Sally

Sally Laden helped turn the disease of depression into a gold mine. Laden was the world’s most influential female “psychopharmacologist,” and each of her creations began with an intonation about the terrible depression epidemic sweeping the globe. In psychiatry, the depression market had proven so huge that extending it to children would be desirable. Therefore, the pediatric exclusivity provision, which provided drug makers with 6 months of patent extension in exchange for conducting trials in the pediatric population, was welcomed by industry. Four major SSRI makers struggled to get into the pediatric depression market from 2000 to 2004. GlaxoSmithKline (GSK), which made the SSRI Paxil (paroxetine), conceived several trials in pediatric depression, and Sally Laden was assigned to write up one trial, #329.

Federal Circuit Addresses Damages in the Hatch-Waxman Context

Morrison Foerster Client Alert, April 14, 2015On 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.