By Kevin E. Noonan --
The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the District Court correctly determined that the provisions of the BPCIA requiring disclosure to the reference product sponsor of a biosimilar applicant's application and relevant manufacturing information was optional rather than mandatory. Sandoz petitioned for rehearing on the panel's decision that the District Court had erred in deciding that the 180-day noticed of commercial marketing for the biosimilar product could not be given to the reference product sponsor prior to FDA approval of their biosimilar application. As is common, the Court's order denying each party's petition contained no information regarding how the individual judges of the Court had voted, and there were no dissents to the decision accompanying the order.
Each party must now decide whether to file a petition for certiorari to the Supreme Court; grant of the petition may be more likely (at least with regard to Amgen's petition) in view of the seeming conflict between the courts' construction of the statutory language and that language's plain meaning, as well as the fractured nature of the panel's decision.