AZ: US Federal Circuit 'Flagrantly Violated Precedent' On Symbicort
Federal Circuit Had Last Month Vacated Stipulated Judgment Of Infringement
The US Court of Appeals for the Federal Circuit has “abandoned the basic principles of significant figures that have long been recognized by this court,” AstraZeneca argues, as part of its petition to have reheard a recent verdict favoring Mylan on the originator’s Symbicort IP.
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In the coming days, Viatris expects to hear back from a court in West Virginia over its legal tussle with AstraZeneca on Symbicort IP. The US-based player has intimated that it may launch the product dependent on the court’s verdict.
Viatris spent a good chunk of its recent investor day updating on its complex generics ambitions, especially considering it is set to be missing biosimilars from its armory in the back half of 2022. A proposed move for the first US generic Symbicort was suggested by management.
Viatris and partner Kindeva Drug Delivery are celebrating a first tentative nod for a generic to one of the most significant respiratory opportunities in the US, but cannot launch at present with the firms having failed to navigate key pieces of intellectual property.