Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 1 of 18 PagelD #: 3232
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`RECKITT BENCKISER
`PHARMACEUTICALS,INC., RB
`PHARMACEUTICALSLIMITED,and
`MONOSOLRX, LLC
`
`Plaintiffs,
`
`Vv.
`
`WATSON LABORATORIES, INC.,
`
`
`Defendants.
`RECKITT BENCKISER
`PHARMACEUTICALS, INC., RB
`PHARMACEUTICALSLIMITED,and
`MONOSOLRX, LLC
`
`Plaintiffs,
`
`V.
`
`Civil Action No. 13-1674-RGA
`
`Consolidated
`
`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;attorneysforplaintiffs.
`
`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.
`
`Dr. Reddy's - EX1024
`Page 1
`
`Dr. Reddy's - EX1024
`Page 1
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 2 of 18 PagelD #: 3233
`
`Fineman (argued), Esq., Richards, Layton & Finger, P.A.; John C.Phillips, Jr., Esq., Phillips,
`Goldman & Spence, P.A., Wilmington, DE;attorneys for defendants.
`
`December IA. 2014
`
`Page 2
`
`Page 2
`
`

`

`
`
`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 3 of 18 PagelD #: 3234
`
`/
`ANDREWS,U.S. DISTRICT JU
`
`;
`
`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’ ANDAsinfringe the ‘150 patent, the ‘832 patent, and
`
`the ‘514 patent. (D.I. 106). The Court has considered the parties’ claim construction briefing
`
`(D.I. 106, 107, 108) and held a Markman hearing on December3, 2014.
`
`II. LEGAL STANDARD
`
`“It is a bedrock principle of patent law that the claimsof a patent define the invention to
`
`whichthe 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
`
`catechism for conducting claim construction.’ Instead, the court is free to attach the appropriate
`
`weight to appropriate sources‘in light of the statutes and policies that inform patent law.’”
`
`SoftView LLC vy, Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
`
`415 F.3d at 1324). When construing patent claims, a matter of law, a court considerstheliteral
`
`language of the claim, the patent specification, and the prosecution history. Markman v.
`
`Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en banc), 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.”
`
`Phillips, 415 F.3d at 1315 (internal quotations and citations omitted).
`
`Page 3
`
`Page 3
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 4 of 18 PagelD #: 3235
`
`Furthermore, “the words of a claim are generally given their ordinary and customary
`
`meaning. .
`
`. [which is] the meaning that the term would haveto a personofordinary skill in the
`
`art in question at the time of the invention,i.e., as of the effective filing date of the patent
`
`application.” Phillips, 415 F.3d at 1312-13 (internal citations and quotation marks omitted).
`
`“(T]he ordinary meaning of a claim term is its meaningto [an] ordinary artisan after reading the
`
`entire patent.” Jd. at 1321 (internal quotation marks omitted). “In somecases, the ordinary
`
`meaning of claim language as understood bya person ofskill in the art may be readily apparent
`
`even to lay judges, and claim construction in such cases involveslittle more than the application
`
`of the widely accepted meaning of commonly understood words.” /d. at 1314 (internalcitations
`
`omitted).
`
`A court may considerextrinsic evidence, which “consists of all evidence externalto the
`
`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
`
`termsto one skilled in the art and how the invention works.
`
`/d. at 1317-19 (internal quotation
`
`marksandcitations omitted). However, extrinsic evidenceis less reliable and less useful in
`
`claim construction than the patent and its prosecution history.
`
`/d.
`
`Moreover,“[a] claim construction is persuasive, not because it follows a certain rule, but
`
`because it defines terms in the context of the whole patent.” Renishaw PLC v. Marposs Societa’
`
`per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
`
`It follows that “a claim interpretation that
`
`would exclude the inventor’s deviceis rarely the correct interpretation.” Osram GmbHv. Int’l
`
`Trade Comm’n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (internal quotation marksandcitation
`
`omitted).
`
`Page 4
`
`
`
`Page 4
`
`

`

`
`
`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 5 of 18 PagelD #: 3236
`
`Ill. CONSTRUCTION OF DISPUTED TERMS
`
`A. The 7150 Patent
`
`Claim 1 of the ‘150 patent is representative:
`
`A mucosally-adhesive water-soluble film product comprising:
`
`an analgesic opiate pharmaceutical active; and
`
`at least one water-soluble polymer componentconsisting 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
`
`the low molecular weight polyethylene oxide being in the range of 100,000 to 300,000 and the
`
`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”(claims1, 10)
`
`a. Plaintiffs’ proposed construction: The plain and ordinary meaningis a
`
`polyethylene oxide component comprising polyethylene oxide within the molecular weight range
`
`Page 5
`
`Page 5
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 6 of 18 PagelD #: 3237
`
`of 600,000 to 900,000 Daltons and at least about 60% polyethylene oxide within the molecular
`
`weight range of 100,000 to 300,000 Daltons.
`
`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 ofall 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 weightsofall 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’s construction: The polyethylene oxide comprises (i) one or more
`
`polyethylene oxides having a lower average molecular weightin the range of 100,000to
`
`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, butthat a person ofordinary skill in the art
`
`“would also understand that there are multiple methodsof 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.” (/d. at p.29) (emphasisin original).
`
`According to Defendants, therefore, because the patent does not provide guidancefor calculating
`
`molecular weight of the PEOs, the term molecular weight should be indefinite. (/d.).
`
`Page 6
`
`
`
`Page 6
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 7 of 18 PagelD #: 3238
`
`The Court finds that “molecular weight” means “average molecular weight,”not actual
`
`molecular weight. Whenthe patent describes examples of films that include the blend of
`
`different weight polymers in Table 22 ofthe patent, it lists percentages of PEOsofdifferent
`
`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 examinerin 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
`
`hearing, Defendants noted that common commercial polymers have single molecular weights,
`
`which a person ofordinary 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. (D.I. 147 at 48). The Court agrees. Molecular
`
`weightin the patent, therefore, must mean average molecular weight.
`
`Both sides cite to Teva Pharmaceuticals USA, Inc. v. Sandoz Inc., 723 F.3d 1363 (Fed.
`
`Cir. 2013) to support their position, but Teva cuts against Plaintiffs’ position. Plaintiffs argue
`
`that the current claim is nearly identical to the “GroupII”claims in Teva, where the court found
`
`that molecular weight referred to precise points on a distribution curve, or what the Plaintiffs call
`
`actual molecular weight.
`
`(D.I. 106 at p.9). A representative claim from GroupII in Teva reads:
`
`“Co-polymer-1 having over 75% ofits 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
`
`GroupII claims, arguing that claim 1 of the ‘150 patent recites 60% of the lower molecular
`
`Page 7
`
`Page 7
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 8 of 18 PagelD #: 3239
`
`weight PEOsfalling within the molecular weight boundary of 100,000 to 300,000. (D.I. 106 at
`
`p-11). Claim 1, however, describes lower molecular weight PEOs within a certain weight range
`
`and higher molecular weight PEOs withina certain range; the lower molecular weight PEOs then
`
`makeupat least 60% of the polymer component, which also includes hydrophilic cellulosic
`
`polymer. Claim 1 does not say that 60% of the low molecular weight PEOsfall within a 100,000
`
`to 300,000 boundary. Instead, the 60% refers to the composition of the lower weight PEOsin
`
`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 anotherset of claims with “molecular weight” construed as
`
`“average molecular weight” were indefinite because there are several different approaches to
`
`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 know 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).'! Ata later date, experts may provide
`
`further guidance on the indefiniteness question.
`
`Defendants argue that the polymer component, comprised of low average molecular
`
`weight PEOs and high average weight PEOs, must comefrom twodifferent sources. (D.I. 106 at
`
`'T also note that commercial polyethylene oxide products appear to use average molecular
`weight to describe themselves.
`I would expect persons ofordinary skill in the art to understand
`which method wasin use in the commercial products, which might inform any understanding of
`the patent.
`
`Page 8
`
`
`
`Page 8
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 9 of 18 PagelD #: 3240
`
`pp.3-6). Plaintiffs respond that only the presences of the required PEOsis relevant; “how they
`
`gotthere (from one bottle or two) is completely irrelevant.” (D.I. 106 at p.16). The Court agrees
`
`that the source of the PEOs, whether from oneor two bottles, to adopt Plaintiffs’
`
`characterization, is not relevant to the construction. Nonetheless, it is clear from the patent that
`
`discrete sets of the low average molecular weight PEOsand the high average weight PEOs must
`
`be present in the product. For example, the description of the invention in the patent describes
`
`29 66
`
`“combining”
`
`“small amounts”of the high molecular weight PEOs with “larger amounts”of the
`
`low molecular weight PEOs. (‘150 patent, 18:6-28). Therefore, at a minimum,there must be
`
`some amount of each PEO. Defendants have voiced concern that Plaintiffs were trying to read
`
`the claims suchthat essentially only lower average molecular weight PEOs would bepresentin
`
`the component, with stray molecules being counted as higher average weight PEOs.* Whether or
`
`not Plaintiffs were trying to read the claims this way, the Court agrees with Defendants that the
`
`product cannot be comprised of only low average molecular weight PEOs, or only low average
`
`molecular weight PEOs with stray higher average molecular weight PEOs.
`
`Defendants proposethat the construction include an upperlimit for the lower average
`
`molecular weight polyethylene oxidesthat is “less than 100%”of the weight of the polymer
`
`component. (D.I. 106 at pp.6-7). Defendants are concernedthat Plaintiffs proposed construction
`
`would allow a product comprised of 100% of the low molecular weight PEO but 0% ofthe high
`
`molecular weight PEO.
`
`(Jd. at p.7). While the Court will not adopt the Defendant’s upperlimit
`
`requirementin its construction of the terms (as the construction already requires the presence of
`
`7 In the briefing, Defendants argue that “[b]ecause of the way PEOsare synthesized,a single
`source of PEO may randomly include somefinite numberof individual PEO moleculesthat
`happento fall within each of the claimed molecular weight ranges.” (D.I. 106 at p.5)(citations
`omitted).
`
`Page 9
`
`Page 9
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 10 of 18 PagelD #: 3241
`
`somehigher average molecular weight PEOs), it seems clear that the product cannot contain only
`
`the low molecular weight PEOs. Indeed, Plaintiffs agreed to this point in the Markman hearing.
`
`(D.1. 147 at 31-32).
`
`2. “molecular weight” (claims 1, 10)
`
`a. Plaintiffs’ proposed construction: The plain and ordinary meaning is the sum
`
`of the atomic weightsofall 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.
`
`c. Court’s construction: Average molecular weight
`
`The court has providedits reasoning for construing “molecular weight” as “average
`
`molecular weight” above.
`
`B. The ‘832 Patent
`
`Claim | of the ‘832 patent is representative:
`
`A film dosage composition comprising:
`
`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 amountto 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 about3.5 in the presenceofsaliva.
`
`Page 10
`
`Page 10
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 11 of 18 PagelD #: 3242
`
`(°832 patent, claim 1).
`
`1. “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” (claim 1)
`
`a. Plaintiffs’ proposed construction: The composition contains one or more
`
`componentsthat provide a local pH sufficient to optimize absorption of said buprenorphine
`
`wherein said local pH is about 3 to 3.5 in the presence ofsaliva, where local pH refers to 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. The term “sufficient to
`
`optimize absorption of said buprenorphine” meanssufficient to reach an optimum level of
`
`buprenorphine absorption that includes a bioequivalent absorption as comparedto the absorption
`
`after administration of Suboxone®tablets.
`
`b. Defendants’ proposed construction: Control the pH ofthe region ofthe carrier
`
`matrix immediately surrounding the active agent as the matrix hydrates and/or dissolves such
`
`that said pH is about 3 to about 3.5 in the mouth.
`
`c. Court’s 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
`
`presence ofsaliva in the mouth, where local pH refers to the pH ofthe region ofthe carrier
`
`matrix immediately surrounding the active agent as the matrix hydrates and/or dissolves, for
`
`example, in the mouth of the user. The term “sufficient to optimize absorption ofsaid
`
`buprenorphine” meanssufficient to reach an optimum level of buprenorphine absorption that
`
`1]
`
`Page 11
`
`
`
`Page 11
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 12 of 18 PagelD #: 3243
`
`becauseit describesaresult, not a limitation, of the claim. (D.I. 106 at p.46). Plaintiffs argue
`
`includes a bioequivalent absorption as comparedto the absorption after administration of
`
`Suboxone® tablets.
`
`Both parties at the Markmanhearing agreed to construing the term to read “in the
`
`presenceofsaliva in the mouth.” (D.I. 147 at 69-70). Two disputes remain: 1) the construction
`
`of “provide a local pH” and 2) the relevance of “‘...sufficient to optimize absorption of said
`
`buprenorphine wherein said local pHis...”
`
`The Court agrees with Plaintiffs that the construction of “provide a local pH”is “provide
`
`a local pH,” not Defendants’ proposalof “control the pH ofthe region...” Defendants argue that
`
`a buffer must provide a local pH “sufficient to optimize absorption of said buprenorphine,”
`
`which cannot be doneonly in a “fleeting moment,” something that the language “provide,” rather
`
`than “control,” allows. (D.I. 106 at p.45). The Court disagrees. There is no compelling reason
`
`to change “provide”to “control,” when “provide”is the language used by the claim. The
`
`interchangeable use of “provide” and “control” in the specification does not mean “provide”
`
`means “control” any more than it meansthat “control” means“provide.”
`
`The Court further agrees with Plaintiffs that the “sufficient to optimize” phrase must be
`
`includedin the construction of the term. Defendants argue that the phrase is unnecessary
`
`that it is a requirementof the claim. (D.I. 106 at p.44). The Court agrees. If the providedlocal
`
`pHisnotsufficient to optimize absorption of said buprenorphine, the claim is not met.
`
`2. “provide a local pH”(claims1, 9)
`
`3 The dispute about“saliva” and “in the mouth” was notreally a claim constructiondispute.
`Rather, the parties were just jockeying for position in regard to possible evidentiary arguments at
`trial.
`
`12
`
`Page 12
`
`Page 12
`
`

`

`a. Plaintiffs’ proposed construction: Plaintiffs propose to construe as part of the
`
`longer phrase (see claim term 1 above).
`
`b. Defendants’ proposed construction: To control the pH ofthe region of the
`
`carrier matrix immediately surrounding the active agent as the matrix hydrates and/or dissolves
`
`in the mouth. Alternatively, the term “provide a local pH”is indefinite.
`
`¢c. Court’s construction: provide a local pH
`
`The Court has provided its reasoning for construing “provide a local pH”as “provide a
`
`local pH” above.
`
`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 13 of 18 PagelD #: 3244
`
`peLSaeTTeaeROBESpeBeTSRAnfaeSEANSBBEANATEESRN
`
`
`
`ekeariesareneETRpatetareapEateeeeLEErerereneenryanrememinpmapepAeFeReRTEARSN
`
`3. “bioequivalent absorption of buprenorphineto that of a tablet having an equivalent
`
`amount of buprenorphine”(claims2, 10)
`
`a. Plaintiffs’ proposed construction: 80% to 125% of the Cmax and AUCvalues
`
`for buprenorphine in a tablet having an equivalent amount of buprenorphine.
`
`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.
`
`c. Court’s construction: 80% to 125% of the Cmax and AUC valuesfor
`
`buprenorphine in a Suboxone® tablet having an equivalent amount of buprenorphine
`
`At the Markmanhearing, Plaintiffs agreed that the “tablet” in the term is a Suboxone®
`
`tablet. (D.I. 147 at 71-72). Therefore, the two proposed constructions differ materially only in
`
`that Defendants propose “same amount,” rather than “equivalent amount,” of buprenorphine.
`
`The Court agrees with Plaintiffs that “equivalent amount” should be used becausethat is what
`
`the claimssay.
`
`13
`
`Page 13
`
`Page 13
`
`

`

`
`
`|
`
`|i§
`
`BETHEeAETET
`
`eeer
`oeimrEAR
`
`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 14 of 18 PagelD #: 3245
`
`C. The ’514 Patent
`
`Claim | 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 amountofat 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;
`
`(ii) a particulate active substantially uniformly stationed in the matrix; and
`
`(iii) a taste-masking agent coated or intimately associated with said
`particulate to provide taste-masking ofthe active;
`
`wherein the combined particulate and taste-masking agent have a particle
`size of 200 micronsorless 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 amountofsaid at least one active.
`
`(‘514 patent, claim 1).
`
`1. “flowable”(claims 1, 28, 62)
`
`a. Plaintiffs’ proposed construction: The term should be given its plain and
`
`ordinary meaning.
`
`b. Defendants’ proposed construction: Capable of being formed into a film and
`
`dried.
`
`c. Court’s construction: The term should be givenits plain and ordinary meaning.
`
`At the Markman hearing, the Defendants’ withdrew their proposal, accepting the plain
`
`and ordinary meaningof the term. (D.I. 147 at 106-8). Defendants reserve the right to argue the
`
`14
`
`Page 14
`
`Page 14
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 15 of 18 PagelD #: 3246
`
`term is indefinite, something they may do ata later date.*
`
`SeeraereRRSENEEDIESTTESre
`
`aeeeeeeeeee
`
`aleyytntpeerIM
`RRmeenpeanAenenteeeRmage
`
`2. “viscosity sufficient to aid in substantially maintaining non-self aggregating
`
`uniformity of the active in the matrix” (claims 1, 28, 62)
`
`a. Plaintiffs’ proposed construction: A viscosity sufficient to provide little to no
`
`aggregation of the active within the film such that individual dosage units do not vary by more
`
`than 10% from the intended amountofactive for that dosage unit.
`
`b. Defendants’ proposed construction: viscosity sufficient to provide little to no
`
`aggregation ofthe active within the film
`
`c. Court’s construction: viscosity sufficient to providelittle to no aggregation of
`
`the active within the film
`
`The Court agrees with Defendantsthat Plaintiffs’ proposed construction would import a
`
`limitation of substantial uniformity, which does not apply to this particular term. (‘514 patent,
`
`67:53-56; see D.I 106 at p. 64). This uniformity is subsequentto casting and drying, not applied
`
`to each step along the way.
`
`3. “substantially uniformly stationed”(claims 1, 28, 62)
`
`a. Plaintiffs’ proposed construction: Stationed in the matrix such that individual
`
`dosage units do not vary by more than 10%from the intended amountofactive for that dosage
`
`unit.
`
`b. Defendants’ proposed construction: 10%orless variation ofthe particulate
`
`active and taste masking agent between measured samples, measured by visual, weight, or
`
`‘1 take the plain and ordinary meaningof“flowable”to be “able to flow.”
`
`15
`
`REPremRETRIEUTSTLAeSHES
`
`ae
`
`Page 15
`
`Page 15
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 16 of 18 PagelD #: 3247
`
`oyLTEIRNDTPRTCEEMTNPMEYEHaaRTURENNRSEESOC
`LegeRheeNoATEORERRTRERESEEPSatSpaANthERTRRRRAT
`
`16
`
`Page 16
`
`chemical analyses
`
`c. Court’s construction: Stationed in the matrix such that individual dosage units
`
`do not vary by more than 10% from the intended amountofactive for that dosage unit.
`
`The parties’ proposed constructions differ materially in two ways: 1) Defendants include
`
`“taste masking agent”in their construction, and 2) Defendants include that measurements be
`
`conducted by “visual, weight or chemical analyses.” The “substantially uniformly stationed”
`
`phrase only appliesto the particulate active, not to the taste masking agent as Defendantsassert:
`
`“(ii) a particulate active substantially uniformly stationed in the matrix.” (‘514 patent, 67:42-43).
`
`Furthermore, the claims make no mention ofthe particular type of measurement techniquesthat
`
`could be conducted to determine appropriate uniformity. The appropriate measurement
`
`techniquesare bestleft to another day, as they do not involve claim construction. Therefore, the
`
`Court adopts the Plaintiffs’ construction.
`
`4. “taste-masking of the active” (claims 1, 28, 62)
`
`a. Plaintiffs’ proposed construction: The term should be givenits plain and
`
`ordinary meaning. If the Court determines to further construe the term, the plain and ordinary
`
`meaningis providing a taste-masking effect with respect to the active.
`
`b. Defendants’ proposed construction: Coating or intimately associating the
`
`active with a taste-masking agent to achieve a uniform distribution of the taste-masked active
`
`throughoutthe film
`
`c. Court’s construction: The term should be given its plain and ordinary meaning.
`
`The construction of this term applies to claims 1, 28 and 62. Claims 1 and 28recite a
`
`“taste-masking agent coated or intimately associated with said particulate to provide taste-
`
`Page 16
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 17 of 18 PagelD #: 3248
`
`maskingofthe active.” Claim 62, however, provides “a taste-masking agent selected from the
`
`group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide
`
`taste-maskingofthe active.” It cannot be the case that Defendants’ proposalof “[c]oating or
`
`intimately associating the active” appliesto all three references of “taste-masking ofthe active,”
`
`FEFASTRA
`
`
`
`IATTTTEcremEPRETEENyeeeempcteenpanneopentacRTaPpRRReeNTNRAAPBENTETAATOEAATTNERTETETT
`
`whentwoofthe claims explicitly spell it out and the third doesnot.
`
`The Court also does not believe that the taste-masking agentis “to achieve a uniform
`
`distribution of the taste-masked active throughoutthe film.” The uniformity required by the
`
`patent is to be “subsequentto casting and drying” in each of the three claims.
`
`Defendants make muchofthe prosecution history’s discussion of the Chenreference,
`
`arguing the inventors distinguished their invention from Chenas possessing taste-making
`
`uniformity, ruling out merely mixing taste-masking agents with actives. (D.I. 106 at p.71).
`
`Plaintiffs argue that Defendants selectively rely on quotations from the Chenreference.
`
`(Jd. at
`
`pp.73-74). The Court agrees with Plaintiffs. It is not self-evident that the inventors sought to
`
`disavow Chenfor lacking taste-masking uniformity. (D.I. 108-19 at 18). Instead, the inventors
`
`appeared to be concerned with uniformity of the film product, after it is dried, not at the taste-
`
`masking agent step. (/d. at 18-19).
`
`5. “capable of being dried without loss of substantial uniformity” (claims 1, 28, 62)
`
`a. Plaintiffs’ proposed construction: Thefilm matrix is capable of being dried
`
`suchthat individual dosage units do not vary by more than 10% from the intended amountof
`
`active for that dosage unit.
`
`17
`
`Page 17
`
`Page 17
`
`

`

`Case 1:13-cv-01674-RGA Document 156 Filed 12/12/14 Page 18 of 18 PagelD #: 3249
`
`b. Defendants’ proposed construction: Wherein, after drying, 10% or less
`
`variation of the particulate active and taste masking agent is observed when comparedto the
`
`sample before drying, measured by visual, weight, or chemical analyses
`
`c. Court’s construction: The film matrix is capable of being dried such that
`
`individual dosage units do not vary by more than 10% from the intended amountofactive for
`
`that dosage unit.
`
`The Court’s analysis is similar to term 3 of this patent provided above. The Court agrees
`
`with Plaintiffs that the proper comparison is between the intended amount and the film matrix
`
`after drying. It is not proper to compare the sample before and after drying. Furthermore, the
`
`claims make no mentionofthe particular type of measurement techniques to determine
`
`appropriate uniformity. The appropriate measurement techniquesare not a matterfor resolution
`
`by claim construction.
`
`IV. CONCLUSION
`
`Within five days the parties shall submit a proposed order consistent with this
`
`Memorandum Opinion suitable for submissionto the jury.
`
`18
`
`Page 18
`
`
`
`teeheetneRIERAeeagemcAreerenaeiAarnERINaeAPAoesaiyaI
`
`
`
`siaieainieris
`
`eSRemnIPmemaiSAoevpnaermarenearammametananon
`
`
`
`V+prteeeanrintaeniyanURraeteneN
`
`Page 18
`
`