The Hatch-Waxman Act of 1984 established a system whereby generic manufacturers can seek to market generic equivalents of a pioneer's patented drug prior to the patent's expiry. But the original Act also contained provisions that were exploited by patent holders to delay generic competition and thereby extend their monopoly sales. Congress amended the Hatch-Waxman Act to address these abusive practices with the Medicare Modernization Act of 2003. This Note analyzes how the 2003 amendments failed to remedy exploitation of the Hatch-Waxman Act by pharmaceutical patent holders who use reverse payments and authorized generics to manipulate the 180-day market exclusivity given to the first generic challenger.
Continuing Abuse of the Hatch-Waxman Act by Pharmaceutical Patent Holders and the Failure of the 2003 Amendments,
60 Hastings L.J. 171
Available at: https://repository.uchastings.edu/hastings_law_journal/vol60/iss1/6