Biosimilar Appellate Update: Genentech v. Immunex, Genentech v. Amgen, Janssen v. Celltrion

Below we provide an update on some recent developments from several biosimilar-related cases on appeal before the Federal Circuit. 

Genentech v. Immunex Rhode Island, Fed. Cir. Case No. 19-2155 – briefing complete in bevacizumab preliminary injunction appeal

On January 21, Genentech filed a reply brief in its appeal to the Federal Circuit seeking to overturn the district court’s denial of Genentech’s motion to enjoin the U.S. marketing of MVASI (bevacizumab-awwb), a biosimilar of AVASTIN.  As we previously reported, Genentech’s opening brief argued that although Amgen served a notice of commercial marketing pursuant to subsection (l)(8)(A) of the BPCIA in 2017, Amgen was required to provide a new notice because it subsequently filed supplements to its approved biosimilar application.  Genentech argued in its reply brief that because Amgen failed to provide a second notice, Amgen was legally barred from commercially marketing its biosimilar until 180 days after it served such notice.  Oral argument has not yet been set.

Genentech v. Amgen, Fed. Cir. Case No. 19-2156 – oral argument scheduled in trastuzumab preliminary injunction appeal

The Federal Circuit scheduled oral argument for March 3, 2020 in the appeal of the district court’s denial of Genentech’s motion to enjoin the launch of Amgen’s KANJINTI (trastuzumab-anns), a biosimilar of HERCEPTIN.   As we have reported, Genentech argues in the appeal that the district court committed two errors in denying Genentech’s motion for preliminary injunction.  First, the court committed error in holding that Genentech would not be irreparably harmed by KANJINTI’s launch due to Genentech’s timing in seeking injunctive relief.  Second, according to Genentech, the court erred in holding that Genentech would not be irreparably harmed because Genentech had settled litigation with other biosimilar manufacturers by licensing them to enter the market in the future. 

Janssen v. Celltrion, Fed. Cir. Case No. 18-2321 – infliximab summary judgment appeal

As we previously reported, Janssen appealed the district court’s order granting Celltrion’s motion for summary judgment of non-infringement of U.S. Patent No. 7,598,083, covering Janssen’s REMICADE.  Celltrion cross-appealed the district court’s denial of Celltrion’s motion to dismiss for lack of standing.  The Federal Circuit has scheduled oral argument in the appeal for March 4, 2020.