Shook, Hardy & Bacon Partner John Garretson has co-authored an article for the Food and Drug Law Institute's Update explaining how a recent decision has affected generic drug approval through the use of "skinny labels."
Companies seeking U.S. Food and Drug Administration (FDA) approval for the generic versions of previously approved drugs have two options if they want to market their generic versions before the approved drug's patent expires, Garretson and Herman Yue explain. They delve into the less common pathway to FDA approval: "the filing of so-called 'Section viii' certifications in conjunction with the use of 'skinny labels.'" If the approved drug is protected only by method of use patents, other companies may be able to file for approval of the generic by focusing on newly discovered uses for the drug not specified in the patents. By disclaiming the approved drug's specific methods of use covered by patents—and listing only other uses—a generic can earn FDA approval without conflicting with the patents, thus allowing for earlier approval.
Garretson and Yue describe several recent cases centered on this less-common pathway to FDA approval and explore the effects of each on "skinny labeling" law, focusing especially on a Maryland federal court's decision in Hospira v. Burwell. "The Hatch-Waxman Act was designed as a compromise to balance the competing interests of branded and generic manufacturers," they conclude. "Following Hospira, the Section viii approval pathway threatens to unbalance this compromise by providing a route for generic drug manufacturers to obtain immediate FDA approval of uses for their generic drug products that are covered by the branded pharmaceutical’s method of use patent(s)."