United States District Court, D. Delaware
ENZO LIFE SCIENCES, INC., Plaintiff.
HOLOGIC INC., GRIFOLS DIAGNOSTICS SOLUTIONS, INC., and GRIFOLS, S.A., Defendants.
E. Farnan, Michael J. Faman, FARNAN LLP, Wilmington, DE John
M. Desmarais, Michael P. Stadnick, Justin P.D. Wilcox, Jordan
Malz, Peter C. Magic, Kerri-Ann Limbeek, DESMARAIS LLP, New
York, NY Attorneys for Plaintiff Enzo Life Sciences, Inc.
L. Pascale, Pilar G. Kraman, YOUNG CONAWAY STARGATT &
TAYLOR LLP, Wilmington, DE Matthew M. Wolf, ARNOLD &
PORTER KAYE SCHOLER LLP, Washington, DC Jennifer Skelnar,
Wallace Wu, ARNOLD & PORTER KAYE SCHOLER LLP, Los
Angeles, CA Marty Koresawa, ARNOLD & PORTER KAYE SCHOLER
LLP, San Francisco, CA Attorneys for Defendants Hologic Inc.,
Grifols Diagnostics Solutions, Inc., and Grifols, S.A.
U.S. DISTRICT JUDGE
Enzo Life Sciences, Inc. ("Plaintiff) sued Defendants
Hologic, Inc., Grifols Diagnostics Solutions, Inc., and
Grifols S.A. (collectively, "Defendants"), alleging
that Defendants infringe Plaintiffs U.S. Patent No. 6, 221,
581 ('"581 patent"). (See generally
D.I. 28-1) The patent relates to "[n]uclei acid
hybridization assays" that are "detection processes
in which target polynucleotides can be detected or the
presence or absence of genetic mutations or defects in
genetic material can be determined" using "[d]ouble
hybrid or multihybrid probes." '581 patent,
before the Court are the parties' disputes over the
meaning of certain claim terms in the asserted claims. The
parties submitted technology tutorials (D.I. 88, 89),
comments on the opposing side's technology tutorial (D.I.
96, 99), and claim construction briefs (D.I. 83, 84, 95, 97).
The Court held a claim construction hearing on July 2, 2018.
(See D.I. 115 ("Tr.")) Thereafter, on
August 17, the parties provided their updated positions on
one disputed term. (D.I. 127)
ultimate question of the proper construction of a patent is a
question of law. See Teva Pharm. USA, Inc. v. Sandoz,
Inc., 135 S.Ct. 831, 837 (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).
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 statutes and policies that
inform patent law." Id.
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).
"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).
likewise true that "[differences 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).
also possible that "the specification may reveal a
special definition given to a claim 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).
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),
aff'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.
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 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
"[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 GmbH v. Int'l Trade
Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007)
(quoting Modine Mfg. Co. v. U.S. Int'l Trade
Comm'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
patent claim is 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." Nautilus, Inc. v. Biosig
Instruments, Inc., 134 S.Ct. 2120, 2129 (2014). A claim
may be indefinite if the patent does not convey with
reasonable certainty how to measure a claimed feature.
See Teva Pharm. USA, Inc. v. Sandoz, Inc., 789 F.3d
1335, 1341 (Fed. Cir. 2015). But "[i]f such an
understanding of how to measure the claimed [feature] was
within the scope of knowledge possessed by one of ordinary
skill in the art, there is no requirement for the
specification to identify a particular measurement
technique." Ethicon Endo-Surgery, Inc. v. Covidien,
Inc., 796 F.3d 1312, 1319 (Fed. Cir. 2015).
CONSTRUCTION OF DISPUTED TERMS
'581 patent is entitled "Processes for Detecting
Polynucleotides, Determining Genetic Mutations or Defects in
Genetic Material, Separating or Isolating Nucleic Acid of
Interest from Samples, and Useful Compositions of Matter and
Multi-hybrid Complex Compositions." The claimed
invention relates to "methods for the detection of a
target genetic material having a desired base sequence or
gene" and "methods for the detection of mutations,
such as a point mutation or the detection of a gene or
base." '581 patent, 1:18-23. It is "based upon
techniques which utilize two labeled single stranded
polynucleotide segments which are complementary to the same
or the opposite strands of the target genetic material."
Id. 1:24-27. According to the patent, this process
"result[s] in the formation of a double hybrid and/or a
multihybrid." Id. 1:27-29.
"A multihybrid complex composition which comprises three
or more nucleic acid strands and two or more separate and
mutually exclusive hybrids in said
complex"/"A process for forming the
multihybrid complex composition of claim
Plaintiff the preamble is not
Defendants the preamble is
Court the preamble is limiting
argues that the preamble is not limiting because "the
body of claim 123 provides a structurally complete
formulation of the invention" (D.I. 84 at 4) and the
preamble "is not necessary to understand[ing] the
[claim] limitations" (D.I. 97 at 2). Defendants argue
that the preamble is limiting because it provides an
antecedent basis for an element recited in the body of the
claim and "breathes 'life and meaning' into the
claimed invention" (D.I. 83 at 4), as the
"purported invention was a particularly defined
multihybrid composition, not a generic composition with
multiple hybrids" (D.I. 95 at 3).
preamble is generally construed to be limiting if it recites
essential structure or steps, or if it is necessary to give
life, meaning, and vitality to the claim." Proveris
Sci. Corp. v. Innovasystems, Inc., 739 F.3d 1367, 1372
(Fed. Cir. 2014) (internal quotation marks omitted). A
preamble may be construed as limiting "when it recites
particular structure or steps that are highlighted as
important by the specification" and when
"limitations in the body of the claim rely upon and
derive antecedent basis from the preamble, [which] then . . .
may act as a necessary component of the claimed
patent-in-suit, formation of a "multihybrid
complex" is an important characteristic of the
invention. It is mentioned in the title ("multihybrid
complex compositions") and the abstract ("Double
hybrid or multihybrid probes and compositions are usefully
combined with capture assay and immobilization to provide for
detection processes . . . ."). All three of the
patent's figures illustrate the formation of a
multihybrid and describe it as essential to the claimed
invention. See '581 patent, Fig. 1 (showing
"[h]ybridization to form the multihybrid" as final
step); id. Fig. 2 (same); id. Fig. 3
(same); see also Id. 2:45-3:18 ("Brief
description of the Figures" describing figures depicting
various embodiments and noting, "[w]hen the method of
the invention is carried out. . . numerous single stranded
polynucleotide segments . . . hybridize ... to form the
the specification expressly defines the multihybrid and makes
numerous references to it. See Id. 3:38-44
("double hybrid can be interconnected so as to form a
multihybrid (hereinafter referred to as the
'multihybrid')"); see also, e.g., Id.
5:37-43 ("formation of the multihybrid due to the
particles bridging the double hybrids . . . [that] forms a
precipitate or glob or glob-like structure which itself is
much more readily detectable than the double hybrid");
id. 12:26-50 (explaining how invention can be used
to detect different types of ...