title: Hatch-Waxman in the Federal Courts: from 1994--2004.
abstract: Decisions of the federal courts play a crucial role in drug development. Litigation related to drug development and approval under the abbreviated new drug application ("ANDA") process over the past 10 years was evaluated, examining over 300 written decisions from 22 U.S. District Courts and the U.S. Court of Appeals for the Federal Circuit. These written decisions represent the majority of patent litigation between brand and generic drug manufacturers. The reported data set provides critical information for the drug development and litigation strategies of both brand and generic manufacturers. The examination also provides a realistic portrayal of the anticipated outcome if a legal action is initiated.
authors.affiliation: Darby & Darby, PC, New York, NY, USA. pludwig@darbylaw.com
authors.forename: S Peter
authors.initials: SP
authors.lastname: Ludwig
authors.forename: Kristin Behrendt
authors.initials: KB
authors.lastname: Kosinski
authors.forename: Jonathan
authors.initials: J
authors.lastname: Harris
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015195:Drug Design; D004345:Drug Industry; D016568:Drugs, Generic / Q000191:economics; D035082:Federal Government; D006801:Humans; D008389:Marketing of Health Services; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic