Overlapping Method of Use Patents to Prevent Generic Entry

Brand-name pharmaceutical companies increasingly use overlapping patents and FDA use codes to delay the generic entry. This study uses two recent cases, icosapent ethyl (Vascepa) and sacubitril-valsartan (Entresto), to show how these tactics can obstruct the skinny labeling pathway for generic products. To restore balance between exclusivity and competition in the US pharmaceutical market, reforms to use codes and the legal standards for patent ingringement are necessary.