Generics manufacturers including Sandoz, Zydus Lifesciences, and Lupin will have to face up to another round of litigation in the US over a key patent shielding Astellas Pharma’s Myrbetriq (mirabegron), after the US Court of Appeals for the Federal Circuit vacated and remanded a lower court’s earlier finding of invalidity.
In handing down the decision, the panel of three Federal Circuit judges criticized the lower court for “disregard[ing] the longstanding principle of party presentation and, in doing so, abus[ing] its...