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Amgen Panel Denies Emergency Motion for Injunction Pending En Banc Consideration

Today the Federal Circuit panel that decided Amgen v. Sandoz (summaryopinion) denied Amgen’s emergency motion for an injunction pending consideration of its petition for en banc review. The panel (Judges Lourie, Newman, and Chen) denied the motion without opinion, but did note that Judge Newman would have granted the motion. Unless the en banc court intervenes and grants the motion – and it is unclear whether it will even consider it – the original injunction issued by the panel will dissolve today and Sandoz will be able to market its biosimilar cancer drug Zarxio beginning tomorrow, September 3. Zarxio would be the first product approved under the BPCIA biosimilar pathway to be marketed in the United States.

The panel’s denial of Amgen’s emergency motion is not surprising, since the majority of the panel, with Judge Newman dissenting, already denied Amgen’s request for an injunction extending beyond September 2. Under the Federal Circuit’s internal operating procedures, pre-merits motions directed to the en banc court are not circulated to the other active judges until the original panel acts upon them. It is therefore possible that the full court will consider Amgen’s emergency motion now that it has been denied by the panel. On the other hand, Amgen’s emergency motion, while seemingly directed to the full court, did not expressly ask for en banc consideration, so the panel’s decision may end up being the last word on Amgen’s request for temporary relief. Either way, the en banc court will continue to consider the parties’ cross-petitions for rehearing en banc, which will be fully briefed and submitted on September 8.

Categories: Biosimilars, BPCIA
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