Category: News

Washington, DC - A new Federal Trade Commission staff report found that, despite a considerable increase in the total number of final Hatch-Waxman patent settlements in FY 2016, significantly fewer settlements included the types of reverse payments that are likely to be anticompetitive.

This report is the Bureau of Competition’s third snapshot of such agreements since the Supreme Court’s decision in FTC v. Actavis, which held that a brand drug manufacturer’s reverse payment to a generic competitor to settle patent litigation can violate the antitrust laws. Generic drugs often cost less than brand drugs, helping to make medicines more affordable for millions of American consumers and thereby keep health care costs down.

The report summarizes data on the 232 final patent settlements filed with the FTC and the Department of Justice during FY 2016 pursuant to requirements imposed by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. According to the report:

“The data are clear: the Supreme Court’s Actavis decision has significantly reduced the kinds of reverse payment agreements that are most likely to impede generic entry and harm consumers,” said Chairman Joe Simons. “These annual reports are an important tool to monitor how patent settlement agreements continue to evolve, and to identify provisions that might be anticompetitive.”

Staff will continue to publish annual MMA reports as quickly as practicable.