United States District Court, D. Delaware
Eli Lilly and Company (“Lilly”) has filed a
motion to stay this antitrust action until after resolution
of a related patent infringement action it brought against
Plaintiff Eagle Pharmaceuticals, Inc.
(“Eagle). For the reasons set forth below,
Lilly's motion to stay will be granted.
pending before me are two cases involving the same parties
and patent (the '209 patent as defined below). The first
is a patent infringement action captioned Eli Lilly and
Company v. Eagle Pharmaceuticals, Inc., C.A. No.
17-1293-MSG. In that case, Eagle submitted a New Drug
Application (“NDA”) to the Food and Drug
Administration (“FDA”) with a Paragraph IV
certification stating that U.S. Patent No. 7, 772, 209 (the
“'209 patent”) will not be infringed by the
manufacture, use, offer for sale, sale, or importation of
Eagle's NDA product, or alternatively, that the '209
patent is invalid. (C.A. No. 17-1293, D.I. 7 at ¶ 28).
Lilly is the assignee of the '209 patent which is listed
in the FDA's Orange Book as covering the drug product
ALIMTA®. (C.A. No. 17-1293, D.I. 1 at ¶ 22). In
September 2017, Lilly sued Eagle, pursuant to 35 U.S.C.
§ 271(e)(2), alleging that the use of Eagle's
proposed NDA Product will infringe the '209 patent either
literally or under the doctrine of equivalents and that Eagle
will induce and contribute to that infringement.
(Id. at ¶ 24-34). In October 2017, Eagle
asserted a counterclaim, pursuant to 21 U.S.C. §
355G)(5)(c)(ii)(I), seeking the correction or removal of
Lilly's “use code” for the branded drug
ALIMTA®. (C.A. No. 17-1293, D.I. 7 at ¶¶
189, 204-207). Eagle claims that a use code Lilly submitted
for ALIMTA® misrepresents the approved method of use
covered by the claims of the '209 Patent. (Id.
at ¶¶ 204-207). Discovery in the patent case is
ongoing and trial is currently set for September 9, 2019.
(Id. at ¶ 17).
second case before me is the above-captioned antitrust
action. In August 2017, Eagle filed a complaint in the U.S.
District Court for the District of New Jersey alleging that
Lilly violated antitrust laws by submitting for inclusion in
the FDA's Orange Book an “incorrect and
overbroad” use code for ALIMTA®, thereby preventing
Eagle's entry into the relevant market. In response,
Lilly filed a motion to transfer the antitrust action to this
court or, in the alternative, stay the antitrust action until
after resolution of the patent action. In July 2018, the
Honorable John M. Vazquez granted the motion to transfer and
denied the motion to stay as moot. After transfer to the
District of Delaware, Lilly renewed its motion to stay. A
schedule has not yet been set in this antitrust matter,
although the parties have proposed a jury trial sometime in
the second half of 2020.
has broad discretion to grant or deny a motion to stay.
Apotex, Inc. v. Senju Pharma. Co., 921 F.Supp.2d
308, 313 (D. Del. 2013). In exercising that discretion, the
court considers: (1) whether a stay will simplify the issues
for trial, (2) whether discovery is complete and a trial date
has been set, and (3) whether a stay would cause the
non-movant to suffer undue prejudice from any delay or allow
the movant to gain a clear tactical advantage. Id.
that a stay of this antitrust action until after the patent
infringement action is resolved will simplify the issues,
primarily because Eagle's antitrust claims involve
questions of patent law. To prevail on its antitrust claim,
Eagle will have to show, among other things, that the use
code Lilly submitted is not one “with respect to which
a claim of patent infringement could reasonably be
asserted.” 21 C.F.R. § 314.53(b)(1). If Eagle
loses the pending patent infringement action, it is doubtful
Eagle could make such a showing. In addition, if Eagle's
product infringes a valid claim of the '209 patent, then
Eagle may not have an antitrust claim, because Eagle's
product was lawfully prohibited from going on the market
before the '209 patent expires, regardless of the
propriety of Lilly's use code. See In re Wellbutrin
XL Antitrust Litig., 868 F.3d 132, 151-52, 165 (3d Cir.
2017) (finding no antitrust injury by delay of generic
competition where patent lawfully blocked market entry).
Thus, the issues in the antitrust case will at least be
narrowed, if not disposed of entirely, by the resolution of
the patent case.
argues that a stay would be wasteful, because it would not be
able to proceed with discovery on overlapping issues. (D.I.
55 at 7). I disagree. Eagle can pursue discovery relevant to
the patent infringement counterclaims based on Lilly's
use code and will not be prohibited from seeking this
discovery simply because it overlaps with the antitrust
claims in this action. Moreover, a delay of antitrust
specific discovery-which courts have recognized can be
“voluminous, time-consuming, and expensive”
(see, e.g., D.I. 40 at 13)-will avoid
potential waste if the claims in the antitrust action are
narrowed or mooted by the resolution of the patent
discovery in the patent action is ongoing and a trial is
currently scheduled for September 2019. No schedule has been
entered yet in the antitrust action, and the parties are
requesting a jury trial sometime in late 2020. Thus,
resolving the patent action before the antitrust action makes
sense, and will also “avoid possible inconsistent
results by different fact-finders.” SanDisk
Corporation v. Round Rock Research, LLC, 2014 WL
12768216, at *2 (D. Del. July 1, 2014) (staying antitrust
litigation until the verdict in the patent jury trial to
avoid inconsistent results by different fact-finders).
foregoing reasons, Lilly's motion for a stay (D.I. 49) is
granted. This action is stayed at least until the conclusion
of trial in the patent action. An appropriate order will be
 On May 18, 2017, Chief Judge D. Brooks
Smith of the United States Court of Appeals for the Third
Circuit designated me as a visiting judge for the District of
Delaware, pursuant to 28 U.S.C. § 292(b), to ...