The Hatch-Waxman Act: encouraging innovation and generic drug competition.
Congress carefully crafted the Hatch-Waxman Act to address two competing goals: to spur new pharmaceutical development and to encourage greater public access to generic drugs. To that end, the Act contains important provisions directed to fulfilling each goal, including provisions favorable to either branded drug or generic drug manufacturers. This article addresses those provisions in the context of issues pertaining to patent rights and in light of the congressional goals.
Sokal
Allen M
AM
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, 901 New York Avenue, NW, Washington, DC 20001-4413, USA.
Gerstenblith
Bart A
BA
D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry; D016568:Drugs, Generic / Q000191:economics; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*
D016568:Drugs, Generic