Tag: Post-Licensure Notice

Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation

11th July, 2016 - 4:37 am Categories: IP Litigation News & Updates patent infringement Patent Litigation Patents Pharma/Biotech Patent Litigations 0 Comments

In Amgen v. Apotex (No. 2016-1308), the US Court of Appeals for the Federal Circuit on July 5, 2016 affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing of a biosimilar product begins, regardless of whether the applicant provided the § … Continue reading Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation