SCOTUS agrees to hear Amgen v Sandoz dispute
The US Supreme Court has agreed to hear the biosimilars dispute between Amgen and Sandoz.
The petition for a writ of certiorari was filed by Sandoz in February 2016, requesting review of the case, in which the US Court of Appeals for the Federal Circuit interpreted key provisions of the Biologics Price Competition and Innovation Act (BPCIA).
The Federal Circuit said in July 2015 that the ‘patent dance’ exchange is optional under provisions set out in the BPCIA.
The court, however, added that a biosimilar applicant must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration.
Amgen has marketed Neupogen (filgrastim) since 1991, but in May 2014 Sandoz filed an application at the Food and Drug Administration (FDA) for approval of a biosimilar version of the drug under the brand name Zarxio.
Before Sandoz received FDA approval, it notified Amgen that it intended to bring Zarxio to market immediately after receipt of approval.
Sandoz then informed Amgen that it would not provide its biosimilar application to Amgen and that Amgen was entitled to sue Sandoz.
The FDA approved Sandoz’s Zarxio in March 2015 as the first biosimilar filgrastim product in the US.
The Supreme Court is expected to answer two questions.
First, the court will answer whether notice of commercial marketing given before FDA approval can be effective.
It will also answer whether it is improper to treat section 262(l)(8)(A) of the BPCIA “notice of commercial marketing” provision as a stand-along requirement and as creating an injunctive remedy that delays all biosimilars by 180 days after approval.
