Amgen Inc. et al v. Sanofi et al

Filing 751

MEMORANDUM OPINION. Signed by Judge Richard G. Andrews on 2/8/2019. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

AMGEN INC., AMGEN
MANUFACTURING, LTD, and AMGEN
USA INC. ,
Plaintiffs;
V.

CivilActionNo. 14-1317-RGA

SANOFI, SANOFI-AVENTIS U.S. LLC,
AVENTISUB LLC, f/d/b/aAVENTIS
PHARMACEUTICALS INC. , and
REGENERON PHARMACEUTICALS, INC. ,
Defendants.

MEMORANDUM OPINION
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 for Plaintiffs.
David 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.

February

_f_ ,2019

AND
~ i
RICT JUDGE:
Currently 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.
I.

BACKGROUND
Plaintiffs 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 oflaw, 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 oflaw 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).
1

Defendants 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).
II.

LEGAL ST AND ARD
A Rule 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 nonmoving 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).

2

III.

DISCUSSION
Defendants 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).
Courts 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 '! 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).
A. The Willfulness Ruling was an Appealable Judgment under 28 U.S.C. § 1292
The 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
3

disagree with Plaintiffs and determine that the Court's willfulness ruling was an appealable
judgment under 28 U.S .C. § 1292.
Plaintiffs rely on Bosch v. Pylon Manufacturing Corp. , 719 F.3d 1305 (Fed. Cir. 2013)
(en bane), to argue that the willfulness ruling was not an appealable final judgment. In Bosch,
the Federal Circuit determined that under 28 U.S.C . § 1292(c)(2), which gives the Federal
Circuit exclusive jurisdiction over appeals from judgments that are "final except for an
accounting," the Federal Circuit may "entertain appeals from patent infringement liability
determinations when willfulness issues are outstanding and remain undecided" because "an
accounting ... include[ s] the determination of willfulness" in addition to a trial on damages. 719
F.3d at 1313, 1319.
There, the district court had purported to certify the judgment on liability issues as final
under Rule 54(b), which the majority did not address. Id. at 1307-20. As Judge O' Malley noted,
Rule 54(b) certification was improper because Rule 54(b) requires resolution of all issues
regarding a claim including liability and relief. Id. at 1332 n.2 (O'Malley, J. , dissenting) (citing

Cadleway Props. v. Ossian State Bank, 478 F.3d 767, 769 (7th Cir. 2007); Reyher v. Champion
Int'l Corp., 975 F.2d 483,487 (8th Cir. 1992)); see also Alfred E. Mann Foundation for
Scientific Research v. Cochlear Corp., 841 F.3d 1334 (Fed. Cir. 2016) ("judgments where
assessment of damages ... remains to be resolved have never been considered ' final' for
purposes of Rule 54(b )") (cleaned up). Therefore, the relevant inquiry is not whether the
willfulness ruling was included in the Rule 54(b) final judgment, 1 but whether the willfulness
ruling could have been appealed under§ 1292(c)(2).

1

Plaintiffs reliance on Trilogy Comm 'ns, Inc. v. Tim es Fiber Comm 'ns, Inc., 109 F.3d 739 (Fed. Cir. 1997) where
the district court had not rendered any judgment on the cross-appellant's counter-claims, is therefore inapposite. Id.
at 745 (cross-appellant appealed from denial of summary judgment).

4

As Bosch makes clear, had willfulness not been decided, the Federal Circuit in this case
would still have had jurisdiction over the appeal under § 1292(c)(2).2 Here, however, the Court
had granted judgment as a matter of law of no willful infringement at the time Defendants
appealed. (D.I. 302). Therefore, the question is whether the Federal Circuit had jurisdiction over
a final judgment that included a final decision on willfulness. I determine that the Federal
Circuit had jurisdiction to hear a cross-appeal of the willfulness ruling under § 1292(c)(2). In

Alfred E. Mann Foundation/or Scientific Research v. Cochlear Corp., 841 F.3d 1334 (Fed. Cir.
2016), the Federal Circuit entertained a cross-appeal of the district court's JMOL on willful
infringement where judgment on infringement and invalidity had been entered and damages had
yet to be determined. Id. at 1346. Here, as in Mann, the Court made a final determination on
willfulness, but damages were still outstanding, as the parties had agreed to determine the
damages from infringement themselves, rather than require a damages trial. (D.I. 346 at
1285:12-20). As demonstrated by Mann, the Federal Circuit has jurisdiction under§ 1292(c)(2)
over the issue of willfulness where damages have not been decided. 3 See also Bosch, 719 F.3d at
1313 (separately holding that damages calculation is included in an "accounting" and therefore
appeals may be taken where damages determination has yet to occur). Therefore, I determine that
the Court's willfulness ruling was an appealable judgment under § 1292(c)(2).

B. Cross-Appeal was Required
Plaintiffs argue that, even if the willfulness ruling could have been appealed, cross-appeal
of the willfulness ruling was not required because an appellate decision would not have enlarged

2

This of course ignores that the Federal Circuit had independent jurisdiction over the injunction aspects of the
appeal. 28 U.S.C. § 1292(a)(l). See Amgen v. Sanofi, 872 F.3d at 1371 ("[Appellants] appeal from a final judgment
... holding [the asserted patents] not invalid and granting a permanent injunction ... .").
3
The district court had granted a motion for new trial on damages. Mann, 841 F.3d at 1339.

5

the scope of the judgment. (D.I. 452 at 10-11). Defendants argue that a cross-appeal of the
willfulness ruling would have enlarged Plaintiffs ' rights because it would have permitted
Plaintiffs to seek greater damages on remand. (D.I. 449 at 8). Plaintiffs respond that because
damages were not included in the judgment, an appeal on willful infringement would not have
enlarged its rights. (D.I. 452 at 11). However, that assertion is contrary to the Federal Circuit's
decision in Mann where the court of appeals entertained a cross-appeal of the district court's
JMOL on willful infringement where it also determined that there "ha[ d] not been a final
decision on the damages issue." 841 F.3d at 1346 (holding it lacked jurisdiction to consider
district court's order vacating the jury' s damages award and ordering a new damages trial).
Thus, here, that damages had not yet been determined would not have barred a cross-appeal of
the Court's willfulness ruling. Had Plaintiffs cross-appealed and succeeded, they would have
enlarged their rights to seek a willfulness finding and up to a trebling of damages for
infringement on remand.

C. The Amended Rule 54(b) Judgment did not Implicitly Vacate the Willfulness
Ruling
Plaintiffs argue that the Court' s amendment of the Rule 54(b) judgment reserved the
determination of willfulness for post-appeal proceedings. (D.I. 452 at 8-9). Defendants argue
that the language of the order altering the judgment does not function to reserve the
determination of willfulness. (D.I. 449 at 9).
The Court' s order altering the judgment does not clearly address the finality of the
willfulness ruling. (D.I. 427 at 3). It references only the potential "enhancement" of those
supplemental damages . (Id.) . Plaintiffs sought preservation of supplemental damages due to
Defendants' ongoing infringement and its "stipulation of infringement, a jury verdict of validity,

6

the judgment, and ... a permanent injunction." (D.I. 406 at 6). However, Plaintiffs also
explicitly noted that "[e]nhancement of supplemental damages is appropriate, even when there
has been no prior finding of willfulness." (Id. at 7). Plaintiffs now suggest that the order
amending the judgment was an "implicit vacatur" of the Court' s willfulness ruling. Defendants
argue that the willfulness ruling is dispositive as the Court' s order amending the judgment did
not address the willfulness ruling. (D.I. 449 at 3, 9-10).
I agree with Defendants. Willfulness is not a component of damages. As Plaintiffs
recognize (D.I. 406 at 7), willfulness has independent significance as a predicate for an award of
enhanced damages. As explained above, the willfulness ruling was a final decision subject to
appeal. The order amending the judgment dealt only with the preservation of supplemental
damages issues that had not been determined. (D.I. 427 at 3). I will not read an intent to vacate
a legal ruling on an independent legal issue, willfulness, into such an order. Therefore,
Plaintiffs' claim for willful infringement is barred.

IV.

CONCLUSION
For the foregoing reasons, Defendants' Motion for Judgment on the Pleadings is

GRANTED. An accompanying order will be entered.

7