintiffs that the “sufficient to optimize” phrase must be
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`included in the construction of the term. Defendants argue that the phrase is unnecessary
`
`because it describes a result, not a limitation, of the claim. (D.I. 106 at p.46). Plaintiffs argue
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`that it is a requirement of the claim. (D.I. 106 at p.44). The Court agrees. If the provided local
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`pH is not sufficient to optimize absorption of said buprenorphine, the claim is not met.
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`2. “provide a local pH” (claims 1, 9)
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`3 The dispute about “saliva” and “in the mouth” was not really a claim construction dispute.
`Rather, the parties were just jockeying for position in regard to possible evidentiary arguments at
`trial.
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`12
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112l14 Page 13 of 18 PagelD #: 3244
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`a. Plainttjfifs ’ proposed construction: Plaintiffs prOpose to construe as part of the
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`longer phrase (see claim term 1 above).
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`b. Defendants ’ proposed construction: To control the pH of the region of the
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`carrier matrix immediately surrounding the active agent as the matrix hydrates andt'or dissolves
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`in the mouth. Alternatively, the term “provide a local pH” is indefinite.
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`0. Court ’5 construction: provide a local pH
`
`The Court has provided its reasoning for construing “provide a local pH” as “provide a
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`local pH” above.
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`3. “bioequivalent absorption of buprenorphine to that of a tablet having an equivalent
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`amount of buprenorphine” (claims 2, 10)
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`a. Plaintififs ’ proposed construction: 80% to 125% of the Cmax and AUC values
`
`for buprenorphine in a tablet having an equivalent amount of buprenorphine.
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`b. Defendants ’ proposed construction: 80% to 125% of the Cmax and AUC
`
`values for buprenorphine in a Suboxone® tablet having the same amount of buprenorphine.
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`c. Court ’s construction: 80% to 125% of the Cmax and AUC values for
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`buprenorphine in a Suboxone® tablet having an equivalent amount of buprenorphine
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`At the Marlonan hearing, Plaintiffs agreed that the “tablet” in the term is a Suboxone®
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`tablet. (DJ. 14'? at 71-72). Therefore, the two proposed constructions differ materially only in
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`that Defendants propose “same amount,” rather than “equivalent amount,” of buprenorphine.
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`The Court agrees with Plaintiffs that “equivalent amount” should be used because that is what
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`the claims say.
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`13
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`Page 13
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112t14 Page 14 of 18 PagelD #: 3245
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`C. The ’514 Patent
`
`Claim 1 of the ‘514 patent is representative:
`
`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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`(ii) a particulate active substantially uniformly stationed in the matrix; and
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`(iii) a taste-masking agent coated or intimately associated with said
`particulate to provide taste-masking of the active;
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`wherein the combined particulate and taste-masking agent have a particle
`size of 200 microns or less and said flowable water-soluble or water
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`swellable film-forming matrix is capable of being dried withOut loss of
`substantial uniformity in the stationing of said particulate active therein;
`and
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`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, claim I).
`
`1. “t10wable” (claims I, 28, 62)
`
`a. Piafntiffi‘ ’ proposed construction: The term should be given its plain and
`
`ordinary meaning.
`
`b. Defendants ’ proposed construction: Capable of being fermed into a film and
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`dried.
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`0. Court ’3 construction: The term should be given its plain and ordinary meaning.
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`At the Markman hearing, the Defendants’ withdrew their proposal, accepting the plain
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`and ordinary meaning of the term. (D.I. 147 at 106-8). Defendants reserve the right to argue the
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112t14 Page 15 of 18 PagelD #: 3246
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`term is indefinite, something they may do at a later date.4
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`2. “viscosity sufficient to aid in substantially maintaining non-self aggregating
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`uniformity of the active in the matrix” (claims 1, 28, 62)
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`a. Plaintiffs ’ proposed canstructfon: A viscosity sufficient to provide little to no
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`aggregation of the active within the film such that individual dosage units do not vary by more
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`than 10% from the intended amount of active for that dosage unit.
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`b. Defendants ’ proposed construction: viscosity sufficient to provide little to no
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`aggregation of the active within the film
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`0. Court ’5 construction: viscosity sufficient to provide little to no aggregation of
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`the active within the film
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`The Court agrees with Defendants that Plaintiffs’ proposed construction would import a
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`limitation of substantial uniformity, which does not apply to this particular term.
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`(‘5 I4 patent,
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`6?:53-56; see D.I 106 at p. 64). This uniformin is subsequent to casting and drying, not applied
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`to each step along the way.
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`3. “substantially uniformly stationed” (claims 1, 23, 62)
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`a. Plainttfis ’ proposed construction: Stationed in the matrix such that individual
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`dosage units do not vary by more than 10% from the intended amount of active for that dosage
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`unit.
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`b. Defendants ’ proposed constructiort: 10% or less variation of the particulate
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`active and taste masking agent between measured sampies, measured by visual, weight, or
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`4 I take the plain and ordinary meaning of “flowable” to be “able to flow.”
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`15
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`Page 15
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112l14 Page 16 of 18 PagelD #: 3247
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`chemical analyses
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`c. Court ’5 construction: Stationed in the matrix such that individual dosage units
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`do not vary by more than 10% from the intended amount of active for that dosage unit.
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`The parties’ proposed constructions differ materially in two ways: 1) Defendants include
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`“taste masking agent” in their construction, and 2) Defendants include that measurements be
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`conducted by “visual, weight or chemical analyses.” The “substantially uniformly stationed”
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`phrase only applies to the particulate active, not to the taste masking agent as Defendants assert:
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`“(ii) a particulate active substantially uniformly stationed in the matrix.” (‘5 1 4 patent, 67:42-43).
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`Furthermore, the claims make no mention of the particular type of measurement techniques that
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`could be conducted to determine appropriate uniformity. The appropriate measurement
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`techniques are best left to another day, as they do not involve claim construction. Therefore, the
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`Court adopts the Plaintiffs’ construction.
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`4. “taste-masking of the active” (claims 1, 28, 62)
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`a. Plaintiffs ’ proposed construction: The term should be given its plain and
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`ordinary meaning. If the Court determines to further construe the term, the plain and ordinary
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`meaning is providing a taste-masking effect with respect to the active.
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`b. Defendant‘s ’ proposed construction: Coating or intimately associating the
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`active with a taste-masking agent to achieve a uniform distribution of the taste-masked active
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`throughout the film
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`0. Court ’3 construction: The term should be given its plain and ordinary meaning.
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`The construction of this term applies to claims 1, 28 and 62. Claims 1 and 28 recite a
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`“taste-masking agent coated or intimately associated with said particulate to provide taste-
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`Page 16
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112l14 Page 17 of 18 PagelD #: 3248
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`masking of the active.” Claim 62, however, provides “a taste—masking agent selected from the
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`group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide
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`taste-masking of the active.” It cannot be the case that Defendants’ proposal of “[c]oating or
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`intimately associating the active” applies to all three references of “taste-masking of the active,”
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`when two of the claims explicitly spell it out and the third does not.
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`The Court also does not believe that the taste-masking agent is “to achieve a uniform
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`distribution of the taste-masked active throughout the film.” The uniformity required by the
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`patent is to be “subsequent to casting and drying” in each of the three claims.
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`Defendants make much of the prosecution history’s discussion of the Chen reference,
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`arguing the inventors distinguished their invention frOm Chen as possessing taste-making
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`uniformity, ruling out merely mixing taste-masking agents with actives. (D.I. 106 at p.71).
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`Plaintiffs argue that Defendants selectively rely on quotations from the Chen reference.
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`(Id. at
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`pp.73~74). The Court agrees with Plaintiffs. It is not self-evident that the inventors sought to
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`disavow Chen for lacking taste-masking uniformity. (D.I. 108-19 at 18). Instead, the inventors
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`appeared to be concerned with uni fonnity of the film product, after it is dried, not at the taste-
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`masking agent step.
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`(1d. at 18~19).
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`5. “capable of being dried without loss of substantial uniformity” (claims 1, 28, 62)
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`a. Plaintiflfr ’ proposed construction: The film matrix is capable of being dried
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`such that individual dosage units do not vary by more than 10% frorn the intended amount of
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`active for that dosage unit.
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`Case 1:13-cv-01674-RGA Document 156 Filed 12112l14 Page 18 of 18 PagelD #: 3249
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`b. Defendant‘s ’ proposed construction: Wherein, after drying, 10% or less
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`variation of the particulate active and taste masking agent is observed when compared to the
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`sample before drying, measured by visual, weight, or chemical analyses
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`(2. Court ’5 construction: The film matrix is capable of being dried such that
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`individual dosage units do not vary by more than 10% from the intended amount of active for
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`that dosage unit.
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`The Court’s analysis is similar to term 3 of this patent provided above. The Court agrees
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`with Plaintiffs that the proper comparison is between the intended amount and the film matrix
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`after drying. It is not proper to compare the sample before and after drying. Furthermore, the
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`claims make no mention of the particular type of measurement techniques to determine
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`appropriate uniformity. The appropriate measurement techniques are not a matter for resolution
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`by claim construction.
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`IV. CONCLUSION
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`Within five days the parties shall submit a proposed order consistent with this
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`Memorandum Opinion suitable for submission to the jury.
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`Page 18
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`Page 18
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