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Fed. Cir. Mulls Roche’s Bid to Halt Sales of Amgen Biosimilar

June 3, 2020, 7:54 PM

Roche Holding AG‘s Genentech Inc. tried to convince the Federal Circuit at argument that Amgen Inc. didn’t provide sufficient notice before launching its biosimilar of Genentech cancer therapy drug Avastin.

Amgen’s late notice created a “hurried and chaotic motions practice” when Genentech sought to keep the biosimilar Mvasi from going to market, Luke McCloud of Williams & Connolly LLP in Washington argued for Genentech. That’s exactly what the Biologics Price Competition and Innovation Act’s notice provision is meant to avoid, he said.

The trial court allowed the biosimilar to go to market and Amgen began selling the product. The U.S. Court of Appeals for the Federal Circuit refused to halt sales temporarily early in the appeal. Genentech is now asking the court to prevent Amgen from marketing Mvasi to new patients.

Judge Kathleen M. O’Malley asked McCloud why Genentech didn’t seek an injunction based on infringement claims of its patents on Avastin and “not just hang your hat on this notice argument.”

Genentech hasn’t had the chance to take pre-launch discovery into the patent merits and the injunctive relief factors, McCloud said.

Genentech sued Amgen subsidiary Immunex Rhode Island Corp. for infringement of multiple patents for Avastin, used to treat colorectal cancer.

‘Possible Mischief’

The biologics law requires the biosimilar maker to tell the drugmaker 180 days before commercial marketing of the biosimlar. Genentech argued Amgen’s notice of Mvasi’s launch was improper because Amgen later filed supplements to its approved biosimilar application.

“Isn’t there possible mischief here?” O’Malley asked Amgen’s counsel Jeffrey A. Lamken of MoloLamken LLP in Washington. “Doesn’t this imply that there could be a bait and switch that you could change the process you’re going to use at the last minute?”

The notice is just “a heads up about launch,” Lamken said.

“Congress reasonably determined that you only get that heads up once, when the product is going to market,” he said. “It didn’t intend to give makers a permanent notice-based superintendence over changes to the product after the notice was given.”

The potential for a bait and switch is “a significant problem,” McCloud said. “Congress would not have created a statutory scheme that could be so easily gamed.”

Judge Kimberly A. Moore pressed McCloud on what exactly triggers the notice requirement, calling Genentech’s view of the statute “extraordinarily broad.”

The parties are also fighting over Amgen’s Kanjinti, a biosimilar of Genentech’s breast cancer drug Herceptin.

Judge Todd M. Hughes also served on the panel.

The case is Genentech, Inc. v. Immunex Rhode Island Corp., Fed. Cir., No. 19-2155, argued 6/3/20.

To contact the reporter on this story: Perry Cooper in Washington at

To contact the editors responsible for this story: Roger Yu at, Keith Perine at