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Fed. Trade Comm'n v. Actavis, Inc.

The Eleventh Circuit erred in affirming the dismissal of theFTC’s complaint. Pp. 8–21. (a) Although the anticompetitive effects of the reverse settlement agreement might fall within the scope of the exclusionary potential ofSolvay’s patent, this does not immunize the agreement from antitrust attack. For one thing, to refer simply to what the holder of a validpatent could do does not by itself answer the antitrust question.Here, the paragraph IV litigation put the patent’s validity and preclusive scope at issue, and the parties’ settlement—in which, the FTC alleges, the plaintiff agreed to pay the defendants millions to stay outof its market, even though the defendants had no monetary claim against the plaintiff—ended that litigation. That form of settlement is unusual, and there is reason for concern that such settlements tend to have significant adverse effects on competition. It would be incongruous to determine antitrust legality by measuring the settlement’s anticompetitive effects solely against patent law policy, and not against procompetitive antitrust policies as well. Both are relevant in determining the scope of monopoly and antitrust immunityconferred by a patent, see, e.g., United States v. Line Material Co., 333 U. S. 287, 310, 311, and the antitrust question should be answered by considering traditional antitrust factors. For another thing, this Court’s precedents make clear that patent-related settlement agreements can sometimes violate the antitrust laws. See, e.g., United States v. Singer Mfg. Co., 374 U. S. 174; United States v. New Wrinkle, Inc., 342 U. S. 371; Standard Oil Co. (Indiana) v. United States, 283 U. S. 163. Finally, the Hatch-Waxman Act’s general procompetitive thrust—facilitating challenges to a patent’s validity andrequiring parties to a paragraph IV dispute to report settlement terms to federal antitrust regulators—suggests a view contrary to the Eleventh Circuit’s. Pp. 8–14. (b) While the Eleventh Circuit’s conclusion finds some support in ageneral legal policy favoring the settlement of disputes, its related underlying practical concern consists of its fear that antitrust scrutiny of a reverse payment agreement would require the parties to engage in time-consuming, complex, and expensive litigation to demonstrate what would have happened to competition absent the settlement. However, five sets of considerations lead to the conclusion that this concern should not determine the result here and that the FTC should have been given the opportunity to prove its antitrust claim. First, the specific restraint at issue has the “potential for genuine adverse effects on competition.” FTC v. Indiana Federation of Dentists, 476 U. S. 447, 460–461. Payment for staying out of the market keeps prices at patentee-set levels and divides the benefit between the patentee and the challenger, while the consumer loses.And two Hatch-Waxman Act features—the 180-day exclusive-rightto-sell advantage given to the first paragraph IV challenger to win FDA approval, §355(j)(5)(B)(iv), and the roughly 30-month period that the subsequent manufacturers would be required to wait out before winning FDA approval, §355(j)(5)(B)(iii)—mean that a reverse settlement agreement with the first filer removes from considerationthe manufacturer most likely to introduce competition quickly. Second, these anticompetitive consequences will at least sometimesprove unjustified. There may be justifications for reverse paymentthat are not the result of having sought or brought about anticompetitive consequences, but that does not justify dismissing the FTC’scomplaint without examining the potential justifications. Third, where a reverse payment threatens to work unjustified anticompetitive harm, the patentee likely has the power to bring about thatharm in practice. The size of the payment from a branded drugmanufacturer to a generic challenger is a strong indicator of such power. Fourth, an antitrust action is likely to prove more feasibleadministratively than the Eleventh Circuit believed. It is normally not necessary to litigate patent validity to answer the antitrust question. A large, unexplained reverse payment can provide a workablesurrogate for a patent’s weakness, all without forcing a court to conduct a detailed exploration of the patent’s validity. Fifth, the fact that a large, unjustified reverse payment risks antitrust liability doesnot prevent litigating parties from settling their lawsuits. As in other industries, they may settle in other ways, e.g., by allowing the generic manufacturer to enter the patentee’s market before the patentexpires without the patentee’s paying the challenger to stay out prior to that point. Pp. 14–20. (c) This Court declines to hold that reverse payment settlementagreements are presumptively unlawful. Courts reviewing suchagreements should proceed by applying the “rule of reason,” rather than under a “quick look” approach. See California Dental Assn. v. FTC, 526 U. S. 756, 775, n. 12. Pp. 20–21. 677 F. 3d 1298, reversed and remanded.

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