Hatch-Waxman at 40: A Critical Examination of its Past and Future

When:
Location:
Food & Drug Law Institute
People:

September 24, 2024 marks the 40th anniversary of the Drug Price Competition and Patent Term Restoration Act, commonly referred to as the Hatch-Waxman Act. This legislation was established to drive medical innovation and provide affordable generic drug options to patients. Generic drugs are an estimated 3 trillion-dollar industry nurtured by thoughtful adjustments to the approval process, patent litigation eligibility, and other checks to strike a balance between competition and innovation. Over the decades, how has this legislation fared against drug shortages, inflation, and patent system abuses? Does it accomplish its dual aims of promoting innovation and incentivizing rapid marketplace competition from generics? This webinar explores a retrospective and prospective view of Hatch-Waxman, 40 years since its inception.