Hikma Pharmaceuticals has petitioned the U.S. Supreme Court after the CAFC overturned a district court's decision in favor of Hikma regarding allegations of induced infringement by Amarin Pharma. The CAFC held that Amarin's claims about Hikma's product labels and public statements met plausibility standards rather than requiring definitive evidence. Hikma's petition raises critical legal questions about when generic labels are sufficient to avoid infringement claims and whether mere references to a brand’s drug constitute inducement. The outcome could significantly impact the operational landscape for generic drug manufacturers.
"Hikma's petition highlights serious concerns regarding the implications of the CAFC's decision, portraying it as a significant shift that undermines the generic drug expediting process."
"The CAFC emphasized the review of allegations for plausibility rather than probability, indicating a standard that could impose stricter scrutiny on generic drugmakers."
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