United States District Court, D. Delaware
JUNO THERAPEUTICS, INC., MEMORIAL SLOAN KETTERING CANCER CENTER, and SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH, Plaintiffs;
KITE PHARMA, INC., Defendant.
B. Blumenfeld, Esq., MORRIS, NICHOLS, ARSHT & TUNNELL
LLP, Wilmington, DE; Morgan Chu, Esq., IRELL & MANELLA
LLP, Los Angeles, CA; Andrei Iancu, Esq., IRELL & MANELLA
LLP, Los Angeles, CA; Alan J. Heinrich, Esq., IRELL &
MANELLA LLP, Los Angeles, CA; Elizabeth C. Tuan, Esq., IRELL
& MANELLA LLP, Los Angeles, CA.
Attorneys for Plaintiff Kelly E. Farnan, Esq., RICHARDS
LAYTON & FINGER, P.A., Wilmington, DE; Leora Ben-Ami,
Esq., KIRKLAND & ELLIS LLP, New York, NY; Patricia A.
Carson, Esq., KIRKLAND & ELLIS LLP, New York, NY; Mira
Mulvaney, Esq., KIRKLAND & ELLIS LLP, New York, NY;
Christopher J. Citro, Esq., KIRKLAND & ELLIS LLP, New
York, NY. Attorneys for Defendant
ANDREWS, U.S. DISTRICT JUDGE
before the Court is Defendant's Motion to Dismiss (D.I.
8) and related briefing (D.I. 9, 16, 19). For the reasons
that follow, Defendant's motion is granted.
in this action are the assignee and exclusive licensee of
U.S. Patent No. 7, 446, 190 ("the '190
patent"). (D.I. 16 at 7). Plaintiffs have not yet
successfully developed an FDA approved therapy based on the
invention disclosed in the '190 patent. (D.I. 9 at 10).
Defendant, on the other hand, has initiated submission of a
Biologies License Application ("BLA") to the FDA
for a therapy Plaintiffs contend infringes or will infringe
the '190 patent.(D.I. 16 at 6). Defendant filed a petition
for Inter Partes Review ("IPR") with the Patent
& Trademark Office in 2015 seeking cancellation of all
claims of the '190 patent. (D.I. 1, ¶19). The
petition was granted, but on December 16, 2016, the Patent
Trial and Appeal Board ("PTAB") issued a final
decision finding Petitioner (Defendant in the instant action)
had not proven that any of the claims were invalid. (D.I. 16
at 9). Plaintiffs brought this action on December 19, 2016,
seeking a declaratory judgment that Defendant infringes or
will infringe the '190 patent.
purpose of the Declaratory Judgment Act is "to prevent
avoidable damages from being incurred by a person uncertain
of his rights and threatened with damage by delayed
adjudication." Minnesota Min. & Mfg. Co. v.
Norton Co., 929 F.2d 670, 673 (Fed. Cir. 1991).
court properly to exercise declaratory judgment jurisdiction,
there must exist "a substantial controversy, between
parties having adverse legal interests, of sufficient
immediacy and reality to warrant the issuance of a
declaratory judgment." Maryland Cas. Co. v. Pac.
Coal & Oil Co., 312 U.S. 270, 273 (1941).
Determining whether immediacy and reality are present is fact
specific and must be determined on a case-by-case basis by
considering the totality of the circumstances. Medlmmune,
Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007).
"The burden is on the party claiming declaratory
judgment jurisdiction to establish that such jurisdiction
existed at the time the claim for declaratory relief was
filed and that it has continued since." Benitec
Australia, Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1344
(Fed. Cir. 2007).
order to meet the immediacy prong, "there must be a
showing of 'meaningful preparation' for making or
using that product." Cat Tech LLC v. TubeMaster,
Inc., 528 F.3d 871, 881 (Fed. Cir. 2008) (quoting
Arrowhead Indus. Water, Inc. v. Ecolochem, Inc., 846
F.2d 731, 736 (Fed. Cir. 1988)). Timing is important for a
showing of immediacy. The longer the time between when suit
is initiated and when potential infringement may occur,
"the more likely the case lacks the requisite
immediacy." Sierra Applied Scis., Inc. v. Advanced
Energy Indus., Inc., 363 F.3d 1361, 1379 (Fed. Cir.
2004). For example, immediacy was not found where an accused
infringer's product "would not be finished until at
least 9 months after the complaint was filed" and the
accused infringer had not engaged in any marketing
activities. Lang v. Pac. Marine & Supply Co.,
895 F.2d 761, 764 (Fed. Cir. 1990). The Federal Circuit also
found immediacy lacking where a potentially infringing
product was not "built and operational until about a
year after the complaint was filed-a period longer than the
nine months determined to be too long in Lang."
Sierra Applied Scis., Inc., 363 F.3d at 1379.
seeks dismissal of this declaratory judgment action, arguing
the Court lacks subject matter jurisdiction. (D.I. 9 at 11).
Defendant contends its activities to date fall within the
Safe Harbor Provision of the Patent Act and are, therefore,
non-infringing activities. (Id.). Defendant further
argues the alleged future infringement is speculative, as it
is unclear when, or even whether, Defendant's BLA will be
approved. (Id. at 18).
initial matter, I reject Plaintiffs' argument that
Defendant's filing of a petition for IPR and its
subsequent appeal of the PTAB's final decision means that
Defendant "acknowledges its belief that Article III
jurisdiction exists over the parties' dispute regarding
the '190 Patent." (D.I. 16 at 12). Because the right
to appeal an IPR decision is provided by statute,
"certain requirements of standing-namely immediacy and
redressability, as well as prudential aspects that are not
part of Article III-may be relaxed." Consumer
Watchdog v. Wisconsin Alumni Research Found., 753 F.3d
1258, 1261 (Fed. Cir. 2014). In other words, Defendant's
IPR appeal is not subject to the same requirement of
immediacy as Plaintiffs' declaratory judgment action.
argue that there is no "bright-line rule" that the
§ 271(e)(1) safe harbor protects an alleged infringer
from a declaratory judgment action. (D.I. 15). The Safe
Harbor Provision of the Patent Act provides protection for
potentially infringing activities if those activities are
"solely for uses reasonably related to the development
and submission of information under a Federal law which
regulates the manufacture, use, or sale of drugs or
veterinary biological products." 35 U.S.C. §
271(e)(1). Defendant argues that all of its activities to
date related to the accused product fall within this
provision. (D.I. 9 at 12). Specifically, Defendant contends
that it has only manufactured the accused product in
connection with "clinical development studies, "
designed to ...