We recently posted about Sandoz’s petition to the Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz here. In their opposition brief filed Monday, Amgen argued that delaying the 180-day notice until after approval would confirm that any requested injunction blocking the biosimilar is factually based.
Amgen also filed a conditional cross-petition requesting review of the Federal Circuit’s finding that biosimilar makers have the option to disclose their approval applications as part of BPCIA’s patent dance. In Amgen v. Sandoz, the Federal Circuit held that the patent dance is optional, but by opting out, the 180-day notice becomes mandatory after approval. Because the cross-petition is conditional, the Supreme Court would only review this issue if it also grants Sandoz’s petition for review.
Stay tuned to the Big Molecule Watch for further developments.