Tag: Hatch-Waxman Act

Patent law in pharmaceuticals balances innovation with access: brands get 12-14 years of exclusivity to recoup $2.6B in R&D, then generics slash prices by 90%. The Hatch-Waxman Act makes this work - but loopholes like evergreening and pay-for-delay threaten it.

Paragraph IV certifications let generic drug makers legally challenge brand-name patents before market entry. This Hatch-Waxman tool drives competition, lowers drug prices, and offers 180-day exclusivity to the first challenger.