Sandoz appeals to US Supreme Court over ‘patent dance’ ruling

Sandoz has petitioned the US Supreme Court to review the US Court of Appeals for the Federal Circuit’s ruling in the ‘patent dance’ dispute.

In a writ of certiorari, filed yesterday, February 16, Sandoz asked the court to review the part of the ruling that said a biosimilar maker must give 180-days’ pre-marketing notice to the biologic company before launching its product.

The dispute, between Sandoz and rival Amgen, centres on the Biologics Price Competition and Innovation Act (BPCIA), which provides a shortened regulatory pathway for biosimilar drugs. It includes a mechanism known as the ‘patent dance’, which allows parties to address any patent claims while an applied-for drug is being approved.

Novartis-owned Sandoz’s attempt to market a biosimilar version of Amgen’s Neupogen (filgrastim) drug was the subject of the dispute.

In a ruling handed down in July last year, the federal circuit said that the so-called patent dance is optional under provisions set out in the BPCIA. But the court 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 (FDA).

Both parties unsuccessfully attempted to have the case heard en banc at the federal circuit.

Sandoz appealed against the 180-day part of the ruling, while Amgen appealed against the part which said the patent dance was optional.

In its petition, Sandoz has asked: “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.”

Sandoz began marketing its biosimilar version of the drug, called Zarxio, in September last year following the federal circuit’s July decision.