Case 1:17-cv-01471-GMS Document 84 Filed 04/17/18 Page 1 of 5 PageID #: 8318
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
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`GENENTECH, INC. and CITY OF HOPE,
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`V.
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`AMGEN INC.
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`Plaintiffs,
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`Defendant,
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`Civ. No. 17-1407-GMS
`Civ. No. 17-1471-GMS
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`MEMORANDUM
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`In two related patent-infringement actions, plaintiffs Genentech, Inc. and City of Hope
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`(collectively, "Genentech") have asserted multiple counts against defendant Amgen Inc.
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`("Amgen") based on Amgen's plans to commercialize Mvasi™, a biosimilar version of
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`Genentech's Avastin®. During the parties' so-called patent dance, Amgen made a statement
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`pursuant to 42 U.S.C. § 262(/)(3)(B) that it did not intend to begin commercial marketing of
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`Mvasi™ before December 18, 2018. Amgen later served notice that it would not commence
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`commercial marketing before April 4, 2018, a date earlier than the one previously provided.
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`Accordingly, Genentech seeks a declaratory judgment in both actions that Amgen cannot market
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`Mvasi™ before December 18, 2018. (See Civ. No. 17-1407, D.I. 41 at ,r,r 36-42 (count I); Civ.
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`No. 17-1471, D.I. 39 at ,r,r 336-46 (count 30)). 1 Amgen has moved to dismiss these counts-which
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`the court will refer to as the "commercial marketing" claim-for failure to state a claim and for
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`lack of subject matter jurisdiction under Fed. R. Civ. P. 12(b)(6) and 12(b)(l) respectively. (Civ.
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`No. 17-1407 at D.I. 45; Civ. No. 17-1471 at D.I. 43). For the reasons stated below, the court finds
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`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.
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`Case 1:17-cv-01471-GMS Document 84 Filed 04/17/18 Page 2 of 5 PageID #: 8319
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`that it currently lacks subject matter jurisdiction over Genentech's commercial marketing claim.
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`Accordingly, Amgen's motion is granted, and Genentech's commercial marketing claim is
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`dismissed without prejudice.
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`I.
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`BACKGROUND
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`On January 4, 2017, the FDA accepted Amgen's Abbreviated Biologics License
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`Application ("aBLA") for Mvasi™, thereby kicking off the "patent dance" prescribed by the
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`Biologics Price Competition and Innovation Act ("BPCIA"), 42 U.S.C. § 262(!). (D.I. 41 ,r,r 2, 5).
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`The patent dance is a carefully calibrated statutory scheme that requires the "reference product
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`sponsor" (i.e., Genentech) and the "applicant" (i.e., Amgen) to disclose and exchange information
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`in furtherance of "preparing to adjudicate, and then adjudicating, claims of infringement." Sandoz,
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`Inc. v. Amgen, Inc., 137 S. Ct. 1664, 1670 (2017).
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`Pursuant to paragraph (3)(A) of the patent dance, Genentech provided Amgen with a list
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`of 27 patents over which "a claim of patent infringement could reasonably be asserted." (D.I. 41
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`'t[ 8 (citing 42 U.S.C. § 262(!)(3)(A)). At that point, Amgen had to make a choice under paragraph
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`(3)(B): argue that the patents are "invalid, unenforceable, or will not be infringed by the
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`commercial marketing of [Mvasi™]," or make a "statement that [it] does not intend to begin
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`commercial marketing of [Mvasi™] before the date that such patent expires." 42 U.S.C. §
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`262(/)(3)(B).
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`On May 23, 2017, Amgen served its response.
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`(D.I. 41 'ti 9). It challenged 19 of the 27
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`patents as "invalid, unenforceable, or not infringed" and declared that it does not intend to begin
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`commercial marketing ofMvasi™ before December 18, 2018, when all of the 8 remaining patents
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`will have expired. (Id.). Then, on October 6, 2017, Amgen provided notice under paragraph
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`(8)(A) that it "will commence commercial marketing of Mvasi™ ... no earlier than 180 days from
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`2
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`Case 1:17-cv-01471-GMS Document 84 Filed 04/17/18 Page 3 of 5 PageID #: 8320
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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
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`that it would not commence commercial marketing before April 4, 2018, which is 8 months earlier
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`than the December 18, 2018 date previously provided. Genentech's commercial marketing claim
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`seeks to enforce Amgen's earlier representation that it would not launch Mvasi™ until the later
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`December date. 2 (D.I. 1).
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`II.
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`STANDARD OF REVIEW
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`The party asserting subject matter jurisdiction has the burden of proving its existence.
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`Lincoln Ben. Life Co. v. AEI Life, LLC, 800 F.3d 99, 105 (3d Cir. 2015). "Challenges to subject
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`matter jurisdiction under Rule 12(b)(l) may be facial or factual." Id. (quoting Common Cause of
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`Pa. v. Pennsylvania, 558 F.3d 249,257 (3d Cir. 2009)). A facial attack contests the sufficiency of
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`the pleadings, whereas a factual attack contests the sufficiency of jurisdictional facts.
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`Id.
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`In
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`reviewing a facial attack, the court considers only the allegations in the complaint and any
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`documents referenced in or attached to the complaint, in the light most favorable to the plaintiff.
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`Church of Universal Bhd v. Farmington Twp. Supervisors, 296 F. App'x 285,288 (3d Cir. 2008).
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`In contrast, when reviewing a factual attack, the court may weigh and consider evidence outside
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`the pleadings. Gould Elecs. Inc. v. United States, 220 F.3d 169, 176 (3d Cir. 2000). Finally, in a
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`factual challenge, "no presumptive truthfulness attaches to plaintiffs' allegations." Mortensen v.
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`First Fed Sav. & LoanAss'n, 549 F.2d 884,891 (3d Cir. 1977).
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`2
`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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`3
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`III. DISCUSSION
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`Amgen argues that there is no cognizable legal theory that would grant Genentech the relief
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`it seeks from the commercial marketing claim.
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`(D.I. 46 at 12-13, D.I. 53 at 4-11).
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`In the
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`alternative, Amgen argues that if Genentech is relying on a quasi-contract theory, there is no
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`binding representation, no breach of a binding of representation, and no detrimental reliance. (D .I.
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`46 at 13-16). Genentech responds that its commercial marketing claim is not based on a quasi(cid:173)
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`contract theory. (D.I. 53 at 10-11). Instead, the claim is based on a private right action arising
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`under the BPCIA itself. (Id.). This is a novel legal theory not yet addressed by any court. More
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`important, there is no need to delve into this unchartered territory at this time.
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`For a court to exercise jurisdiction under the Declaratory Judgment Act, there must be an
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`"actual controversy." 28 U.S.C. § 2201(a). The controversy must be "of sufficient immediacy
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`and reality to warrant the issuance of a declaratory judgment."' Juno Therapeutics, Inc. v. Kite
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`Pharma, Inc., 2017 WL 2559735, at *1 (D. Del. June 13, 2017) (quoting Md Cas. Co. v. Pac.
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`Coal & Oil Co., 312 U.S. 270, 273 (1941)). It is unclear whether Amgen will actually launch
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`Mvasi™ before December 18, 2018. Genentech points to no evidence of an actual controversy
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`other than the notice of commercial marketing. The 180 days in the commercial marketing notice
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`expired on April 4, 2018, and there is no indication that Mvasi™ has actually launched. The court
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`recently heard from the parties at a scheduling conference. The parties are currently engaged in
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`discovery and appear interested in cooperating. The court is left with the impression that the
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`commercial marketing claim is not of "sufficient immediacy" to warrant the issuance of a novel
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`declaratory judgment. If this claim ripens into an actual controversy, where Amgen launches
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`Mvasi™ before December 18, 2018, there will be an opportunity for Genentech to seek a
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`temporary restraining order or a preliminary injunction at that time.
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`IV. CONCLUSION
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`For the foregoing reasons, Amgen's motions to dismiss (Civ. No. 17-1407 at D.I. 45; Civ.
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`No. 17-1471 at D.I. 43) are granted. Count 1 of the 17-1407 complaint and count 30 of the 17-
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`1471 complaint are dismissed without prejudice. An appropriate order will be entered.
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`Dated: April fl_, 2018
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