Tag: Hatch-Waxman Act

Paragraph IV certifications let generic drug makers challenge brand-name patents before launch, speeding up access to affordable medicines. Learn how the Hatch-Waxman Act enables this system and why it saves billions.

Generic drug patents and exclusivity periods vary by country, affecting when affordable versions reach patients. The U.S., EU, Canada, and others have different rules on patent extensions, data protection, and generic incentives - with major impacts on drug prices and access.

The Federal Circuit Court holds exclusive authority over all U.S. pharmaceutical patent cases, shaping when generics enter the market, how patents are enforced, and the cost of medicines. Its rulings on ANDA litigation, dosing patents, and jurisdiction have transformed drug development.