PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

_____________

No. 18-1807

_____________

FEDERAL TRADE COMMISSION,

 Appellant

v.

SHIRE VIROPHARMA, INC.

_____________

On Appeal from the United States District Court

for the District of Delaware

District Court No. 1-17-cv-00131

District Judge: The Honorable Richard G. Andrews

Argued December 11, 2018

Before: SMITH, Chief Judge, McKEE, and FISHER, 

Circuit Judges

(Filed: February 25, 2019)
2

Bradley S. Albert

Meredyth Andrus

Thomas J. Dillickrath

Matthew M. Hoffman [ARGUED]

June Im

Nicholas Leefer

Joel R. Marcus

Joseph Mathias

James H. Weingarten

Federal Trade Commission

600 Pennsylvania Avenue, N.W.

Washington, DC 20580

Counsel for Appellant

J. Clayton Everett, Jr.

Scott A. Stempel

Morgan Lewis & Bockius

1111 Pennsylvania Avenue, N.W.

Suite 800 North

Washington, DC 20004

Noah J. Kaufman

Morgan Lewis & Bockius

One Federal Street

Boston, MA 02110

Steven A. Reed [ARGUED]

Jessica J. Taticchi

Morgan Lewis & Bockius
3

1701 Market Street

Philadelphia, PA 19103

Counsel for Appellee

George P. Slover

Consumers Union

1101 17th Street, N.W.

Suite 500

Washington, DC 20036

Counsel for Amicus Appellant

Richard A. Samp

Washington Legal Foundation

2009 Massachusetts Avenue, N.W.

Washington, DC 20036

Counsel for Amicus Appellee

________________

OPINION OF THE COURT

________________

SMITH, Chief Judge.
4

Shire ViroPharma, Inc. (“Shire”),1 manufactured 

and marketed the lucrative drug Vancocin, which is 

indicated to treat a life-threatening gastrointestinal 

infection. After Shire got wind that manufacturers were 

considering making generic equivalents to Vancocin, it 

inundated the United States Food and Drug 

Administration (“FDA”) with allegedly meritless filings to 

delay approval of those generics. The FDA eventually 

rejected Shire’s filings and approved generic equivalents 

to Vancocin, but the filings nonetheless resulted in a high 

cost to consumers—Shire had delayed generic entry for 

years and reaped hundreds of millions of dollars in profits.

Nearly five years later—and after Shire had 

divested itself of Vancocin—the Federal Trade 

Commission (“FTC”) filed suit against Shire in the United 

States District Court for the District of Delaware under 

Section 13(b) of the Federal Trade Commission Act, 15 

U.S.C. § 53(b). The FTC sought a permanent injunction 

and restitution, alleging that Shire’s petitioning was an 

unfair method of competition prohibited by the Act. Shire 

moved to dismiss, arguing that the FTC’s allegations of 

long-past petitioning activity failed to satisfy Section 

13(b)’s requirement that Shire “is violating” or “is about 

 

1 Shire ViroPharma, Inc. is the corporate successor 

to ViroPharma, which it acquired in 2014—after the 

petitioning activity at issue in this case ceased.
5

to violate” the law. The District Court agreed and 

dismissed the case.

On appeal, the FTC urges us to adopt a more 

expansive view of Section 13(b). According to the FTC, 

the phrase “is violating, or is about to violate” in Section 

13(b) is satisfied by showing a past violation and a 

reasonable likelihood of recurrent future conduct. We 

reject the FTC’s invitation to stretch Section 13(b) beyond 

its clear text. The FTC admits that Shire is not currently 

violating the law. And the complaint fails to allege that 

Shire is about to violate the law. We will therefore affirm 

the District Court’s judgment.

I.2

A.

A company that wishes to manufacture and market

a new drug in the United States must submit to the FDA a 

New Drug Application (“NDA”) demonstrating the safety 

 

2 We derive the facts of this case from the FTC’s 

complaint. In our review of the grant of the motion to 

dismiss, we take the allegations to be true and construe 

them in the light most favorable to the FTC. In re: Tower 

Air, Inc., 416 F.3d 229, 232 n.1 (3d Cir. 2005).
6

and efficacy of the product.3 Usually, the NDA filer 

demonstrates safety and efficacy by using expensive in 

vivo clinical endpoint studies, where researchers provide 

sick patients with either the proposed drug or a placebo to 

compare the safety and efficacy of the drug with the

placebo. See Fed. Trade Comm’n v. Actavis, Inc., 570 

U.S. 136, 142 (2013) (describing the “long, 

comprehensive, and costly testing process” underlying an 

NDA). After FDA approval, the manufacturer must seek 

approval through a supplemental NDA if it wishes to

change the drug or its label.

A generic drug manufacturer need not file an NDA 

because it is essentially copying the approved branded 

drug. The generic manufacturer must instead file an 

Abbreviated New Drug Application (“ANDA”), which 

relies on the approved drug’s profile for safety and 

efficacy. See id. (“The Hatch-Waxman process, by 

allowing the generic to piggy-back on the pioneer’s 

 

3 The regulatory scheme employed by the FDA is 

governed by the Food, Drug, and Cosmetic Act, 21 U.S.C. 

§ 301, as amended by the Drug Price Competition and 

Patent Term Restoration Act of 1984 (“Hatch-Waxman”), 

Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified as 

amended at 21 U.S.C. § 355 and 35 U.S.C. § 271(e) 

(1994)), and the Medicare Prescription Drug, 

Improvement, and Modernization Act of 2003, Pub. L. No. 

108-173, 117 Stat. 2066 (2003).
7

approval efforts, speeds the introduction of low-cost 

generic drugs to market, thereby furthering drug 

competition.” (internal alteration, quotation marks, and 

citation omitted)). The generic manufacturer must 

demonstrate, inter alia, that the proposed generic drug is 

bioequivalent to the referenced branded drug.4 See 21 

C.F.R. § 314.3(b) (defining bioequivalence as “the 

absence of a significant difference in the rate and extent to 

which the active ingredient or active moiety in 

pharmaceutical equivalences or pharmaceutical 

alternatives becomes available at the site of drug 

action . . . .”).

B.

Shire develops, manufactures, and markets branded 

drugs. Until Shire divested itself of the product in 2014, 

 

4 The FDA has flexibility in determining how a 

manufacturer must establish bioequivalence. See, e.g., 21 

C.F.R. § 320.24(a) (providing that the FDA may require 

either in vivo or in vitro studies to demonstrate 

bioequivalence).
8

this included Vancocin capsules.5 Vancocin capsules are

an oral antibiotic used to treat Clostridium-difficile

associated diarrhea, which is a serious, potentially lifethreatening gastrointestinal infection. When Vancocin 

capsules were developed, the NDA did not include in vivo 

clinical endpoint studies because the capsules were an 

alternative delivery system to Vancocin oral solution, 

which the FDA already knew to be safe and effective. 

Instead, the NDA included in vitro dissolution data (which 

measures how quickly the capsules dissolve) and in vivo

pharmacokinetic data (which compares the absorption of 

the drug in capsule form versus oral solution form).

In April 1986, the FDA approved Vancocin 

capsules. Shire acquired Vancocin capsules in November 

2004. From then until 2011, Vancocin capsules were 

Shire’s largest revenue-generating product. Vancocin 

capsules accounted for all of Shire’s net revenue until 

2009 and up to 53% of its net revenue in 2011. United 

 

5 We take judicial notice of this fact—which is not 

in the complaint—from Shire’s Form 8-K filings with the 

Securities Exchange Commission. Shire plc, Form 8-K, 5

(Oct. 24, 2014), https://bit.ly/2SxTOm8; see Oran v. 

Stafford, 226 F.3d 275, 289 (3d Cir. 2000) (taking judicial 

notice of SEC filings).
9

States sales for Vancocin capsules grew from $40 million 

in 2003 to almost $300 million in 2011.

Generic manufacturers, attracted by Vancocin’s 

financial success, wanted to enter the market. Vancocin 

was vulnerable to generic competition because it lacked 

both patent protection and regulatory exclusivity. One 

primary barrier to generic entry remained—the FDA’s 

recommendation that generic manufacturers seeking to 

demonstrate bioequivalence conduct in vivo clinical 

endpoint studies. Ironically, these tests were more 

expensive and onerous than the in vitro dissolution testing 

and in vivo pharmacokinetic studies that had been used to 

gain approval of Vancocin capsules in the first place. The 

FDA apparently realized this inconsistency; in October 

2004 it convened a public meeting of the Advisory 

Committee for Pharmaceutical Science (the “Advisory 

Committee”)6to reassess bioequivalence testing for 

locally-acting gastrointestinal drugs like Vancocin.

Shire became increasingly concerned that the FDA 

might allow generic manufacturers to demonstrate 

bioequivalence using in vitro data. Shire thus hired a 

 

6 The Advisory Committee is a body of sixteen 

independent experts from academia, non-profits, and 

hospitals. These experts are “knowledgeable in the fields 

of pharmaceutical sciences, clinical pharmacology, and 

gastrointestinal diseases.” Compl. ¶ 85.
10

bioequivalence consultant to advise it on the FDA’s likely 

course of action. In November 2005, the consultant

confirmed Shire’s suspicions, advising Shire that the FDA 

would likely allow generic manufacturers to submit in 

vitro dissolution data to establish bioequivalence to 

Vancocin capsules. The consultant counseled Shire to 

submit a citizen petition “sooner than later” but warned

that without supporting clinical data, Shire “could not 

convince the FDA of its position against use of in vitro

dissolution testing.” Compl. ¶ 45.

Shire’s fear came to pass: the FDA indeed changed 

its position on bioequivalence testing for Vancocin 

capsules. In February 2006, the FDA advised a generic 

manufacturer that bioequivalence for Vancocin capsules 

could be demonstrated by in vitro dissolution testing. The 

FDA also shared this guidance with other generic 

manufacturers that inquired. In March 2007, the first 

generic manufacturer submitted its ANDA for Vancocin 

capsules. Two other generic manufacturers followed suit 

later that year.

C.

Not surprisingly, Shire wanted to protect its 

monopoly on the Vancocin market. Among its options 

was a citizen petition. The First Amendment guarantees 

individuals the right to petition the government. U.S. 

Const. amend. I. Consistent with that right, the 

Administrative Procedure Act permits any “interested 
11

person” to petition a federal agency “for the issuance, 

amendment, or repeal of a rule.” 5 U.S.C. § 553(e); see 

also 21 C.F.R. § 10.30 (FDA regulation governing citizen 

petitions).

The filing of a citizen petition can substantially 

delay approval of a generic drug. During the time period 

at issue here, the FDA automatically suspended ANDA 

approval if a branded manufacturer filed a citizen 

petition.7 The FDA is obligated to respond to every citizen 

petition within 180 days.8 Id. § 10.30(e)(5); see also 21 

 

7 Although inapplicable to Shire’s citizen petition, 

Congress passed the Food and Drug Administration 

Amendments Act of 2007 to assuage the FDA’s fear that 

many brand manufacturers’ citizen petitions were 

meritless attempts to delay generic competition. See 21 

U.S.C. § 355(q). Post-2007, the FDA cannot delay ANDA 

approval due to a citizen petition unless “a delay is 

necessary to protect the public health.” Id.

§ 355(q)(1)(A)(ii). Under the amendment, the FDA may

also deny a citizen petition filed “with the primary purpose 

of delaying” ANDA approval that “does not on its face 

raise valid scientific or regulatory issues.” Id.

§ 355(q)(1)(E).

8 This time period has since been shortened to 150 

days. 21 C.F.R. § 10.30(e)(5).
12

U.S.C. § 355(q)(1)(F). But the FDA’s response need not 

dispose of the entire petition within that time. The FDA 

may deny the petition, approve it in whole or in part, 

provide a tentative response, or delay a decision by 

modifying or postponing any suggested action. See 21 

C.F.R. § 10.30(e)(2)(i)–(iv).

From March 2006 to April 2012, Shire submitted a 

total of forty-three filings to the FDA and instituted three

federal court proceedings—all allegedly to delay the 

approval of generic Vancocin capsules by convincing the 

FDA to require ANDA applicants to conduct in vivo

clinical endpoint studies. Shire’s filings ranged from a 

citizen petition and amendments thereto to public 

comments on other manufacturers’ ANDAs. Many of 

these filings were around the same time Shire suspected 

the FDA was nearing approval of generic equivalents to 

Vancocin.

On April 9, 2012, the FDA rejected Shire’s citizen 

petition.9 The FDA concluded that Shire’s scientific 

challenges to the bioequivalence recommendation 

“lack[ed] merit” and “were unsupported.” Compl. ¶ 104

(internal quotation marks omitted); App. 77–95. On that 

same day the FDA approved three ANDAs for generic 

 

9 Shire did not prevail in any of its lawsuits, which 

were either dismissed or withdrawn.
13

Vancocin capsules. Shire lost almost 70% of its unit sales 

for Vancocin capsules within three months.

D.

Nearly five years later, on February 7, 2017, the 

FTC sued Shire, seeking a permanent injunction and 

equitable monetary relief under Section 13(b) of the FTC 

Act. The FTC claimed that Shire’s conduct—submitting 

serial, meritless filings—had harmed consumers and 

competition because it enabled Shire to maintain and 

extend its monopoly by delaying the FDA’s approval of 

generic alternatives to Vancocin capsules. See 15 U.S.C. 

§ 45(a).

The FTC alleged that, absent an injunction, “there 

is a cognizable danger” that Shire will “engage in similar 

conduct causing future harm to competition and 

consumers.” Compl. ¶ 150. It based this assertion on

Shire’s (1) knowledge that its petitioning campaign would 

enrich it at the expense of consumers; (2) incentive to 

engage in similar conduct in the future; and (3) 

opportunity to engage in similar conduct in the future. As 

to the third point, the FTC specifically alleged that Shire 

“marketed and developed drug products,” namely 

Cinryze, “for commercial sale in the United States, and it 

could do so in the future.” Id. ¶¶ 8, 151.

Shire moved to dismiss the complaint, arguing that 

the FTC had failed to plead sufficient facts to invoke its 
14

authority under Section 13(b). Shire also contended that 

its petitioning activity was immune from antitrust 

challenge pursuant to the Noerr-Pennington doctrine. See 

E. R.R. Presidents Conference v. Noerr Motor Freight, 

Inc., 365 U.S. 127, 136 (1961); United Mine Workers of 

Am. v. Pennington, 381 U.S. 657, 670 (1965). The FTC 

responded that Section 13(b) authorized its lawsuit and 

that Shire had engaged in sham petitioning, which is not 

protected by Noerr-Pennington.

The District Court granted Shire’s motion to 

dismiss, ruling that the FTC had failed to plead sufficient 

facts to show that Shire “is violating, or is about to violate” 

the law.

10

 The Court flatly rejected the FTC’s contention 

that Shire was about to violate the law merely because it 

had the incentive and opportunity to engage in similar 

conduct in the future.

 

10 Despite the District Court’s grant of Shire’s 

motion to dismiss—which was couched in jurisdictional 

terms—the Court also reached Shire’s Noerr-Pennington

defense. The Court declined to dismiss the case on these 

grounds, explaining that the allegations in the complaint 

were sufficient to invoke the sham petitioning exception—

at least at the pleading stage. Because we affirm the 

District Court’s dismissal, Shire’s Noerr-Pennington

defense is not before us on appeal.
15

The FTC filed this timely appeal.

II.

We begin by addressing whether Section 13(b)’s 

requirements are jurisdictional. The FTC contends that 

Section 13(b) is not jurisdictional while Shire argues the 

opposite. The District Court appears to have assumed—

without expressly analyzing the issue—that Section 13(b) 

does not impose a jurisdictional requirement.11

The Supreme Court of the United States has 

instructed us to assume that statutory limitations are 

nonjurisdictional unless Congress provides otherwise. In 

Arbaugh v. Y&H Corp., the Court addressed whether Title 

VII’s definition of “employer” (which only includes those 

having fifteen or more employees) “affects federal-court 

subject-matter jurisdiction or, instead, delineates a 

substantive ingredient of a Title VII claim for relief.” 546 

U.S. 500, 503 (2006). The Court held that it was the latter, 

cautioning courts against “drive-by jurisdictional rulings” 

 

11 The District Court’s opinion was murky on this 

point, citing both Rule 12(b)(1) and 12(b)(6) of the Federal 

Rules of Civil Procedure. At several points the District 

Court couched its inquiry as jurisdictional, yet still

addressed the merits of Shire’s Noerr-Pennington defense. 

Regardless of the District Court’s conclusion, our review 

is plenary.
16

that fail to actually assess “whether the federal court had 

authority to adjudicate the claim in suit.” Id. at 511

(citation omitted).

The Supreme Court reiterated that a plaintiff obtains 

the “basic statutory grant[]” of subject matter jurisdiction 

in 28 U.S.C. § 1331 by pleading a colorable claim that 

arises under the Constitution or the laws of the United 

States. Id. at 513. The plaintiff in Arbaugh had invoked 

federal question jurisdiction by pleading a claim under 

Title VII. Id. The Court held that the fifteen-employee 

threshold went to the merits of the Title VII claim, 

explaining that Congress had not clearly delineated it as a 

jurisdictional requirement. Id. at 514–16. The Supreme 

Court created a “readily administrable bright line”—

“when Congress does not rank a statutory limitation on 

coverage as jurisdictional, courts should treat the 

restriction as nonjurisdictional in character.” Id. at 516.

Under the standard announced in Arbaugh, Section 

13(b)’s “is” or “is about to violate” requirement is

nonjurisdictional. Section 13(b) provides, in relevant part:

Whenever the [FTC] has reason to believe—
17

(1) that any person, partnership, or 

corporation is violating, or is about to 

violate, any provision of law enforced 

by the [FTC,] and

(2) that the enjoining thereof pending the 

issuance of a complaint by the [FTC] 

and until such complaint is dismissed 

by the [FTC] or set aside by the court 

on review, or until the order of the 

[FTC] made thereon has become final, 

would be in the interest of the public—

the [FTC] . . . may bring suit in a district court 

of the United States to enjoin any such act or 

practice.

15 U.S.C. § 53(b) (emphasis added).

The FTC’s claim arises under a law of the United 

States—15 U.S.C. § 53(b). It thus falls within the general 

grant of jurisdiction in § 1331. The District Court also had 

jurisdiction under 28 U.S.C. §§ 1337(a) and 1345.

Section 13(b) includes no indicia that Congress 

intended to “rank a statutory limitation . . . as 

jurisdictional”; as such, we must follow the Supreme 

Court’s “readily administrable bright line” rule and treat 

the statutory language as nonjurisdictional. Arbaugh, 546 

U.S. at 516. Whether a person “is violating, or is about to 
18

violate” the law relates to the merits of a Section 13(b)

claim, and does not indicate that Congress intended to strip

district courts of their authority to resolve the FTC’s claim. 

Because “nothing in [Section 13(b)] displays any intent to 

withdraw federal jurisdiction . . . we will not presume that 

the statute means what it neither says nor fairly implies.” 

Verizon Md. Inc. v. Pub. Serv. Comm’n of Md., 535 U.S. 

635, 644 (2002).

We conclude that the District Court had jurisdiction 

pursuant to 28 U.S.C. §§ 1331, 1337(a), and 1345.
19

III.12

A.

The FTC Act declares “[u]nfair methods of 

competition in or affecting commerce” to be unlawful, 15 

U.S.C. § 45(a)(1), and directs the FTC to prevent 

violations of the Act, id. § 45(a)(2). The FTC has multiple 

instruments in its toolbox to combat unfair methods of 

competition; among these are administrative proceedings 

and lawsuits in federal court. See id. §§ 45(b), 53(b).

Section 5(b), the FTC’s administrative remedy, is 

its traditional enforcement tool. See id. § 45(b). Since its 

inception, the FTC Act has provided for administrative 

 

12 We exercise jurisdiction under 28 U.S.C. § 1291. 

Because Section 13(b)’s requirements are 

nonjurisdictional, we consider the dismissal to be under

Rule 12(b)(6) of the Federal Rules of Civil Procedure. We 

exercise plenary review over the District Court’s order 

granting a motion to dismiss for failure to state a claim. 

Mariotti v. Mariotti Bldg. Prods., Inc., 714 F.3d 761, 765 

(3d Cir. 2013). We accept “all well-pleaded allegations in 

the complaint as true and view[] them in the light most 

favorable to the plaintiff.” Id. The movant can obtain 

relief only if the complaint’s allegations, “however true, 

could not raise a claim of entitlement to relief.” Id.

(alteration and internal quotation marks omitted).
20

proceedings to remedy unfair methods of competition. 

Federal Trade Commission Act § 5, 38 Stat. 719 (1914) 

(current version at 15 U.S.C. § 45(b) (2018)). If the FTC 

has “reason to believe” that a person, partnership, or 

corporation “has been or is using” unfair methods of 

competition, the FTC can issue an administrative

complaint “stating its charges in that respect.” 15 U.S.C. 

§ 45(b). If after receiving the FTC’s complaint the 

respondent contests the charges, the parties adjudicate in a 

trial-type proceeding in front of an administrative law 

judge (“ALJ”). Either party may appeal the ALJ’s 

decision. If the FTC believes the respondent is violating 

the law, it issues a written report and serves a cease and 

desist order upon the respondent. Id. The respondent has 

sixty days to seek review “in the appropriate court of 

appeals.”13 Id.

In addition to cease and desist orders, Section 5 

provides for limited monetary remedies. If a respondent 

violates a cease and desist order, the FTC may seek a civil 

penalty of no more than $10,000 per violation. Id. § 45(l). 

The civil penalty is recoverable in a “civil action brought 

by the Attorney General.” Id. The FTC may also file a 

civil action to recover a penalty for knowing violations of 

 

13 The appropriate court of appeals is “any circuit 

where the method of competition . . . was used or where 

[the respondent] resides or carries on business.” 15 U.S.C.

§ 45(c).
21

rules “respecting unfair or deceptive acts or practices.” Id.

§ 45(m)(1)(A). In these actions the District Court is 

permitted “to grant mandatory injunctions and such other 

and further equitable relief” as appropriate to enforce the 

FTC’s final order. Id. § 45(l).

Section 13 authorizes the FTC—in certain 

circumstances—to file suit in federal district court. Unlike 

Section 5, Section 13 was not part of the original FTC Act. 

Rather, Section 13(b) was added later in an effort to solve 

one of the main problems of the FTC’s relatively slowmoving administrative regime—the need to quickly enjoin 

ongoing or imminent illegal conduct. In Section 5 

proceedings, the FTC must prevail to obtain a cease and 

desist order. See id. § 45(b). Even if the FTC issues a 

cease and desist order, it must seek a court’s aid in 

enforcing the order. Id. § 45(l) To remedy this 

shortcoming and allow a quicker response, Congress 

amended the FTC Act in 1973 to allow the FTC to obtain 

a temporary restraining order or preliminary injunction in 

federal court whenever it “has reason to believe” that 

violations of the FTC Act are occurring or are about to 

occur. Id. § 53(b). Section 13(b) thus empowers the FTC 

to speedily address ongoing or impending illegal conduct, 

rather than wait for an administrative proceeding to 

conclude. See id.
22

B.

The crux of the FTC’s claim is that it is entitled to 

pursue immediate relief in the District Court under Section 

13(b), rather than via the administrative remedy set forth 

in Section 5. We begin with the text of the FTC Act. See 

Murphy v. Millennium Radio Grp. LLC, 650 F.3d 295, 302

(3d Cir. 2011) (“When the statute’s language is plain, the 

sole function of the courts—at least where the disposition 

required by the [text] is not absurd—is to enforce it 

according to its terms.” (internal quotation marks 

omitted)). Section 13(b) provides, in relevant part,

Whenever the [FTC] has reason to believe—

(1) that any person, partnership, or 

corporation is violating, or is about to 

violate, any provision of law enforced 

by [the FTC,] and

(2) that the enjoining thereof 

pending the issuance of a complaint by 

the [FTC] and until such complaint is 

dismissed by the [FTC] or set aside by 

the court on review, or until the order 

of the [FTC] made thereon has become 

final, would be in the interest of the 

public—
23

the [FTC] by any of its attorneys designated 

by it for such purpose may bring suit in a 

district court of the United States to enjoin 

any such act or practice. Upon a proper 

showing that, weighing the equities and 

considering the [FTC]’s likelihood of 

ultimate success, such action would be in the 

public interest, and after notice to the 

defendant, a temporary restraining order or a 

preliminary injunction may be granted 

without bond: Provided, however, That if a 

complaint is not filed within such period (not 

exceeding 20 days) as may be specified by 

the court after issuance of the temporary 

restraining order or preliminary injunction, 

the order or injunction shall be dissolved by 

the court and be of no further force and effect: 

Provided further, That in proper cases the 

[FTC] may seek, and after proper proof, the 

court may issue, a permanent injunction.

15 U.S.C. § 53(b)(1)–(2) (first emphasis added).

Section 13(b) requires that the FTC have reason to 

believe a wrongdoer “is violating” or “is about to violate” 

the law. Id. § 53(b)(1). We conclude that this language is 

unambiguous; it prohibits existing or impending conduct. 

Simply put, Section 13(b) does not permit the FTC to bring 

a claim based on long-past conduct without some evidence 
24

that the defendant “is” committing or “is about to” commit 

another violation.

The plain language of Section 13(b) is reinforced by 

its history. “Generally, where the text of a statute is 

unambiguous, the statute should be enforced as written 

and only the most extraordinary showing of contrary 

intentions in the legislative history will justify a departure 

from that language.” Millennium Radio Grp. LLC, 650 

F.3d at 302 (internal quotation marks omitted). When

Congress added Section 13(b), the provision was expected 

to be used for obtaining injunctions against illegal conduct

pending completion of FTC administrative hearings. See

S. Rep. No. 93-151, at 30 (1973) (“The purpose of 

[Section 13(b)] is to permit the [FTC] to bring an 

immediate halt to unfair or deceptive acts or practices 

when . . . [a]t the present time such practices might 

continue for several years until agency action is 

completed.”). The provision was not designed to address 

hypothetical conduct or the mere suspicion that such 

conduct may yet occur. Cf. id. (explaining that Section 

13(b) is meant to “bring an immediate halt to unfair or 

deceptive acts or practices. . . .”). Nor was it meant to 

duplicate Section 5, which already prohibits past conduct.

C.

The FTC’s arguments to the contrary are 

unconvincing. The FTC contends that relief under Section 

13(b) is appropriate when it shows a reasonable likelihood 
25

that past violations will recur. In other words, “when a 

defendant has already violated the law but the illegal 

conduct has ceased, injunctive relief should be granted if 

‘there exists some cognizable danger of recurrent 

violation.’” Br. of Appellant 21 (quoting United States v. 

W.T. Grant Co., 345 U.S. 629, 633 (1953)).

The FTC borrows its “likelihood of recurrence” 

standard from the common law standard for an award of 

injunctive relief. A party can generally obtain injunctive 

relief for past conduct that is likely to recur; the wrongdoer 

cannot avoid an injunction by voluntarily ceasing its 

illegal conduct. W.T. Grant Co., 345 U.S. at 632. 

Although injunctive relief can survive discontinuance of 

the illegal conduct, “the moving party must satisfy the 

court that relief is needed. The necessary determination is 

that there exists some cognizable danger of recurrent 

violation, something more than the mere possibility which 

serves to keep the case alive.” Id. at 633.

The FTC insists that other courts have 

“consistently” applied the likelihood of recurrence 

standard in Section 13(b) cases. Br. of Appellant 21–22. 

This is true, and unsurprising, given that Section 13(b) 

explicitly authorizes the FTC to obtain injunctions. But 

none of the cases cited by the FTC considers the issue 

presented here—the meaning of Section 13(b)’s threshold 

requirement that a party “is” violating or “is about to” 

violate the law.
26

The FTC relies heavily on Federal Trade 

Commission v. Evans Products Co., 775 F.2d 1084, 1087 

(9th Cir. 1985). There, the United States Court of Appeals 

for the Ninth Circuit upheld the denial of an injunction 

under Section 13(b), ruling that “an injunction will issue 

only if the wrongs are ongoing or likely to recur.” Id. The 

FTC sued a home seller at least two years after it had 

stopped making allegedly illegal misrepresentations. Id.

at 1085–88. The district court denied the FTC’s motion 

for an injunction; the Ninth Circuit affirmed, ruling that 
27

the seller’s conduct had completely ceased and was not 

likely to recur.14 Id.

In another case cited by the FTC, Federal Trade 

Commission v. Accusearch Inc., the United States Court of 

Appeals for the Tenth Circuit upheld a Section 13(b) 

injunction prohibiting the operator of a website that sold 

illegally-acquired personal data from engaging in future 

misconduct. 570 F.3d 1187, 1191 (10th Cir. 2009). The 

Tenth Circuit did not even quote—let alone analyze—

Section 13(b)’s “about to violate” language because it was 

 

14 Although the result in Evans Products Co. cuts 

against the FTC, the Commission tries to rely on portions 

of the Ninth Circuit’s reasoning. The Ninth Circuit, 

however, did not interpret “about to violate.” See Fed. 

Trade Comm’n v. Evans Prods. Co., 775 F.2d 1084, 1086 

(9th Cir. 1985). Instead, it gave Chevron deference to the 

FTC’s interpretation of a different part of Section 13(b)—

the so-called permanent injunction proviso. See id. The 

FTC claimed that the permanent injunction proviso was a 

standalone cause of action that authorized it to obtain a 

permanent injunction against violations of any provision 

of law it enforced. See id. Here, however, the FTC has 

expressly disclaimed reliance on the permanent injunction 

proviso, see Br. of Appellant 23 n.8, making the FTC’s 

arguments relying on Evans Products Co. at best 

inapposite and at worst misleading.
28

clear that the website operator had the capacity and 

motivation to engage in similar conduct in the future. See

id. at 1202. The Tenth Circuit did not address whether the 

FTC had properly filed suit under Section 13(b).

The FTC next protests that our interpretation of “is 

about to violate” would make it harder to get in the 

courthouse door than to win injunctive relief.15 The FTC 

contends that the likelihood of recurrence standard—

which applies when a court is considering whether to grant 

or deny injunctive relief—must be the sole standard to 

plead a Section 13(b) claim. But the FTC cannot 

overcome Congress’s plain language in Section 13(b), 

which requires the FTC to plead, at the time it files suit, 

that a violation “is” occurring or “is about to” occur. 15 

U.S.C. § 53(b). Furthermore, the FTC ignores that the 

“about to violate” and “likelihood of recurrence” standards 

coexist. The “about to violate” pleading requirement—

 

15 The FTC argues that the District Court erred by 

imposing a “higher” pleading threshold of “imminent

recurrence.” Br. of Appellant 22. The FTC is wrong. The 

District Court never imposed an imminence requirement. 

In fact, it didn’t even use the word “imminent” in its 

opinion. The Court held that the factual allegations in the 

FTC’s complaint failed to “plausibly suggest [Shire] is 

‘about to violate’ any law enforced by the FTC, 

particularly when the alleged misconduct ceased almost 

five years before filing of the complaint.” Op. 12.
29

which is applied right out of the gate—is not inconsistent 

with the likelihood of recurrence standard, which a court 

uses to determine the FTC’s entitlement to an injunction.

The FTC also places much weight on cases 

interpreting the Securities Act of 1933 and the Securities 

Exchange Act of 1934. These Acts permit the Securities 

Exchange Commission to seek injunctive relief in federal 

court when a defendant “is engaged” or is “about to 

engage” in a violation of securities laws. 15 U.S.C. 

§§ 77t(b) and 78u(d)(1). We reject the FTC’s invitation to 

import the interpretation of “is” or “is about to” contained 

in cases interpreting the securities laws. We “look to other 

statutes pertaining to the same subject matter which 

contain similar terms” only if “the ordinary meaning of a 

statute and the statute’s legislative history fail to provide 

sufficient guidance to a term’s meaning.” Liberty LincolnMercury, Inc. v. Ford Motor Co., 171 F.3d 818, 823 (3d 

Cir. 1999). Here, the plain language of Section 13(b) 

answers the question for us—“is about to violate” means 

something more than a past violation and a likelihood of 

recurrence. If we were in doubt, the structure and history 

of the FTC Act support our interpretation. Moreover, the 

statutory scheme—the addition of Section 13(b) to cure a 

shortcoming of Section 5(b)—is not similar to the 

securities laws, which have always permitted suits for 

injunctions. See also Amicus Br. of Washington Legal 

Foundation 9 (“While several other statutes include 

language similar to the FTC’s ‘about to violate’ language, 
30

none of those statutes include agency-litigating authority 

that even remotely resembles the overall structure and 

history of the FTC Act.”).

Finally, the FTC trots out the old adage that a 

remedial statute like the FTC Act should be construed 

broadly. Because Section 13(b)’s “is” or “is about to”

requirement allegedly conflicts with the remedial purpose 

of the FTC Act, the FTC says we should disregard the

plain meaning of that language. Of course, none of the 

authority the FTC cites stands for the broad proposition 

that we can ignore clear statutory language if it does not

promote a remedial interpretation. See Touche Ross & Co. 

v. Redington, 442 U.S. 560, 578 (1979) (explaining that 

“generalized references” to “remedial purposes” of a 

statute will “not justify reading a provision more broadly 

than its language and the statutory scheme reasonably 

permit” (internal quotation marks omitted)).

The FTC points to a parade of horribles that it 

predicts will result if we uphold the District Court’s 

decision.16 See, e.g., Br. of Appellant 35 (“Limiting the 

FTC’s Section 13(b) authority to cases of ongoing or 

imminent violation would make it easy for wrongdoers to 

 

16 The FTC also claims that the District Court’s 

interpretation could interfere with other statutes that 

contain similar language. Given the unique history and 

structure of the FTC Act, we consider this fear unfounded.
31

evade Congress’ purposes in creating the regime. As soon 

as a potential defendant got wind that the FTC was 

investigating its activities, it could simply stop those 

activities and render itself immune from suit in federal 

court unless the FTC could allege and prove an imminent 

re-violation.”). But there is no reason to believe that our 

decision today unnecessarily restricts the FTC’s ability to 

address wrongdoing. Section 5 authorizes administrative

proceedings based on past violations. And, of course, if 

the FTC believes that a wrongdoer is “about to violate” the 

law during the pendency of an administrative proceeding, 

it could then come to court and obtain an injunction under 

Section 13(b).

The FTC’s understandable preference for litigating 

under Section 13(b), rather than in an administrative 

proceeding, does not justify its expansion of the statutory 

language. If the FTC wants to recover for a past 

violation—where an entity “has been” violating the law—

it must use Section 5(b). 15 U.S.C. § 45(b). If the FTC 

instead chooses to use Section 13(b), it must plead that a 

violation of the law “is” occurring or “is about to” occur. 

Id. § 53(b). Here, the FTC wants to use the most 

advantageous aspects of each statutory provision—to 

punish Shire for a past violation using the less onerous 

enforcement mechanism. But the FTC’s attempt to 

squeeze Shire’s conduct into the “about to violate” 

category distorts Section 13(b) beyond its intended 

purpose. Section 13(b) cannot accommodate the FTC’s 
32

interpretation—that “about to violate” means only that a 

violation could recur at some future point.

In short, we reject the FTC’s contention that Section 

13(b)’s “is violating” or “is about to violate” language can 

be satisfied by showing a violation in the distant past and 

a vague and generalized likelihood of recurrent conduct.17 

Instead, “is” or “is about to violate” means what it says—

the FTC must make a showing that a defendant is violating

or is about to violate the law.

 

17 The FTC also asserts that Section 13(b)’s “reason 

to believe” language confers upon it unreviewable 

discretion to file suit. See 15 U.S.C. § 53(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. . .[the FTC] may bring 

suit in a district court of the United States to enjoin any 

such act or practice.” (emphasis added)). We decline to 

consider this argument because the FTC failed to raise it 

in the District Court. Garza v. Citigroup Inc., 881 F.3d 

277, 284 (3d Cir. 2018) (“It is well established that 

arguments not raised before the District Court are waived 

on appeal.” (internal citation omitted)). Even if this 

argument were not waived, we would find it unpersuasive. 

Here, there is no evidence to support the FTC’s “reason to 

believe” Shire is violating or is about to violate the law.
33

D.

Here, the FTC never initiated Section 5 proceedings 

against Shire.18 Instead, the FTC waited until five years 

after Shire had stopped its allegedly illegal conduct before 

seeking an injunction under Section 13(b). Viewed under 

the correct standard, the FTC’s complaint fails to allege 

that Shire “is violating” or “is about to violate” the law. 

The FTC does not contest that Shire is not currently 

violating the law. Indeed, Shire divested itself of

Vancocin in 2014, two years after generic competition 

entered the market.

Instead, the FTC relies on Section 13(b)’s “is about 

to violate” language. The few factual allegations in the 

FTC’s forty-five page complaint that suggest Shire “is 

about to violate” the law are woefully inadequate to state 

a claim under Section 13(b). The FTC alleges generally 

that Shire “is engaged in the business of, among other 

things, developing, manufacturing, and marketing branded 

drug products, including inter alia, Cinryze.” Compl. ¶ 8. 

As to the likelihood that Shire will engage in illegal 

 

18 At oral argument in the District Court, the FTC 

explained that it “generally” pursues administrative 

proceedings and a preliminary injunction simultaneously. 

App. 381. It is unclear why the FTC did not use that 

strategy here, particularly when Shire’s allegedly illegal 

conduct ceased long before the FTC filed suit.
34

behavior, the FTC alleges, “[a]bsent an injunction, there is 

a cognizable danger that [Shire] will engage in similar 

conduct causing future harm to competition and 

consumers. [Shire] knowingly carried out its 

anticompetitive and meritless petitioning campaign to 

preserve its monopoly profits. It did so conscious of the 

fact that this conduct would greatly enrich it at the expense 

of consumers.” Id. ¶ 150. Without mentioning Cinryze by 

name, the FTC alleges that Shire “has the incentive and 

opportunity to continue to engage in similar conduct in the 

future. At all relevant times, [Shire] marketed and 

developed drug products for commercial sale in the United 

States, and it could do so in the future. Consequently, 

[Shire] has the incentive to obstruct or delay competition 

to these or other products.” Id. ¶ 151.

The District Court concluded that these vague 

allegations failed to “plausibly suggest [Shire] is ‘about to 

violate’ any law enforced by the FTC, particularly when 

the alleged misconduct ceased almost five years before 

filing of the complaint.” Op. 12. We agree. Taking the 

factual allegations in the complaint as true, Shire stopped 

its sham petitioning campaign in 2012 when the FDA 

approved generic equivalents to Vancocin. The complaint 

contains no allegations that Shire engaged in sham 

petitioning in the five-year gap between the 2012 cessation 

in petitioning and the 2017 lawsuit. The complaint also 

lacks specific allegations that Shire is “about to violate” 
35

the law by petitioning as to Cinryze, the only other drug 

mentioned.

At oral argument in the District Court, the FTC 

provided more support for its argument that Shire “is about 

to violate” the law. The FTC explained that Shire is 

“perfectly positioned” to commit violations in the future 

because it is already marketing a “blockbuster drug” that 

is in the pipeline. Id. at 11. That drug, Cinryze, is not ripe 

for generic entry but has “the same type of significance as 

Vancocin . . . .” Id. We need not consider whether these 

allegations might satisfy the pleading standard. None of 

these facts—other than that Shire markets Cinryze—are 

pleaded in the complaint, which the FTC chose not to 

amend. Based upon the pleading before us, we conclude 

that the FTC has failed to plead that Shire is “about to 

violate” any law.

In this case, given the paucity of allegations in the 

complaint, the FTC fails to state a claim under any 

reasonable definition of “about to violate.” Whatever the 

outer reach of “about to violate” may be, the facts in this 

case do not approach it.19 We therefore leave for another 

 

19 We also reject the FTC’s standalone claim for 

equitable monetary relief. Assuming that such relief is 

available under Section 13(b), the FTC must still meet the 

“is” or “is about to” requirement.
36

day the exact confines of Section 13(b)’s “about to 

violate” language.

IV.

Under Section 13(b) of the FTC Act, the FTC must 

plead that Shire “is” violating or “is about to” violate the 

law. But Shire indisputably is not currently violating the 

law, nor is it alleged to be poised to do so anytime in the 

foreseeable future. The FTC thus fails to state a claim 

upon which relief can be granted. We will affirm the 

District Court’s judgment.

The FTC’s improper use of Section 13(b) to pursue 

long-past petitioning hasthe potential to discourage lawful 

petitioning activity by interested citizens—activity that is

protected by the First Amendment. Because we affirm the 

District Court’s judgment dismissing the complaint, we 

need not address the issue further but suggest that the FTC 

be mindful of such First Amendment concerns.