New opinion — FTC’s suit against drug maker was filed too late [updated]

FTC v. Shire Viropharma — civil — affirmance — Smith

The Federal Trade Commission brought a federal action against a drug company, alleging that the drug company wrongfully delayed approval of generic competition to its lucrative drug through a string of meritless FDA filings. The FTC brought the action over 4 years after the company’s challenged actions, under a statute that permits the FTC to sue a company that “is violating” or “is about to violate” the law. Today, the Third Circuit held that this statutory provision does not authorize suit based on a long-past action plus a reasonable likelihood of recurrence, affirming judgment in favor of the company.

Here’s the (exceptional, in my view) introduction:

Shire ViroPharma, Inc. … 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 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.

And the notable concluding paragraph:

The FTC’s improper use of Section 13(b) to pursue long-past petitioning has the 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.

Joining Smith were McKee and Fisher. Arguing counsel were Matthew Hoffman for the FTC and Steven Reed of Morgan Lewis for the drug company.

Update: here is a provocative analysis by Debevoise, entitled “The Third Circuit Sharply Curtails the FTC’s Preferred Enforcement Power.” Highlights:

On February 25, 2019, the United States Court of Appeals for the Third Circuit upset
decades of Federal Trade Commission (FTC) practice by significantly limiting when the
FTC can bring competition and consumer protection enforcement actions in federal



The FTC could seek a rehearing or a rehearing en banc from the Third Circuit, and may
ultimately seek Supreme Court review. But given Shire’s bad facts and a strong
possibility that the current Supreme Court would agree with the Third Circuit’s “plain
language” analysis, the FTC may not want to risk extending this ruling beyond the
Third Circuit. The FTC may instead prefer to seek legislative intervention. Many FTC
reform bills have been introduced in Congress in recent years, and this decision could
lead to the introduction of additional bills in the 116th Congress.

Section 13(b) has been a cornerstone of the FTC’s consumer protection and competition
enforcement efforts. This decision will have immediate, far-reaching ramifications on
that strategy’s use in the Third Circuit for both antitrust and consumer protection
(including false advertising and privacy/cybersecurity) matters.