Hatch/Waxman Act

The Hatch-Waxman Act Balancing Innovative and Initiative Competition.536... [Pg.533]

The following sections of this paper examine the economic characteristics of the R D process in pharmaceuticals that make patents so crihcal. Sections 30.2 to 30.4 discuss the costs of innovation in pharmaceuhcals and the effects on innovative and imitative competition of the 1984 Hatch-Waxman Act. Section 30.5 considers whether the biotech industry is different from the pharmaceuhcal industry in terms of R D costs. Section 30.6 considers the distribution of returns on R D in these industries. The final section presents conclusions and policy considerations. [Pg.535]

II. Drivers of Generic Industry Growth The Hatch-Waxman Act... [Pg.153]

The Hatch-Waxman Act dramatically altered the nature and terms of generic competition after 1984. First, the Act established an Abbreviated New Drug Application (ANDA), which substantially reduced the cost of generic entry. Second, the Act allowed generic manufacturers to conduct their testing prior to patent expiration. This allowed generics to enter the market much more quickly after patent expiration than previously. [Pg.154]

Patent Challenges and the Strategic Use of the Hatch-Waxman Act by Brand Firms... [Pg.169]

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