Timing is Everything: FCA Affirms OSIP’s Timing Interpretation in Patent Register Dispute
On August 8, 2025, the Federal Court of Appeal (“FCA”) held that Amgen Inc. (“Amgen”), a biosimilar manufacturer, was not required to address Bayer Inc.’s (“Bayer”) newly issued patent (the “315 Patent”) for EYLEA (aflibercept) under the PM(NOC) Regulations because it had not been added to the Patent Register when Amgen’s New Drug Submission […]