Fed Circuit erred in Sandoz v Amgen, says solicitor general
The US Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration (FDA), according to the acting solicitor general.
The statement was made in an amicus brief filed at the US Supreme Court by Noel Francisco on February 17.
In January this year, the Supreme Court agreed to hear the biosimilar dispute after Sandoz requested a writ of certiorari.
Previously, the Federal Circuit had interpreted key provisions of the Biologics Price Competition and Innovation Act (BPCIA).
In its interpretation, the court held that the ‘patent dance’ exchange is optional under provisions set out in the BPCIA but that a biosimilar applicant must give 180 days’ pre-marketing notice after approval by the FDA.
But the federal government disagreed, arguing that the BPCIA text “directly addresses the requisite timing by specifying the ‘late[st]’ date ‘before’ commercial marketing on which notice must be given”.
It added: “Nothing limits how early the applicant may give notice after FDA accepts its abbreviated Biologics License Application for review.”
Neupogen (filgrastim) had been marketed by Amgen since 1991, but in May 2014 Sandoz filed an application at the FDA for approval of a biosimilar under the brand name Zarxio.
Sandoz notified Amgen that it intended to bring Zarxio to market immediately after receipt of FDA approval.
The biosimilar applicant then informed Amgen that it wouldn’t provide its biosimilar application to Amgen and that Amgen was entitled to sue Sandoz.
Zarxio was approved by the FDA in March 2015.
According to the brief, the Federal Circuit also erred in holding that notice is required even after the applicant declines to provide information.
It argued that once the applicant has departed from the patent dance process, “the sponsor may immediately bring an artificial infringement claim for all relevant patents”.
The Biosimilars Council, a division of the Association for Accessible Medicines, recently filed a brief in support of Sandoz.
