The U.S. Court of Appeals for the Federal Circuit ("CAFC") recently affirmed a district court judgement of invalidity in a Hatch-Waxman patent challenge for a generic drug used to treat idiopathic pulmonary fibrosis. In finding that evidence of actual physician practice was relevant in the determination of induced infringement, the CAFC has clarified that "past conduct is relevant to what will happen in the future". 1 What is Hatch-Waxman litigation?
The Hatch-Waxman Act ("the Act") established the U.S. Food and Drug Administration’s (FDA) approval and litigation process for generic drugs. The Act created the Abbreviated New Drug Application (ANDA) […]
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