Sandoz has filed a petition for a writ of certiorari, asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision. The petition is available here. Sandoz has asked the High Court to decide whether the 180-day notice of commercial marketing can only be given after the proposed biosimilar product receives FDA-approval.
Sandoz’s question presented is:
“Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a standalone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.”
Amgen’s response will be due in late March, though it could obtain an extension. Absent an unusually long extension, the Court would likely rule on the petition before its summer recess, but if cert were granted the case would not be heard until fall and likely not decided until 2017.
The time has expired for Amgen to file its own free-standing cert petition. Under the Supreme Court’s rules, it is conceivable that Amgen could file a “conditional cross-petition” – a petition asking that, if (and only if) the Court takes up Sandoz’s petition, it also take up the issue on which Sandoz won and Amgen lost in the Federal Circuit: whether the BPCIA’s information disclosure provisions are “mandatory.” Conditional cross-petitions are rarely granted; if the Court takes such a cross-petition, it generally does to ensure that its review of an issue is not unduly circumscribed by the question as drafted by the petitioner.