Tag: Hatch-Waxman Act

Patent Term Restoration: How Pharmaceutical Companies Legally Extend Drug Exclusivity

Patent term restoration lets pharmaceutical companies recover lost patent time due to FDA delays. Learn how the Hatch-Waxman Act works, who qualifies, and why it's critical for drug development.

Federal Circuit Court: Authority on Pharmaceutical Patent Cases

The Federal Circuit Court controls all U.S. pharmaceutical patent appeals, shaping how generics enter the market, how patents are enforced, and whether new dosing regimens can be protected. Its rulings impact drug prices, litigation costs, and innovation.