A Brief Introduction to Competition Concerns in 'Pay-for-Delay' Settlement Agreements Between Brand-Name and Generic Drug Companies

Abstract:     
Antitrust authorities in both the United States and Europe have expressed deep concern over settlements of antitrust cases in the pharmaceutical sector, settlements involving “reverse payments” from plaintiffs to defendants, large sums paid by branded pharmaceutical companies to generic competitors in exchange for promises to stay off the market. Such “pay-for-delay” settlements have proliferated in the United States since federal circuit courts of appeals have found them unproblematic despite the Federal Trade Commission’s persistently strong position that they violate the antitrust laws.

These cases arise at the intersection of three statutory regimes seeking to promote innovation, three clusters of doctrine and policy that have interacted only to reach impasse: the Patent Act, the 1984 amendment to the Food, Drug, and Cosmetic Act, and finally the Sherman Anti-Trust Act. Antitrust is a late comer to the fierce competition over patented drugs, competition that permeates the approval process in the Food & Drug Administration [the FD , competition that is restrained by these pay-for-delay settlement agreements. To set the stage, we begin with the Patent Act and its relationship to the FDA approval process. The story of pay-for-delay settlements then proceeds to the settlement agreements and their antitrust implications.

We conclude that the best solution in these antitrust cases would be adoption of the FTC’s approach of presumptive illegality. Together with an amendment proposed to fix the food and drug act, the presumptive illegality of pay-for-delay settlements under the antitrust laws would make the market for pharmaceuticals more price competitive, open weak patents to serious challenge, and as a result save consumers billions of dollars annually without taking from branded drug companies legitimately earned incentives to engage in research and development.

Number of Pages in PDF File: 11

Keywords: antitrust, competition, FDA, FTC, patents, pharmaceuticals, settlements

Accepted Paper Series