Sandoz Inc. v. Amgen Inc. (15-1039)
Question
Under the Biologics Price Competition and Innovation Act of 2009, can notice of commercial marketing of a “biosimilar product” be effective if given prior to approval by the Food and Drug Administration?
Does the notice requirement delay sale of biosimilar products by 180 days after notice?
Does the Act only permit a remedy for a claim of patent infringement?
Petitioner: Sandoz Inc.
Respondent: Amgen Inc., et al.
Granted: 2017-01-13 00:00:00
Decided: 2017-06-12 00:00:00
Argued: 2017-04-26 10:05:00
Uploaded: 2017-06-02 21:06:00
Advocates: Deanne E. Maynard, Anthony A. Yang, Seth P. Waxman
Links: Oyez | Opinion | Youtube
Tags: Food and Drug Administration, Biologics Price Competition and Innovation Act
