Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At the center of that complex regulatory scheme is a Food and Drug Administration (FDA) publication known as the “Orange Book.” As detailed below, sponsors of innovator (i.e., “branded”) drugs are required by law to submit certain types of patents covering their drugs for publication in the Orange Book (although the precise scope of that requirement has been subject to much litigation over the years and recent statutory amendment).
Originally published in the November 2024 issue of Concurrences.
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