Following the parties’ petitions for rehearing en banc in Amgen v. Sandoz, Amgen has filed an emergency motion for an injunction to block the launch of Sandoz’s FDA-approved biosimilar filgrastim product, pending the Federal Circuit’s en banc consideration and review. Sandoz is currently enjoined from marketing its biosimilar product, Zarxio, until September 2, 2015, in light of the Federal Circuit’s decision that Sandoz’s statutorily required 180-day notice of commercial marketing was legally ineffective before March 6, 2015, when Sandoz received FDA approval for the product and issued another notice of commercial marketing to Amgen.
As we reported in an earlier post, once a party files a petition for rehearing at the Federal Circuit, the panel has up to ten working days to vote on panel rehearing, and then the members of the en banc court have up to ten working days to request a response to the petition. Once a response is filed, there are ten working days to call for a vote on rehearing en banc. In some cases, the en banc process can take even longer.
Both Amgen and Sandoz filed separate petitions for rehearing en banc on August 20, 2015 [here and here], and the Federal Circuit invited both parties to file a response to the other party’s petition on or before September 8, 2015 [here and here]. We will continue to monitor and update readers on further developments in this important case.