Law360, New York (February 10, 2017, 8:06 PM EST) -- The Federal Circuit erred by forcing biosimilar makers to win approval before supplying 180-day notice of sales to rivals, Sandoz told the U.S. Supreme Court on Friday, kicking off a showdown with Amgen that has multibillion-dollar stakes.
In an opening brief, Sandoz attacked the Federal Circuit's finding that 180-day notice — a requirement of the Biologics Price Competition and Innovation Act — can be given only after a biosimilar is licensed. The finding was crucial because it may effectively give 180 days of extra exclusivity to originator biologics that often earn billions of dollars per year.
The dispute centers on a BPCIA...
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