The Federal Circuit reversed in part and vacated and remanded in part the decision of the District of Delaware permanently enjoining Avadel CNS Pharmaceuticals LLC from seeking approval from the FDA of Lumryz for the treatment and marketing of idiopathic hypersomnia, in this patent infringement action by Jazz Pharmaceuticals Inc. The appeals reversed the injunction to the extent it enjoins Avadel from initiating new clinical trials for Lumryz and from offering open-label extension periods to current clinical trial participants. And the Federal Circuit vacated and remanded the injunction to the extent it enjoins Avadel from seeking FDA approval for new indications ...
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