Federal Circuit Keeps FDA Hold in MSN-Novartis Drug-Patent Fight

A Delaware district court must maintain its pause of an order that the FDA delay final approval of MSN Laboratories Pvt. Ltd.’s copy of Novartis AG’s Entresto while an appeals court considers MSN’s request to block it, the Federal Circuit ruled.

The generic-drug maker is appealing rulings that block the early launch of its copy of the blockbuster heart-disease drug and preserve Novartis’ market exclusivity until a patent’s pediatric exclusivity expires in July. The US Court of Appeals for the Federal Circuit on May 2 ordered the district court to keep its temporary stay in effect as the appellate judges ...