Tag: Hatch-Waxman Act

30-Month Stay: How Patent Litigation Delays Generic Drug Approval

The 30-month stay under the Hatch-Waxman Act lets brand drug companies delay generic approval by triggering patent lawsuits. While designed to protect innovation, it's often used to extend monopolies, costing consumers billions annually.

Read More

Generic Patent Case Law: Landmark Court Decisions That Shape Drug Prices

Landmark court decisions in generic patent law shape how quickly affordable drugs reach patients. From Amgen v. Sanofi to Amarin v. Hikma, these rulings define the line between innovation and competition-and directly impact drug prices.

Read More