On May 6, 2025, the Federal Circuit overturned a Delaware district court's injunction against Avadel CNS Pharmaceuticals, which had obstructed the company's ability to conduct clinical research and seek regulatory approval for its drug Lumryz, designed to treat narcolepsy. The ruling emphasized that the injunction violated the Hatch-Waxman Act's 'safe harbor' provision, thus protecting Avadel's pre-approval activities. The case originated from Jazz Pharmaceuticals asserting U.S. Patent No. 11,147,782 against Avadel's product and attempting to restrict its commercialization and research efforts related to idiopathic hypersomnia, illustrating the complexities of patent law in the pharmaceutical industry.
The Federal Circuit ruled that the injunction unlawfully covered conduct protected by the Hatch-Waxman Act's 'safe harbor' provision, exempting Avadel's pre-approval research.
The dispute arose from Jazz Pharmaceuticals' assertion of U.S. Patent No. 11,147,782 against Avadel's once-nightly formulation of sodium oxybate, Lumryz.
Jazz claimed that Avadel's NDA constituted an act of artificial infringement, but the FDA's approval of Lumryz countered their argument.
The court's reversal allows Avadel to proceed with clinical research for expanded uses of Lumryz, thereby upholding the Hatch-Waxman Act's protections.
Collection
[
|
...
]