Intellectual Property Practice Group Co-Leader Imron Aly was featured on the potential implications of the “Patient Right to Know Drug Prices Act,” which will require patent settlement agreements between brand manufacturers and biosimilar developers to be reviewed by both the Federal Trade Commission (FTC) and the Department of Justice (DOJ).
“Having the DOJ and the FTC review settlements is the norm already in the small-molecules world, so it won’t be anything unexpected or different for the biologics world,” Imron said. “As a policy it’s been enforced quite strictly; in fact, since that policy had taken place for small molecules there’s been over 12 challenges by the FTC against individual settlements.”
Imron added that the FTC has stated it will continue to review settlement agreements, with its apparent understanding that almost anything of value other than a launch date is subject to review.
Watch the clip here.