United States District Court, D. Delaware
before the Court is Defendant Shire ViroPharma Inc.'s
motion to dismiss pursuant to Federal Rules of Civil
Procedure 12(b)(1) and 12(b)(6). (D.I. 19). The matter has
been fully briefed. (D.I. 20, 22, 23). The Court heard oral
argument on February 2, 2018. (D.I. 45) ("Tr.").
February 7, 2017, the Federal Trade Commission
("FTC") filed this action against ViroPharma
pursuant to Section 13(b) of the FTC Act, 15 U.S.C. §
53(b). (D.I. 2). ViroPharma is a Delaware corporation that
develops, manufactures, and markets branded pharmaceuticals.
(Id. ¶ 8). The complaint contains one count,
alleging that ViroPharma violated Section 5(a) of the Act, 15
U.S.C. § 45(a), by engaging in an unfair method of
competition. (Id. ¶ 154).
action arises out of ViroPharma's use of the U.S. Food
and Drug Administration's ("FDA") citizen
petition process. (Id. ¶ 1). More
specifically, the FTC alleges that ViroPharma used the
FDA's citizen petition process to maintain its monopoly
on Vancocin Capsules. (Id.). The FTC maintains that
ViroPharma's meritless petitioning activity "harmed
competition and consumer welfare by obstructing and delaying
the FDA approval process for a generic version of
Vancocin." (Id. ¶ 144).
complaint alleges that ViroPharma "inundated the FDA
with regulatory and court filings-forty-six in all."
(Id. ¶ 1). The filings occurred between March
2006 and April 2012.(Id. ¶ 49). They are listed
at paragraph 118 of the complaint. The filings include
twenty-four citizen petition filings, eighteen public
comments, a Supplemental New Drug Application, and three
seeks a permanent injunction and other equitable relief.
must grant a motion to dismiss pursuant to Rule 12(b)(1) if
it lacks subject matter jurisdiction to hear a claim. In
re Schering Plough Corp. Intron/Temodar Consumer Class
Action, 678 F.3d 235, 243 (3d Cir. 2012). "In
evaluating a Rule 12(b)(1) motion, a court must first
determine whether the movant presents a facial or factual
attack." Id. "In reviewing a facial
challenge, which contests the sufficiency of the pleadings,
the court must only consider the allegations of the complaint
and documents referenced therein and attached thereto, in the
light most favorable to the plaintiff." Id. In
this case, ViroPharma's Rule 12(b)(1) arguments
constitute a "facial attack" because ViroPharma
contends the complaint lacks sufficient factual allegations
to establish jurisdiction. See id.
evaluating whether a complaint adequately pleads the elements
of standing, courts apply the standard of reviewing a
complaint pursuant to a Rule 12(b)(6) motion . . .."
Id; see also Baldwin v. Univ. of Pittsburgh Med.
Ctr., 636 F.3d 69, 73 (3d Cir. 2011) ("A dismissal
for lack of statutory standing is effectively the same as a
dismissal for failure to state a claim."). That standard
is set forth below. "With respect to 12(b)(1) motions in
particular, [however, ] [t]he plaintiff must assert facts
that affirmatively and plausibly suggest that the pleader has
the right he claims (here, the right to jurisdiction), rather
than facts that are merely consistent with such a
right." In re Schering, 678 F.3d at 244
reviewing a motion to dismiss pursuant to Rule 12(b)(6), the
Court must accept the complaint's factual allegations as
true. See Bell Atl. Corp. v. Twombly, 550 U.S. 544,
555-56 (2007). Rule 8(a) requires "a short and plain
statement of the claim showing that the pleader is entitled
to relief." Id. at 555. 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. Id. ("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
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. "In deciding a Rule 12(b)(6) motion, a
court must consider only the complaint, exhibits attached to
the complaint, matters of public record, as well as
undisputedly authentic documents if the complainant's
claims are based upon these documents." Mayer v.
Belichick, 605 F.3d 223, 230 (3d Cir. 2010).
makes two principal arguments in its motion to dismiss.
First, it argues the FTC has failed to plead the facts
necessary to invoke its authority under Section 13(b) of the
Act. (D.I. 20 at 17). Second, it argues ViroPharma's
alleged conduct is immune from challenge under the
Noerr-Pennington doctrine. (Id. at 26).
first argument raises what appear to be novel questions in
regard to the proper interpretation of Section 13(b) of the
FTC Act. Section 13(b) provides in relevant part: (b)
Whenever the Commission has reason to believe-
(1) that any person, partnership, or corporation is
violating, or is about to violate, any provision of law
enforced by ...