So Long, Safe Harbor: Pay-for-Delay Riskier After Supreme Court Opinion
This article was originally published in RPM Report
Executive Summary
The Supreme Court’s majority opinion in Federal Trade Commission v. Actavis makes it easier for FTC and private plaintiffs to challenge reverse payment settlements between branded drug companies and their would-be generic competitors. While the opinion declines to find “pay-for-delay” deals presumptively anticompetitive (a win for industry), it also strips a safe harbor used by the appeals courts (a clear loss).
You may also be interested in...
The End Of Pay-For-Delay? FTC Sees An Opportunity In AndroGel Lawsuit
Reverse payment settlements are a popular tactic for settling patent disputes between brand companies and their generic competitors. The Federal Trade Commission has aggressively (but mostly unsuccessfully) fought “pay-for-delay” deals in the courts, arguing that they drive up drug prices. Now FTC has its best chance yet at convincing the Supreme Court to hear the issue. Is this the end of pay-for-delay?
Pazdur’s Big Moment: ‘Project Odyssey’ Webinar Gives Oncology Chief External Buy-In On His Ideas To Revamp ODAC
OCE Director Richard Pazdur is known for cultivating 'Pazdur moments' during advisory committees when he feels the conversation has gone off track. A recent webinar with ODAC members created a perfect opportunity to promote his agenda.
Another Chance For VALID? Negative Reaction To FDA’s LDT Proposal May Reopen Legislative Talks
All of the witnesses testifying to a House E&C Committee hearing said they preferred the flexibility and targeted enforcement of the VALID Act to FDA’s proposed rule. Will Congress finally be spurred to act?