United States District Court, D. New Jersey
SANOFI-AVENTIS U.S. LLC et al., Plaintiffs,
MYLAN GMBH et al., Defendants.
OPINION & ORDER
STANLEY R. CHESTER, U.S.D.J.
matter comes before the Court on the application for claim
construction by Plaintiffs Sanofi Aventis U.S. LLC,
Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop
Industrie ("Sanofi") and Defendants Mylan GmbH,
Biocon Research Ltd., Biocon S.A., and Biocon Sdn. Bhd.
(collectively, "Mylan"). In this patent
infringement action, the parties seek construction of claim
terms in six U.S. Patents. For the reasons that follow, this
Court finds that, with the exception of "thread,"
where Defendants' proposed construction is unopposed,
neither party has overcome the presumption that the claim
terms carry their ordinary meaning.
case arises from a patent infringement dispute involving a
set of pharmaceutical patents related to a diabetes
treatment. Plaintiffs own U.S. Patent Nos. 7, 476, 652 and 7,
713, 930 (the "formulation patents") and U.S.
Patent Nos. 8, 603, 044; 8, 679, 069; 8, 992, 486; and 9,
526, 844 (the "device patents"). The formulation
patents, generally, are directed to insulin formulations;
Sanofi markets such formulations under the Lantus® brand
name. The device patents, generally, are directed to
prefilled delivery pen devices that are used to inject
medication into the body; Sanofi markets such devices under
the Lantus SoloSTAR® brand name. Defendants have
submitted a 505(b)(2) New Drug Application seeking FDA
approval to market products which, Plaintiffs contend,
infringe these patents.
parties' briefs refer to claim construction decisions in
two cases before Judge Andrews in the District of Delaware,
Sanofi-Aventis U.S. LLC v. Eli Lilly & Co.,
14-cv-l 13 (RGA) (D. Del.) ("the Lilly case") and
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme
Corp., 16-cv-812 (RGA) (D. Del.) ("the
Merck case"). In these cases, Sanofi asserted
some of the formulation and device patents at issue against
The law of claim construction
court's determination "of patent infringement
requires a two-step process: first, the court determines the
meaning of the disputed claim terms, then the accused device
is compared to the claims as construed to determine
infringement." Acumed LLC v. Stryker Corp., 483
F.3d 800, 804 (Fed. Cir. 2007). "[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." Teva
Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841
focus of claim construction is the claim language itself:
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. Attending this principle, a claim
construction analysis must begin and remain centered on the
claim language itself, for that is the language the patentee
has chosen to 'particularly point out and distinctly
claim the subject matter which the patentee regards as his
Innova/Pure Water, Inc. v. Safari Water Filtration
Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir. 2004)
Federal Circuit has established this framework for the
construction of claim language:
We have frequently stated that the words of a claim 'are
generally given their ordinary and customary meaning.' We
have made clear, moreover, that the ordinary and customary
meaning of a claim term 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. The inquiry into how a person
of ordinary skill in the art understands a claim term
provides an objective baseline from which to begin claim
interpretation. . .
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. In such
circumstances, general purpose dictionaries may be helpful.
In many cases that give rise to litigation, however,
determining the ordinary and customary meaning of the claim
requires examination of terms that have a particular meaning
in a field of art. Because the meaning of a claim term as
understood by persons of skill in the art is often not
immediately apparent, and because patentees frequently use
terms idiosyncratically, the court looks to those sources
available to the public that show what a person of skill in
the art would have understood disputed claim language to
mean. Those sources include the words of the claims
themselves, the remainder of the specification, the
prosecution history, and extrinsic evidence concerning
relevant scientific principles, the meaning of technical
terms, and the state of the art.
Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314
(Fed. Cir. 2005) (citations omitted).
Claim construction of the disputed terms
parties dispute the interpretation of four claim terms in the
formulation patents: "chemical entity,"
"esters and ethers of polyhydric alcohol," "at
least one chemical entity chosen from," and
"effective amount to avoid turbidity."
parties dispute the meaning of the phrase, "chemical
entity," which appears in claims 1, 2, 7, 17, 18, 19,
23, and 24 of the '652 Patent, as well as claims 1, 14,
15, and 16 of the '930 Patent. Plaintiffs contend that
the term has its ordinary meaning, which a skilled artisan
would understand to be "chemical compound."
Defendants contend that the term should be construed to mean,
"surfactant that reduces turbidity." Defendants
here attempt to import limitations from the embodiments
without any demonstration that the patentees used
"expressions of manifest exclusion or restriction."
Defendants ignore this requirement, and cite VirnetX,
Inc. v. Cisco Sys., 767 F.3d 1308, 1318 (Fed. Cir. 2014)
for this statement: "The fact that anonymity is
'repeatedly and consistently' used to characterize
the invention strongly suggests that it should be read as
part of the claim." As Plaintiffs note in response,
Defendants have taken this out of context. Crucially, in
VirnetX, the Federal Circuit began the analysis of
the construction of "secure communication link"
with this foundation: "As an initial matter, we note
that there is no dispute that the word 'secure' does
not have a plain and ordinary meaning in this context, and so
must be defined by reference to the specification."
Id. at 1317. Defendants have not established that
premise here. A typical use of this phrase appears in claim 1
of the '652 patent: "at least one chemical entity
chosen from polysorbate 20 and polysorbate
80." The meaning of "chemical entity"
in this example is clear on its face; Defendants point to no
ambiguity. Unlike Virnetx, the term here, in the
context of the claim, has a plain meaning.
absence of expressions of manifest exclusion, the Court
declines to narrow the meaning of a claim term that is, on
its face, unambiguous, and used in claim phrases which are
precise. Defendants have not overcome the presumption that
"chemical entity" carries its ordinary meaning
which, as Plaintiffs state, is "chemical compound."
parties dispute the meaning of "chosen from," as
used in the phrase, "at least one chemical entity chosen
from." Plaintiffs propose that the term has its plain
and ordinary meaning. Defendants propose that "chosen
from" means "selected to be included in the
pharmaceutical formulation from." Defendants seek to
insert into the claim language a scienter requirement.
Defendants point to nothing in any of these patents that
indicates that the inventors patented a formulation process
requiring a particular mental state when deciding between
polysorbate 20 and polysorbate 80. Consider, again, claim 1
of the '652 patent, which begins as follows: "A
pharmaceutical formulation comprising . . ." The claim
on its face covers a formulation, not a method for
formulating. As Plaintiffs argue, the patentees drafted these
claims using a Markush group. Gillette Co. v. Energizer
Holdings, Inc., 405 F.3d 1367, 1372 (Fed. Cir. 2005)
("A Markush group lists specified alternatives in a
patent claim, typically in the form: a member selected from
the group consisting of A, B, and C") "Chosen
from" has its ordinary meaning.
"the polysorbate 20 is present in an effective amount to
parties agree that this phrase, which appears only in claim 8
of the '652 patent, has its ordinary meaning, but they
dispute what that ordinary meaning is. Plaintiffs propose
that the ordinary meaning is "the polysorbate 20 is
present in an effective amount to prevent cloudiness."
Defendants propose that the ordinary meaning is "the
amount of polysorbate chosen prevents cloudiness."
Defendants explain that the only meaningful difference
between the two constructions involves the question of
whether the claim language requires the polysorbate 20 to be
chosen, as previously discussed. For the reasons already
stated, the Court will not insert a scienter requirement into
these formulation claims. The ordinary meaning of this phrase
does not require any particular mental state.
"esters and ethers of polyhydric alcohols"
this term involves chemistry, the parties appear to agree on
the meaning within chemistry. Neither party identifies any
remaining ambiguity in the claim language. The parties'
briefs, which give very short treatment to this dispute,
identify no actual question about the meaning of this term.
Instead, the briefs debate the question of whether
Plaintiffs' proposed construction is redundant. Since the
parties agree about how a chemist would understand this
phrase, the Court concludes that the parties do not have any
substantive dispute over the meaning of this term.
parties dispute the construction of thirteen terms in the
device patents. These four patents descend from one
application, No. 10/790, 225, through chains of continuation
applications. The parties agree that the device patents share
a common specification.
the exception of "thread," where Defendants'
proposed construction is unopposed, this Court resolves all
of the claim construction disputes before it by application
of one fundamental principle of Federal Circuit law:
"There is a heavy presumption that claim terms are to be
given their ordinary and customary meaning." Aventis
Pharm, Inc. v. Amino Chems. Ltd., 715 F.3d 1363, 1373
(Fed. Cir. 2013). "Properly viewed, the 'ordinary
meaning' of a claim term is its meaning to the ordinary
artisan after reading the entire patent."
Phillips, 415 F.3d at 1321. "An accused
infringer may overcome this 'heavy presumption' and
narrow a claim term's ordinary meaning, but he cannot do
so simply by pointing to the preferred embodiment or other
structures or steps disclosed in the specification or
prosecution history." CCS Fitness, Inc. v. Brunswick
Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). In short,
this Court finds that neither party, for any claim term in
dispute, has overcome the presumption that each term has its
propose this construction: "A rod that engages with the
drive sleeve/driver/driving member to advance the piston
during dose dispensing." Defendants propose this
construction: "a rod that moves axially to advance the
piston." Neither party contends that the term has its
their opening brief, Plaintiffs present only one argument to
support their proposed construction: "it aligns with the
intrinsic record. . ." (Pis.' Br. 28.) Under Federal
Circuit law, this is not sufficient to overcome the
presumption of ordinary meaning. In particular, as to the
proposed subphrase, "that engages with the drive
sleeve/driver/driving member," Plaintiffs point to three
claims, from three of the device patents, which require such
engagement. These do not support their position. Two of the
three examples point to characteristics of other components:
1) claim 1 of the '069 patent ("internal threading
[of drive sleeve] adapted to engage an external thread of
said piston rod") (Pis.' Br. 29); and 2) claim 1 of
the '486 patent ("internal threading [of driver]
adapted to engage an external thread of said piston
rod") (id.) Note that, in both of these examples, the
language states characteristics of the threading of the drive
sleeve and driver, as well as characteristics of the
interaction between the "external thread of said piston
rod" and the internal thread of the other component.
Plaintiffs do not explain why these expressly stated
characteristics should be incorporated into the construction
of "piston rod." In these two examples, the claim
expressly discloses that the piston rod has an external
thread with a particular interaction with other components.
Since this is expressly stated, why should it be made
implicit in the ...