United States District Court, D. Delaware
CIPLA LTD. and CIPLA USA, INC., Plaintiffs,
AMGEN INC., and TEVA PHARMACEUTICALS USA, INC., Defendants. AMGEN INC., and TEVA PHARMACEUTICALS USA, INC., Counterclaim-Plaintiffs
CIPLA LTD. and CIPLA USA, INC., Counterclaim-Defendants.
HONORABLE LEONARD P. STARK UNITED STATES DISTRICT COURT
before the Court is Amgen Inc.'s ("Amgen")
motion for an injunction pending appeal, see Fed. R.
Civ. P. 62(d), or, in the alternative, for a 14-day
injunction to enable Amgen to pursue, at the Third Circuit,
an expedited motion for an injunction pending appeal,
see Fed. R. App. P. 8(d). (D.I. 192) The relevant
facts are set out in the Court's May 2, 2019 Opinion,
which denied Amgen's motion (D.I. 121) for a preliminary
injunction to stop Cipla Ltd. and Cipla USA, Inc. (together,
"Cipla") from selling its generic cinacalcet
product ("Cipla Product"). (See D.I. 186)
("Opinion" or "Op, ") The Court found
that Amgen had not demonstrated a likelihood of success on
the merits of its claim that Cipla breached the parties'
settlement agreement ("Amgen-Cipla Agreement") by
selling Cipla Product. (Id.) After reviewing
briefing relating to the pending motion (D.I. 194, 197, 199),
IT IS HEREBY ORDERED that Amgen's motion
(D.I. 192) is DENIED, for the following
Federal Rule of Civil Procedure 62(d) provides, in relevant
part, that a court may grant an injunction while an appeal is
pending from an interlocutory order that refuses to grant the
injunction. To succeed on its Rule 62(d) motion, Amgen must
demonstrate: (1) a "strong showing" that it is
likely to succeed on the merits in its appeal; (2) absent an
injunction it will be irreparably harmed; (3) an injunction
or stay will not substantially injure Cipla; and (4) an
injunction will not harm the interests of the public.
Hilton v. Braunskill, 481 U.S. 770, 776 (1987);
see also Winter v. Natural Res. Def. Council, Inc.,
555 U.S. 7, 24 (2008). An injunction pending appeal is
"extraordinary" relief. United States v.
Cianfrani, 573 F.2d 835, 846 (3d Cir. 1978). The
decision of whether to grant an injunction pending appeal is
one within the discretion of the district court. See In
re Revel AC, Inc., 802 F.3d 558, 567 (3d Cir. 2015).
substantial portion of Amgen's briefing is devoted to its
contention that it should obtain its requested injunction
pending appeal merely by showing (on the first prong of the
test) just a "reasonable chance, or probability" of
success on the merits, a burden which may even be lower than
the one Amgen confronted in moving for a preliminary
injunction. (See, e.g., D.I. 194 at 1) The Court
disagrees. A "strong showing" of likelihood of
success is required to prevail on a Rule 62(d) motion.
See Hilton, 481 U.S. at 776; see also All. for
the Wild Rockies v. Kruger, 35 F.Supp.3d 1259, 1270 (D.
Mont. 2014) ("[I]njunctions are extraordinary remedies.
This maxim carries particular significance when a plaintiff
seeks an injunction pending appeal."). In any event,
Amgen has not shown even a reasonable chance or probability
of success on the merits.
Amgen also faults the Court for resolving uncertainties
against it. (See, e.g., D.I. 199 at 7) The Court
found Section 5.6 to be clear and unambiguous and denied the
preliminary injunction principally on this basis.
(See Op. at 10-24) To the extent the Court
identified material factual uncertainties in the record -
e.g., whether Teva has ceased selling its product -Amgen will
have the burden of proof on these disputes as this case
proceeds on the merits (i.e., to prevail on its breach of
contract counterclaim). Amgen also had the burden on its
motion for a preliminary injunction. Amgen's criticisms
of the Court's Opinion, thus, do not persuade the Court
that Amgen has a reasonable chance of prevailing on appeal.
Amgen argues that the Court's interpretation of Section
5.6 of the Amgen-Cipla Agreement renders
"superfluous" the rest of the "Agreement's
licensing and acceleration structure." (D.I. 194 at 5, 6
n.2) Amgen further faults the Court's interpretation for
"undermin[ing] the overall contractual scheme"
(id. at 4), which intends to "place Cipla on
equal footing with other generic manufacturers" (D.I.
199 at 4). Neither Amgen's new arguments, nor its
reiteration of already-rejected arguments, persuades the
Court that Amgen is likely to succeed on the merits of its
appeal. Amgen has failed to persuade the Court that the
Court's reading of sentence  of Section 5.6, as
clearly and unambiguously requiring denial of the preliminary
injunction motion, is incorrect. Nor has Amgen provided any
persuasive basis for the Court to predict that Amgen's
arguments will fare better on appeal. The Court's role is
to determine Amgen's and Cipla's rights and
responsibilities under the Amgen-Cipla Agreement, not to
maintain "parity" (D.I. 194 at 6) among generic
manufacturers or effectuate any other intent that is
inconsistent with the contractual language the parties
negotiated and executed.
the reasons articulated in its Opinion, Court finds that
Amgen has demonstrated that it will be irreparably harmed in
the absence of an injunction pending appeal. (D.I. 186 at
29-31) The balance of harms also favors Amgen, narrowly.
(See Id. at 31-36)Finally, the public interest also
slightly favors Amgen here, for the same reasons as already
given in the Opinion. (See Id. at 36-37)
Nonetheless, because Amgen has not met its burden with
respect to likelihood of success on appeal, the Court will
deny the motion for an injunction pending appeal.
Court will also deny the lesser, alternative relief sought by
Amgen, which is a 14-day injunction to allow Amgen to pursue,
at the Third Circuit, an expedited motion to grant an
injunction pending appeal, see Fed. R. App. P. 8(d).
(D.I. 194 at 14-15) Again, Amgen has failed to show
likelihood it will succeed with its appeal. Additionally, the
balance of harms and the public interest do not favor
disrupting the market for generic cinacalcet over the next
two weeks as Amgen seeks to obtain expedited relief from the
Court of Appeals. While it is unclear how great of a benefit
Amgen would obtain by prohibiting further Cipla sales during
that short timeframe, the harm to Cipla from having to
undertake a brief halt in its sales activities - and the harm to
the public from temporarily (and perhaps confusingly) losing
access to a generic drug it currently may purchase - seems
substantial. Amgen, having lost on its motion to
preliminarily enjoin Cipla's sales, will not be rewarded
with an injunction to enjoin (even for two weeks) those very
same sales simply because it has filed an
appeal. See generally Ortho Pharm. Corp. v.
Amgen, Inc., 882 F.2d 806, 813 (3d Cir. 1989) (stating
that goal of preliminary injunctive relief is
"preservation of the status quo").
 Amgen's reliance on In re
Revel AC, Inc., 802 F.3d at 567-69, for a lower
standard, is unavailing. In re Revel expressly
states that a movant for a stay pending appeal must
provide "a strong showing of the likelihood of
success." Id. at 565.
 Amgen's appeal is from the denial
of a preliminary injunction, so the Court of Appeals will
apply a "deferential" abuse of discretion standard
of review. See Reilly v. City of Harrisburg, 858
F.3d 173, 179 (3d Cir. 2017), as amended (June 26,
 The Court recognizes that in
describing Cipla's intended "nine-figure sale"
it mistakenly equated this with "at least $1
billion" of sales, when it should have characterized it
as only between $100 million and $999 million in sales.
Correcting this error ...