The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims ...

The Federal Circuit opinion was authored by Judge Prost and joined by Judges Taranto and Hughes.

The Federal Circuit's recent ruling that patents listed in the FDA's Orange Book must cover the active ingredient of a drug has sparked significant debate in the pharmaceutical industry. The court's ...

For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all ...