Abuse of the Hatch-Waxman Act: Mylan\u27s Ability to Monopolize Reflects Weaknesses

Abstract

The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, is intended to lower the average price paid by consumers for prescription drugs. The Hatch-Waxman Act attempts to do so by simplifying the application process for generic drug manufacturers, allowing generic drug applications to circumvent the lengthy FDA testing and approval process that brand-name manufacturers must undergo. Though the Hatch-Waxman Act has successfully created a clear path to the market for generic drugs, it contains loopholes that allow brand name and generic companies to engage in practices aimed at maximizing monopoly profits, effectively depriving consumers of a generic option. Some of these practices include: reverse payments, citizen petitions, product hopping, and the misclassification of drugs. This Note argues that pharmaceutical companies have engaged in some of these practices and that the Hatch-Waxman Act must be amended to prevent these companies from continuing to circumvent the true intention of the Act