title: The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms.
abstract: This purpose of this paper is to investigate the impact of Paragraph IV patent infringement decisions on brand drug pharmaceutical firms. Paragraph IV decisions determine whether a generic firm can enter before the period of exclusivity ends. I construct a novel dataset of all Paragraph IV decisions and find that they disproportionately involve the highest revenue drugs, significant periods of patent protection, and a non-trivial portion of all brand drugs facing generic entry. I also estimate the impact of Paragraph IV decisions on brand firm profitability and find they have large value consequences.
authors.affiliation: Department of Economics, Owen G Glenn Building, The University of Auckland, Auckland, New Zealand. laura@alumni.caltech.edu
authors.forename: Laura E
authors.initials: LE
authors.lastname: Panattoni
mesh_terms: D004345:Drug Industry / Q000191:economics*; D016568:Drugs, Generic / Q000191:economics*; D004465:Economic Competition; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States
chemical_list: D016568:Drugs, Generic