On September 9, 2016, Apotex Inc. filed a petition for a writ of certiorari in the Amgen Inc. v. Apotex Inc. case decided by the Federal Circuit on July 5, 2016. Apotex’s petition was placed on the Supreme Court’s docket on September 14, 2016 as No. 16-332. Amgen’s response is due on October 14, 2016.
There are two issues raised in Apotex’s petition: (1) whether a biosimilar applicant must provide notice of commercial marketing when it complied with the patent dance; and (2) if notice of commercial marketing is required, whether notice can be effective prior to FDA approval of the biosimilar application. The Federal Circuit held that notice of commercial marketing is mandatory and not effective until after the biosimilar application is approved. Amgen, 2016 U.S. App. LEXIS 12353, at *36 (“We conclude that an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.”).
Apotex makes two arguments in its petition: (1) the notice of commercial marketing provision provided by the Biologics Price Competition and Innovation Act (“BPCIA”) is not mandatory, especially where the biosimilar applicant engaged in the patent dance; and (2) even if notice is required, it can be provided before a biosimilar application is approved.