Norwich Pharmaceuticals, Inc. v. Robert F. Kennedy, Jr.

Summary

The court held that the FDA correctly concluded that Actavis had not forfeited its 180-day marketing exclusivity under the failure-to-market provision because a triggering event had not occurred for every Paragraph IV certification in Actavis's ANDA. The court held, however, that the FDA applied the wrong causation standard to the failure-to-obtain-tentative-approval provision, which requires but-for causation. The court therefore affirmed in part, reversed in part, and remanded for the agency to reconsider forfeiture under the correct standard.