United States District Court, D. Delaware
H. LUNDBECK A/S, et al. Plaintiffs,
APOTEX INC., et al, Defendants.
E. Dellinger and Jack B. Blumenfeld, MORRIS, NICHOLS, ARSHT
& TUNNELL LLP, Wilmington, DE George F. Pappas, Einar
Stole, Christopher N. Sipes, Brianne Bharkhda, Priscilla G.
Dodson, Alaina Whitt, Allison Schmitt, and Yiye Fu, COVINGTON
& BURLING LLP, Washington, DC Attorneys for Plaintiffs.
Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP,
Wilmington, DE Laura A. Lydigsen, Joshua E. Ney, and Judy K.
He, BRINKS GILSON & LIONE, Chicago, IL Attorneys for
Defendants Sandoz Inc. and Lek Pharmaceuticals d.d.
U.S. District Judge.
before the Court is Defendants Sandoz Inc. and Lek
Pharmaceuticals d.d.'s ("Defendants") motion
for certification of an interlocutory appeal pursuant to 28
U.S.C. § 1292(b) (D.I. 378). For the reasons stated
below, the motion is denied.
H. Lundbeck A/S, Takeda Pharmaceutical Company Ltd., Takeda
Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals
International AG, and Takeda Pharmaceuticals America, Inc.
("Plaintiffs") brought this patent infringement
case against Defendants based on Defendants' Abbreviated
New Drug Applications ("ANDA"), which seek approval
from the U.S. Food and Drug Administration ("FDA")
to market generic versions of Plaintiffs' Trintellix drug
product prior to the expiration of certain of Plaintiffs'
patents. Trintellix is indicated for treating Major
Depressive Disorder ("MDD").
Plaintiffs initiated this suit, they alleged that
Defendants' proposed ANDA product would infringe three
patents: U.S. Patent Nos. 8, 722, 684 ("the '684
patent"), 8, 969, 355 ("the '355 patent"),
and 9, 227, 946 ("the '946 patent'").
Thereafter, Plaintiffs made two FDA-approved changes to their
Trintellix label. First, Plaintiffs included information
related to Trintellix's positive effects on cognitive
impairment. Consequently, Plaintiffs also added U.S. Patent
9, 125, 910 ("the '910 patent") to
Trintellix's entry in the FDA's "Orange
Book." The '910 patent claims a "method of
treating cognitive impairment involving a decline in speed of
processing, executive function, attention, or verbal learning
and memory in a patient diagnosed with depression."
(D.I. 387 Ex. O at 39:31-34) Second, Plaintiffs added data
related to Trintellix's positive effects on treatment of
emergent sexual dysfunction. Correspondingly, they also added
U.S. Patent 9, 278, 096 ("the '096 patent") to
Trintellix's Orange Book entry. The '096 patent
claims (in part) a "method for the treatment of a
disease selected from the group consisting of depression,
anxiety, abuse and chronic pain . . . wherein [a] patient has
previously received medication or is still receiving
medication for the treatment of said disease, [and] the
medication is ceased or reduced or has to be ceased or
reduced due to sexually related adverse events." (D.I.
387 Ex. L at 20:30-43)
then moved to amend to their complaints, seeking to add
claims for a declaratory judgment that Defendants would be
liable for contributory infringement of the '910 and
'096 patents. (See D.I. 224) After considering
Defendants' opposition (D.I. 234), the Court granted
Plaintiffs' motion to amend (D.I. 260). Defendants then
filed their pending motion for certification of an
interlocutory appeal of the Court's order granting the
motion to amend. (D.I. 378)
28 U.S.C. § 1292(b), the Court has discretion to certify
orders for interlocutory review where "exceptional
circumstances" merit a departure from the final judgment
rule. See Coopers & Lybrand v. Livesay, 437 U.S.
463, 475 (1978); see also Microsoft Mobile Inc. v.
Interdigital, Inc., 2016 WL 8302609, at *1 (D. Del. June
13, 2016) ("Interlocutory appeal is meant to be used
sparingly and only in exceptional cases where the interests
cutting in favor of immediate appeal overcome the presumption
against piecemeal litigation."). The Court can certify
orders that (i) address a "controlling question of
law" as to which there is (ii) "substantial ground
for difference of opinion" if (iii) an immediate appeal
"may materially advance the ultimate termination of the
litigation." 28 U.S.C. § 1292(b); see also Katz
v. Carte Blanche Corp., 496 F.2d 747, 754-55 (3d Cir.
1974). The decision to certify an order for appeal under
§ 1292(b) lies within the sound discretion of the
District Court. See St. Clair Intellectual Prop.
Consultants, Inc. v. Samsung Elecs. Co., 2010 WL
1213367, at *4 (D. Del. Mar. 28, 2010).
question presented for certification is a "controlling
question of law" when it "would result in a
reversal of judgment after a final hearing."
Katz, 496 F.2d at 755. Such questions should not
require the appellate court to make "factual
determinations better left to the district court."
Miller v. Bolger, 802 F.2d 660, 666-67 (3d Cir.
request certification of the following question:
Whether Plaintiffs can state a cognizable claim for
contributory infringement of an Orange Book-listed patent
based on the filing of Sandoz Inc.'s ANDA where Sandoz
Inc. has submitted a section viii ...