PatentsUSA
Serial Patent Litigation Under Hatch-Waxman Delays Affordable Generic Drugs for Years
The Hatch-Waxman Act established a framework to balance patent protection and generic drug entry through Paragraph IV certifications and a 30-month automatic stay on FDA approvals during patent litigation. However, brand manufacturers have leveraged serial patent litigation—filing successive infringement suits on new…
Tuesday, May 26, 2026