Supreme Court Hears Oral Argument in Sandoz Inc. v. Amgen Inc.

Fitzpatrick Case Update
April 27, 2017

On April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. on two questions regarding the Biologics Price Competition and Innovation Act (“BPCIA”): (1) whether  a biosimilar applicant’s 180 days’ notice of commercial marketing is properly given only after its biosimilar product has been approved by the FDA, and (2) whether a biosimilar applicant is obligated to provide its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor within 20 days after the FDA accepts the aBLA for filing, thereby triggering early patent litigation.

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