Compromise On “Pay For Delay”? Supreme Court Hunts for Middle Ground
This article was originally published in RPM Report
During Supreme Court oral arguments in the AndroGel pay-for-delay case, the government and drug manufacturers each pushed for a one-size-fits-all antitrust interpretation of brand-generic reverse payment settlements. But the most likely outcome will probably fall somewhere in the middle: allowing the deals to continue, but with additional scrutiny to ensure they are not anticompetitive.
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The high court will determine whether brand-generic reverse payments to settle patent disputes are presumptively anticompetitive and unlawful when it takes up FTC v. Actavis; a ruling affirming the lower court would enable companies to enter agreements without the threat of litigation.
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?
Surge of interest prompts US FDA to consider how to adjust feedback, including potentially creating a separate team to answer more basic questions.