On Friday, October 16, 2015, the Federal Circuit denied the petitions for rehearing by the panel and rehearing en banc filed by both parties in Amgen v. Sandoz. Amgen petitioned for rehearing of the panel’s decision holding that the information sharing provisions of the Biologics Price Competition and Innovation Act (BPCIA), namely, the disclosure of a biosimilar’s application and manufacturing information, were optional. Sandoz petitioned for rehearing of the panel’s decision that the 180-day notice of commercial marketing could not be given to the reference product sponsor prior to FDA approval.
It will be interesting to see whether either, both or none of the parties petition for certiorari to the U.S. Supreme Court. Given that both parties asked the full Federal Circuit to overturn parts of the fractured panel’s decision, it seems likely that one or both will seek review. Petitions are due in 90 days.
In the meantime, a number of interesting questions remain. For example, how much information must be shared during the patent dance? This is a question currently being examined in pending BPCIA litigations between Amgen v. Hospira and Janssen v. Celltrion.
Also, based on certain statements in the Federal Circuit’s decision, there is a question whether participation in the patent dance exempts biosimilar applicants from having to provide the 180-day notice of commercial marketing to the reference product sponsor upon receipt of FDA approval. This question is currently being examined in pending litigations between Amgen v. Hospira, Amgen v. Apotex and Janssen v. Celltrion.
Please continue to watch the BRIC Wall Blog for updates on Amgen v. Sandoz.
This post was written by Lisa Mueller.