Janssen, Celltrion Brawl Over Fed. Circ. Biosimilar Ruling

By Jeff Overley (August 26, 2015, 7:43 PM EDT) -- Janssen Biotech Inc. and Celltrion Inc. are squaring off in Massachusetts federal court with competing views of a recent Federal Circuit interpretation of the Biologics Price Competition and Innovation Act, debating whether it made advance-notice of biosimilar marketing mandatory in all circumstances.

The competing views were expressed in documents filed this week as part of patent infringement litigation that Janssen launched earlier this year to delay Celltrion's proposed biosimilar version of blockbuster biologic Remicade. At issue is whether the Federal Circuit's recent ruling in Amgen Inc. v. Sandoz Inc. made the BPCIA's 180-day advance-notice provision mandatory even when a biosimilar maker participates...

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