Overlapping Method of Use Patents to Prevent Generic Entry.

Abstract

Brand-name pharmaceutical firms increasingly use method of use patents and associated Orange Book "use codes" to delay generic entry, complicating the skinny labeling pathway that permits low-cost generics to omit patented indications from their labels and market their products for unpatented uses. Recent litigation, however, shows how overlapping use codes - targeting patient subgroups or biomarker thresholds rather than distinct conditions - can obstruct the skinny labeling pathway. Case studies of icosapent ethyl (Vascepa) and sacubitril-valsartan (Entresto) illustrate how overlapping use codes delay generic entry, inflate costs, and limit patient access. Reforms are needed to improve FDA and USPTO oversight of use code assignments and clarify legal standards for induced infringement, which would preserve the balance between rewarding innovation and ensuring timely access to affordable medicines.