United States District Court, D. Delaware
AMGEN INC., AMGEN MANUFACTURING, LIMITED, and AMGEN USA INC., Plaintiffs;
SANOFI, SANOFI-AVENTIS U.S. LLC, AVENTISUB LLC, f/d/b/a AVENTIS PHARMACEUTICALS INC., and REGENERON PHARMACEUTICALS, INC., Defendants.
Melanie K. Sharp, James L. Higgins, and Michelle M.
Ovanesian, YOUNG CONAWAY STARGATT & TAYLOR, LLP,
Wilmington, DE; William G. Gaede, III (argued), MCDERMOTT
WILL & EMERY LLP, Menlo Park, CA; Sarah Chapin Columbia
and K. Nicole Clouse, MCDERMOTT WILL & EMERY LLP, Boston,
MA; Rebecca Harker Durtry, MCDERMOTT WILL & EMERY LLP,
Washington, DC; Christopher B. Mead, LONDON & MEAD,
Washington, DC; Keith R. Hummel, David N. Greenwald, Lauren
A. Moskowitz, Geoffrey G Hu, and Sharonmoyee Goswami,
CRAVATH, SWAINE & MOORE LLP, New York, NY; Lauren Martin
and Megan Y. Yung, QUINN EMANUEL URQUHART & SULLIVAN,
LLP, Boston, MA, attorneys for Plaintiffs.
E. Wilks and Scott B. Czerwonka, WILKS, LUKOFF &
BRACEGIRDLE, LLC, Wilmington, DE; Matthew M. Wolf (argued),
ARNOLD & PORTER KAYE SCHOLER LLP, Washington, DC; David
K. Barr and Daniel L. Reisner, ARNOLD & PORTER KAYE
SCHOLER LLP, New York, NY; Deborah E. Fishman, ARNOLD &
PORTER KAYE SCHOLER LLP, Palo Alto, CA; John Josef Molenda
and Vishal Chandra Gupta, STEPTOE & JOHNSON LLP, New
York, NY, attorneys for Defendants.
ANDREWS U.S. DISTRICT JUDGE
pending before the Court are Defendants' Renewed Motion
for Judgment as a Matter of Law ("JMOL") that the
Asserted Patent Claims are Invalid and, in the alternative,
Motion For a New Trial. (D.I. 883, 886). I have reviewed the
briefing for these motions. (D.I. 885, 888, 922, 923, 982,
983). I heard helpful oral argument on August 8, 2019.
(Hr'g Tr.). The Parties submitted supplemental letters
after argument. (D.I. 1045, 1046).
Amgen, Inc., Amgen Manufacturing, Ltd., and Amgen USA Inc.
filed suit against Defendants Sanofi, Sanofi-Aventis U.S.
LLC, Aventisub LLC, and Regeneron Pharmaceuticals, Inc. on
October 17, 2014 alleging infringement of U.S. Patent Nos. 8,
583, 698 ("the '698 patent"), 8, 829, 165
("the '165 patent"), and 8, 859, 741 ("the
'741 patent"). (D.I. 1, 10, 184). Plaintiffs later
amended the Complaint to add claims of infringement of U.S.
Patent Nos. 8, 871, 913 ("the '913 patent"), 8,
871, 914 ("the '914 patent"), 8, 883, 983
("the '983 patent"), and 8, 889, 834 ("the
'834 patent"). (D.I. 184). The parties stipulated to
infringement of selected claims for trial,  (D.I. 235), and
tried issues of validity to the jury in March 2016. During
trial, the Court granted JMOL of non-obviousness and no
willful infringement. (D.I. 345 at 1076:6-1077:6; D.I. 302).
The issue of damages was not tried to the jury. (D.I. 346 at
1285:16-20). The jury determined the patents were valid.
(D.I. 303). Plaintiffs moved for a permanent injunction (D.I.
306), which was granted (D.I. 392), and then stayed. (D.I.
401). Defendants appealed. (D.I. 402).
appeal, the Federal Circuit affirmed the grant of
Plaintiffs' JMOL of non-obviousness and the denial of
Defendants' JMOL of no written description and enablement
but reversed for errors made in evidentiary rulings and jury
instructions and remanded the case for a new trial on written
description and enablement. Amgen Inc. v. Sanofi,
872 F.3d 1367, 1381-82 (Fed. Cir. 2017). The Federal Circuit
also vacated the permanent injunction. Id.
remand, the Parties tried the issues of written description
and enablement to the jury.The jury verdict found claim 7 of
the '741 patent and claims 19 and 29 of the '165
patent valid, but invalidated claims 7 and 15 of the '165
patent for lack of written description. (D.I. 817).
Defendants now ask that the Court overturn the jury verdict
under Federal Rule of Civil Procedure 50(b) or grant a new
trial under Rule 59. (D.I. 883, 886).
claims of the '165 patent still in dispute read as
1. An isolated monoclonal antibody, wherein, when bound to
PCSK9, the monoclonal antibody binds to at least one of the
following residues: SI53, 1154, P155, R194, D238, A239, 1369,
S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID
NO:3, and wherein the monoclonal antibody blocks binding of
PCSK9 to LDLR.
19. The isolated monoclonal antibody of claim 1 wherein the
isolated monoclonal antibody binds to at least two of the
following residues S153, 1154, P155, R194, D238, A239, 1369,
S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9
listed in SEQ ID NO:3.
29. A pharmaceutical composition comprising an isolated
monoclonal antibody, wherein the isolated monoclonal antibody
binds to at least two of the following residues S153, 1154,
P155, R194, D238, A239, 1369, S372, D374, C375, T377, C378,
F379, V380, or S381 of PCSK9 listed in SEQ ID NO:3 and blocks
the binding of PCSK9 to LDLR by at least 80%.
patent, els. 1, 19, 29 (disputed claims bolded)). The claim
of the '741 patent still in dispute reads as follows:
1. An isolated monoclonal antibody that binds to PCSK9,
wherein the isolated monoclonal antibody binds an epitope on
PCSK9 comprising at least one of residues 237 or 238 of SEQ
ID NO: 3, and wherein the monoclonal antibody blocks binding
of PCSK9 to LDLR.
2. The isolated monoclonal antibody of claim 1, wherein the
isolated monoclonal antibody is a neutralizing antibody.
7. The isolated monoclonal antibody of claim 2,
wherein the epitope is a functional epitope.
patent, els. 1-2, 7 (disputed claim bolded)).
JUDGMENT 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)
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." Per
kin-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.
Judgment as a Matter of Law of No. Written
argue that no reasonable jury could conclude that the claims
are supported by written description under either the
representative species test or the structural features test.
(D.I. 888 at 4-5).
written description requirement contained in 35 U.S.C. §
112, ¶ 1 requires that the specification "clearly
allow persons of ordinary skill in the art to recognize that
the inventor invented what is claimed." Ariad
Pharm., Inc., v. Eli Lilly & Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010) (en banc) (cleaned up). "In other
words, the test for sufficiency is whether the disclosure of
the application relied upon reasonably conveys to those
skilled in the art that the inventor had possession of the
claimed subject matter as of the filing date."
Id. "This inquiry, as we have long held, is a
question of fact. Thus, we have recognized that determining
whether a patent complies with the written description
requirement will necessarily vary depending on the
context." Ariad, 598 F.3d at 1351 (internal
citations omitted). For patents that claim a broad genus (a
major class or kind of thing) while disclosing only species
of that genus (subclasses), the written description
requirement is more specific. There are two tests. They are
the representative species test and the structural features
test. The Federal Circuit has summarized their requirements
Demonstrating possession "requires a precise
definition" of the invention. To provide this
"precise definition" for a claim to a genus, a
patentee must disclose "a representative number of
species falling within the scope of the genus or structural
features common to the members of the genus so that one of
skill in the art can visualize or recognize the members of
Amgen, 872 F.3d at 1373 (quoting Ariad, 598
F.3d at 1350).
representative species test does not require disclosure of
every species in the genus and there is no bright-line rule
"governing  the number of species that must be
disclosed to describe a genus claim, as this number
necessarily changes with each invention, and it changes with
progress in a field." Ariad, 598 F.3d at 1351.
However, "merely drawing a fence around the outer limits
of a purported genus is not an adequate substitute for
describing a variety of materials constituting the genus and
showing that one has invented a genus and not just a
species." Id. at 1350. "One needs to show
that . . . one has conceived and described sufficient
representative species encompassing the breadth of the
genus." AbbVie, 759 F.3d at 1300.
the structural features test, "[f]unctional claim
language can meet the written description requirement when
the art has established a correlation between structure and
function," such that disclosure of the function
implicitly discloses the common structural features of the
genus. Ariad, 598 F.3d at 1350.
party must prove invalidity for lack of written description
by clear and convincing evidence." Vasudevan
Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682
(Fed. Cir. 2015). Because lack of written description,
"like any other ground of invalidity, must be
established by clear and convincing evidence,"
Defendants' burden on a JMOL motion is "doubly high:
it must show that no reasonable jury could have failed to
conclude that [Defendants'] case had been established by
clear and convincing evidence." Boehringer Ingelheim
Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339,
1353 (Fed. Cir. 2003) (internal citation omitted).
with the representative species test. Defendants argue that
to satisfy the representative species test in the antibody
context, the patentee "must adequately describe
representative antibodies to reflect the structural diversity
of the claimed genus" and "describe some species
representative of antibodies that are structurally similar
to" infringing antibodies. AbbVie, 759 F.3d at
1301. Defendants argue that Plaintiffs have not satisfied the
representative species test because the undisputed evidence
at trial indicated that the amino acid sequences of the
disclosed antibodies and the infringing Competitor
Antibodies were completely different from one
another. (D.I. 888 at 6-7). Plaintiffs argue that there was
substantial evidence submitted at trial supporting a jury
finding that the disclosed antibodies were representative of
the structural diversity of the genus, including the
Competitor Antibodies. (D.I. 923 at 5-6).
with Plaintiffs that substantial evidence supports the jury
verdict under the representative species test. The record
contains contradictory evidence on (1) what the appropriate
comparison metric was, (2) whether there was sufficient
similarity between the amino acid sequences of the Competitor
Antibodies and the disclosed examples in the patents, and (3)
whether there was functional similarity between the
Competitor Antibodies and the disclosed examples in the
Plaintiffs' experts repeatedly disputed the use of amino
acid sequence as an appropriate comparison to determine
whether the disclosed species were representative of the
genus. (D.I. 865 at 638:8-11, 768:18-20, 765:10-766:12,
769:14-770:24). Plaintiffs' experts testified that
three-dimensional structure was the appropriate metric for
comparison and presented substantial evidence of similarity
in the three-dimensional structure of the antibodies
disclosed in the patent and the Competitor
Antibodies. (Id. at 621:5-629:1,
633:12-637:17, 764:6-767:15, 724:9-10, 725:21-727:4,
772:154-775:17; D.I. 864 at 449:5-9).
even if amino acid sequence was the appropriate metric for
comparison, substantial evidence supported a finding of
structural similarity between the Amgen Antibodies and the
Competitor Antibodies. The amino acid sequence differences
between the Competitor Antibodies are not as extreme as in
AbbVie. In AbbVie, the Court determined
that "[a]ll of the antibodies described in AbbVie's
patents were derived from Joe-9 and have VH3 type heavy
chains and Lambda type light chains" and "the
patents [did] not describe any example  of fully human
IL-12 antibodies having heavy and light chains other than the
VH3 and Lambda types." AbbVie, 759 F.3d at
1300. Unlike there, here there was testimony of 80%
similarity between the disclosed antibodies and the
Competitor Antibodies' amino acid sequences, (D.I. 864 at
371:2-10, 374:19-24), and the disclosed antibodies cover more
classes of antibodies than the patent disclosed in
AbbVie. (D.I. 865 at 771:3-11). Dr. Rees testified
that there are eight different families of binding and
blocking antibodies disclosed by the patents. (D.I. 865 at
Plaintiffs presented substantial evidence of functional
similarity. There was significant testimony that the
antibodies disclosed in the 2008 patent application, while
binding to different residues across the "sweet
spot," blocked PCSK9 binding to LDL-R through a variety
of binding interactions. (D.I. 864 at 471:24-372:6; D.I. 865
at 630:14-25, 649:10-650:1, 651:1-652:11).
jury was entitled to credit the testimony of Plaintiffs'
experts. Thus, substantial evidence in the record supports
the jury verdict of validity under the representative species
satisfaction of the representative species test is sufficient
to support a finding of validity under written description, I
need not address the Common Structural Features Test.
Defendants have failed to show "that no reasonable jury
could have failed to conclude that [Defendants'] case
[for lack of written description] had been established by
clear and convincing evidence." Boehringer, 320
F.3d at 1353 (internal citation omitted). I will therefore
deny Defendants' motion for JMOL on the issue of written
Judgment as a Matter of Law of No. Enablement
argue that no reasonable jury could conclude that the
asserted claims were enabled. (D.I. 888 at 13-14). Defendants
advance two arguments: (1) the claims are not enabled because
the vast majority of antibodies within the full scope of the
claims are impossible to make, and (2) undue experimentation
is required to make antibodies within the claimed genus.
(Id. at 14). The Parties agreed at oral argument