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BioWorld - Saturday, June 13, 2026
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Home » US court reversed in safe harbor overreach
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US court reversed in safe harbor overreach

May 9, 2025
By Mari Serebrov
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Finding that a lower court went too far with an injunction that ignores the Hatch-Waxman safe harbor protections for drug development, the U.S. Court of Appeals for the Federal Circuit handed Avadel CNS Pharmaceuticals LLC a win of sorts.
BioWorld Regulatory Neurology/psychiatric Small molecule U.S. Courts Patents

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