United States District Court, D. Delaware
GENENTECH, INC. and CITY OF HOPE, Plaintiffs,
AMGEN INC., Defendant.
Michael P. Kelly, Daniel M. Silver, MCCARTER &ENGLISH,
LLP, Wilmington, Delaware; William F. Lee, Lisa J. Pirozzolo,
Emily R. Whelan, Kevin S. Prussia, Andrew J. Danford, WILMER
CUTLER PICKERING HALE AND DORR LLP, Boston, Massachusetts;
Robert J. Gunther Jr., WILMER CUTLER PICKERING HALE AND DORR
LLP, New York, New York; Daralyn J. Durie, Adam R. Brausa,
DURIE TANGRI LLP, San Francisco, California. Counsel for
Plaintiff Genentech, Inc.
C. Belgam, Eve H. Ormerod, SMITH KATZENSTEIN & JENKINS
LLP, Wilmington, Delaware; Michelle Rhyu, Susan Krumplitsch,
Daniel Knauss, COOLEY LLP, Palo Alto, California; Orion
Armon, COOLEY LLP, Broomfield, Colorado; Eamonn Gardner,
COOLEY LLP, San Diego, California. Counsel for Defendant
CONNOLLY, UNITED SPATES DISTRICT JUDGE
action arises under the Biologies Price Competition and
Innovation Act of 2009 (BPCIA), Pub. L. No. 111-148,
§§ 7001-7003, 124 Stat. 119, 804-21 (2010)
(codified as amended at 42 U.S.C. § 262, 35 U.S.C.
§ 271(e), 28 U.S.C. § 2201(b), 21 U.S.C. § 355
et seq.). Plaintiffs Genentech, Inc. and City of Hope have
sued Defendant Amgen Inc. based on Amgen's submission of
a Biologies License Application (BLA) for approval to market
Kanjinti, a biosimilar of Genentech's drug product
15, 2018, Amgen served Genentech a Notice of Commercial
Marketing pursuant to § 262(/)(8)(A) of the BPCIA.
Kanjinti was approved by the FDA on June 13, 2019. Four weeks
later, on July 10, 2019, Genentech moved for a temporary
restraining order and preliminary injunction to prevent Amgen
from commercially launching, marketing, or selling Kanjinti
until the Court renders a decision on the merits of
Genentech's patent infringement claims following trial,
and until the Court of Appeals for the Federal Circuit has
adjudicated any appeal of that decision. D.I. 273; D.I. 274.
That same day, I arranged an emergency teleconference with
the parties and orally ordered a standstill until I received
Amgen's response to Genentech's motions and had an
opportunity to consider fully the issues and rule on the
merits. For the foregoing reasons, I will deny
Genentech's motions for a temporary restraining order and
non-proprietary names for Herceptin and Kanjinti are
respectively trastuzumab and trastuzumab-anns. For purposes of a
trial scheduled for December 2019, the parties are litigating
ten patents which cover: (i) the trastuzumab antibody itself
(the Composition Patent); (ii) techniques for identifying
patients who might benefit from trastuzumab therapy (the HER2
Diagnostic Patents); (2) various aspects of cell culture,
purification, and antibody manufacturing purification (the
Manufacturing Patents); and (3) methods of administration (the
Dosing Patents). D.I. 44; D.I. 60 at 2-3; D.I. 75.
Genentech's motions seek relief based on claims in the
three Dosing Patents: U.S. Patent Nos. 6, 627, 196 (the
"#196 patent"), 7, 371, 379 (the "#379
patent") and 10, 160, 811 (the "#811 patent").
All three patents relate to methods of treating cancer with a
specific dosage regimen: intravenous ("IV")
administration of an initial 8 mg/kg dose followed by one or
more 6 mg/kg doses separated by three weeks. D.I. 279-1, Ex.
1, Cl. 11; Ex. 2, Cl. 11; Ex. 3, Cl. 6. The #379 patent
further recites coadministration with a chemotherapy agent.
Id., Ex. 2, Cl. 6. The #811 patent further recites
treatment of breast cancer. Id., Ex. 3, Cl. 11.
preliminary injunction is "a drastic and extraordinary
remedy that is not to be routinely granted." Intel
Corp. v. ULSI Sys. Tech, Inc., 995 F.2d 1566, 1568 (Fed.
Cir. 1993). To obtain such extraordinary relief, the moving
party must prove that: (1) it has a reasonable likelihood of
success on the merits; (2) it would suffer irreparable harm
in the absence of an injunction; (3) the balance of hardships
tips in its favor; and (4) an injunction would have a
favorable impact on the public interest. Amazon.com, Inc.
v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed.
Cir. 2001). "These factors, taken individually, are not
dispositive; rather, the district court must weigh and
measure each factor against the other factors and against the
form and magnitude of the relief requested."
Hybritech Inc. v. Abbott Lab., 849 F.2d 1446, 1451
(Fed. Cir. 1988). The grant or denial of a preliminary
injunction is within the sound discretion of the district
court. Polymer Tech., Inc. v. Bridwell, 103 F.3d
970, 973 (Fed. Cir. 1996).
standards for a preliminary injunction also apply to a motion
for a temporary restraining order when, as here, the opposing
party has notice of the motion. See Takeda Pharm. USA,
Inc. v. W.-Ward Pharm. Corp., 2014 WL 5088690, at *1 (D.
Del. Oct. 9, 2014). Accordingly, Genentech's motion for a
temporary restraining order rises and falls with its motion
for a preliminary injunction.
to the movant's burden are the likelihood of success and
irreparable harm factors." Sofamor Danek Grp., Inc.
v. DePuy-Motech, Inc., 74 F.3d 1216, 1219 (Fed. Cir.
1996). "A court may decline to issue a preliminary
injunction if the movant does not prove either of these
factors." Jeneric/Pentron, Inc. v. Dillon Co.,
205 F.3d 1377, 1380 (Fed. Cir. 2000). Here, I am denying the
motion for preliminary injunction, because Genentech has
failed to establish irreparable harm.
patentee's undue delay in seeking a preliminary
injunction "negates the idea of irreparability."
Pfizer, Inc. v. Teva Pharm., USA, Inc., 429 F.3d
1364, 1382 (Fed. Cir. 2005); Polymer Tech., 103 F.3d
at 974 (same). Genentech has known of Amgen's intent to
market Kanjinti since Amgen served its 180-day Notice of
Commercial Marketing on May 15, 2018. In addition, Genentech
received information through discovery that made clear
Amgen's plan to launch its marketing of Kanjinti in July
2019. Specifically, in February 2019, Amgen produced to
Genentech documents showing that it filed a
"resubmission" to the FDA in December
2018. Given the known six-month regulatory
timeline for the FDA to consider the resubmission
(see D.I. 289-1, Ex. 11 at 4), Genentech would have
understood at the time that the FDA would act on the
resubmission by the end of June 2019. In April 2019, Amgen
produced documents with its launch plan redactions removed,
thus enabling Genentech to see that Amgen planned to launch
in July 2019. Id. at Ex. 12. From late April through
mid-June, five Amgen witnesses testified during depositions
that Amgen was preparing to be ready to launch Kanjinti in
July 2019. D.I. 289-1, Ex. 14 at 66:12-67:3, 83:9-12; Ex. 15
at 40:20-23; Ex. 16 at 79:6-10, 81:3-6; Ex. 17 at 18:5-10;
and Ex. 18 at 32:11-33:18.
approved Kanjinti on June 13, 2019. But Genentech did not
file its motion for a preliminary injunction until July 10,
2019-fourteen months after receiving the Notice of Commercial
Marketing, three months after receiving a fairly specific