Sandoz Among Defeated As US Federal Circuit Breathes New Life Into US Myrbetriq Patent

US District Court ‘Abused Its Discretion’ In Earlier Overturning Mirabegron IP

A US district court “misapprehended its role in adjudicating the issue of patentability,” the US Federal Circuit found, as it vacated and remanded the lower court’s US patent invalidity decision, raising fresh questions in a market that has already seen generic launches from a pair of manufacturers.

US Court of Appeals for the Federal Circuit sign
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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 discretion,” because it rendered its decision to invalidate claims of

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