IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`COSMO TECHNOLOGIES LIMITED,
`V ALEANT PHARMACEUTICALS
`INTERNA TI ON AL, and V ALEANT
`PHARMACEUTICALS LUXEMBOURG
`S.A.R.L.,
`
`Plaintiffs,
`
`C.A. No. 15-164-LPS
`
`v.
`
`ACT A VIS LABORATORIES FL, INC.,
`
`Defendant.
`
`COSMO TECHNOLOGIES LIMITED,
`V ALEANT PHARMACEUTICALS
`INTERNATIONAL, and V ALEANT
`PHARMACEUTICALS LUXEMBOURG
`S.A.R.L.,
`
`Plaintiffs,
`
`C.A. No. 15-193-LPS
`
`v.
`
`ALVOGEN PINE BROOK, LLC.,
`
`Defendant.
`
`Jack B. Blumenfeld and Maryellen Noreika, MORRIS, NICHOLS , ARSHT & TUNNELL LLP,
`Wilmington, DE
`Bruce M. Wexler, Joseph M . O'Malley, Jr. , Melanie R. Rupert, David M. Conca, and Nicholas
`A. Tymoczko, PAUL HASTINGS LLP, New York, NY
`
`Attorneys for Plaintiffs.
`
`John C. Phillips, PHILLIPS GOLDMAN & SPENCE, P.A. , Wilmington, DE
`Elizabeth J. Holland, Natasha E. Daughtrey, and Naomi Birbach, GOODWIN PROCTOR LLP,
`New York, NY
`John T. Bennett, GOODWIN PROCTOR LLP, Boston, MA
`
`Attorneys for Defendant Actavis Laboratories FL, Inc.
`
`MYLAN Ex 1012, Page 1
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`

`

`Karen Keller, Jeffrey T. Castellano, and David Fry, SHAW KELLER LLP, Wilmington, DE
`Matthew J. Becker and Stacie L. Ropka, AXINN, VELTROP & HARKRIDER LLP, Hartford,
`CT
`Delphine W. Knight Brown, AXINN, VELTROP & HARKRIDER LLP, New York, NY
`
`Attorneys for Defendant Alvogen Pine Brook, LLC.
`
`MEMORANDUM OPINION
`
`September 7, 2016
`Wilmington, Delaware
`
`MYLAN Ex 1012, Page 2
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`

`

`Plaintiffs Cosmo Technologies Limited, Valeant Pharmaceuticals International, and
`
`Valeant Pharmaceuticals Luxembourg S.A.R.L. ("Plaintiffs") filed suit against Defendants
`
`Actavis Laboratories FL, Inc. and Alvogen Pine Brook, LLC, ("Defendants") alleging
`
`infringement of U.S. Patent Nos. 7,410,651 (the '"651patent"),RE43,799 (the '"799 patent"),
`
`8,784,888 (the "'888 patent"), 8,293,273 (the '"273 patent"), and 9,320,716 (the "'716 patent"). 1
`
`The patents are directed to formulations containing budesonide, which are used to treat ulcerative
`
`colitis. Presently before the Court is the construction of disputed terms of the patents' claims.
`
`The parties submitted technology tutorials (D.I. 65 and 69) and claim construction briefs
`
`(D.I. 66, 70, 75, 80, 138, 139, 145, and 147). The Court held a claim construction hearing on
`
`July 11 , 2016. (See D.I. 163 ("Tr."))
`
`I.
`
`LEGAL ST AND ARDS
`
`The ultimate question of the proper construction of a patent is a question oflaw. See
`
`Teva Pharm. USA, Inc. v. Sandoz, Inc., 13 5 S. Ct. 831 , 83 7 (2015) (citing Markman v. Westview
`
`Instruments, Inc. , 517 U.S. 370, 388-91 (1996)). "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) (internal quotation marks omitted).
`
`"[T]here is no magic formula or catechism for conducting claim construction.' Id. at 1324.
`
`Instead, the court is free to attach the appropriate weight to appropriate sources "in light of the
`
`1Plaintiffs also first sued Par Pharmaceutical, Inc. See Cosmo Techs. Ltd. v. Par Pharm.,
`Inc. , C.A. No. 1 :15-cv-00116-LPS. That case has since settled. (See D.I. 160) However, all of
`the docket entries cited in this Memorandum Opinion were filed in the Par case, so each D.I.
`reference herein is to C.A. No. 15-116, unless otherwise noted.
`
`1
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`MYLAN Ex 1012, Page 3
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`

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`statutes and policies that inform patent law." Id.
`
`"[T]he words of a claim are generally given their ordinary and customary meaning ...
`
`[which is] the meaning that the term would have to a person of ordinary skill in the art in
`
`question at the time of the invention, i.e., as of the effective filing date of the patent application."
`
`Id. at 1312-13 (internal citations and quotation marks omitted). " [T]he ordinary meaning of a
`
`claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321
`
`(internal quotation marks omitted). The patent 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." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
`
`While "the claims themselves provide substantial guidance as to the meaning of particular
`
`claim terms," the context of the surrounding words of the claim also must be considered.
`
`Phillips, 415 F.3d at 1314. Furthermore, " [o]ther claims of the patent in question, both asserted
`
`and unasserted, can also be valuable sources of enlightenment . . . [b ]ecause claim terms are
`
`normally used consistently throughout the patent .... " Id. (internal citation omitted).
`
`It is likewise true that "[d]ifferences among claims can also be a useful guide . ... For
`
`example, the presence of a dependent claim that adds a particular limitation gives rise to a
`
`presumption that the limitation in question is not present in the independent claim." Id. at 1314-
`
`15 (internal citation omitted). This "presumption is especially strong when the limitation in
`
`dispute is the only meaningful difference between an independent and dependent claim, and one
`
`party is urging that the limitation in the dependent claim should be read into the independent
`
`claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003 ).
`
`It is also possible that "the specification may reveal a special definition given to a claim
`
`2
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`MYLAN Ex 1012, Page 4
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`

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`term by the patentee that differs from the meaning it would otherwise possess. In such cases, the
`
`inventor' s lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven
`
`when the specification describes only a single embodiment, the claims of the patent will not be
`
`read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope
`
`using words or expressions of manifest exclusion or restriction." Hill-Rom Servs. , Inc. v. Stryker
`
`Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358
`
`F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).
`
`In addition to the specification, a court "should also consider the patent' s prosecution
`
`history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir.
`
`1995), ajf'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence,"
`
`"consists of the complete record of the proceedings before the PTO [Patent and Trademark
`
`Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d
`
`at 1317. "[T]he prosecution history can often inform the meaning of the claim language by
`
`demonstrating how the inventor understood the invention and whether the inventor limited the
`
`invention in the course of prosecution, making the claim scope narrower than it would otherwise
`
`be." Id.
`
`In some cases, "the district court will need to look beyond the patent's intrinsic evidence
`
`and to consult extrinsic evidence in order to understand, for example, the background science or
`
`the meaning of a term in the relevant art during the relevant time period." Teva , 135 S. Ct. at
`
`841. Extrinsic evidence "consists of all evidence external to the patent and prosecution history,
`
`including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d
`
`at 980. For instance, technical dictionaries can assist the court in determining the meaning of a
`
`3
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`MYLAN Ex 1012, Page 5
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`

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`term to those of skill in the relevant art because such dictionaries "endeavor to collect the
`
`accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d
`
`at 1318. In addition, expert testimony can be useful "to ensure that the court' s understanding of
`
`the technical aspects of the patent is consistent with that of a person of skill in the art, or to
`
`establish that a particular term in the patent or the prior art has a particular meaning in the
`
`pertinent field. " Id. Nonetheless, courts must not lose sight of the fact that "expert reports and
`
`testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from
`
`bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be
`
`useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely
`
`to result in a reliable interpretation of patent claim scope unless considered in the context of the
`
`intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the
`
`scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney
`
`Bowes, Inc. v. Hewlett-Packard Co. , 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90
`
`F.3d at 1583).
`
`Finally, "[t]he construction that stays true to the claim language and most naturally aligns
`
`with the patent's description of the invention will be, in the end, the correct construction."
`
`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 device is rarely the correct
`
`interpretation." Osram GmbHv. Int'l Trade Comm 'n, 505 F.3d 1351 , 1358 (Fed. Cir. 2007)
`
`(quoting Modine Mfg. Co. v. U S Int '/ Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
`
`4
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`MYLAN Ex 1012, Page 6
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`

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`II.
`
`CONSTRUCTION OF DISPUTED TERMS2
`
`A.
`
`"matrix"3
`
`Plaintiffs
`a macroscopically homogeneous structure in all its volume
`
`Defendants
`a homogeneous structure in all its volume in which an ingredient or ingredients are dispersed
`
`Court
`a homogeneous structure in all its volume
`
`The parties agree that a matrix is a "homogeneous structure in all its volume." They
`
`disagree about whether the matrices of the patents-in-suit must have an ingredient or ingredients
`
`dispersed within them. Plaintiffs argue that the concept of a matrix generally does not include
`
`such a requirement and that they do not believe one should be included here. (See Tr. at 39)
`
`Defendants contend that in the context of the disputed claim term the Court should construe
`
`"matrix" as a structure in which an ingredient is or ingredients are dispersed because the asserted
`
`claims impose such a requirement.
`
`Defendants may be correct as to the overall scope of the claims, but this does not mean
`
`that a dispersion requirement must be included in the "matrix" term. "Extracting a single word
`
`from a claim divorced from the surrounding limitations can lead construction astray." !GT v.
`
`Bally Gaming Int'!, Inc., 659 F.3d 1109, 1117 (Fed. Cir. 2011). To the extent the claims are
`
`2Plaintiffs and Defendant Alvo gen previously disputed the meaning of "hydrophilic first
`matrix," which appears in claims 1-13 of the ' 943 patent. The parties subsequently stipulated
`that the term would have the same construction as the "hydrophilic matrix" portion of the term
`"outer hydrophilic matrix," discussed below. (See C.A. No. 15-193-LPS D.I. 153 ; see also Tr.
`35-38) Hence, the Court will not address "hydrophilic first matrix" separately.
`
`3This term appears in claims 1-4 and 6-9 of the ' 651 patent and claims 1-7 of the ' 799
`
`patent.
`
`5
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`MYLAN Ex 1012, Page 7
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`concerned principally (or even exclusively) with structures in which ingredients are dispersed, it
`
`is not the word "matrix" that imposes this limitation. Rather, other claim language establishes
`
`whether and what (if any) ingredients are dispersed in the matrix. See, e.g. ' 651 pat. col. 8: 1-14
`
`(claiming composition consisting essentially of "a lipophilic matrix ... in which the active
`
`ingredient is at least partially inglobulated; ... an amphiphilic matrix; .. . and an outer
`
`hydrophilic matrix consisting ofhydrogel forming-compounds in which the lipophilic matrix and
`
`the amphiphilic matrix are dispersed . . . ")(emphasis added). For this reason, the Court will not
`
`construe "matrix" as inherently including an ingredient or ingredients dispersed within its
`
`structure - although separate limitations in some of the claims may impose such a requirement.
`
`The parties also disagree about whether the claimed matrices must be macroscopically
`
`homogeneous. The specifications of the patents in which this term appears describe compression
`
`of a lipophilic and amphiphilic matrix to yield "a macroscopically homogeneous structure in all
`
`its volume, namely a matrix containing a dispersion of lipophilic granules in a hydrophilic
`
`matrix." See, e.g. ' 651 pat. col. 4:45-51. Although this statement indicates that a matrix may be
`
`macroscopically homogeneous, it does not specify that the claimed matrices must be
`
`macrosopically homogeneous, or that macroscopic homogeneity is an inherent property of
`
`matrices in general. Absent implicit or explicit lexicography or disavowal, the Court may not
`
`read limitations from the specification into the claims. See Thorner v. Sony Computer Entm 't
`
`Am. LLC, 669 F.3d 1362, 1366-68 (Fed. Cir. 2012). Thus, the Court will not limit the claims to
`
`"macroscopically" homogeneous structures.
`
`Defendants' extrinsic evidence - including an expert declaration and dictionary
`
`definitions - does not alter the outcome.
`
`6
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`MYLAN Ex 1012, Page 8
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`B.
`
`"macroscopically homogeneous composition"4 and "macroscopically homogeneous
`structure"5
`
`Plaintiffs
`a composition of uniform structure throughout, as observed by the naked eye
`
`Defendants
`a matrix containing a dispersion oflipophilic granules containing active ingredient, in a
`hydrophilic matrix
`
`Court
`a composition of uniform structure throughout, as observed by the naked eye
`
`The parties disagree about whether these terms are limited to one particular type of
`
`composition or structure that is described in the specification. As already noted, the Court may
`
`not read limitations from the specification into the claims absent express or implicit lexicography
`
`or disavowal. A patentee need not use "explicit[ly] definitional" language to express its intent to
`
`limit claim scope. SciMed Life Sys. Inc. v. Advanced Cardiovascular Sys. Inc., 242 F.3d 1337,
`
`1344 (Fed. Cir. 2001). However, any implicit definition or disclaimer must be "so clear that it
`
`equates to an explicit one." Thorner, 669 F.3d at 1638.
`
`Defendants contend that the patent defines "macroscopically homogeneous structure" as
`
`"a matrix containing a dispersion of lipophilic granules in a hydrophilic matrix." In support of
`
`their position, Defendants point to language in the specification that describes a process of
`
`"compression of [a] mixture oflipophilic and/or amphiphilic matrix, hydrogel-forming
`
`compound and, optionally, active ingredient not inglobulated in the lipophilic matrix, yield[ing] a
`
`macroscopically homogeneous structure in all its volume, namely, a matrix containing a
`
`4This term appears in claim 1 the ' 888 patent.
`
`5This term appears in claims 1, 12, 22, and 24-26 of the ' 716 patent.
`
`7
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`MYLAN Ex 1012, Page 9
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`dispersion oflipophilic granules in a hydrophilic matrix." ' 888 pat. col. 5:5-10; '716 pat. col.
`
`5:5-10 (emphasis added).
`
`It is apparent that the words "matrix containing a dispersion of lipophilic granules in a
`
`hydrophilic matrix" describe a particular macroscopically homogeneous structure that results
`
`from compressing a particular mixture as described in the patent specification. But the
`
`specification nowhere suggests that these words define the term "macroscopically homogeneous
`
`structure" itself. As such, the term "macroscopically homogeneous structure" will be given its
`
`plain and ordinary meaning, which is set forth in Plaintiffs ' proposed construction. 6
`
`C.
`
`"outer hydrophilic matrix"7
`
`Plaintiffs
`a matrix with an affinity for water within which other matrices are incorporated
`
`Defendants
`a matrix with the overall property of having an affinity for water that is located outside
`separate, inner matrices
`
`Court
`a matrix with an affinity for water within which other matrices are incorporated
`
`The parties agree that the claimed matrix is hydrophilic, meaning that it has an affinity for
`
`water. (D.I. 66 at 15; D.I. 70 at 17) Defendants ask the Court to specify that the matrix has an
`
`6With respect to the '716 patent, Defendants argue that during prosecution the patentee
`disavowed structures other than those described in the specification. However, the patentee
`distinguished the claimed invention from a prior art patent on the ground that the prior art
`included no description of structure, whereas the invention of the '716 patent includes a
`"controlled release mechanism in the form of a macroscopically homogeneous structure." (D.I.
`139 Exh. 4 at 4) Because Defendants have not shown that controlled release requires "a matrix
`containing a dispersion oflipophilic granules containing active ingredient, in a hydrophilic
`matrix," the Court is not persuaded that the patentee' s statements about controlled release limit
`the claims to the embodiment set forth in Defendants' construction.
`
`7This term appears in claim 1 of the ' 651 patent and claim 1 of the ' 799 patent.
`
`8
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`MYLAN Ex 1012, Page 10
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`

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`affinity for water "overall." The Court agrees with Defendants that the term "hydrophilic"
`
`modifies "matrix" (i.e., that the matrix itself must have the property of hydrophilicity). (See D .I.
`
`70 at 17; Tr. at 62-63) But adding the term "overall" is not necessary to make this clear, so the
`
`Court will not do so.
`
`The parties also disagree about the meaning of the modifier "outer." Plaintiffs argue that
`
`"outer" merely conveys that the hydrophilic matrix is the "dominant presence" in the claimed
`
`formulations, and that the claims do not require the inner and outer matrices to have a particular
`
`defined, spatial relationship. (Tr. 52, 71-73 , 80-84) Defendants argue that the inner and outer
`
`matrices are each a single, distinct geometry, with the outer matrix subsuming the inner matrix.
`
`(Tr. at 63-66)
`
`In support of their position that the inner and outer matrices have defined, separate
`
`geometries, Defendants cite the Federal Circuit's decision in Shire Dev. LLC v. Watson Pharm.,
`
`Inc., 787 F.3d 1359 (Fed. Cir. 2015). (See Tr. at 63 -66) There, the Federal Circuit construed
`
`terms of a patent (not one of the patents-in-suit here) claiming pharmaceutical compositions
`
`having "inner" and "outer" matrices. Id at 1367-68. The Federal Circuit found that the patent
`
`involved in Shire used these terms to specify that the relationship between the inner and outer
`
`matrices was that of an "inner volume ... separate from the outer volume." Id. at 1367.
`
`The patents-in-suit here, by contrast, do not require the claimed outer matrices to embody
`
`a single volume that is distinct from, or has a defined spatial relationship with, the other matrices.
`
`The patents' claims describe the outer hydrophilic matrix as "consisting of hydro gel forming
`
`compounds in which the lipophilic matrix and amphiphilic matrix are dispersed." See, ' 651 pat.
`
`col. 8:10-14; ' 799 pat. col. 12:7-9. The specification refers to embodiments prepared by mixing
`
`9
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`MYLAN Ex 1012, Page 11
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`

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`"matrix granules" of the lipophilic and amphiphilic matrices with "hydrophilic excipients" until
`
`the matrices are "homogeneously dispersed" within the hydrophilitic substance. See ' 799 pat.
`
`col. 7:33-55 ; see also 1 :19-24. The specification describes how such a mixture may form a
`
`"macroscopically homogeneous structure in all its volume, namely . .. a dispersion of lipophilic
`
`granules in a hydrophilic matrix." ' 799 pat. col. 4:50-56. These examples do not refer to "two
`
`matrices with a defined spatial relationship," wherein the outer matrix is located outside separate,
`
`inner matrices, each having a single, defined geometry. See Shire, 787 F.3d. at 1368. Therefore,
`
`the Court will adopt Plaintiffs ' proposed construction, which more broadly describes a dominant
`
`matrix in which other matrices are incorporated.
`
`D.
`
`"lipophilic matrix" 8
`
`Plaintiffs
`a matrix with a poor affinity towards aqueous fluids
`
`Defendants
`a matrix with the overall property of having an affinity for lipids
`
`Court
`a matrix having an affinity for lipids and a poor affinity towards aqueous fluids
`
`At the claim construction hearing, the parties agreed it is appropriate to construe
`
`"lipophilic matrix" as "a matrix having an affinity for lipids with a poor affinity towards aqueous
`
`fluids. " (Tr. at 58-59) Their only remaining dispute with respect to this term pertains to whether
`
`"lipophilic matrix" should be described as having the "overall property" of being lipophilic.
`
`Defendants argue that the words "overall property" clarify that the matrix itself, and not just
`
`some substances within the matrix, must have the property of being lipophilic. (See Tr. at 62-63
`
`8This term appears in claims 1, 3, 4 and 6 of the '651 patent and claims 1, 3, 4, and 6 of
`the '799 patent.
`
`10
`
`MYLAN Ex 1012, Page 12
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`

`

`(discussing Defendants' view of meaning of "overall property" using the term "hydrophilic" as
`
`an example)) As noted above, the Court agrees with Defendants that "hydrophilic" modifies
`
`"matrix" - so, here, the matrix itself must have the quality of being lipophilic - but, as also
`
`already noted, the Court does not believe the words "overall property" are required in order to
`
`convey this meaning.
`
`E.
`
`"amphiphilic matrix"9
`
`Plaintiffs
`a matrix with substance(s) that have both an affinity for lipids and an affinity for water
`
`Defendants
`a matrix with the overall properties of having an affinity for lipids and having an affinity for
`water
`
`Court
`a matrix containing amphiphilic substances, and as a result having both an affinity for lipids
`and an affinity for water
`
`At the claim construction hearing, the parties agreed that the amphiphilic matrices of the
`
`claims contain amphiphilic substances. (Tr. at 87-88, 90-91 ) They further agreed that the term
`
`"amphiphilic" modifies "matrix" as a whole, meaning that the matrix itself has both an affinity
`
`for lipids and an affinity for water. (Id.) Finally, there is no dispute that the matrix has
`
`amphiphilic properties because it contains amphiphilic substances (as opposed to, for example,
`
`having such properties because it contains both hydrophilic and lipophilic substances in equal
`
`amounts). 10 (Tr. at 90-92) The Court has construed the claim term accordingly.
`
`9This term appears in claims 1, 2, and 5 of the '651 patent and claims 1, 2, and 5 of the
`'799 patent.
`
`10Plaintiff argues that the Court must construe "amphiphilic matrix" in a way that
`specifies that the matrix has amphiphilic properties due to its amphiphilic ingredients, in order to
`clarify that the matrix is not comprised of just lipophilic and hydrophilic substances (and not
`
`11
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`MYLAN Ex 1012, Page 13
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`

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`F.
`
`"melting point" 11
`
`Plaintiffs
`the temperature at which a solid begins to change from a solid to a liquid
`
`Defendants
`the temperature at which solid and liquid phases of a compound are at equilibrium
`
`Court
`the temperature at which solid and liquid phases of a compound are at equilibrium
`
`The parties agree that the patents-in-suit do not define "melting point." Each contends
`
`that its proposed construction is the plain and ordinary meaning of the term to a person having
`
`ordinary skill in the art. Each also submitted expert reports and dictionary definitions in support
`
`of its construction.
`
`The intrinsic record does not define "melt" and does not favor one party' s proposed
`
`construction over the other' s. Plaintiffs highlight the fact that the specification lists as examples
`
`of lipophilic compounds - the compounds whose melting point is specified in the claims - only
`
`mixtures that melt over a range of temperatures. (Tr. at 91-96) Plaintiffs' expert opines that,
`
`because the claims refer to the "melting point" of substances that in fact melt over a range of
`
`temperatures, a person of ordinary skill would understand that the patents' "focus with respect to
`
`the claimed melting point(s) is when the melting transition begins." (Id. at~~ 22, 23) Plaintiffs'
`
`expert further finds the specifications' references to "melting or softening" to provide additional
`
`amphiphilic substances) that together cause the matrix to exhibit amphiphilic properties overall.
`The Court is persuaded that this specificity helps to clarify this term and includes it in its
`construction. The absence of such specificity in the Court' s construction of the lipophilic and
`hydrophilic matrix terms should not be understood as a determination that the claims do not
`require lipophilic and hydrophilic matrices to have lipophilic and hydrophilic properties resulting
`from their lipophilic or hydrophilic ingredients. That issue has not been put before the Court.
`
`11 This term appears in claim 1 of the ' 651 patent and claim 1 of the ' 799 patent.
`
`12
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`MYLAN Ex 1012, Page 14
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`

`support for Plaintiffs' construction, because a person of ordinary skill in the art would know that
`
`"[i]mpure compounds and mixtures generally melt over a range of temperatures, and may first
`
`soften." (D.I. 68 ~ 21 ) As further support, Plaintiffs cite a number of general scientific
`
`dictionaries that describe "melting point" as the beginning of the transition from solid to liquid
`
`phase. (Id. at~ 24) Plaintiffs argue that these dictionaries are more relevant than those
`
`Defendants cite because Defendants' dictionaries refer to melting points of pure substances, each
`
`of which melt at a single temperature. (Tr. at 96-97)
`
`Defendants' expert contends that the specialized dictionaries on which Defendants rely
`
`provide the definition of melting point a person of ordinary skill in the art of chemistry and
`
`pharmaceutical science would understand to be used in the patents-in-suit: the temperature at
`
`which a compound that is melting would reach an equilibrium between its solid and liquid
`
`phases. (D.I. 71 at~ 35) While Defendants' expert agrees that the claimed compounds may
`
`change phase over a range of temperatures, he contends that a person of ordinary skill in the art
`
`would be able to determine the equilibrium point of the solid and liquid phases for the claimed
`
`compounds - so there would still be a single "melting point." (Id.~ 35) He further contends
`
`that a person of ordinary skill in the art would not view the term "melting point" differently just
`
`because it is mentioned alongside "softening." Rather, the expert explains, a person of ordinary
`
`skill in the art would understand that "softening" is a separate term and refers to a different way
`
`in which materials change from solid to liquid phase, and that "melting" and "softening" occur in
`
`different types of substances. (D .I. 81 at ~ 5) Thus, the patents' references to "melting or
`
`softening" should be read as "melting or softening - whichever would occur in this material."
`
`(See id. at~ 6)
`
`13
`
`MYLAN Ex 1012, Page 15
`
`

`

`Based on the extrinsic evidence - which the Court reads in light of the intrinsic evidence
`
`(and only after finding the intrinsic evidence lacks sufficient clarity to point to the proper
`
`construction) - the Court finds that "melting point" is a term of art in chemistry and to
`
`pharmaceutical scientists. The Court is persuaded that the specialized dictionaries cited by the
`
`Defendants reflect the plain and ordinary meaning of "melting point" to a person of ordinary skill
`
`in the art at the time of the invention. 12
`
`Defendants' "equilibrium" definition is consistent with the intrinsic record. The parties
`
`agree that a compound may "melt" over a range of temperatures, and it is undisputed that a
`
`person of ordinary skill in the art could determine the melting point of the claims' "lipophilic
`
`compounds." Further, the patents ' use of the terms "soften" and "melt" in the alternative (e.g.,
`
`"soften or melt" or "soften and/or melt") suggests that the patentee understood melting and
`
`softening to be separate processes. See, e.g., '651 pat. col. 3:30-35, 4:4-14; ' 799 pat. col. 3:39-
`
`45, 4:11-21.
`
`Thus, the Court credits Defendants' expert' s position that, while a layperson may
`
`understand "softening" as the first step in the process of "melting," a person of ordinary skill in
`
`the art would understand that softening and melting are two distinct forms of phase change. The
`
`Court adopts Defendants' proposed construction.
`
`12The parties generally agree that a person of ordinary skill in the art is an individual with
`a formal education in pharmaceutical science or a related field, along with either an advanced
`degree or work experience. (See D.I. 68 if 18 and D.I 71 if 22)
`
`14
`
`MYLAN Ex 1012, Page 16
`
`

`

`G.
`
`"lipophilic/amphiphilic matrix" 13
`
`Plaintiffs
`lipophilic or amphiphilic
`
`Defendants
`The term is indefinite
`
`Court
`lipophilic and amphiphilic matrices
`
`Defendants contend that this term is indefinite, arguing that a person of ordinary skill in
`
`the art reading the specification and claims would not know whether "lipophilic/amphiphilic"
`
`refers to "lipophilic and amphiphilic," "lipophilic or amphiphilic," or "both lipophilic and
`
`amphiphilic."
`
`"[I]n assessing definiteness, claims are to be read in light of the patent' s specification and
`
`prosecution history." Nautilus, Inc. v. Biosig Instruments, Inc. , 134 S. Ct. 2120, 2128 (2014). A
`
`patent claim is only indefinite if, "viewed in light of the specification and prosecution history, [it
`
`fails to] inform those skilled in the art about the scope of the invention with reasonable
`
`certainty." Id. at 2129.
`
`Here, a person of ordinary skill in the art reading the term "lipophilic/amphiphilic" in its
`
`full context would know that the term means "lipophilic and amphiphilic." The intrinsic
`
`evidence provides such a person with at least reasonable certainty.
`
`Claim 1 recites a lipophilic matrix, an amphiphilic matrix, and an outer hydrophilic
`
`matrix in which the lipophilic and amphiphilic matrices are dispersed. The claim then describes
`
`the active ingredient as dispersed in both the hydrophilic matrix and the lipophilic/amphiphilic
`
`13This term appears in claim 1 of the ' 799 patent.
`
`15
`
`MYLAN Ex 1012, Page 17
`
`

`

`matrix. This context suggests that "lipophilic/amphiphilic matrix" refers collectively to the two
`
`inner matrices that are dispersed within the outer hydrophilic matrix. The specification, which
`
`repeatedly refers to lipophilic and amphiphilic inner matrices as both being dispersed within the
`
`outer hydrophilic matrix, provides further support for this construction. See, e. g. , ' 799 pat. col.
`
`3:4-12. The parties have not cited any special knowledge or technical understanding that would
`
`lead a person of ordinary skill in the art to interpret this term any differently. Thus, the Court
`
`construes the term as "lipophilic and amphiphilic matrices."
`
`III. CONCLUSION
`
`The Court will construe the disputed claim terms as described above. An appropriate
`
`Order follows .
`
`16
`
`MYLAN Ex 1012, Page 18
`
`

`

`Case 1:15-cv-00193-LPS Document 168 Filed 09/07/16 Page 1 of 2 PageID #: 4174
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`COSMO TECHNOLOGIES LIMITED,
`V ALEANT PHARMACEUTICALS
`INTERNATIONAL, and V ALEANT
`PHARMACEUTICALS LUXEMBOURG
`S.A.R.L.,
`
`Plaintiffs,
`
`v.
`
`ACTA VIS LABORATORIES FL, INC.,
`
`Defendant.
`
`COSMO TECHNOLOGIES LIMITED,
`V ALEANT PHARMACEUTICALS
`INTERNATIONAL, and V ALEANT
`PHARMACEUTICALS LUXEMBOURG
`S.A.R.L.,
`
`Plaintiffs,
`
`v.
`
`AL VOGEN PINE BROOK, LLC.,
`
`Defendant.
`
`C.A. No. 15-164-LPS
`
`C.A. No. 15-193-LPS
`
`At Wilmington, this 7th day of September, 2016:
`
`ORDER
`
`For the reasons set forth in the Memorandum Opinion issued this date,
`
`IT IS HEREBY ORDERED that the disputed claim terms in U.S. Patent Nos. 7,410,651
`
`(the '"651patent"), RE43 ,799 (the '" 799 patent"), 8,784,888 (the '" 888 patent"), 8,293 ,273 (the
`
`"'273 patent"), and 9,320, 716 (the "' 716 patent") are construed as follows:
`
`1
`
`MYLAN Ex 1012, Page 19
`
`

`

`Case 1:15-cv-00193-LPS Document 168 Filed 09/07/16 Page 2 of 2 PageID #: 4175
`
`Claim Term
`
`matrix
`
`Court's Construction
`
`a homogeneous structure in all its volume
`
`[' 651 patent, claims 1-4 and 6-
`9; ' 799 patent, claims 1-7]
`
`macroscopically
`homogeneous composition I
`macroscopically
`homogeneous structure
`
`[' 888 patent, claim 1; ' 716
`patent, claims 1, 12, 22, 24-26]
`
`outer hydrophilic matrix
`
`[' 651 patent, claim 1; ' 799
`patent, claim 1]
`
`lipophilic matrix
`
`[' 651 patent, claims 1, 3, 4, 6;
`' 799 paten