OCTOBER TERM 2012 · DECIDED JUNE 17, 2013 · 5–3

570 U. S. ___ · No. 12-416 · Argued March 25, 2013

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F.T.C. v. Actavis, Inc.

Reversed and remandedFinal ruling
generic drugsantitrust lawpharmaceutical patentsdrug pricesFTC enforcement

Opinion of the Court by Justice Breyer, joined by Justices Kennedy, Ginsburg, Sotomayor, and Kagan

The Supreme Court ruled that so-called 'reverse payment' settlements—where a brand-name drug maker pays a generic competitor to abandon a patent challenge and stay off the market—can violate antitrust law, rejecting a lower court's rule that such deals are automatically legal if they fall within the patent's scope.

The decision means the Federal Trade Commission can sue over these settlements, and courts must weigh their competitive harm case by case, rather than treating them as immune simply because a patent was involved.

How it got here: The FTC sued over the settlement; a federal trial court dismissed the case, the Eleventh Circuit affirmed, and the FTC asked the Supreme Court to review it.

The Case in Depth

What happened

Solvay Pharmaceuticals held a patent on the testosterone drug AndroGel. When generic drug makers Actavis, Paddock, and Par sought to sell generic versions, Solvay sued them for patent infringement. Rather than litigate to a conclusion, the companies settled: the generics agreed to delay entering the market for years and to promote AndroGel, while Solvay paid them tens of millions of dollars.

The question before the Court

Can a brand-name drug company violate antitrust law by paying a generic competitor to drop its patent challenge and delay entering the market?

The Court's answer

Yes — the Court ruled that these reverse-payment settlements are not automatically shielded from antitrust law just because the payment stays within what the patent might have allowed. Courts must instead apply the antitrust "rule of reason," weighing the settlement's likely competitive harm against any legitimate business justifications, because a large, unexplained payment can itself signal that the patent holder doubted its patent's strength and was really just buying off competition.

The Court declined to go as far as the FTC wanted, though, refusing to treat these settlements as presumptively illegal. Instead, the FTC must prove its case like any other antitrust plaintiff, showing the payment's size, its relation to litigation costs, and the absence of a legitimate justification.

Curious how the Court got there? See the step-by-step legal reasoning →

Why it matters

Millions of consumers could see cheaper generic drugs sooner, since pharmaceutical companies now face a real risk of antitrust liability for paying generics to delay competition. Drug makers and generic manufacturers will need to restructure how they settle patent disputes, and the FTC gains a stronger tool to challenge deals it views as anticompetitive.

What changes now

The case goes back to the lower courts, where the FTC will now have the chance to prove its antitrust claim against the settling drug companies under the rule-of-reason standard the Court adopted. This is a final ruling on the legal standard to apply, but it does not decide whether this particular settlement actually violated antitrust law — that determination is left for further proceedings on remand.

What this does not decide

The Court did not decide whether reverse-payment settlements are presumptively illegal, nor did it rule on whether this particular settlement actually violated antitrust law. It also did not require courts to resolve the underlying patent's validity as part of the antitrust analysis.

Concurrences and dissents

Dissent — Justice Roberts

Solvay paid a competitor to respect its patent—conduct which did not exceed the scope of its patent.The dissent's view that the settlement should be immune from antitrust scrutiny.

Chief Justice Roberts argued that a patent creates a lawful zone of monopoly power, and that a settlement acting within that zone should be immune from antitrust scrutiny regardless of payment size. He would have held that Solvay's payment to the generics, made to secure their agreement to honor its patent, did not exceed the patent's scope and therefore raised no antitrust problem. He warned the majority's approach would discourage settlements and force parties to relitigate patent validity inside antitrust suits.

How the Court got there

The legal reasoning, step by step

  1. The Court rejected the view that a settlement is automatically immune from antitrust law whenever its effects stay within the scope of what a valid patent could have allowed, reasoning that patent policy and competition policy must both factor into the antitrust analysis, not patent policy alone.
  2. The Court noted that because the patent's validity and scope were still contested in the underlying lawsuit when the parties settled, no one actually knew whether the patent would have justified excluding competitors — so simply pointing to hypothetical patent rights doesn't resolve the antitrust question.
  3. Drawing on earlier cases where patent-related settlements were still found to violate antitrust law, the Court concluded that patent holders do not get a blanket exemption from antitrust scrutiny just because a patent is somewhere in the picture.
  4. The Court identified five reasons an unexplained, large reverse payment can signal illegal anticompetitive conduct: it can suppress competition, it often lacks a legitimate justification, it indicates the payer's market power, courts can assess it without deciding the patent's validity, and parties can still settle in other ways (such as an earlier market-entry date) without paying competitors to stay away.
  5. Because a large, unjustified payment can serve as a workable stand-in for weighing anticompetitive risk, the Court held that antitrust suits challenging these settlements do not require courts to first resolve whether the patent itself was valid.
  6. The Court applied the 'rule of reason' — the standard antitrust test weighing a practice's harms against its business justifications — rather than a stricter presumption of illegality, concluding the FTC must still prove its case with evidence particular to the settlement at issue.

Doctrinal impact

Laws and provisions at issue

Federal Trade Commission Act § 5

Federal law letting the FTC challenge unfair methods of competition, including antitrust violations.

Sherman Act § 1

Federal law banning agreements that unreasonably restrain trade or competition.

Hatch-Waxman Act

1984 federal law creating streamlined procedures for generic drugs and resolving related patent disputes.

21 U.S.C. § 355(j)(2)(A)(vii)(IV)

Provision letting generic drug makers certify a listed patent is invalid or not infringed.

Cases affected by this decision

Reaffirms United States v. Line Material Co. (333 U. S. 287)

The Court relies on this case to say both patent and antitrust policy matter in defining a patent's lawful monopoly scope.

Reaffirms United States v. Singer Mfg. Co. (374 U. S. 174)

Cited as an example where a patent-related settlement was still found to violate antitrust law.

Reaffirms California Dental Assn. v. FTC (526 U. S. 756)

The Court uses this case's standard to decide the ordinary rule of reason applies, not a quick-look approach.

Supreme Court Opinion

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F.T.C. v. Actavis, Inc. | SCOTUS Reporter