USA: Unpacking the shift – Heightened antitrust scrutiny on Orange Book listings

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...
By: WilmerHale

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