United States District Court, D. Delaware
me is a patent infringement case wherein Plaintiff Shire
ViroPharma Incorporated (“Plaintiff”) alleges
that Defendants CSL Behring LLC and CSL Behring GMBH
(collectively, “Defendant”) has infringed
Plaintiff's U.S. Patent No. 9, 616, 111 through the
development and marketing of Defendant's drug
Haegarda®. The parties currently seek construction of
two of the patent's disputed terms pursuant to
Markman v. Westview Instruments, Inc., 52 F.3d 967,
976 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996)
(“Markman”). The disputed claim terms are
construed as indicated in this Memorandum and accompanying
angioedema (“HAE”) is a rare genetic disorder
causing insufficient natural production of functional or
adequate amounts of a protein called C1 esterase inhibitor
(“C1-INH”). This protein helps to regulate
several complex processes involved in immune system function
and fibrinolytic system function. HAE exists in two forms.
Type I occurs where the individual produces either no or low
C1-INH. Type II is present where the individual has the
normal amount of C1-INH, but it does not properly function.
suffering from HAE experience symptoms including
unpredictable, recurrent attacks of swelling commonly
affecting the hands, feet, arms, legs, face, abdomen, tongue,
genitals, and larynx. Currently, only approximately 6, 500
people in the United States suffer from this condition.
be treated by administration of a drug containing a C1
esterase inhibitor in order to restore the levels of C1-INH
to levels sufficient to prevent or reduce the frequency or
severity of HAE attacks. HAE can be treated either
acutely-meaning immediate treatment of an HAE attack in order
to slow it down or stop it altogether-or
prophylactically-meaning administration of a medication on a
regular basis to prevent attacks.
The ‘111 Patent
April 11, 2017, the United States Patent and Trademark Office
(“PTO”) issued U.S. Patent No. 9, 616, 111 (the
“‘111 patent”), entitled “C1-INH
Compositions and Methods for the Prevention and Treatment of
Disorders Associated with C1 Esterase Inhibitor
Deficiency.” The ‘111 patent is directed to
methods of treating hereditary angioedema
A method for treating hereditary angioedema
(HAE) said method comprising subcutaneously administering to
a subject in need thereof a composition comprising a C1
esterase inhibitor, a buffer selected from citrate or
phosphate, and having a pH ranging from 6.5-8.0, wherein the
C1 esterase inhibitor is administered at a concentration
of at least about 400 U/mL and a dose of at
least about 1000 U and wherein the administration of the
composition comprising the C1 esterase inhibitor increases
the level of C1 esterase inhibitor in the blood of the
subject to at least about 0.4 U/mL, and wherein the C1
esterase inhibitor comprises an amino acid sequence at least
95% identical to residues 23 of 500 of SEQ ID NO:1.
(‘111 Patent, col. 13, lines 13-25 (emphasis added).)
remaining asserted claims depend from claim 1. Several of
these dependent claims are also at issue here. Claim 3
recites: “[t]he method of claim 1, wherein the
composition is administered daily, every other day, or every
three days.” (Id., col. 13, lines 29-30.)
Claim 4 recites: “[t]he method of claim 1, wherein the
composition is administered one, two, or three times a
week.” (Id., col. 13, lines 31-32.) Claims 7,
8, and 9 state:
7. The method of claim 1, wherein the administration of the
composition comprising a C1 esterase inhibitor results in HAE
8. The method of claim 1, wherein the administration of the
composition comprising a C1 esterase inhibitor results in
treatment of an HAE attack.
9. The method of claim 1, wherein the administration of the
composition results in at least a reduction in the severity
and/or number of HAE attacks.
(Id., col. 13, line 38-col. 14, line 18.) Finally,
claim 15 teaches “[t]he method of claim 1, wherein the
administration of the composition comprising the C1 esterase
inhibitor increases the level of C1 esterase inhibitor in the
blood of the subject up to about 1 U/mL.” (Id.
col. 14, lines 30-33.)
to the Second Amended Complaint, on July 25, 2017, Defendants
began U.S. sales of a prophylactic C1 esterase inhibitor
treatment for subcutaneous administration. Defendants
marketed the new C1 esterase inhibitor product as
“HAEGARDA, ” which received FDA approval on June
22, 2017. Defendants immediately issued a press release
announcing the availability of HAEGARDA in the United States.
(Sec. Am. Compl. ¶¶ 20-21.) The HAEGARDA product
label instructs, in part, that the drug is a
“plasma-derived concentrate of C1 Esterase Inhibitor
(Human)” to be used for “routine prophylaxis to
prevent Hereditary Angioedema (HAE) attacks in adolescent and
adult patients.” (Id. ¶ 24.) The label
further directs HAEGARDA's self-administration by
subcutaneous injection. (Id. ¶¶ 20-21, 24,
initiated this action on April 11, 2017, the same day that
the ‘111 patent issued. It filed its Second Amended
Complaint on August 24, 2017, alleging direct infringement,
inducement of infringement, contributory infringement, and
18, 2018, the parties submitted opening claim construction
briefs setting forth their positions on two disputed terms in
the ‘111 patent. I held a Markman hearing
regarding these terms on September 12, 2018. Having fully
reviewed the parties' briefing and evidentiary
submissions, I now set forth the legal construction of the
disputed claim terms.
STANDARD OF REVIEW
first step in a patent infringement analysis is to define the
meaning and scope of the claims of the patent.
Markman, 52 F.3d at 976. Claim construction, which
serves this purpose, is a matter of law exclusively for the
court. Id. at 979. “‘[T]here is no magic
formula or catechism for conducting claim construction.'
Instead, the court is free to attach the appropriate weight
to appropriate sources ‘in light of the statutes and
policies that inform patent law.'” SoftView LLC
v. Apple Inc., No. 10-389, 2013 WL 4758195, at *1 (D.
Del. Sept. 4, 2013) (quoting Phillips v. AWH Corp.,
415 F.3d 1303, 1324 (Fed. Cir. 2005)).
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, 415 F.3d at
1312 (internal quotation marks omitted). The focus of a
court's analysis must therefore begin and remain on the
language of the claims, “for it is that language that
the patentee chose to use to ‘particularly point[ ] out
and distinctly claim[ ] the subject matter which the patentee
regards as his invention.'” Interactive Gift
Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331
(Fed. Cir. 2001) (quoting 35 U.S.C. § 112, & 2). The
terms used in the claims bear a “heavy
presumption” that they mean what they say and have
their ordinary and customary meaning. Texas Digital Sys.,
Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202 (Fed. Cir.
2002). That ordinary meaning “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.”
Phillips, 415 F.3d at 1313.
a person of ordinary skill in the art would not understand
the ordinary and customary meaning of a claim term in
isolation. As such, the ordinary meaning may be derived from
a variety of sources including intrinsic evidence, such as
the claim language, the written description, drawings, and
the prosecution history; as well as extrinsic evidence, such
as dictionaries, treatises, or expert testimony. Dow
Chem. Co. v. Sumitomo Chem. Co., Ltd., 257 F.3d 1364,
1373 (Fed. Cir. 2001).
“most significant source” of authority is
“the intrinsic evidence of record, i.e., the patent
itself, including the claims, the patent
specification and, if in evidence, the prosecution
history.” Vitronics Corp. v. Conceptronic,
Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996); see also
Phillips, 415 F.3d at 1313 (holding that a person of
ordinary skill in the art is deemed to read the claim terms
in the context of the entire patent, including the
specification). The specification “is the single best
guide to the meaning of a disputed term” and is usually
dispositive as to the meaning of words. Vitronics,
90 F.3d at 1582. Although it is improper to import
limitations from the specification into the claims,
“one may look to the written description to define a
term already in a claim limitation, for a claim must be read
in view of the specification of which it is a part.”
Renishaw PLC v. Marposs Societa' per Azioni, 158
F.3d 1243, 1248 (Fed. Cir. 1998). On occasion, “the
specification may reveal a special definition given to a
claim term . . . that differs from the meaning it would
otherwise possess. In such cases, the inventor's
lexicography governs.” Phillips, 415 F.3d at
1316. The specification may also “reveal an intentional
disclaimer, or disavowal, of claim scope by the inventor . .
. [, which] is regarded as dispositive.” Id.
“The 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, 158 F.3d at 1250.
court “should also consider the patent's
prosecution history, if it is in evidence.”
Markman, 52 F.3d at 980. This consists of “the
complete record of proceedings before the Patent Office and
includes the prior art cited during examination.”
Phillips, 415 F.3d at 1317. “Like the
specification, the prosecution history provides evidence of
how the [Patent and Trademark Office] and the inventor
understood the patent.” Id. at 1317.
Nonetheless, it is the least probative form of intrinsic
evidence because it “represents an ongoing negotiation
between the PTO and the applicant, rather than the final
product of that negotiation.” Id.
ambiguity still exists after considering all the intrinsic
evidence, the court may rely on extrinsic evidence, which is
“all evidence external to the patent and prosecution
history, including expert and inventor testimony,
dictionaries, and learned treatises.” Markman,
52 F.3d at 980. “[D]ictionaries, and especially
technical dictionaries, . . . have been properly recognized
as among the many tools that can assist the court in
determining the meaning of particular terminology.”
Phillips, 415 F.3d at 1318. Additionally, expert
testimony can provide background on the technology at issue,
explain how it works, speak to what a person of ordinary
skill in the art would understand, and establish that a
particular term has a particular meaning in the pertinent
field. Id. Notably, however, extrinsic evidence is
“less significant than the intrinsic record in
determining ‘the legally operative meaning of claim
language.'” C.R. Bard, Inc. v. U.S. Surgical
Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (quoting
Vanderlande Indus. Nederland BV v. Int=l Trade
Comm=n, 366 F.3d 1311, 1318 (Fed. Cir. 2004)).
during claim construction, “[t]he sequence of steps
used by the judge in consulting various sources is not
important; what matters is for the court to attach the
appropriate weight to be assigned to those sources in light
of the statutes and policies that inform patent law.”
Phillips, 415 F.3d at 303.
claim terms of the ‘111 patent are in dispute.
Specifically, the parties disagree on the correct
construction of (1) the phrase “treating hereditary
angioedema” and (2) the phrase “increases the
level of C1 esterase inhibitor in the blood of the subject up
to about 1 U/mL.” I address each claim term below.
first disputed claim term is the phrase “treating
hereditary angioedema, ” which appears in claim 1 of
the ‘111 patent. (‘111 patent, col. 13, line 13.)
Plaintiff proposes the following construction:
[A]ny type of treatment that imparts a benefit to a patient
afflicted with HAE, including improvement in the condition of
the patient (e.g., in one or more symptoms), delay in the
progression of the condition, etc. In a particular
embodiment, the treatment of HAE results in at least a
reduction in the severity and/or number of HAE attacks.
(Pl.'s Opening Claim Constr. Br. 4.) Defendant offers a
different proposed construction:
[I]mparting a benefit to a patient experiencing HAE symptoms,
including improvement in one or more of the symptoms
associated with HAE or delaying the progression of the
severity of HAE symptoms, wherein such treatment does not
include inhibiting or preventing HAE symptoms.
(Def.'s Opening Claim Constr. Br. 7.)
distinction between these two proposals lies in the precise
definition of the word “treating.” Plaintiff
posits that “treating” encompasses both acute and
prophylactic care, whereas Defendant urges that
“treating” is limited to purely acute care.
Considering the various sources identified by the parties and
for the following reasons, I will adopt Plaintiff's
The Definitions Section
specification is the single best guide to the meaning of a
disputed term.” Pressure Prods. Med. Supplies, Inc.
v. Greatbatch Ltd., 599 F.3d 1308, 1314-15 (Fed. Cir.
2010) (quotations omitted). “When a patentee explicitly
defines a claim term in the patent specification, the
patentee's definition controls.” Martek
Biosicences Corp. v. Nutrinova, Inc., 579 F.3d 1364,
1380 (Fed. Cir. 2009); see also 3M Innovative Props. Co.
v. Avery Dennison Corp., 350 F.3d 1365, 1374 (Fed. Cir.
2003) (“Because 3M expressly acted as its own
lexicographer by providing a definition of embossed in the
specification, the definition in the specification controls
the meaning of embossed, regardless of any potential conflict
with the term's ordinary meaning as reflected in
technical dictionaries.”); Jack Guttman, Inc. v.
Kopykake Enters., Inc., 302 F.3d 1352, 1360 (Fed. Cir.
2002) (“Where . . . the patentee has clearly defined a
claim term, that definition ‘[u]sually . . . is
dispositive;' it is the single best guide to the meaning
of a disputed term.”) (quotations omitted).
the ‘111 patent specification contains a separate
“Definitions” section designed to ascribe precise
meanings to certain terms within the claims. Although the
specific term “treating” is not defined, the verb
form “treat” is among the listed definitions. The
The term “treat” as used herein refers to any
type of treatment that imparts a benefit to a patient
afflicted with a disorder, including improvement in the
condition of the patient (e.g., in one or more of the
symptoms), delay in the progression of the condition, etc. In
a particular embodiment, the treatment of HAE results in at
least a reduction in the severity and/or number of HAE
(‘111 patent, col 6, lines 39-45.) As the definition
specifically refers to “any type of
treatment” imparting a benefit to a patient with HAE
and explicitly states that “treatment” includes
“at least a reduction in the severity and/or number of
HAE attacks, ” it seemingly includes both acute and
effort to rebut this broad language, Defendant remarks that
the “Definitions” section separately defines the
word “prevent” to mean:
[T]he prophylactic treatment of a subject who is at risk of
developing a condition (e.g., HAE or HAE attack) resulting in
a decrease in the probability that the subject will develop
(‘111 patent, col 6, lines 35-38.) It posits that
“[t]he Federal Circuit has consistently . . . [held]
that when two terms are defined differently in the
specification, one term cannot be construed to encompass the
definition of the second term.” (Def.'s Answering
Cl. Constr. Br. 4 (citing Speedtrack, Inc. v. Endeca
Techs., Inc., 524 Fed.Appx. 651, 656 (Fed. Cir. 2013);
Trintec Indust., Inc. v. Top-U.S.A. Corp., 295 F.3d
1292, 1296-97 (Fed. Cir. 2002).) Defendant goes on to argue
that because these distinct definitions of
“treat” and “prevent” do not overlap,
they necessarily create a distinction between acute treatment
and prophylactic therapy, the latter of which is not included
in claim 1.
argument is not supported by the specification as a whole. As
a general notion, there is a presumption that different terms
in a claim have different meanings. Chicago Bd. Options
Exchange, Inc. v. Int'l Secs. Exchange, LLC, 677
F.3d 1361, 1369 (Fed. Cir. 2012); accord Primos, Inc. v.
Hunter's Specialities, Inc., 451 F.3d 841, 848 (Fed.
Cir. 20016). “However, simply noting the difference in
the use of claim language does not end the matter. Different
terms or phrases in separate claims may be construed to cover
the same subject matter where the written description and
prosecution history indicate that such a reading of the terms
or phrases is proper.” Nystrom v. TREX Co.,
424 F.3d 1136, 1143 (Fed. Cir. 2005); see also Edwards
Lifesciences LLC v. Cook Inc., 582 F.3d 1322, 1330 (Fed.
Cir. 2009) (holding that the terms “graft, ”
“graft structure, ” “bifurcated base
structure, ” and “bifurcated base graft
structure” have the same meaning where they were
“used interchangeably in the specification and the
claims”); Hyperphrase Techs., LLC v. Google,
Inc., 260 F App'x 274, 278 (Fed. Cir. 2007) (noting
that the terms “data reference, ” “record
reference, ” “specifying reference, ” and
“reference” were interchangeable); St. Clair
Intellectual Prop Consultants, Inc. v. Acer, Inc., Nos.
09-354, 09-705, 10-282, 2012 WL 3536454, at *9 (D. Del. Aug.
7, 2012) (finding terms “mode” and
“state” could be used interchangeably).
the express language used in the Definitions section
overcomes any presumption that “treat” and
“prevent” have mutually exclusive meanings. The
definition of “treat” is “any form of
treatment that imparts a benefit to a patient afflicted
with a disorder, ” such as HAE. This includes prophylactic
treatment. Thereafter, “prevent” is defined as
“the prophylactic treatment of a subject who
is at risk of developing a condition, ” such as HAE or
an HAE attack. Contrary to Defendant's argument,
“prophylactic treatment” of a person who is at
risk of having an HAE attack is a subset of “any type
of treatment” for a person with HAE. In other words,
the definitions are not mutually exclusive, but rather appear