United States District Court, D. Delaware
SANOFI-AVENTIS U.S. LLC, et al., Plaintiffs,
MERCK SHARP & DOHME CORP., Defendant.
Douglas E. McCann, Martina Tyreus Hufnal, Ronald P. Golden
III, FISH & RICHARDSON P.C., Wilmington, DE; John S.
Goetz (argued), Brian D. Coggio, FISH & RICHARDSON P.C.,
New York, NY; Ahmed J. Davis, Min Woo Park, Sarah M. Cork,
FISH & RICHARDSON P.C., Washington, DC; Matt Colvin, FISH
& RICHARDSON P.C., Dallas, TX; D. Michael Underhill
(argued), Jon R. Knight, BOIES SCHILLER & FLEXNER LLP,
Washington, DC; William D. Marsillo, Alex Potter, BOIES
SCHILLER & FLEXNER LLP, Armonk, NY; Bill Ward, Martin
Ellison, BOIES SCHILLER & FLEXNER LLP, Santa Monica, CA.
Attorneys for Plaintiffs
G. Connolly III, Ryan P. Newell, Mary Akhimien, CONNOLLY
GALLAGHER LLP, Wilmington, DE; Raymond N. Nimrod (argued),
Brian P. Biddinger, Gregory D. Bonifield (argued), John P.
Galanek, Amanda K. Antons, Matthew Traupman (argued), QUINN
EMANUEL URQUHART & SULLIVAN, LLP, New York, NY. Attorneys
ANDREWS, U.S.TMSTRICT JUDGE
before the Court is the issue of claim construction of
multiple terms in U.S. Patent Nos. 8, 603, 044 (the
'"044 patent"), 8, 679, 069 (the '"069
patent"), 8, 992, 486 (the '"486 patent"),
9, 526, 844 (the '"844 patent"), 9, 533, 105
(the '"105 patent"), 9, 457, 152 (the
'"152 patent"), 9, 592, 348 (the '"348
patent"), 7, 476, 652 (the '"652 patent"),
7, 713, 930 (the '"930 patent"), and 9, 604,
008 (the '"008 patent"). The Court has
considered the parties' joint claim construction brief.
(D.I. 127). The Court heard oral argument on November 6,
2017. (D.I. 164) ("Tr.").
September 16, 2016, Plaintiffs filed this action against
Defendant Merck Sharp & Dohme Corp. alleging infringement
often patents. (D.I. 1). With the Court's permission,
Plaintiffs filed First Amended (D.I. 58) and Second Amended
(D.I. 93) complaints on April 5, 2017 and June 28, 2017,
respectively, in which they asserted additional patents. The
patents-in-suit generally relate to a diabetes
pharmaceutical, or to pen-type injectors used to administer
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. AWHCorp.,
415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc).
'"[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., 2013 WL
4758195, at *1 (D. Del. Sept. 4, 2013) (quoting
Phillips, 415 F.3d at 1324) (alteration in
original). When construing patent claims, a court considers
the literal language of the claim, the patent specification,
and the prosecution history. Marhnan v. Westview
Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995)
(en banc), aff'd, 517 U.S. 370 (1996). Of these
sources, "the 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." Phillips, 415 F.3d at 1315.
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. "[T]he ordinary meaning of a
claim term is its meaning to [an] ordinary artisan after
reading the entire patent." Id. at 132.
"In some cases, the ordinary meaning of claim language
as understood by a person of skill in the art may be readily
apparent even to lay judges. and claim construction in such
cases involves little more than the application of the widely
accepted meaning of commonly understood words."
Id. at 1314.
court relies solely upon the intrinsic evidence-the patent
claims, the specification, and the prosecution history-the
court's construction is a determination of law. See
Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831,
841 (2015). The court may also make factual findings based
upon consideration of extrinsic evidence, which
"consists of all evidence external to the patent and
prosecution history, including expert and inventor testimony,
dictionaries, and learned treatises." Phillips,
415 F.3d at 1317-19. Extrinsic evidence may assis the court
in understanding the underlying technology, the meaning of
terms to one skilled in the art, and how the invention works.
Id. Extrinsic evidence, however, is less reliable
and less useful in claim construction than the patent and its
prosecution history. Id.
claim construction is persuasive, not because it follows a
certain rule, but because it defines terms in the context of
the whole patent." 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).
CONSTRUCTION OF DISPUTED TERMS
"chemical entity" ('652 patent, claims 1, 2, 7,
17, 18, 19, 23, 24; '930 patent, claims 1, 14, 15,
Plaintiffs' proposed construction: no
construction necessary; plain and ordinary meaning
Defendant's proposed construction:
"surfactant that stabilizes the formulation, in a
concentration of 5-200 ng/rnL"
Court's construction: no construction necessary;
plain and ordinary meaning Plaintiffs argue the Court need
not construe the term "chemical entity" because its
plain and ordinary meaning is apparent to a person of
ordinary skill in the art. (D.I. 127 at 14). They fault
Defendant for "attempt[ing] to re-write the claim
entirely." (Id. at 15). Defendant's
proposed construction, according to Plaintiffs, improperly
imports into the claims a function and a limitation from the
specification. (Id). Plaintiffs also assert that
Defendant's proposed construction runs afoul of the claim
differentiation doctrine. (Id. at 16).
responds by arguing that the scope of the claims is limited
in two principal ways. First, Defendant argues the scope is
limited by the "present invention" description in
the specification, which according to Defendant, makes clear
the invention requires that the "chemical entity"
be present in an amount sufficient to stabilize the
formulation, that is, in a concentration of 5-200 μg/ml.
(Id. at 19). Defendant primarily relies upon the
following sentence from the "detailed description of the
invention" in the '652 patent: "The surfactants
are present in the pharmaceutical composition in a
concentration of 5-200 μg/ml, preferably 5-120 ug/ml and
particularly preferably of 20-75 μg/ml." (See
Id. at 18; Tr. at 18:10-14). Second, Defendant argues
the scope of the '652 patent is limited by disavowal.
Specifically, Defendant argues that because the "patent
specification distinguished two prior art references on the
basis that they did not describe surfactants that provided
'stabilization in an acidic solution, '" the
term should "be construed to require an amount
sufficient to stabilize the preparation." (D.I. 127 at
20). Finally, Defendant asserts that Plaintiffs'
statements during patent prosecution provide another basis
upon which to find disavowal of claim scope. (Id.).
not persuaded by Defendant's argument that Plaintiffs
have limited the scope of the claims by disavowal such that
the surfactant in the claims must "stabilize  the
formulation, in a concentration of 5-200 μg/ml." A
patentee may disavow claim scope through a description in the
specification of the "present invention." E.g.,
Luminara Worldwide, LLC v. Liown Elecs. Co. Ltd., 814
F.3d 1343, 1353 (Fed. Cir. 2016). To do so, however, the
patentee must make "clear and unmistakable statements ..
. that limit the claims, such as 'the present invention
includes . . .' or 'the present invention is . .
.' or 'all embodiments of the present invention are.
. ..'" Id. "When a patentee
'describes the features of the present invention as a
whole, ' he implicitly alerts the reader that 'this
description limits the scope of the invention.'"
opinion, the patentee has not done so here. The sentence upon
which Defendant primarily relies is far from a "clear
and unmistakable" statement limiting the claims. See
Id. The sentence begins, "The surfactants are
present in the pharmaceutical composition . . . ."
('652 patent, 3:55-56). It does not purport to describe
"features of the present invention as a whole, "
Luminara, 814 F.3d at 1353, and, in fact, it never
refers to the "present invention" at all. Rather,
when read in context, the sentence cannot properly be
understood to limit the claims. The entire paragraph
generally relates to the types of surfactants that "can
be used" or are "preferred." (See
'652 patent, 3:50-56). Nor do any of the other portions
of the specification upon which Defendant relies constitute
"clear and unmistakable" statements limiting the
claims. Luminara, 814 F.3d at 1353. Those portions
generally refer to the object or goals of the invention, and,
accordingly, cannot be characterized as unambiguous
statements of disavowal. (See D.I. 127 at 18
(quoting '652 patent, 3:32-36)).
I am not persuaded that Plaintiffs have disavowed claim scope
by "distinguishing] or disparag[ing] prior art based on
the absence of [a particular] feature." Poly-Am.,
L.P v. API Indus., Inc., 839 F.3d 1131, 1136 (Fed. Cir.
2016). The standard for finding disavowal is
"exacting." GE Lighting Sols., LLC v. AgiLight,
Inc., 750 F.3d 1304, 1309 (Fed. Cir. 2015). "To
find disavowal, [the court] must find that the specification
is 'both so clear as to show reasonable clarity and
deliberateness, and so unmistakable as to be unambiguous
evidence of disclaimer.'" Openwave Sys., Inc. v.
Apple Inc., 808 F.3d 509, 513 (Fed. Cir. 2015).
opinion, it is not clear that Plaintiffs distinguished prior
art references WO 00/23098 and WO 02/076495 on the basis that
they do not describe "stabilization by the
surfactant." (See D.I. 127 at 19-20). The
prosecution history indicates that Plaintiffs distinguished
those references on the basis that they "do not
describe the stabilization in an acidic solution."
(Id. at 26). Plaintiffs argue, therefore, that the
present invention was distinguished from the prior art by
"pH and insulin type, not stabilization."
(Id.). I do not think the prosecution history is
entirely clear on this point. In any event, where the reason
for distinguishing the prior art is ambiguous, there can be
no basis for concluding that Plaintiffs clearly and
deliberately disavowed claim scope. See Openwave,
808 F.3d at 513. Similarly, it is not clear that Plaintiffs
distinguished prior art references before the patent examiner
on the basis that they did not disclose a formulation that
would be stable. For the same reasons, therefore, I find
Plaintiffs have not disavowed claim scope through their
statements during patent prosecution.
I agree with Plaintiffs that Defendant's proposed
construction runs afoul of the claim differentiation
doctrine. Under the doctrine, there is "a presumption
that distinct claims, particularly an independent claim and
its dependent claim, have different scopes." World
Class Tech. Corp. v. Ormco Corp., 769 F.3d 1120, 1125
(Fed. Cir. 2014); see also Am. Med. Sys., Inc. v.
Biolitec, Inc., 618 F.3d 1354, 1360 (Fed. Cir. 2010)
("Under the doctrine of claim differentiation, 
dependent claims give rise to a presumption that the broader
independent claims are not confined to that range."
the asserted independent claims do not include concentration
limitations, while dependent claims in the '652 and
'930 patents recite several specific ranges. These ranges
include 5-200 μg/ml, required by Defendant's proposed
construction, as well as 5-120 |ag/ml and 20-75 μg/ml.
('652 patent, 12:13-18; '930 patent, 12:36-41).
Defendant's proposed construction would render
meaningless the difference in scope between these claims.
Contrary to Defendant's contentions, this is not a case
where claim differentiation is "overcome by a contrary
construction dictated by the written description or
prosecution history." Seachange Int'l, Inc. v.
C-COR, Inc., 413 F.3d 1361, 1369 (Fed. Cir. 2005).
I will not adopt Defendant's proposed construction. I
conclude that no construction is needed for the term
"chemical entity." It will be construed according
to its plain and ordinary meaning.
"housing" ('844 patent, claim 21; '105
patent, claims 1, 4; '008 patent, claims 1, 3, 6,
parties included the term "housing" in their joint
claim construction brief. However, Defendant has agreed to
Plaintiffs' proposed construction. (D.I. 127 at 36 n.
10). Thus, there is no need for the Court to construe this
"main housing" / "external housing"
('044 patent, claims 1, 2, 3, 8-11, 20; '069 patent,
claims 1, 2; '486 patent, claims 1, 3, 4, 26-28, 31, 35,
38-39, 43-45, 48)
Plaintiffs 'proposed construction: "an
exterior unitary or multipart component configured to house,
fix, protect, guide and/or engage with one or more inner
Defendant's proposed construction: "single,
indivisible component that is an external case or
Court's construction: "an exterior unitary
or multipart component configured to house, fix, protect,
guide and/or ...