Genentech, Inc. et al v. Amgen Inc.
Filing
86
MEMORANDUM. Signed by Judge Gregory M. Sleet on 4/17/2018. Associated Cases: 1:17-cv-01407-GMS, 1:17-cv-01471-GMS(mdb)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
GENENTECH, INC. and CITY OF HOPE,
Plaintiffs,
V.
AMGEN INC.
Defendant,
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Civ. No. 17-1407-GMS
Civ. No. 17-1471-GMS
MEMORANDUM
In two 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
,r,r 36-42 (count I); Civ.
No. 17-1471, D.I. 39 at ,r,r 336-46 (count 30)). 1 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)(l) 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
Because the parties make essentially identical arguments in both actions, all cites
hereinafter are to the docket for Civ. No. 17-1407 unless stated otherwise.
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 without prejudice.
I.
BACKGROUND
On January 4, 2017, the FDA accepted Amgen's Abbreviated Biologics License
Application ("aBLA") for Mvasi™, thereby kicking off the "patent dance" prescribed by the
Biologics Price Competition and Innovation Act ("BPCIA"), 42 U.S.C. § 262(!). (D.I. 41
,r,r 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).
Pursuant 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
't[ 8 (citing 42 U.S.C. § 262(!)(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).
On May 23, 2017, Amgen served its response.
(D.I. 41
'ti 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 ofMvasi™ 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
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the date of this letter." (D.I. 41 at ,r 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. 2 (D.I. 1).
II.
STANDARD OF REVIEW
The 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)(l) 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. & LoanAss'n, 549 F.2d 884,891 (3d Cir. 1977).
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As part of briefing on the motion to dismiss, Genentech provided several letters the parties
exchanged regarding Amgen' s commercial marketing notice. (See D.I. 54, Exs. 1-7). On a motion
to dismiss, the court is confined to the allegations in the complaint, exhibits attached to the
complaint, documents incorporated by reference, and items subject to judicial notice. Szczuka v.
Delaware, 2018 WL 934599, at *2 (D. Del. Feb. 16, 2018). These letters were not referenced in
the complaint nor attached to the complaint. Thus, there is no basis for the court to consider them
without converting this motion to dismiss into a motion for summary judgment.
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III.
DISCUSSION
Amgen 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 quasicontract 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.
For a 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.
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IV.
CONCLUSION
For the 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 171471 complaint are dismissed without prejudice. An appropriate order will be entered.
Dated: April
fl_, 2018
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