COMMENTARY: The Case Against Market Exclusivity for Purified Enantiomers of Approved Drugs

Abstract

Advances in synthetic chemistry offer pharmaceutical manufacturers a novel means of extending their monopolies over proprietary drugs beyond the 20-year limit of the patent laws. Pharmaceutical companies now have the capability to produce superior drugs by purifying existing drugs into their isomer components. The Food and Drug Administration (FDA) is considering whether to grant new drug status to these purified compounds, and to afford them several years of market exclusivity. This Comment argues that the FDA should not extend such market exclusivity to purified isomers of existing drugs.