United States District Court, D. New Jersey
JAZZ PHARMACEUTICALS, INC., and JAZZ PHARMACEUTICALS IRELAND LIMITED, Plaintiffs,
AMNEAL PHARMACEUTICALS, LLC, et al., Defendants. Jazz Defendants The Court Phrase Jazz Defendants The Court Defendants The Court
the Court is the parties' request for claim construction.
The Court held a Markman hearing on April 27, 2017.
(D.E. No. 350). This Opinion sets forth the Court's
constructions of the disputed terms.
Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland
Limited (together, “Jazz”) market the drug
product Xyrem®, which is used to treat patients with two
of the most prevalent symptoms of narcolepsy: excessive
daytime sleepiness and cataplexy. Defendants filed Abbreviated
New Drug Applications with the FDA seeking approval to market
generic versions of Xyrem®. Jazz sued Defendants for
patent infringement under 35 U.S.C. § 100 et
seq., alleging, among other things, that Defendants'
proposed generic versions of Xyrem® will infringe
is sold as a concentrated oral solution that is diluted by
the patient with water prior to its use at bedtime. The
active ingredient in Xyrem® is sodium oxybate (also known
as gamma-hydroxybutyrate, or GHB). Under certain conditions,
GHB may become chemically unstable and break down. GHB
solutions may also become prone to microbial contamination.
Markman decision involves eleven patents stemming
from two patent families: the ‘431 patent family and
the ‘306 patent family. The ‘431 patent family
covers pharmaceutical compositions of GHB-and methods of
making and using such pharmaceutical compositions- that are
chemically stable and microbial resistant, without the need
for a preservative.
‘306 patent family (comprising what are known as
“drug-drug-interaction”-patents) covers specific
methods of treating sleep disorders in patients receiving
both GHB and valproate. Valproate (also known as divalproex
sodium) is used as an anticonvulsant and mood-stabilizing
drug, primarily for treating epilepsy and bipolar disorder.
Significantly, valproate is involved in processes that can
both raise and lower the levels of GHB in a patient. So, the
DDI patents claim methods for safely co-administering GHB and
valproate to treat patients with sleep disorders.
parties submitted a Joint Claim Construction and Prehearing
Statement identifying seven disputed terms. (D.E. No. 315
(“Joint Stmt.”)). Following Markman
briefing,  the parties submitted an Amended Joint
Claim Construction and Prehearing Statement reducing the
number of disputed terms to five. (D.E. No. 348 (“Am.
Basics of Claim Construction
patent claim is that “portion of the patent document
that defines the scope of the patentee's rights.”
Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct.
831, 835 (2015). When the parties in a patent infringement
action “present a fundamental dispute regarding the
scope of a claim term, it is the court's duty to resolve
it.” O2 Micro Int'l Ltd. v. Beyond Innovation
Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008).
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 [(a
“POSA”)] in question at the time of the
invention, i.e., as of the effective filing date of the
patent application.” Phillips v. AWH Corp.,
415 F.3d 1303, 1313 (Fed. Cir. 2005). To determine the
ordinary and customary meaning of a disputed term, the court
must look to “those sources available to the public
that show what a [POSA] would have understood [the] disputed
claim language to mean.” Id. at 1314.
Intrinsic and Extrinsic Evidence
determining the proper construction of a claim, the court has
numerous sources that it may properly utilize for guidance.
These sources . . . include both intrinsic evidence (e.g.,
the patent specification and file history) and extrinsic
evidence (e.g., expert testimony).” Vitronics Corp.
v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.
respect to intrinsic evidence, “the claims themselves
provide substantial guidance as to the meaning of particular
claim terms.” Phillips, 415 F.3d at 1314.
Indeed, “the context in which a term is used in the
asserted claim can be highly instructive.” Id.
Similarly, “[o]ther claims of the patent in question,
both asserted and unasserted, can also be valuable sources of
enlightenment as to the meaning of a claim term.”
the specification “is always highly relevant to the
claim construction analysis” and “is the single
best guide to the meaning of a disputed term.”
Id. at 1315 (quoting Vitronics, 90 F.3d at
1582). “[T]he specification may reveal a special
definition given to a claim term by the patentee” or
“may reveal an intentional disclaimer, or disavowal, of
claim scope by the inventor.” Id. at 1316.
Thus, “the specification necessarily informs the proper
construction of the claims, ” and it is “entirely
appropriate for a court, when conducting claim construction,
to rely heavily on the written description for guidance as to
the meaning of the claims.” Id. at 1316-17.
Notably, however, the court may “not read limitations
from the specification into claims.” Thorner v.
Sony Computer Entm't Am. LLC, 669 F.3d 1362, 1366
(Fed. Cir. 2012). In particular, the Federal Circuit has
“repeatedly warned against confining the claims to . .
. embodiments” described in the specification.
Phillips, 415 F.3d at 1323.
court must also consider the patent's prosecution
history, i.e., “the complete record of the proceedings
before the PTO . . . includ[ing] the prior art cited during
the examination of the patent.” Id. at 1317.
Although the prosecution history “often lacks the
clarity of the specification and thus is less useful for
claim construction purposes, ” it can nevertheless
“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.
court may also rely on extrinsic evidence, i.e., “all
evidence external to the patent and prosecution history,
including expert and inventor testimony, dictionaries, and
learned treatises.” Id. But, extrinsic
evidence “is unlikely to result in a reliable
interpretation of patent claim scope unless considered in the
context of the intrinsic evidence.” Id. at
Indefiniteness at the Markman Stage
claims must “inform those skilled in the art about the
scope of the invention with reasonable certainty, ”
when read in light of the specification and prosecution
history. Nautilus, Inc. v. Biosig Instruments, Inc.,
134 S.Ct. 2120, 2129 (2014). A patent claim that fails to so
inform a POSA is indefinite. Teva Pharms. USA, Inc. v.
Sandoz, Inc., 789 F.3d 1335, 1340-41 (Fed. Cir. 2015).
“A party challenging the validity of a patent must
establish invalidity by clear and convincing evidence.”
Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283,
1294 (Fed. Cir. 2015) (citing Microsoft Corp. v. i4i Ltd.
P'ship, 131 S.Ct. 2238, 2242 (2011)). “Of
course, claims are not indefinite merely because they present
a difficult task of claim construction.”
Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d
1244, 1249-50 (Fed. Cir. 2008). Rather, “if the meaning
of the claim is discernible, even though the task may be
formidable and the conclusion may be one over which
reasonable persons will disagree, ” the claim is
sufficiently clear to avoid invalidity on indefiniteness
grounds. See id.
indefiniteness presents a question of law, and district
courts may find claims indefinite at the Markman
stage. See, e.g., Interval Licensing LLC v. AOL,
Inc., 766 F.3d 1364, 1368-74 (Fed. Cir. 2014) (affirming
the district court's indefiniteness ruling at claim
construction post-Nautilus); Mycone Dental
Supply Co. v. Creative Nail Design, Inc., No. 11-4380,
2014 WL 3362364, at *4 (D.N.J. July 9, 2014)
(“[I]ndefiniteness is a significant issue to be
adjudicated at claim construction . . .
Construction of Disputed Claim Terms
The ‘431 Patent Family
“Third Container Means”
17 of the ‘650 patent:
set of claim 15, comprising a third container means
capable of retaining a first container means, a second
container means, and one or more delivery vehicles capable of
administering the pharmaceutical composition to the
“a container distinct from a first and second
This is a means-plus-function term under 35 U.S.C.
§ 112 ¶ 6; and it is indefinite.
This is a means-plus-function term under 35 U.S.C.
§ 112 ¶ 6; and it is indefinite.
“Third Container Means” is a
threshold matter, the parties dispute whether “third
container means” is a means-plus-function limitation.
“A means-plus-function limitation recites a function to
be performed rather than definite structure or materials for
performing that function.” Lockheed Martin Corp. v.
Space Systems/Loral, Inc., 324 F.3d 1308, 1318 (Fed.
Cir. 2003). The relevant statutory language provides that
[a]n element in a claim for a combination may be expressed as
a means or step for performing a specified function without
the recital of structure, material, or acts in support
thereof, and such claim shall be construed to cover the
corresponding structure, materials, or acts described in the
specification and equivalents thereof.
35 U.S.C. § 112, ¶ 6.
the word “means” in claim language creates a
presumption that § 112, ¶ 6 applies. TriMed,
Inc. v. Stryker Corp., 514 F.3d 1256, 1259 (Fed. Cir.
2008). This presumption, however, can be rebutted in two
ways. Sage Prods., Inc. v. Devon Indus., Inc., 126
F.3d 1420, 1427 (Fed. Cir. 1997). First, “where a claim
uses the word ‘means, ' but specifies no function
for the ‘means, ' it does not implicate section
112.” Id. Second, “where a claim recites
a function, but then goes on to elaborate sufficient
structure, material, or acts within the claim itself to
perform entirely the recited function, the claim is not in
means-plus-function format.” Id. at 1427-28.
The second scenario applies here.
Federal Circuit has explained that “[s]ufficient
structure exists when the claim language specifies the exact
structure that performs the functions in question without
need to resort to other portions of the specification or
extrinsic evidence for an adequate understanding of the
structure.” TriMed, Inc., 514 F.3d at 1259-60.
Courts “decide on an element-by-element basis, based
upon the patent and its prosecution history, whether §
112, ¶ 6 applies.” Cole v. Kimberly-Clark
Corp., 102 F.3d 524, 531 (Fed. Cir. 1996).
argues that “third container means” is not a
means-plus-function limitation because the claims containing
that term recite sufficient structure. (Jazz Open. Br. at
5-8; Jazz Resp. Br. at 6-9). Specifically, Jazz contends that
the claims “describe a structure-a container-that is
used to hold other structures such as a first and second
container and delivery vehicles.” (Jazz Open. Br. at
8). According to Jazz, “Defendants recognize that the
terms ‘first container means' and ‘second
container means' recite sufficient structure because
Defendants do not contend that these terms fall under §
112, ¶ 6.” (Id.). And Jazz asserts that
the claims' functional description for “third
container means”-i.e., that the “third container
means” is “capable of” performing a
function-does not convert the term into a means-plus-function
counter that, as an initial matter, “third container
means” is presumed to be a means-plus-function
limitation because the claim contains the word
“means.” (Def. Open. Br. at 13; Def. Resp. Br. at
8). Defendants then argue that there is no evidence to rebut
this presumption, as the “claims plainly recite three
functions for the ‘third container means' and do
not describe any contemplated structure to perform those
functions.” (Def. Open. Br. at 13). In fact, according
to Defendants, “there is no explicit structure at
all recited for the ‘third container
means.'” (Id. at 14) (emphasis in
original). Rather, Defendants argue that “the word
‘container' conveys the general function of
containing, not a specific structure.” (Id. at
15). Defendants further argue that “even if
‘container' could reasonably refer to some endless
category of structures, it is far from sufficient to rebut