Kate Y. Jung


The Safe-Harbor provision of the Hatch-Waxman Act allows generic drug manufacturers to use a patented invention during pre-market testing of generic drugs. However, the U.S. Court of Appeals for the Federal Circuit’s recent interpretation of the Safe-Harbor provision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. created controversy when it extended the Safe-Harbor exemption to post-FDA approval. This extension was done in an unprecedented manner and would “allow almost all activity by pharmaceutical companies to constitute ‘submission’ and therefore justify a free license to trespass.” The U.S. Supreme Court has yet to settle this matter, and courts are now faced with the unenviable task of adopting one of two irreconcilable but binding interpretations. This comment analyzes the conflict between the Federal Circuit judges’ interpretations of the Safe-Harbor of the Hatch-Waxman Act. After analyzing the conflict, this comment offers guidelines that the Supreme Court should consider in limiting the Safe-Harbor provision in the Hatch-Waxman Act. Further, this comment proposes that courts should grant compulsory RAND licensing for analytical or diagnostic method patents if the patent is essential and required to meet the FDA’s standards.