6 Wake Forest Intell. Prop. L.J. 23
The Hatch-Waxman Act, passed by Congress in 1984 in an effort to relieve the pressure of rising drug prices, paved the way for generic manufacturers of medications to enter the marketplace. Many commentators are concerned that the ease of obtaining FDA approval for generic manufacturers and shorter patent terms for brand name drugs may result in less incentive for research-based pharmaceutical companies to invest in drug development. The demands of research-based pharmaceutical companies and generic manufacturers pull in different directions on the Act, but analysis of the current state of the law does suggest ways of balancing the interests of society with incentives for research-based companies to continue drug development.