SCOTUS Denies Classen Review, Sustains Safe Harbor Spat

The U.S. Supreme Court Jan. 14 denied a petition by GlaxoSmithKline (GSK) to review a patent infringement case it hoped would expand Hatch-Waxman’s safe-harbor provisions to the company’s benefit. The Federal Circuit ruled in GSK v. Classen Immunotherapies that GSK was not protected in using Classen’s patents for vaccination scheduling methods during postmarket safety studies.
Clinical Trials Advisor