Big Molecule Watch
December 23, 2016


On Tuesday, Amgen filed its supplemental brief opposing Sandoz’s petition for writ and responding to the Solicitor General’s brief, which we discussed here. In sum, the Solicitor General sided with Sandoz, stating that:

  • notice of commercial marketing before FDA approval is consistent with § 262(l)(8)(A);
  • injunctive relief is not available for a failure to furnish notice under § 262(l)(8)(A) because nothing in the BPCIA creates a cause of action to enforce the notice provision; and
  • if an applicant fails to provide information under § 262(l)(2)(A), a sponsor’s recourse is to commence a patent-infringement action.

Amgen characterized the government’s position as rendering optional “an intricate, integrated statute” that Congress wrestled over for years. Amgen again urges the Supreme Court to deny Sandoz’s petition, arguing that the BPCIA issues should be allowed to develop further in the lower courts, but that if Sandoz’s petition is granted, Amgen’s cross-petition should also be granted as the government recommended.

Arguing that notice of commercial marketing must follow FDA licensure, Amgen repeats its arguments from its original opposition to Sandoz’s petition, summarized here. Amgen also criticizes the Solicitor General for mischaracterizing the Federal Circuit’s comment that requiring notice after FDA licensure would help ensure a “fully crystallized controversy regarding the need for injunctive relief.” Whether there is a technical basis to sue for infringement as created by the subsection 262(k) pathway, Amgen argues, is a very different question from whether injunctive relief can be awarded—and critical information provided by FDA approval is necessary to determine injunctive relief. Finally, Amgen argues that if injunctive relief is not available to compel a biosimilar applicant to provide the 180-day notice, then Congressional purposes in requiring notice are gutted.