SHIRE PHARMACEUTICAL DEVELOPMENT INC. et al v. AMNEAL PHARMACEUTICALS LLC et al

Filing 117

OPINION FILED. Signed by Judge Robert B. Kugler on 8/2/16. (js)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
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SHIRE DEVELOPMENT LLC, SHIRE
PHARMACEUTICAL DEVELOPMENT
INC., COSMO TECHNOLOGIES LIMITED,
and NOGRA PHARMA LIMITED,
Plaintiffs,
v.
AMNEAL PHARMACEUTICALS LLC,
AMNEAL PHARMACEUTICALS OF NEW
YORK, LLC, AMNEAL
PHARMACEUTICALS CO. (I) PVT. LTD.,
and AMNEAL LIFE SCIENCES PVT. LTD.,
Defendants.

Civil No. 15-2865 (RBK/JS)
OPINION

KUGLER, United State District Judge:
This patent infringement action is brought by Plaintiffs Shire Development LLC, Shire
Pharmaceutical Development Inc., Cosmo Technologies Limited, and Nogra Pharma Limited
(collectively, “Shire”) against Defendants Amneal Pharmaceuticals LLC, Amneal
Pharmaceuticals of New York, LLC, Amneal Pharmaceuticals Co. (I) Pvt. Ltd., and Amneal Life
Sciences Pvt. Ltd. (collectively, “Amneal”). This matter is before the Court for claim
construction of certain terms contained with U.S. Patent 6,773,720 (the “ ’720 Patent”) pursuant
to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) on submission of initial briefs
by both parties [Dkt. Nos. 77, 79] and responsive briefs [Dkt. Nos. 87, 89]. The Court held a
claim construction hearing (the “Hearing”) on July 25, 2016. (See Hr’g Tr. [Dkt. No. 115].)
After reviewing the parties’ submissions and hearing arguments of counsel, the Court construes
the disputed claim terms as described herein.

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I.

FACTUAL BACKGROUND AND PROCEDURAL HISTORY
This suit arises from Amneal’s submission of an Abbreviated New Drug Application

(“ANDA”) to the Food and Drug Administration (“FDA”), which, in conjunction with Amneal’s
Paragraph IV certification under the Hatch-Waxman Act, constituted a technical act of
infringement. (Compl. [Dkt. No. 1] ¶ 32); 35 U.S.C. § 271(e)(2)(A); Eli Lilly & Co. v.
Medtronic, Inc., 496 U.S. 661, 678 (1990); Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817
F.3d 755, 790 (Fed Cir. 2016). By filing its ANDA, Amneal seeks to market a generic version of
Shire’s Lialda® product, a drug used to treat inflammatory bowel diseases such as ulcerative
colitis and Crohn’s disease.
Shire contends that Amneal’s product will infringe claims 1 and 3 of the ’720 Patent,
which state as follows:
1. Controlled-release oral pharmaceutical compositions containing as an active
ingredient 5-amino-salicylic acid, comprising:
a) an inner lipophilic matrix consisting of substances selected from the group
consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or
amides thereof, fatty acid mono-, di- or triglycerids, waxes, ceramides, and
cholesterol derivatives with melting points below 90° C., and wherein the
active ingredient is dispersed both in said the [sic] lipophilic matrix and in
the hydrophilic matrix;
b) an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and
said outer hydrophilic matrix consists of compounds selected from the
group consisting of polymers or copolymers of acrylic or methacrylic acid,
alkylvinyl polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses,
polysaccharides, dextrins, pectins, starches and derivatives, alginic acid,
and natural or synthetic gums;
c) optionally other excipients;
wherein the active ingredient is present in an amount of 80 to 95% by weight
of the total composition, and wherein the active ingredient is dispersed both in
the lipophilic matrix and in the hydrophilic matrix.

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3. Compositions as claimed in claim 1, in the form of tablets, capsules, [and]
min[i]tablets.
(’720 Patent, col. 6 ll. 7–31, 35–36.)
The parties dispute the scope and meaning of the number of claim terms within claim 1 of
the ’720 Patent. These terms are: (1) inner lipophilic matrix; (2) outer hydrophilic matrix; (3)
dispersed; (4) wherein the active ingredient is dispersed both in [ ] the [said] lipophilic matrix
and in the hydrophilic matrix; (5) consisting of substances; and (6) consists of compounds.1 The
Court exercises jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a).

II.

LEGAL STANDARD
The law of claim construction is well settled. The court begins its analysis with the

words of the claim, which “are generally given their ordinary and customary meaning.” Phillips
v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotations omitted).
The “ordinary and customary meaning . . . is the meaning that the term would have to a person of
ordinary skill in the art [(a “POSITA” or “POSA”)] at the time of the invention.” Id. at 1313.
The claims are read in the context of the entire patent, including the specification, which
“necessarily informs the proper construction of the claims.” Id. at 1313, 1316. Then, the court
turns to the prosecution history, when provided by the parties, which “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. at 1317. After exhausting these three sources of
evidence, known as the intrinsic evidence, the court may “rely on extrinsic evidence, which

1

The parties initially also disputed the meaning of the term “melting point”. However, at the
start of the Hearing, the parties informed the Court that they had agreed that no construction was
necessary of “melting point” beyond plain and ordinary meaning.
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‘consists of all evidence external to the patent and prosecution history, including expert and
inventor testimony, dictionaries, and learned treatises.’” Id. (quoting Markman v. Westview
Instruments, Inc., 52 F.3d 967, 980 (Fed Cir. 1995), aff’d 517 U.S. 370 (1996)).
Rulings of the Federal Circuit on issues of claim construction for a given patent are
binding on later district courts analyzing the same patent. See Key Pharms. v. Hercon Labs.
Corp., 161 F.3d 709, 716 (Fed. Cir. 1998) (reviewing claim construction independently and
“recogniz[ing] the national stare decisis effect that this court’s decisions on claim construction
have”). Additionally, interpretations of other district courts of the same terms in the same patent
or patent family are highly relevant and persuasive authority, although not necessarily binding.
See Depomed, Inc. v. Sun Pharma Global FZE, Civ. No. 11-3553 (JAP), 2012 WL 3201962, at
*4 (D.N.J. Aug. 3, 2012) (giving deference to prior claim constructions in related cases); see also
Markman v. Westview Instruments, Inc., 517 U.S. 370, 391 (1996) (“[T]reating interpretive
issues as purely legal will promote (though it will not guarantee) intrajurisdictional certainty
through the application of stare decisis on those questions not yet subject to interjurisdictional
uniformity under the authority of the single appeals court.”).
Claim construction “is not for a jury but ‘exclusively’ for ‘the court’ to determine.” Teva
Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 835 (2015) (quoting Markman, 517 U.S. at
390). “[W]hen the district court reviews only evidence intrinsic to the patent (the patent claims
and specifications, along with the patent’s prosecution history), the judge’s determination will
amount solely to a determination of law, and the Court of Appeals will review that construction
de novo.” Id. at 841. However, where the court turns to extrinsic evidence and makes factual
findings in support of its construction, “this subsidiary factfinding must be reviewed for clear
error on appeal.” Id.

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III.

RELATED CASES
This Court is not the first that has been invited to construe the claims of the ’720 Patent.

The claims terms in dispute have been construed by multiple district court judges, and the terms
“inner lipophilic matrix” and “outer hydrophilic matrix” have been the subject of discussion by
the Federal Circuit as well.
Shire filed suit against Watson Pharmaceuticals, Inc. and related entities in 2012, which
has resulted in three separate opinions of relevance here. The district court, Judge Middlebrooks,
first construed many of the same claims at issue here in Shire Dev. LLC v. Watson Pharm., Inc.,
No. 12-cv-60862, 2013 WL 174843 (S.D. Fla. Jan. 17, 2013), rev’d in part, 787 F.3d 1359 (Fed.
Cir. 2015) (“Watson I”). Following a bench trial, the generic appealed to the Federal Circuit,
challenging the constructions of “inner lipophilic matrix” and “outer hydrophilic matrix.” The
Federal Circuit issued an opinion, reported at Shire Dev. LLC v. Watson Pharm., Inc., 746 F.3d
1326 (Fed. Cir. 2014) (“Vacated Watson”), which was then vacated by the Supreme Court for the
Federal Circuit to consider further in light of the Supreme Court’s decision in Teva. See Shire
Dev., LLC v. Watson Pharm., Inc., No. 14-206, 135 S. Ct. 1174 (Mem.) (2015). The Federal
Circuit on remand from the Supreme Court reversed the district court’s construction of “inner
lipophilic matrix” and “outer hydrophilic matrix,” and then remanded for further proceedings.
Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359 (Fed. Cir. 2015), on remand from 135 S.
Ct. 1174 (Mem.) (2015) (“Watson II”).2 On remand from the Federal Circuit, the district court
construed the terms “inner lipophilic matrix” and “outer hydrophilic matrix” consistent with the

2

Although the first opinion of the Federal Circuit was vacated, the discussion of claim
construction Watson II is identical to the discussion in Vacated Watson. Compare Vacated
Watson, 746 F.3d at 1331–34 (Sections III.A and III.B) with Watson II, 787 F.3d at 1365–68
(Sections III.A and III.B).
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opinion in Watson II, and ultimately found the ’720 Patent valid and infringed by the generic.
Shire Dev. LLC v. Watson Pharm., Inc., No. 12-cv-60862, 2016 WL 1258885 (S.D. Fla. Mar. 28,
2016), on remand from 787 F.3d 1359 (Fed. Cir. 2015), appeal docketed, No. 16-1785 (Fed. Cir.
Apr. 4, 2016) (“Watson III”). The generic has again appealed.
Additionally, Shire filed suit against Osmotica Pharmaceutical Corporation and related
entities in 2012. The issue of claim construction was first referred to Special Master Berenato,
which resulted in a Report and Recommendation to the district court, Judge Totenberg. Shire
Dev. LLC v. Osmotica Pharm. Corp., No. 12-cv-904, 2013 WL 11740203 (N.D. Ga. Sept. 25,
2013) (Berenato, S.M.), adopted-in-part, Dkt. No. 173 (N.D. Ga. Sept. 25, 2014) (“Osmotica
R&R”). Following the Federal Circuit’s now-vacated decision in the appeal of Watson I, the
district court ordered a Supplemental Report and Recommendation on the terms “inner lipophilic
matrix” and “outer hydrophilic matrix.” Judge Totenberg then proceeded to construe the claims.
Shire Dev. LLC v. Osmotica Pharm. Corp., No. 12-cv-904, Dkt. No. 173 (N.D. Ga. Sept. 25,
2014), adopting-in-part Osmotica R&R, 2013 WL 11740203 and adopting-in-part Supplemental
Report and Recommendation, Dkt. No. 170 (N.D. Ga. Aug. 29, 2014) (“Osmotica”).
Shire also filed suit against Mylan Pharmaceuticals, Inc. and related entities in 2012. The
district court, Judge Honeywell, construed many of the same claims at issue here. Shire Dev.,
LLC v. Mylan Pharms., Inc., No. 12-cv-1190, 2015 WL 1345322 (M.D. Fla. Mar. 23, 2015)
(“Mylan”). That matter is set for a bench trial to begin this fall. Shire has additionally filed suit
against Cadila Healthcare Limited, which has resulted in a claim construction opinion reported at
Shire Dev., LLC v. Cadila Healthcare Ltd., No. 10-cv-581, 2015 WL 4596410 (D. Del. July 28,
2015) (Jordan, J. by designation) (“Cadila”). A bench trial was recently held in that matter, and
an opinion is forthcoming.

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The parties have additionally noted that a fifth court will shortly be tasked with the same
job of claim construction in an upcoming hearing in Shire Pharm. Dev., Inc. v. Lupin Ltd., No.
15-cv-3437 (D. Md. Filed Nov. 10, 2015). Finally, the parties have also made reference to a
decision by the U.S. Patent and Trademark Office (the “PTO”) to institute Inter Partes Review
in Coalition for Affordable Drugs II LLC v. Cosmo Techs. Ltd., IPR2015-00988.3

IV.

DISCUSSION
A.

“inner lipophilic matrix” and “outer hydrophilic matrix”

These two terms are generally treated as two sides of the same coin. The parties argue
the constructions for these two terms together, and the Court will decide them together as well.
These two terms have been the most litigated, with the following table summarizing the parties’
proposed constructions and the constructions adopted by other courts, discussing only the term
“inner lipophilic matrix” as exemplary of both:

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The decision on claim construction in the inter partes review does not aid this Court, as a
district court and the PTO make claim construction decisions under different standards and
parameters. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2146 (2016) (approving “the
use of the broadest reasonable construction standard in inter partes review, together with use of
an ordinary meaning standard in district court”).
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Shire Proposed
Construction

“a matrix of at least one lipophilic excipient where the matrix
itself exhibits lipophilic characteristics and is separate from the
outer hydrophilic matrix”

Amneal Proposed
Construction

“a matrix that exhibits lipophilic properties and no hydrophilic
properties, and that is separate and structurally distinct from the
outer hydrophilic matrix”

Watson III
2016 WL 1258885, at *8

“a matrix including at least one lipophilic excipient, where the
matrix exhibits lipophilic characteristics and is located within,
and separate from, the outer hydrophilic matrix”

Osmotica
Slip op. at 16

“a macroscopically homogeneous structure in all its volume
that has poor affinity towards aqueous fluids and does not have
an affinity for water . . . and wherein the inner lipophilic matrix
is separate from the outer hydrophilic matrix”

Mylan
2015 WL 1345322, at *6

“a macroscopically homogenous structure in all its volume that
is separate from the outer hydrophilic matrix and that has a
poor affinity towards aqueous fluids”

Cadila
2015 WL 4596410, at *4

“a matrix that exhibits lipophilic properties and is separate from
the outer hydrophilic matrix”

The parties have agreed that (1) “matrix” shall mean “a macroscopically homogenous
structure in all its volume;” (2) “lipophilic” shall mean “poor affinity towards aqueous fluids;”
and (3) “hydrophilic” shall mean “has an affinity for water.” (See Joint Claim Construction
Statement [Dkt. No. 57] at 3.)
The parties generally agree about most of the construction with three sticking points: (1)
the so-called “negative limitation” proposed by Amneal which requires that the matrices not
exhibit any characteristic of the other (i.e., the lipophilic matrix has no hydrophilic properties,
and vice versa); (2) Amneal’s proposed “structurally distinct” requirement; and (3) Shire’s
proposed requirement of “at least one . . . excipient.” Both parties argue that their construction is
the correct interpretation of the Federal Circuit’s decision in Watson II.

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1.

Negative Limitation

This limitation has already been considered in some form by the courts in Osmotica,
Mylan, and Cadila. Judge Totenberg in Osmotica adopted some form of the negative limitation,
see Osmotica, slip op. at 15–16, whereas Judge Honeywell and Judge Jordan each rejected the
limitation, see Mylan, 2015 WL 1345322, at *5–6; Cadila, 2015 WL 4596410, at *3. In
reaching their decisions, each court interpreted the Federal Circuit’s holding that “the matrix that
is deemed the ‘lipophilic’ matrix cannot have hydrophilic properties.” Watson II, 787 F.3d at
1367.4
Relying on that statement from the Federal Circuit, Judge Totenberg in Osmotica held
that “a substance that ‘cannot have hydrophilic properties’ cannot have an affinity for water.”
Osmotica, slip op. at 15–16. However, she did not think that meant the inner lipophilic matrix
was foreclosed from “any affinity for water.” Id. (emphasis in original). Thus, the court’s
construction included the limitation that the matrix “does not have an affinity for water,” which
left open the possibility for some affinity for water. Id. at 16.
On the other hand, Judge Honeywell in Mylan determined that adding the negative
limitation would read too much into the statement of the Federal Circuit. Acknowledging her
departure from Osmotica, she found that the negative limitation was not mandated by Watson II.
Mylan, 2015 WL 1345322, at *5–6. The court interpreted the language in Watson II as “simply
restating the fact that a matrix that has significant amounts of hydrophilic elements mixed with
lipophilic elements—and that consequently does not have an overall poor affinity towards
aqueous fluids—cannot be deemed the ‘lipophilic’ matrix. Id. at *5 (citation omitted). The court

4

The courts in Mylan and Osmotica cite to Vacated Watson. However, this section was identical
in both the vacated opinion and the opinion on remand from the Supreme Court as noted in note
2, supra.
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determined that “a matrix that is lipophilic . . . is necessarily one that is not hydrophilic.
Therefore, defining a lipophilic matrix as one that is additionally not hydrophilic is circular and,
rather than adding precision, adds only confusion.” Id.
Judge Honeywell additionally relied on the Federal Circuit’s later holding that “[w]hether
or not a composition infringes when there is a trace of hydrophilic molecules in the inner
[lipophilic matrix] because of the mixing step inherent in the manufacturing process, for
example, is a question for the fact finder.” Watson II, 787 F.3d at 1637–68. The court
determined that if the negative limitation were to hold true, and that “a lipophilic matrix literally
cannot have any hydrophilic properties, then an inner composition with trace amoutns of
hydrophilic molecules would not infringe as a matter of law,” and the Federal Circuit’s holding
would be superfluous. Mylan, 2015 WL 1345322, at *5.
In noting her disagreement with the court in Osmotica, Judge Honeywell explained that
she “respectfully disagree[d]” that Watson II “would mandate such limitations.” Id. at *6. She
further commented that “after carefully reviewing the Osmotica opinion, the Court remain[ed]
unclear as to what these negative limitations help clarify.” Id.
When faced with the negative limitation in Cadila, Judge Jordan mostly adopted the
reasoning of Judge Honeywell in Mylan. Cadila, 2015 WL 4596410, at *3. He determined that
“adding [the negative] limitation would be, as the Mylan court noted, redundant and potentially
confusing.” Id. He also noted his departure from the construction provided in Osmotica. Id. at
*3 n.4.
Amneal here does not present any new or compelling argument that would justify
departure from the decisions in Mylan and Cadila. Amneal points to no intrinsic evidence from
the claims, specification, or prosecution history that would dictate inclusion of the negative

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limitation. Instead, Amneal relies on the same language from Watson II that was distinguished
in Mylan and Cadila, as well as its expert declaration. (Defs.’ Opening Br. at 14, 17–18.5) The
intrinsic evidence does not support adding in the negative limitation, and including it would be
redundant and confusing as reasoned by the courts in Mylan and Cadila. Therefore, the Court
declines to adopt this portion of Amneal’s proposed construction.

2.

“structurally distinct”

The parties are in agreement that the matrices must be separate. The dispute between
them is whether the matrices must also be “structurally distinct.” The dispute centers around the
proper interpretation of the statements of the Federal Circuit regarding the separate nature of the
matrices.
Initially, in Watson I, Judge Middlebrooks rejected the generic’s position that the inner
and outer matrices must be “separate and distinct.” Watson I, 2013 WL 174843, at *5. The
Federal Circuit reversed this portion of the decision, holding that “the claims require the inner
lipophilic matrix to be separate, if not distinct, from the outer hydrophilic matrix. . . . The
separation of these elements within the claims indicates that the claim requires two separate
matrices.” Watson II, 787 F.3d at 1366 (emphasis added). The court also held that the intrinsic
evidence “compel[s] a claim construction which requires that the inner lipophilic matrix is
separate from the outer hydrophilic matrix.” Id.
Amneal takes the position that “structurally distinct” must be included in the construction
in order to give effect to the holding that “the construction of ‘inner lipophilic matrix’ requires
the inner volume to be separate from the outer volume.” (Defs.’ Opening Br. at 16 (quoting

5

Neither Amneal’s Opening Briefs nor Amneal’s Reply Brief is paginated, despite having a
table of contents and a table of authorities. The page cites herein are to the ECF page numbers.
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Watson II, 787 F.3d at 1367 (emphasis added in quoting source)).) Amneal further argues that
the only way for the inner volume to be separate from the outer volume is for the two volumes to
be “structurally distinct,” thus necessitating the inclusion of the term in its proposed
construction. (Id. at 16–17.) Shire responds that Amneal’s construction is without basis in the
intrinsic record, and at odds with the decision of Watson II that ultimately did not mandate that
the matrices be distinct. (Pls.’ Opening Br. at 8–9.) Shire further responds that the holding only
requires that “the matri[ces] must occupy separate volumes and exhibit separate compositional
characteristics.” (Id. at 8.)
The dispute stems from whether Federal Circuit in holding “if not” really meant “and
also.” The Court concludes they did not. Amneal argued at the Hearing, using a real world
example, that if someone says “That argument is silly, if not ridiculous,” then what that person
really means is “That argument is silly and also ridiculous.” (See Hr’g Tr. at 38:24–39:8.)
However, in the Court’s own experience, that is not what is being said. What it means is, “That
argument is silly and just short of being ridiculous.” If anything, the holding that the matrices
are “separate, if not distinct” means that their separation falls just short of requiring the
distinction Amneal seeks to impart in adding this limitation. But, the Court does not decide that
today.
Much as the negative limitation discussed in Section IV.A.1, supra, is redundant and
possibly adds confusion, so does the “structurally distinct” limitation. The Court also notes that
based on the briefing and the arguments presented at the Hearing, the dispute appears to be an
issue of infringement, rather than claim construction. The addition of “structurally distinct”
above and beyond the agreed-upon “separate” requirement finds no basis in the claims,

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specification, or prosecution history. The extrinsic evidence cited by Amneal also does not
support its inclusion. Thus, the Court declines to adopt this portion of Amneal’s construction.

3.

“at least one . . . excipient”

Finally, Amneal argues that by including “at least one . . . excipient,” Shire is attempting
not only to impose the same “at least one” limitation from “consisting of substances”/“consists of
compounds” that Amneal contests,6 but also to improperly read “substance”/“compound” as
“excipient.” (Defs.’ Opening Br. at 18–20; Defs.’ Resp. Br. at 13–14.) Shire never directly
responds to this issue in briefing or at the Hearing.
Including this limitation would unnecessarily confuse the issues and import an
unnecessary limitation into the construction. The Court does not necessarily agree that
“substance”/“compound” does not have the same meaning as “excipient” here, but it is not
necessary to reach a determination on that issue. The plain language of the claim makes clear
that the matrix (either the inner lipophilic one or the outer hydrophilic one) must consist of
substances or compounds as recited within the claim. (’720 Patent, col. 6 ll. 10–25.) The
limitation does not add anything to the understanding of what constitutes an “inner lipophilic
matrix” or “outer hydrophilic matrix” beyond reading in limitations that occur later in the claim.
Including it would be redundant and unnecessarily confusing based on the intrinsic evidence.
Accordingly, the Court construes the terms as follows: (1) “inner lipophilic matrix”
means “a matrix that exhibits lipophilic properties and is separate from the outer hydrophilic
matrix”; and (2) “outer hydrophilic matrix” means “a matrix that exhibits hydrophilic properties
and is separate from the inner lipophilic matrix.”

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This is discussed in Section IV.D.1, infra.
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B.

“dispersed”

The parties have proposed the following constructions for this term, and other courts have
construed this term as summarized in the below table:
Shire Proposed
Construction

“sufficiently mixed to incorporate one substance with another”

Amneal Proposed
Construction

“homogeneously mixed or combined”

Watson I
2013 WL 174843, at *6

“sufficiently mixed to incorporate one substance with another”

Osmotica
Slip op. at 18

“sufficiently mixed to incorporate one substance within
another”

Mylan
2015 WL 1345322, at *7

plain and ordinary meaning; declined to construe because
generic did not propose a construction that would require
homogeneity

Cadila
2015 WL 4596410, at *6

“sufficiently mixed to incorporate one substance into another”

The dispute between the parties with respect to this term is whether something must be
“homogeneous” to be “dispersed.” Amneal makes two arguments in favor of its position. First,
Amneal points to the specification, and cites the numerous instances where the specification
requires “homogeneous dispersion.” (Defs.’ Opening Br. at 26–27 (citing ’720 Patent, col. 3 ll.
14–17, col. 3 ll. 42–45, col. 4 ll. 10–12, col. 4 ll. 34–43, col. 4 ll. 55–64, col. 5 ll. 8–18, and col.
5 ll. 31–40); Defs.’ Resp. Br. at 23.) Second, Amneal points to the prosecution history of the
’720 Patent, specifically to when claim 1 was amended to replace the term “at least partly
inglobated” with the word “dispersed,” the comments accompanying the amendment, and the
examiner’s amendment in ultimately allowing the claims . (Defs.’ Opening Br. at 24–26 (citing

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Amendment of October 9, 2003 (Defs.’ Ex. 1 [Dkt. No. 77-3]); Notice of Allowance (Defs.’ Ex.
2 [Dkt. No. 77-6])); Defs.’ Resp. Br. at 22–23.)
Shire responds that homogeneity is not required based on the specification, and also
based on extrinsic dictionary evidence. (Pls.’ Opening Br. at 13–15 (citations omitted).) Shire
further responds that the intrinsic evidence cited by Amneal actually supports Shire’s position,
and undercuts Amneal’s position. (Pls.’ Resp. Br. at 10–12; see also Hr’g Tr. at 30:22–31:8.)
Every court confronted with this issue has concluded that “dispersed” does not require
homogeneity, and this Court agrees. The courts in Watson I, Osmotica, and Cadila adopted
constructions that are identical or almost identical with Shire’s proposed construction. See
Watson I, 2013 WL 174843, at *6; Osmotica, slip op. at 18; Cadila, 2015 WL 4596410, at *5–6.
Additionally, although Judge Honeywell in Mylan ordered that the term be given its plain and
ordinary meaning, she also rules that “dispersed” did not require homogeneity. Mylan, 2015 WL
1345322, at *7.
In Watson I, Judge Middlebrooks rejected the argument made by the generic citing to the
specification in support of requiring homogeneity. Watson I, 2013 WL 174843, at *6. Amneal
cites to the same specification evidence here. (See Defs.’ Opening Br. at 26–27 (citations
omitted).) The court noted—as argued here in opposition by Shire—that the specification
referred several times to “homogeneous dispersion,” (e.g., ’720 Patent, col. 3 l. 16, col. 4 l.12,
col. 4 l. 36), so “if the patentees intended ‘dispersed’ to be construed to mean ‘homogeneously
dispersed,’ then stating ‘homogeneous dispersion’ in the specification would be redundant.”
Watson I, 2013 WL 174843, at *6. The court also noted the contrasting references to “simple
dispersion” elsewhere in the patent, (’720 Patent, col. 1 l. 53), signifying that dispersion could

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either simple or homogenous. Watson I, 2013 WL 174843, at *6. In Cadila, Judge Jordan
agreed with this exact reasoning. Cadila, 2015 WL 4596410, at *5–6.
Judge Totenberg did not state any reasoning for her construction in Osmotica, which
rejected the homogeneous requirement, instead simply adopting the report and recommendation
of the special master with respect to this term. See Osmotica, slip op. at 18. In the Osmotica
R&R, the special master rejected the same prosecution disclaimer argument put forth by Amneal
here, and concluded that “the intrinsic evidence makes clear that the term ‘dispersed’ was used in
order to indicate that the material in question was intermixed with the other material, i.e., one
was dispered in the other.” Osmotica R&R, 2013 WL 11740203, at *18.
Finally, Judge Honeywell in Mylan declined to construe the term “dispersed,” but still
rejected the idea that homogeneity was required in the term “dispersed.” Mylan, 2015 WL
1345322, at *7. She remarked that:
The Court recognizes that the district courts in Watson [I] and Osmotica construed
this term according to Shire’s proposed construction. The courts in those cases,
however, gave such constructions to distinguish the general concept of “dispersion”
from the more specific concept of homogeneous distribution. While the Court
agrees that “dispersion” does not necessarily mean that the resulting mixture is
homogeneous, neither of Mylan’s proposed constructions would erroneously
redefine “dispersion” as only homogeneous distribution.
Id. However, this Court faces the exact problem Judge Honeywell did not, and which the courts
in Watson I, Osmotica, and Cadila did—that the generic wants to conflate “dispersion” and
“homogeneous distribution.”
Amneal’s arguments are unavailing, and in line with the courts in Watson I and Cadila,
this Court finds that the evidence from the specification cited by Amneal argues against its
position. The Court similarly finds the evidence from the prosecution history does not support

16

the Amneal’s argument. Accordingly, the Court construes “dispersed” to mean “sufficiently
mixed to incorporate one substance with another.”

C.

“wherein the active ingredient is dispersed both [ ] in the [said] lipophilic
matrix and in the hydrophilic matrix”

The parties have proposed the following constructions for this term, and other courts have
construed this term as summarized in the below table:
Shire Proposed
Construction

“wherein mesalamine is sufficiently mixed to incorporate it
within both the lipophilic matrix and the hydrophilic matrix”

Amneal Proposed
Construction

“wherein mesalamine is homogeneously mixed or combined
within both the inner lipophilic matrix and within the outer
hydrophilic matrix”

Watson I
2013 WL 174843, at *6

“wherein mesalamine is sufficiently mixed to incorporate it
within both the lipophilic matrix and the hydrophilic matrix”

Osmotica
Slip op. at 18

“the active ingredient is sufficiently mixed with the inner
lipophilic matrix and the with the outer hydrophilic matrix to
incorporate the active ingredient in the inner lipophilic matrix
and to incorporate the active ingredient in the hydrophilic
matrix”

Cadila
2015 WL 4596410, at *6

“wherein mesalamine is sufficiently mixed to incorporate it
within both the lipophilic matrix and the hydrophilic matrix”

The parties here have two disputes: (1) whether “dispersed” here will mean
“homogeneous;” and (2) whether Shire’s improperly excludes “inner” and “outer” from its
proposed construction.
With respect to the first dispute, the parties have each inserted their proposed
construction of “dispersed” into this term. Thus, for the same reasons discussed in Section IV.C,
supra, the Court rejects Amneal’s proposed construction that incorporates its proposed
construction for “dispersed.” See also Watson I, 2013 WL 174843, at *6 (rejecting additional

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construction for this term based on the earlier discussion of “dispersed”); Osmotica R&R, 2013
WL 11740203, at *21 (same).
Turning to the second dispute, Amneal argues that by excluding “inner” and “outer” from
its proposed construction, Shire is attempting to blur the lines between the matrices. (Defs.’
Opening Br. at 30–31; Defs.’ Resp. Br. at 23–24.) This appears to again go towards Amneal’s
concern that Shire is not giving proper respect to the requirement that the matrices be “separate”
and is an argument regarding infringement rather than claim construction. Although this issue
does not appear to have been squarely addressed in Cadila, Judge Jordan there declined to
incorporate the words “inner” and “outer” with respect to the matrices, although the generic
proposed them in its construction. Cadila, 2015 WL 4596410, at *6.
The Court finds incorporation of the words “inner” and “outer” to be redundant and
unnecessary. Accordingly, the Court construes “wherein the active ingredient is dispersed both [
] in the [said] lipophilic matrix and in the hydrophilic matrix” to mean “wherein mesalamine is
sufficiently mixed to incorporate it within both the lipophilic matrix and the hydrophilic matrix.”

D.

“consisting of substances” and “consists of compounds”

The parties have proposed the following constructions for this term, and other courts have
construed this term as summarized in the below table. The Court uses only “consisting of
substances” in this table as demonstrative of both terms:

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Shire Proposed
Construction

“consisting of at least one of the recited substances”

Amneal Proposed
Construction

“limits the inner lipophilic matrix to at least two of the recited
substances”

Watson I
2013 WL 174843, at *7

“containing one or more . . . .”

Osmotica
Slip op. at 8

“consisting of at least two . . . .”

Mylan
2015 WL 1345322, at *10

“consisting of two or more . . . .”

Cadila
2015 WL 4596410, at *7

Construed “consisting of” to mean “exclusionary terms
specifying that the element contains only what is expressly set
forth in a recited list, but not excluding impurities and
substances unrelated to said element”

The dispute between the parties centers around (1) whether “consisting of substances”
and “consists of compounds” mandates that there be at least two substances/compounds, or only
one; and (2) the proper interpretation of “consisting of”/”consists of.” The Court goes through
each of these arguments in turn.

1.

Singular vs. Plural

The positions as taken by the parties are not new to this litigation, and more or less repeat
the same arguments presented to the three courts that have already addressed this issue. Amneal
submits that the plain language of the claim—“an inner lipophilic matrix consisting of
substances selected from the group . . .” and “said outer hydrophilic matrix consists of
compounds selected from the group . . .”—supports its position. (Defs.’ Opening Br. at 32;
Defs.’ Resp. Br. at 24–25.) Amneal argues that the grammatical context mandates that there be
at least two substances, because the patent is drafted in the plural. (Id.) Amneal additionally

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argues that in each of the five examples provided in the specification, there are two lipophilic
ingredients for the lipophilic matrix and two hydrophilic ingredients for the hydrophilic matrix.
(Defs.’ Opening Br. at 33–34; Defs.’ Resp. Br. at 25.)
Shire responds that the specification provides for only one substance/compound in each
of the matrices, as the specification states that “the active ingredient is first inglobated in a low
melting excipient or mixture of excipients” and that “the inert matrix granules are subsequently
mixed together with one or more hydrophilic water-swellable excipients.” (Pls.’ Opening Br. at
18 (citing ’720 Patent, col. 2 ll. 50–59 (emphases added)). With respect to the plain meaning of
the claim language, Shire argues that the plural form of substances/compounds was used in order
to achieve grammatical consistency, and does not actually mean two or more. (Id. at 18–19
(citing In re Omeprazole Patent Litig., 84 F. App’x 76, 80 (Fed. Cir. 2003)).) Additionally, at
the Hearing, Shire pointed to a hypothetically drafted claim in which the claim language said
only “substance” or “compound” and argued that it would be grammatically incorrect. (Hr’g Tr.
at 33:19–34:4.)
The courts that have addressed this issue are split. In Watson I, Judge Middlebrooks
agreed with Shire, and relied upon the generic method of production language from the
specification, which is cited here by Shire, to determine that “the intrinsic record supports
[Shire’s] construction of the term, which requires ‘one or more’ of the substances in the list that
follows in the claim.” Watson I, 2013 WL 174843, at *7. The court relied on Versa Corp. v. AgBag Int’l Ltd., 392 F.3d 1325, 1330 (Fed. Cir. 2004) which noted “in context, the plural can
describe a universe ranging from one to some higher number, rather than requiring more than
one item.”

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Conversely, Judge Totenberg in Osmotica rejected these same arguments. Osmotica, slip
op. at 5–8. Noting her disagreement with Judge Middlebrooks, and remarking that she did not
disagree lightly in view of the desired national uniformity of claim construction, she found the
drafting of the claim language in the plural to be dispositive. Id. at 7–8 & n.7. In rejecting the
specification argument made by Shire, the court found an absence of an intent to redefine the
term “substances” or “compounds” to make them singular. Id. at 7–8. The court also rejected
the grammatical consistency argument and Shire’s reliance on In re Omeprazole, finding that the
claims at issue in In re Omeprazole were distinguishable. Id. at 8.
In In re Omeprazole, the claim language at issue was “one or more layers of materials”
and “one or more layers comprising materials.” 84 F. App’x at 80. The Federal Circuit affirmed
the district court’s construction that “materials” could mean just one material, noting that “[t]he
use of the plural ‘materials’ . . . represents an effort to match the tense of ‘layers.’” Id. Judge
Totenberg relied on the fact that the claims at issue here in the ’720 Patent contain no such “one
or more” language occurring earlier. Osmotica, slip op. at 8 n.8.
Similarly, the court in Mylan found the manner in which the claim language was drafted
to be dispositive. Judge Honeywell found that using the plain and ordinary meaning of the claim
terms required two or more substances/compounds. Mylan, 2015 WL 1345322, at *10. The
court noted the grammatical consistency exception argued by Shire, and rejected it, finding that
there was no reason “substances”/“compounds” needed to be drafted in the plural to achieve such
consistency. Id.
The Court agrees with the courts in Osmotica and Mylan. The plain and ordinary
meaning of the claims is that there must be at least two substances/compounds. If the patentee
wanted to have only one substance/compound, then the patentee could have drafted the claim

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accordingly. Shire’s arguments to the specification and grammatical consistency are unavailing.
Additionally, the Court notes that Shire’s hypothetical claim language put up at the Hearing and
referenced above does make grammatical sense, further underscoring the Court’s determination
here.

2.

“consisting of” and “consists of”

The parties agree that “consisting of” and “consists of” are terms of art with well settled
meanings. The disagreement between them appears to stem from what “consisting of” and
“consists of” modify. Amneal argues that the impact of this term is to “limit” the matrices to the
lists of substances/compounds that follow. (Defs.’ Opening Br. at 33; Defs.’ Resp. Br. at 28–30.)
It appears from Amneal’s Reply Brief that Amneal is again concerned that Shire is trying to
make its construction read onto some sort of mixed-matrix formulation. (Defs.’ Resp. Br. at 29–
31.) Shire responds that “consisting of” and “consists of” are not absolute, and in this instance
“limit only the elements set forth in each clause but do not exclude all other elements from the
claim as a whole.” (Pls.’ Opening Br. at 16–18; Pls.’ Resp. Br. at 14.) This precise dispute has
not yet been addressed by any of the other constructing courts.
Shire relies in Mannesmann Demag Corp. v. Engineered Metal Products Co., 793 F.2d
1279, 1282 (Fed. Cir. 1986) in making their argument. (Pls.’ Opening Br. at 17.) Shire misreads
Mannesmann and misapplies grammatical constructs in attempting to find support for its
position.
In Mannesman, the claim read: “1. A vessel for a metal smelting furnace having a
smelting zone including a heat-resistant interior wall . . . characterized by (a) at least a portion of
the interior wall of said vessel above the smelting zone consisting of at least one cooling pipe
coil.” Mannesman, 793 F.2d at 1281 (emphasis added). The court held “[t]he district court
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correctly observed that the phrase ‘consisting of’ appears in clause (a), not the preamble of the
claim, and thus limits only the element set forth in clause (a). The court correctly declined to
read this usage of ‘consisting of’ as excluding all other elements from the claim as a whole.” Id.
at 1282. Shire then argues that its claim is drafted in the exact same manner, and because the
preamble to claim 1 of the ’760 Patent includes the word “comprising,” it means that all of the
elements in the claim “can include substances and compounds other than those identified in
clauses (a) and (b).” (Pls.’ Opening Br. at 17.)
It cannot seriously be disputed that in the claim phrase “an inner lipophilic matrix
consisting of substances,” (’720 Patent, col. 6 l. 10), the phrase “consisting of” is modifying “an
inner lipophilic matrix.” The matrix is being constrained by “consisting of.” Similarly, in the
preamble to the claim, “controlled-release oral pharmaceutical compositions containing as an
active ingredient 5-amino-salicylic acid, comprising,” (id. col. 6 ll. 7–9), the phrase “comprising”
is modifying “controlled-release oral pharmaceutical compositions.” The composition as a
whole is limited by “comprising,” which is open-ended, meaning that the composition as a whole
is not restricted to the elements recited in the claim. However, the matrices, modified by
“consisting of,” which is closed-ended, must exclude any ingredient not specified in the claim.
See Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349, 1360 (Fed. Cir. 2006) (citing
MPEP § 2111.03).
The court in Mannesman does not say otherwise. What the court held in Mannesman was
that the “vessel for a metal smelting furnace” may have elements other than what is recited in the
claim, but that the interior wall was limited to the at least one cooling pipe coil. The holding is
clear. The other case cited by Shire, In re Crish, 393 F.3d 1253, 1257 (Fed Cir. 2004), restates
this interpretation, despite Shire’s characterization of the holding. The court there stated “[t]he

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reasonable interpretation of the claims containing both of the terms ‘comprising’ and ‘consists’ is
that the term ‘consists’ limits [the language it modifies] to the subsequently recited [list], but the
earlier term ‘comprising’ means that the claim can included [that list] plus other [elements].”
Shire’s arguments to the contrary are absurd and stretch the English language.
However, it is unnecessary to actually construe the phrase “consisting of” or “consists of”
due to the well settled legal meaning, other than to make clear that Shire’s understanding is
incorrect.
Accordingly, the Court construes the term as follows: (1) “consisting of substances”
means “consisting of at least two of the recited substances”; and (2) “consists of compounds”
means “consists of at least two of the recited compounds.”

V.

CONCLUSION
For the foregoing reasons, the Court will construe the disputed terms of the ’720 Patent

consistent with this opinion. An appropriate order accompanies this opinion.

Date: August 2nd , 2016

s/ Robert B. Kugler
ROBERT B. KUGLER, U.S.D.J.

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