The Supreme Court in the Sandoz v Amgen biosimilar case has ruled that an injunction is not available under federal law and an applicant may provide notice before obtaining a licence from the FDA. The ruling is a win for Sandoz, but the case was remanded for the Federal Circuit to rule on whether an injunction is still available under state law
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The model covers court-guided settlements, submissions-led determination of infringement and validity issues, and provides leeway for the court to determine a FRAND rate during negotiations