Amgen Inc. et al v. Hospira, Inc.
Filing
68
MEMORANDUM OPINION re 15 MOTION to Dismiss Count I of the Amended Complaint. Signed by Judge Richard G. Andrews on 8/5/2016. (ksr, )
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
AMGEN INC. and AMGEN
MANUFACTURING, LTD.,
Plaintiffs;
v.
Civil Action No. 15-839-RGA
HOSPIRA, INC.,
Defendant.
MEMORANDUM OPINION
Jack B. Blumenfeld, Esq., Maryellen Noreika, Esq., Morris, Nichols, Arsht & Tunnell LLP,
Wilmington, DE; Kevin M. Flowers, Esq. (argued), Matthew C. Nielsen, Esq., John R. Labbe,
Esq., Amanda K. Antons, Esq., Marshall, Gerstein & Borun LLP, Chicago, IL, attorneys for
Plaintiffs Amgen Inc. and Amgen Manufacturing, Ltd.
Dominick T. Gattuso, Esq., Proctor Heyman Enerio LLP, Wilmington, DE; Thomas J. Meloro,
Esq. (argued), Michael W. Johnson, Esq., Dan Constantinescu, Esq., Tara L. Thieme, Esq.,
Willkie Farr & Gallagher LLP, New York, NY, attorneys for Defendant Hospira, Inc.
August
--b ,2016
AND~~is~E:
Presently before the Court is Defendant's Motion to Dismiss Count I of the Amended
Complaint. (D.I. 15). The issues have been fully briefed. (D.I. 16, 17, 19). The Court heard
oral argument on February 17, 2016. (D.I. 24). For the reasons stated herein, Defendant's
motion to dismiss is DENIED.
I.
BACKGROUND
Plaintiffs filed this patent infringement action pursuant to 35 U.S.C. § 271(e)(2)(C),
which was enacted in 2010 as part of the Biologics Price Competition and Innovation Act
("BPCIA"), as well as 35 U.S.C. § 271(a). (D.I. 1). Plaintiffs allege that Defendant's biosimilar
product will infringe U.S. Patent No. 5,856,298, and that Defendant's manufacturing process
infringes U.S. Patent No. 5,756,349. (D.I. 11iii!86-106). Plaintiffs, in Count I of an amended
complaint, also seek a declaratory judgment that Defendant's refusal to give notice of
commercial marketing violates 42 U.S.C. § 262(1)(8)(A). (Id. iii! 76-85). In Count I, Plaintiffs
also seek "injunctive reliefrequiring [Defendant] to provide [Plaintiffs] with legally effective
notice of commercial marketing .... " (Id.
if 85). Defendant's motion to dismiss only concerns
Count I, and is based on both Rules 12(b)(l) and 12(b)(6).
II.
LEGAL STANDARD
Rule 8(a) requires "a short and plain statement of the claim showing that the pleader is
entitled to relief." Fed. R. Civ. P. 8(a)(2). When reviewing a motion to dismiss pursuant to Rule
12(b)(6), the court must accept the complaint's factual allegations as true, but may disregard any
legal conclusions. Fowler v. UPMC Shadyside, 578 F.3d 203, 210-11 (3d Cir. 2009). The
factual allegations do not have to be detailed, but they must provide more than labels,
conclusions, or a "formulaic recitation" of the claim elements. Bell Atl. Corp. v. Twombly, 550
U.S. 544, 555-56 (2007) ("Factual allegations must be enough to raise a right to relief above the
speculative level ... on the assumption that all the allegations in the complaint are true (even if
doubtful in fact)."). There must be sufficient factual matter to state a facially plausible claim to
relief. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). The facial plausibility standard is satisfied
when the complaint's factual content "allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged." Id. ("Where a complaint pleads facts that are
merely consistent with a defendant's liability, it stops short of the line between possibility and
plausibility of entitlement to relief." (quotation marks omitted)).
There are two ways a party may attack a complaint for lack of subject matter jurisdiction
pursuant to Rule 12(b)(l). Constitution Pty. ofPa. v. Aichele, 757 F.3d 347, 357-58 (3d Cir.
2014). "A challenge to a complaint for failure to allege subject matter jurisdiction is known as a
'facial' challenge, and must not be confused with a 'factual' challenge contending that the court
in fact lacks subject matter jurisdiction, no matter what the complaint alleges .... " NE Hub
Partners, L.P. v. CNG Transmission Corp., 239 F.3d 333, 341 n.7 (3d Cir. 2001). In reviewing a
facial challenge under Rule 12(b)(l), the court must accept all factual allegations in the
complaint as true and draw all reasonable inferences in favor of the plaintiff. Id. at 341. "[T]he
court must only consider the allegations of the complaint and documents referenced therein and
attached thereto .... " Gould Elecs. Inc. v. United States, 220 F.3d 169, 176 (3d Cir. 2000).
III.
ANALYSIS
Count I of the Amended Complaint pertains to 42 U.S.C. § 262(1)(8)(A). That subsection
of the BPCIA provides that a "subsection (k) applicant shall provide notice to the reference
product sponsor not later than 180 days before the date of the first commercial marketing of the
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biological product licensed under subsection (k)." 42 U.S.C. § 262(1)(8)(A). 1 The Federal
Circuit has held that "a subsection (k) applicant may only give effective notice of commercial
marketing after the FDA has licensed its product." Amgen Inc. v. Sandoz Inc., 794 F.3d 1347,
1358 (Fed. Cir. 2015),petitionfor cert.filed, 84 U.S.L.W. 3455 (U.S. Feb. 16, 2016) (No. 151039).
Defendant moves pursuant to Rules 12(b)(l) and 12(b)(6), contending that Plaintiffs may
not privately enforce (8)(A). Defendant argues, under both bases for its motion, that Congress
did not intend to create a private right of action, and where there is no intent, "a cause of action
does not exist and courts may not create one, no matter how desirable that might be as a policy
matter, or how compatible with the statute." Alexander v. Sandoval, 532 U.S. 275, 286-87
(2001).
Both bases for Defendant's motion implicate the same analysis, and-since Defendant's
challenge to subject matter jurisdiction is facial 2-the same standard. If Plaintiffs cannot
privately enforce (8)(A), Count I fails to state a claim upon which relief can be granted, and must
be dismissed pursuant to Rule 12(b)(6). Similarly, absent a "private, federal cause of action for
the [alleged] violation, [a complaint] does not state a claim 'arising under the Constitution, laws,
or treaties of the United States,"' and therefore must be dismissed pursuant to Rule 12(b)(l).
Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804, 817 (1986) (quoting 28 U.S.C. § 1331);
see also Smith v. Indus. Valley Title Ins. Co., 957 F.2d 90, 93 (3d Cir. 1992). Thus, the only
relevant question is whether Plaintiffs' (8)(A) claim may proceed.
1
Subsequent citations to subsections of§ 262(1) will omit the"§ 262(1)."
Defendant has not answered the complaint. Therefore, its attack on subject matter jurisdiction is a facial
one. See Mortensen v. First Fed. Sav. & Loan Ass 'n, 549 F.2d 884, 891-92, 892 n.17 (3d Cir. 1977).
2
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While this motion was pending, the Federal Circuit decided Amgen Inc. v. Apotex Inc., F.3d-, 2016 WL 3606770 (Fed. Cir. July 5, 2016). In that case, the district court had concluded
that "Apotex [did] not intend to comply with § 262(1)(8)(A)," and issued an injunction requiring
that, if the FDA approved Apotex's application, Apotex "provide Amgen with at least 180 days
notice before the date of the first commercial marketing of the biological product approved by
the FDA." Amgen, Inc. v. Apotex Inc., No. 15-61631-CIV-COHN/SELTZER, slip op. at 8-9
(S.D. Fla. Dec. 9, 2015) (order granting preliminary injunction). The Federal Circuit affirmed,
concluding that "an applicant must provide a reference product sponsor with 180 days' postlicensure notice before commercial marketing begins, regardless of whether the applicant
provided the (2)(A) notice of FDA review." Apotex, 2016 WL 3606770, at *10. The Federal
Circuit explicitly acknowledged that this mandatory requirement was "enforceable by
injunction." Id. at *6.
As Defendant correctly points out, the Federal Circuit did not squarely address whether
(8)(A) creates a private right of action. Indeed, "Apotex [did] not assert[] that (8)(A) create[ d]
no privately enforceable right." Id. at *8. Instead, the court rejected Apotex's contention that
paragraph (9) of§ 262(1) provided the exclusive remedy for violations of (8)(A). In so holding,
the court reasoned "that the federal courts' 'equitable jurisdiction is not to be denied or limited in
the absence of a clear and valid legislative command,' whether 'in so many words, or by a
necessary and inescapable inference."' Id. at *8 (quoting Porter v. Warner Holding Co., 328
U.S. 395, 398 (1946)). Since Apotex appealed the grant of Amgen's motion for preliminary
injunction, the Federal Circuit did not directly address the propriety of Amgen's request for a
"Declaratory Judgment that Apotex's Notice of Commercial Marketing Violates 42 U.S.C. §
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262(1)(8)(A)." Complaint at 15, Amgen, Inc. v. Apotex Inc., No. 15-61631-CIVCOHN/SELTZER (S.D. Fla. Dec. 9, 2015).
The rationale underpinning Apotex applies with equal force to the declaratory judgment
claim at issue here. "Actions for declaratory judgments are neither legal nor equitable, and
courts have therefore had to look to the kind of action that would have been brought had
Congress not provided the declaratory judgment remedy." Gulf.stream Aerospace Corp. v.
Mayacamas Corp., 485 U.S. 271, 284 (1988). In the context of analyzing the right to a jury trial,
the Third Circuit articulated the following standard:
If the declaratory judgment action does not fit into one of the existing equitable patterns
but is essentially an inverted law suit-an action brought by one who would have been a
defendant at common law-then the parties have a right to a jury. But ifthe action is the
counterpart of a suit in equity, there is no such right.
Asten.Johnson, Inc. v. Columbia Cas. Co., 562 F.3d 213, 223 (3d Cir. 2009) (quoting OwensIllinois, Inc. v. Lake Shore Land Co., 610 F.2d 1185, 1189 (3d Cir. 1979)). Where, as here, "[a]
declaratory judgment action seek[s] ... injunctive relief, [it] is clearly equitable in nature .... "
In re Stambaugh, 532 B.R. 572, 578 (M.D. Pa. 2015). Plaintiffs do not seek any monetary
damages for a violation of (8)(A). Rather, Plaintiffs explicitly request "a declaration of its rights
under the statute and injunctive relief requiring [Defendant] to provide [Plaintiffs] with legally
effective notice of commercial marketing." (D.I. 11
if 85). Absent the availability of declaratory
relief, Plaintiffs would simply seek an injunction.
"The Declaratory Judgments Act was not devised to deprive courts of their equity powers
or of their freedom to withhold relief upon established equitable principles." Great Lakes
Dredge & Dock Co. v. Huffinan, 319 U.S. 293, 300 (1943). Rather, "the express purpose of the
Federal Declaratory Judgment Act was to provide a milder alternative to the injunction remedy."
Alli v. Decker, 650 F .3d 1007, 1014 (3d Cir. 2011) (alteration and quotation marks omitted)
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(quoting Steffel v. Thompson, 415 U.S. 452, 467 (1974)). The Federal Circuit has already
recognized the availability of injunctive relief for violations of (8)(A). If presented with the
question raised by Defendant's motion, it would make sense to come to the same conclusion
regarding the availability of declaratory relief.
IV.
CONCLUSION
For the reasons set forth above, Defendant's motion to dismiss (D.I. 15) is DENIED. An
appropriate order will be entered.
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