Current Edition

Strategies Adopted by Branded Drug Manufacturers against Para IV Filers

This article by Trishna Chetry, T.M. Pramod Kumar, M.P. Venkatesh and Balamuralidhara V. from JSS College highlights the complex and critical regulatory strategies adopted by branded drug manufacturers against ParagraphIV filers in the past. The Hatch-Waxman Act 1984, also known as the Drug Price Competition and Patent Term Restoration Act, grants generic manufacturers the ability to challenge a patent without risking enormous damages from any possible infringement. The idea behind this incentive was to encourage generic firms to invalidate and challenge bad patents. As an outcome, patent infringement and a 30-month FDA stay period became a common scenario.