United States District Court, D. Delaware
AMGEN INC., AMGEN MANUFACTURING, LTD, 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 (argued), James L. Higgins, and Michelle M.
Ovanesian, YOUNG CONAWAY STARGATT & TAYLOR, LLP,
Wilmington, DE; William G. Gaede III, MCDERMOTT WILL &
EMERY LLP, Menlo Park, CA; Sarah C. Columbia and K. Nicole
Clouse, MCDERMOTT WILL & EMERY LLP, Boston, MA; Rebecca
Harker Duttry, MCDERMOTT WILL & EMERY LLP, Washington,
D.C.; Christopher B. Mead, LONDON & MEAD, Washington,
D.C.; Keith R. Hummel, David N. Greenwald, Lauren A.
Moskowitz, Geoffrey G. Hu, and Sharonmoyee Goswami, CRAVATH,
SWAINE & MOORE LLP, New York, NY; Lauren Martin, QUINN
EMANUEL URQUHART & SULLIVAN, LLP, Boston, MA, attorneys
E. Wilks and Scott B. Czerwonka, WILKS, LUKOFF &
BRACEGIRDLE, LLC, Wilmington, DE; Matthew M. Wolf (argued),
ARNOLD & PORTER KAYE SCHOLER LLP, Washington, D.C.; David
K. Barr and Daniel L. Reisner, ARNOLD & PORTER KAYE
SCHOLER LLP, New York, NY; John Josef Molenda and Vishal
Chandra Gupta, STEPOE & JOHNSON LLP, New York, NY; Paul
D. Clement and George W. Hicks, Jr., KIRKLAND & ELLIS
LLP, Washington, D.C., attorneys for Defendants.
ANDREWS, U.S. DISTRICT JUDGE
pending before the Court is Defendants' Motion for
Judgment on the Pleadings under Rule 12(c). (D.I. 448). The
Parties have fully briefed the issues. (D.I. 449, 452, 453).
The Court heard oral argument on January 3, 2019. (D.I. 703).
For the following reasons, Plaintiffs' Motion is
granted-in-part and denied-in-part.
Amgen, Inc., Amgen Manufacturing Limited, and Amgen USA Inc.
(collectively "Plaintiffs") filed suit against
Defendants Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC,
and Regeneron Pharmaceuticals, Inc. (collectively
"Defendants") on October 17, 2014. (D.I. 1).
Plaintiffs assert that Defendants' manufacture and sale
of Praluent, a drug that treats patients with high levels of
low density lipoprotein cholesterol, infringes claims of U.S.
Patent Nos. 8, 829, 165 ("the '165 patent") and
8, 859, 741 ("the '741 patent") (collectively,
"the asserted patents"). (D.I. 1). The parties
stipulated to infringement of certain claims on February 22,
2016. (D.I. 235). During trial, the Court issued two Rule
50(a) orders. The Court determined that as a matter of law,
the patent claims were non-obvious and Plaintiffs had failed
to meet the burden of showing that Defendants'
infringement was willful. (D.I. 345 at 5:2-3; D.I. 302). The
case was submitted to the jury on the remaining invalidity
issues: lack of written description and enablement. The trial
resulted in a judgment for Plaintiffs that the patents are
not invalid. (D.I. 304). After trial, Defendants moved for
renewed judgment as a matter of law on patent validity and
for a new trial. (D.I. 331, 332). Plaintiffs moved for a
permanent injunction. (D.I. 336). The Court denied
Defendants' post-trial motions and entered final judgment
in favor of Plaintiffs under Rule 54(b) on January 3, 2017.
(D.I. 390, 391). The Court granted Plaintiffs' motion for
a permanent injunction on January 5, 2017. (D.I. 392).
appealed from the Rule 54(b) judgment. (D.I. 402). The
Federal Circuit determined that the Court had erred in
precluding post-priority date evidence relevant to written
description and enablement, and by giving faulty jury
instructions on written description. Amgen Inc. v.
Sanofi, 872 F.3d 1367, 1371 (Fed. Cir. 2017). The
Federal Circuit remanded for a new trial on written
description and enablement. Id. Defendants now move
for judgment on the pleadings regarding Plaintiffs'
willful infringement claim. (D.I. 448).
12(c) motion for judgment on the pleadings is reviewed under
the same standard as a Rule 12(b)(6) motion to dismiss when
the Rule 12(c) motion alleges that the plaintiff failed to
state a claim upon which relief can be granted. See Turbe
v. Gov 't of the Virgin Islands, 938 F.2d 427, 428
(3d Cir. 1991); Revell v. Port Auth, 598 F.3d 128,
134 (3d Cir. 2010). The court must accept the factual
allegations in the complaint and take them in the light most
favorable to the non-moving party. See Erickson v.
Pardus, 551 U.S. 89, 94 (2007); Christopher v.
Harbury, 536 U.S. 403, 406 (2002). "When there are
well-ple[d] factual allegations, a court should assume their
veracity and then determine whether they plausibly give rise
to an entitlement to relief." Ashcroft v.
Iqbal, 556 U.S. 662, 679 (2009). The court must
"draw on its judicial experience and common sense"
to make the determination. See Id. In ruling on a
motion for judgment on the pleadings, the court is generally
limited to the pleadings. Mele v. Fed. Reserve Bank of
N.Y., 359 F.3d 251, 257 (3d Cir. 2004). The court may,
however, consider documents incorporated into the pleadings
and those that are in the public record. Pension Ben.
Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d
1192, 1196 (3d Cir. 1993).
argue Plaintiffs have waived their willful infringement claim
by failing to cross-appeal the Court's adverse ruling of
no willfulness as a matter of law ("the willfulness
ruling"), and that Plaintiffs' preservation
arguments are unavailing. (D.I. 449 at 4, 7). Plaintiffs
argue that no waiver has occurred because 1) the willfulness
ruling was not a final judgment that could be appealed, 2)
even if final, an appeal of the willfulness ruling would have
been dismissed, and 3) the amended 54(b) judgment recognized
that the willfulness ruling was superseded by Halo.
(D.I. 452 at 9-10, 14).
routinely hold that a party that fails to cross-appeal an
adverse ruling has waived that claim on remand. See ART
Midwest Inc. v. Atlantic Limited P 'ship XII, 742
F.3d 206, 211 (5th Cir. 2014); Lazare Kaplan Int'l
Inc. v. Photoscribe Techs., Inc., 714 F.3d 1289, 1294
(Fed. Cir. 2013). Waiver is only proper where the party who
failed to cross-appeal was required to do so. "[A] party
must file a cross-appeal if, although successful in the
overall outcome in the district court, the party seeks, on
appeal, to lessen the rights of its adversary or to enlarge
its own rights." Lazare, 714 F.3d at 1293;
see also Aventis Pharma S.A. v. Hospira, Inc., 637
F.3d 1341, 1343 (Fed. Cir. 2011) ("A cross-appeal may
only be filed when a party seeks to enlarge its own rights
under the judgment or to lessen the rights of its adversary
under the judgment.") (cleaned up).
The Willfulness Ruling was an Appealable Judgment under 28
U.S.C. § 1292
parties dispute whether the Court's Rule 50(a) JMOL
ruling of no willful infringement was subject to appeal.
(D.I. 449 at 7-8; see D.I. 453 at 9). Specifically,
Plaintiffs assert that the willfulness ruling was not
"certified" as a final judgment because it was not
included in the Rule 54(b) judgment from which Defendants
appealed. (D.I. 452 at 9). I disagree with Plaintiffs and