The Federal Circuit's reinstated $235 million verdict in GSK v. Teva tests whether a generic's carve-out label can shield it from induced infringement of a method-of-treatment patent.
A unanimous Supreme Court read the Section 271(e)(1) safe harbor broadly, shielding preclinical experiments on patented compounds whenever there is a reasonable basis to believe they could inform an eventual FDA submission.
A unanimous Supreme Court held that a generic drugmaker may use the Hatch-Waxman counterclaim to force a brand to correct an overbroad Orange Book use code that was blocking a lawful skinny-label generic.
The Supreme Court's first reading of the biosimilars statute held that the BPCIA's elaborate pre-litigation information exchange cannot be forced by federal injunction, and that a biosimilar applicant may give its marketing notice before the FDA licenses the product.
