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

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 ...