On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.
Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application. Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs