Manufacturing Patents In Peril After Court Extends Hatch-Waxman “Safe Harbor”

In a dispute related to Amphastar/Watson’s generic enoxaparin, a Federal Circuit panel takes an expansive view of the “Bolar Amendment” and finds that certain post-approval activities are protected from infringement claims, including quality control batch testing of commercial product. The decision draws a blistering dissent from the appeals court’s chief judge, who warns the ruling will “render manufacturing method patents worthless.”