Actavis ruling separates Hatch-Waxman patent litigation from FDA review

Actavis v. United States gave Hatch-Waxman practitioners a clean reminder that patent litigation and FDA review remain separate lanes.

The Federal Circuit emphasized that district courts resolve patent infringement and validity while FDA evaluates safety, effectiveness, and bioequivalence. Patent claims do not become FDA questions merely because litigation runs alongside regulatory review.

For generic-drug strategy, the distinction matters. A court can decide whether the patent statute blocks launch, but it does not decide whether the proposed generic satisfies FDA's scientific and regulatory standards.

IPDispatch should use this case as a procedural anchor in future drug-patent explainers because it helps readers understand where legal leverage ends and agency authority begins.