United States District Court, D. Delaware
E. Farnan and Christine D. Haynes, RICHARDS, LAYTON &
FINGER, P.A., Wilmington, DE; Dominick A. Conde, Christopher
P. Borello and Damien N. Dombrowski, VENABLE LLP, New York,
NY, attorneys for Plaintiff.
B. Blumenfeld and Jeremy A. Tigan, MORRIS, NICHOLS, ARSHT
& TUNNELL LLP, Wilmington, DE; Martin J. Black, Kevin M.
Flannery, Robert Ashbrook, Sharon K. Gagliardi, DECHERT LLP,
Philadelphia, PA; Blake B. Greene, DECHERT LLP, Austin, TX;
Katherine A. Helm, DECHERT LLP, New York, NY, attorneys for
ANDREWS, U.S. DISTRICT JUDGE
pending before the Court is Defendants' Motion for
Judgment as a Matter of Law and New Trial or
Remittitur. (D.I. 336). The parties have fully briefed
the issues. (D.I. 337, 343, 349). For the following reasons,
I will deny Defendants' motion.
27, 2016, Plaintiff Vectura Limited sued Defendants
GlaxoSmithKline LLC and Glaxo Group Limited for direct and
induced infringement of U.S. Patent No. 8, 303, 991
("the '991 patent"). (D.I.I). The'991
patent relates to pharmaceutical compositions for inhalation.
(D.I. 82 at 1). Before trial, Plaintiff narrowed their
infringement case to assert direct infringement of claim 3 of
the '991 patent ("the asserted claim"). (D.I.
307). Plaintiff also pursued a claim of willful infringement
of the asserted claim. (D.I. 307 at 11). Defendants asserted
a noninfringement defense and an invalidity defense under 35
U.S.C. § 103. (Id.; D.I. 320 at 2).
of the '991 patent depends from claims 1 and 2. Together,
the claims read as follows:
1. Composite active particles for use in a pharmaceutical
composition for pulmonary administration, each composite
active particle comprising a particle of active material and
particulate additive material on the surface of that particle
of active material, wherein the composite active particles
have a mass median aerodynamic diameter of not more than 10
urn, and wherein the additive material promotes the
dispersion of the composite active particles upon actuation
of a delivery device.
2. Composite active particles as claimed in claim 1, wherein
the additive material includes one or more of: an amino acid
or derivative thereof; a peptide or derivative thereof, a
phospholipid or derivative thereof, a surface active
material; or a metal stearate and derivative thereof.
3. Composite active particles as claimed in claim 2, wherein
the additive material includes magnesium stearate.
('991 patent, els. 1-3).
five-day trial, the jury returned the following verdict: (1)
Defendants infringed claim 3 of the '991 patent, (2)
claim 3 was not invalid for obviousness, (3) Plaintiff was
entitled to an ongoing royalty payment of three percent for a
total sum of $89, 712, 069 through December 31, 2018, and (4)
Defendants' infringement was willful. (D.I. 321). The
parties have now filed post-trial motions. Defendants renew
their request for JMOL of no infringement, invalidity for
obviousness, and no willful infringement, or in the
alternative, a new trial. Defendants also request a new trial
on damages or remittitur.
Judgement as a Matter of Law
as a matter of law is appropriate if "the court finds
that a reasonable jury would not have a legally sufficient
evidentiary basis to find for [a] party" on an issue.
Fed.R.Civ.P. 50(a)(1). "Entry of judgment as a matter of
law is a 'sparingly' invoked remedy, 'granted
only if, viewing the evidence in the light most favorable to
the nonmovant and giving it the advantage of every fair and
reasonable inference, there is insufficient evidence from
which a jury reasonably could find liability.'"
Marra v. Phila. Hous. Auth, 497 F.3d 286, 300 (3d
Cir. 2007) (citation omitted).
prevail on a renewed motion for JMOL following a jury trial,
a party must show that the jury's findings, presumed or
express, are not supported by substantial evidence or, if
they were, that the legal conclusion(s) implied [by] the
jury's verdict cannot in law be supported by those
findings." Pannu v. Iolab Corp., 155 F.3d 1344,
1348 (Fed. Cir. 1998) (alterations in original).
"'Substantial' evidence is such relevant
evidence from the record taken as a whole as might be
accepted by a reasonable mind as adequate to support the
finding under review." Perkin-Elmer Corp. v.
Computervision Corp., 732 F.2d 888, 893 (Fed. Cir.
assessing the sufficiency of the evidence, the Court must
give the non-moving party, "as [the] verdict winner, the
benefit of all logical inferences that could be drawn from
the evidence presented, resolve all conflicts in the evidence
in his favor and, in general, view the record in the light
most favorable to him." Williamson v. Consol. Rail
Corp., 926 F.2d 1344, 1348 (3d Cir. 1991). The Court may
"not determine the credibility of the witnesses [nor]
substitute its choice for that of the jury between
conflicting elements in the evidence."
Perkin-Elmer, 732 F.2d at 893. Rather, the Court
must determine whether the evidence supports the jury's
verdict. See Dawn Equip. Co. v. Ky. Farms Inc., 140
F.3d 1009, 1014 (Fed. Cir. 1998); Gomez v. Allegheny
Health Servs. Inc., 71 F.3d 1079, 1083 (3d Cir. 1995)
(describing standard as "whether there is evidence upon
which a reasonable jury could properly have found its
verdict"); 9B Charles Alan Wright & Arthur R.
Miller, Federal Practice and Procedure § 2524 (3d
ed. 2008) ("The question is not whether there is
literally no evidence supporting the party against whom the
motion is directed but whether there is evidence upon which
the jury might reasonably find a verdict for that
the moving party bears the burden of proof, the Third Circuit
applies a different standard. This standard
'"requires the judge to test the body of evidence
not for its insufficiency to support a finding, but rather
for its overwhelming effect."' Fireman's
Fund Ins. Co. v. Videfreeze Corp., 540 F.2d 1171, 1177
(3d Cir. 1976) (quoting Mihalchak v. Am. Dredging
Co., 266 F.2d 875, 877 (3d Cir. 1959)). The Court
'"must be able to say not only that there is
sufficient evidence to support the finding, even though other
evidence could support as well a contrary finding, but
additionally that there is insufficient evidence for
permitting any different finding.'" Id. at
1177 (quoting Mihalchak, 266 F.2d at 877).
Rule of Civil Procedure 59(a)(1)(A) provides, in pertinent
part: "The court may, on motion, grant a new trial on
all or some of the issues-and to any party- ... after a jury
trial, for any reason for which a new trial has heretofore
been granted in an action at law in federal court . . .
." Among the most common reasons for granting a new
trial are: (1) the jury's verdict is against the clear
weight of the evidence, and a new trial must be granted to
prevent a miscarriage of justice; (2) newly discovered
evidence exists that would likely alter the outcome of the
trial; (3) improper conduct by an attorney or the court
unfairly influenced the verdict; or (4) the jury's
verdict was facially inconsistent. See Zarow-Smith v.
N.J. Transit Rail Operations, Inc., 953 F.Supp. 581,
584-85 (D.N.J. 1997).
decision to grant or deny a new trial is committed to the
sound discretion of the district court. See Allied Chem.
Corp. v. Daiflon, Inc., 449 U.S. 33, 36 (1980);
Olefins Trading, Inc. v. Han Yang Chem. Corp., 9
F.3d 282, 289 (3d Cir. 1993) (reviewing district court's
grant or denial of new trial motion under the "abuse of
discretion" standard). Although the standard for
granting a new trial is less rigorous than the standard for
granting judgment as a matter of law-in that the Court need
not view the evidence in the light most favorable to the
verdict winner-a new trial should only be granted where
"a miscarriage of justice would result if the verdict
were to stand," the verdict "cries out to be
overturned," or where the verdict "shocks [the]
conscience." Williamson, 926 F.2d at 1352-53.
patent is infringed when a person "without authority
makes, uses, offers to sell, or sells any patented invention,
within the United States .. . during the term of the
patent...." 35 U.S.C. § 271(a). A two-step analysis
is employed in making an infringement determination. See
Markman v. Westview Instruments, Inc., 52 F.3d 967, 976
(Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370
(1996). First, the court must construe the asserted claims to
ascertain their meaning and scope. See Id. The trier
of fact must then compare the properly construed claims with
the accused infringing product. See Id. at 976. This
second step is a question of fact. See Bai v. L & L
Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).
infringement of a claim exists when every limitation recited
in the claim is found in the accused device." Kahn
v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir.
1998). "If any claim limitation is absent from the
accused device, there is no literal infringement as a matter
of law." Bayer AG v. Elan Pharm. Research
Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000).
Judgment as a Matter of Law
accused infringer moves for JMOL of noninfringement, such
relief may be granted only if at least one limitation of the
claim in question does not read on an element of the accused
product. Bayer, 212 F.3d at 1247. I must give
deference to the jury's factual findings and view the
record in the light most favorable to the non-moving party,
Plaintiff. Williamson, 926 F.3dat 1348.
argue that JMOL of noninfringement is appropriate because (1)
there is insufficient evidence to support a finding that the
accused products satisfied the dispersion limitation and (2)
Plaintiff failed to prove the presence of the claimed
composite active particles ("CAPs"). (D.I. 337 at
2). Plaintiff asserts that it presented substantial evidence
supporting the jury's infringement verdict. (D.I. 343 at
2). I agree with Plaintiff that the jury's infringement
verdict is supported by substantial evidence.
The Dispersion Limitation
assert that there is insufficient evidence to supporting the
jury's implied factual finding that the accused products
satisfied the dispersion limitation. (D.I. 337 at 3-4). The
dispersion limitation is found in the following claim
language: "wherein the additive material promotes the
dispersion of the composite active particles upon actuation
of a delivery device." ('991 patent, cl. 1). I
construed this limitation to mean "wherein a composition
that contains one or more [CAPs] has increased dispersion of
the active material upon activating a delivery device for
inhalation into the lungs by a patient, as compared to the
same composition wherein unmodified active particles are
substituted for the [CAPs]." (D.I. 169 at 2). Defendants
argue that to satisfy its burden, Plaintiff was required to
present evidence isolating the impact of the CAPs on the
overall dispersion of the composition as required by the
Court's claim construction. (D.I. 337 at 3-4).
Federal Circuit has made clear that it does not require a
party to show evidence of a direct comparison to satisfy its
burden of proof on infringement even where the court's
claim construction requires a comparison to satisfy the claim
limitation. See Martek Biosciences Corp. v. Nutrinova,
Inc., 579 F.3d 1363, 1372-73 (Fed. Cir. 2009). In
Martek, the Federal Circuit recognized that even
where there is a functional claim limitation requiring
comparison, "circumstantial evidence may be
sufficient" to satisfy the patentee's burden of
proof. Id. As the patentee had presented other
evidence supporting the infringement verdict, the lack of
direct comparative testing did not require JMOL of
noninfringement. Id. Brigham & Women's Hosp.,
Inc. v. Perrigo Co., 761 Fed.Appx. 995 (Fed. Cir. 2019)
does not state otherwise. In Brigham, clinical
testing was the only evidence put forward to prove
infringement; there was no other direct or circumstantial
evidence in the record. Id. at 1003-04. The Federal
Circuit determined that the clinical testing did not measure
the claim limitation and the patentee has not established a
correlation between the claimed limitation and the metric
tested. Id. (studies measured adequate relief
beginning at fifteen minutes, rather than immediate relief
starting within five to ten minutes).
Plaintiff submitted comparison testing and other
circumstantial evidence to the jury. (D.I. 352 at
154:11-156:10; D.I. 353 at 317:7-327:10; PTX-185). Defendants
assert that Study 2 cannot support the infringement verdict
under Brigham. (D.I. 337 at 4-5). However,
Defendants merely reiterate the same arguments made at trial.
Defendants challenge the usefulness of Study 2 because it did
not test the accused products and Plaintiff did not establish
that the Study was representative of the actual products.
(Id.). But Plaintiff did submit evidence that Blend
6 was representative of the accused products. (D.I. 353 at
316:12-327:10; PTX-185 at 4; PTX-129 at 21; PTX 123 at 12).
And unlike Brigham, where the testing submitted did
not test the appropriate metric, here, Study 2 does provide a
comparison of dispersion between a formulation with C APs and
a formulation without CAPs to show "increased dispersion
of the active material ... as compared to the same
composition wherein unmodified active particles are
substituted for the [CAPs]". (PTX-185). There is more
than a mere speculative correlation between the testing
provided and the accused products. (D.I. 353 at
325:15-326:14, 390:12-391:3, 407:22-410:15). Defendants also
challenged the representativeness of the Study and the blends
in front of the jury. (Id. at 360:6-365:2,
404:5-406:21; D.I. 354 at 574:1-576:17). The jury was
entitled not to credit this testimony. (D.I. 307 at 7-8). As
is required on a motion for JMOL, I must give Plaintiff the
benefit of all logical inferences that can be made from the
evidence in the record. Here, a reasonable juror could have
credited Dr. Zhou's testimony over that of
Defendants' expert, Dr. Colombo, determined that Study 2
was representative of the accused products, and thus,
concluded that the dispersion limitation was met.
also challenge the sufficiency of the evidence with regard to
the accused products with umeclidinium as the active
ingredient. (D.I. 337 at 10). Dr. Zhou testified at trial
that the results of Study 2, which tested only blends with
the active ingredient vilanterol, were equally applicable to
compositions using umeclidinium. (D.I. 353 at 324:16-23). The
jury was entitled to credit this testimony, especially where
there was an absence of any contradictory evidence.
there is substantial evidence in the record supporting the
jury's finding that the dispersion limitation was
satisfied by the accused products.
The CAPs Limitation
assert that Plaintiff failed to prove that the accused
products satisfy the CAPs limitation because Plaintiffs
expert testimony established, at best,
"co-association," which does not satisfy the claim
construction. (D.I. 337 at 11). At claim construction, I
construed the claim term "composite active
particle[s]" to mean "[a] single particulate
entit[y/ies] made up of a particle of active material to
which one or more particles of additive material are fixed
such that the active and additive particles do not separate
in the airstream." (D.I. 169 at 1).
continue to assert that "co-association" cannot
show that the additive is "fixed" to the active
particle. However, Defendants focus upon the wrong inquiry.
As I stated, "fixed" is not a technical term.
(Pretrial Hr'g Tr. at 21:17-18). Plaintiff was required
to establish that the additive magnesium stearate was
"fixed to the active particle such that it does not
separate in the airstream." (D.I. 169 at 1). Plaintiff
has done so. Plaintiff presented testimony of SEM-EDX,
ToF-SIMS, and SPAMS testing to show that the accused products
satisfy the CAPs limitation. (D.I. 352 at 188:19-190:10,
194:10-199:11, 201:12-204:23, 211:17-212:5; D.I. 353 at
327:12-335:12, 336:15-353:13, 379:8-11). Dr. Zhou repeatedly
testified that magnesium stearate was sufficiently coated or
fixed to the active particles such that the magnesium
stearate and the active did not separate in the airstream.
(D.I. 353 at 328:23-329:15, 341:11-22, 345:2-14, 350:2-19,
351:18-352:16). This is substantial evidence supporting the
jury's implied factual finding that the accused products
satisfy the CAPs claim limitation.
there is substantial evidence supporting the jury's
factual findings that the accused products satisfy each and
every claim limitation, as construed by the Court. Therefore,