On April 7, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in Astrazeneca AB v. Apotex Corp., No. 2014-1221, affirming an award of a reasonable royalty of 50% in a case arising from the Hatch-Waxman Act. While largely affirming a damages award of over $70 million, the Federal Circuit reversed the district court’s award of damages during the period of pediatric exclusivity that AstraZeneca’s product held after patent expiration.

The case provides important guidance regarding damages in the Hatch-Waxman context, and in particular whether damages are available in the period of pediatric exclusivity awarded to pharmaceutical patent holders who conduct qualifying pediatric studies.