DC Cir. Adopts 'But-For' Test for ANDA Exclusivity Forfeiture
The D.C. Circuit has reversed longstanding FDA practice on 180-day generic drug exclusivity, holding that a first-filer's failure to obtain timely tentative approval is only excused if an agency delay was the 'but-for' cause.
In a significant ruling for generic drug manufacturers, the D.C. Circuit rejected the FDA's long-standing 'multiple sufficient causes' test for an exception to the forfeiture of 180-day market exclusivity. Previously, the FDA allowed a first Abbreviated New Drug Application (ANDA) filer to retain its valuable exclusivity if a change in approval requirements was merely one of several reasons for failing to obtain tentative approval within the statutory 30-month window.
In Norwich Pharmaceuticals, Inc. v. Kennedy, the court replaced this with a stricter 'but-for' causation standard. A first filer must now demonstrate it would have met the deadline were it not for the FDA-imposed change. The court reasoned that Congress did not intend to grant a 'windfall' to applicants with otherwise deficient filings. This decision raises the bar for first filers to excuse delays, creating new opportunities for subsequent applicants to challenge a competitor's exclusivity. The court also affirmed that forfeiture for 'failure to market' depends on the first applicant's certifications, not those of later filers. The case was remanded for the FDA to apply the new standard. Counsel should immediately reassess ANDA strategies in light of this ruling.