United States District Court, D. Delaware
GENENTECH, INC. and CITY OF HOPE, Plaintiffs,
AMGEN INC. Defendant,
related patent-infringement actions, plaintiffs Genentech,
Inc. and City of Hope (collectively, "Genentech")
have asserted multiple counts against defendant Amgen Inc.
("Amgen") based on Amgen's plans to
commercialize Mvasi™, a biosimilar version of
Genentech's Avastin®. During the parties'
so-called patent dance, Amgen made a statement pursuant to 42
U.S.C. § 262(/)(3)(B) that it did not intend to begin
commercial marketing of Mvasi™ before December 18,
2018. Amgen later served notice that it would not commence
commercial marketing before April 4, 2018, a date earlier
than the one previously provided. Accordingly, Genentech
seeks a declaratory judgment in both actions that Amgen
cannot market Mvasi™ before December 18, 2018.
(See Civ. No. 17-1407, D.I. 41 at ¶¶ 36-42
(count I); Civ. No. 17-1471, D.I. 39 at ¶¶ 336-46
(count 30)). Amgen has moved to dismiss these
counts-which the court will refer to as the "commercial
marketing" claim-for failure to state a claim and for
lack of subject matter jurisdiction under Fed.R.Civ.P.
12(b)(6) and 12(b)(1) respectively. (Civ. No. 17-1407 at D.I.
45; Civ. No. 17-1471 at D.I. 43). For the reasons stated
below, the court finds that it currently lacks subject matter
jurisdiction over Genentech's commercial marketing claim.
Accordingly, Amgen's motion is granted, and
Genentech's commercial marketing claim is dismissed
January 4, 2017, the FDA accepted Amgen's Abbreviated
Biologies License Application ("aBLA") for
Mvasi™, thereby kicking off the "patent
dance" prescribed by the Biologies Price Competition and
Innovation Act ("BPCIA"), 42 U.S.C. §
262(1). (D.I. 41 ¶¶ 2, 5). The patent
dance is a carefully calibrated statutory scheme that
requires the "reference product sponsor" (i.e.,
Genentech) and the "applicant" (i.e., Amgen) to
disclose and exchange information in furtherance of
"preparing to adjudicate, and then adjudicating, claims
of infringement." Sandoz, Inc. v. Amgen, Inc.,
137 S.Ct. 1664, 1670 (2017).
to paragraph (3)(A) of the patent dance, Genentech provided
Amgen with a list of 27 patents over which "a claim of
patent infringement could reasonably be asserted." (D.I.
41 ¶ 8 (citing 42 U.S.C. § 262(f)(3)(A)). At that
point, Amgen had to make a choice under paragraph (3)(B):
argue that the patents are "invalid, unenforceable, or
will not be infringed by the commercial marketing of
[Mvasi™], " or make a "statement that [it]
does not intend to begin commercial marketing of
[Mvasi™] before the date that such patent
expires." 42 U.S.C. § 262(/)(3)(B).
23, 2017, Amgen served its response. (D.I. 41 ¶ 9). It
challenged 19 of the 27 patents as "invalid,
unenforceable, or not infringed" and declared that it
does not intend to begin commercial marketing of Mvasi™
before December 18, 2018, when all of the 8 remaining patents
will have expired. (Id.). Then, on October 6, 2017,
Amgen provided notice under paragraph (8)(A) that it
"will commence commercial marketing of Mvasi™ ...
no earlier than 180 days from the date of this letter."
(D.I. 41 at ¶ 17; D.I. 47-1, Ex. A). In other words,
Amgen provided notice that it would not commence commercial
marketing before April 4, 2018, which is 8 months earlier
than the December 18, 2018 date previously provided.
Genentech's commercial marketing claim seeks to enforce
Amgen's earlier representation that it would not launch
Mvasi™ until the later December date. (D.I. 1).
STANDARD OF REVIEW
party asserting subject matter jurisdiction has the burden of
proving its existence. Lincoln Ben. Life Co. v. AEI Life,
LLC, 800 F.3d 99, 105 (3d Cir. 2015). "Challenges
to subject matter jurisdiction under Rule 12(b)(1) may be
facial or factual." Id. (quoting Common
Cause of Pa. v. Pennsylvania, 558 F.3d 249, 257 (3d Cir.
2009)). A facial attack contests the sufficiency of the
pleadings, whereas a factual attack contests the sufficiency
of jurisdictional facts. Id. In reviewing a facial
attack, the court considers only the allegations in the
complaint and any documents referenced in or attached to the
complaint, in the light most favorable to the plaintiff.
Church of Universal Bhd. v. Farmington Twp.
Supervisors, 296 F. App'x 285, 288 (3d Cir. 2008).
In contrast, when reviewing a factual attack, the court may
weigh and consider evidence outside the pleadings. Gould
Elecs. Inc. v. United States, 220 F.3d 169, 176 (3d Cir.
2000). Finally, in a factual challenge, "no presumptive
truthfulness attaches to plaintiffs' allegations."
Mortensen v. First Fed. Sav. & Loan Ass'n,
549 F.2d 884, 891 (3d Cir. 1977).
argues that there is no cognizable legal theory that would
grant Genentech the relief it seeks from the commercial
marketing claim. (D.I. 46 at 12-13, D.I. 53 at 4-11). In the
alternative, Amgen argues that if Genentech is relying on a
quasi-contract theory, there is no binding representation, no
breach of a binding of representation, and no detrimental
reliance. (D.I. 46 at 13-16). Genentech responds that its
commercial marketing claim is not based on a quasi-contract
theory. (D.I. 53 at 10-11). Instead, the claim is based on a
private right action arising under the BPCIA itself.
(Id.). This is a novel legal theory not yet
addressed by any court. More important, there is no need to
delve into this unchartered territory at this time.
court to exercise jurisdiction under the Declaratory Judgment
Act, there must be an "actual controversy." 28
U.S.C. § 2201(a). The controversy must be "of
sufficient immediacy and reality to warrant the issuance of a
declaratory judgment.'" Juno Therapeutics, Inc.
v. Kite Pharma, Inc., 2017 WL 2559735, at *1 (D. Del.
June 13, 2017) (quoting Md. Cas. Co. v. Pac. Coal &
Oil Co., 312 U.S. 270, 273 (1941)). It is unclear
whether Amgen will actually launch Mvasi™ before
December 18, 2018. Genentech points to no evidence of an
actual controversy other than the notice of commercial
marketing. The 180 days in the commercial marketing notice
expired on April 4, 2018, and there is no indication that
Mvasi™ has actually launched. The court recently heard
from the parties at a scheduling conference. The parties are
currently engaged in discovery and appear interested in
cooperating. The court is left with the impression that the
commercial marketing claim is not of "sufficient
immediacy" to warrant the issuance of a novel
declaratory judgment. If this claim ripens into an actual
controversy, where Amgen launches Mvasi™ before
December 18, 2018, there will be an opportunity for Genentech
to seek a temporary restraining order or a preliminary
injunction at that time.
foregoing reasons, Amgen's motions to dismiss (Civ. No.
17-1407 at D.I. 45; Civ. No. 17-1471 at D.I. 43) are granted.
Count 1 of the 17-1407 complaint and count 30 of the 17-1471
complaint are dismissed without prejudice. An appropriate
order will be entered.