Sandoz wants Supreme Court to review first BPCIA decision
Washington DC | 19 February 2016

Sandoz has asked the US Supreme Court to review aspects of the Court of Appeals for the Federal Circuit’s ruling concerning the 180-day waiting period for biosimilar makers.

Generics manufacturer Sandoz filed a petition to the Supreme Court on 16 February, questioning the Federal Circuit’s July 2015 decision, in which it held that Sandoz did not have to comply with the optional information exchange and patent dance procedures when seeking approval for its biosimilar.

It was the first time the Federal Circuit addressed the Biologics Price Competition and Innovation Act (BPCIA).

Following the decision, Sandoz launched its cancer drug Zarxio (filgrastim-sndz), in September 2015, the first biosimilar to be released in the US.

Sandoz’s Supreme Court petition, filed on 16 February, follows Amgen deciding not to seek its own review of the decision.

In October last year, the Federal Circuit refused to rehear its first analysis of the BPCIA and denied applications from both parties.

Amgen had wanted a rehearing of the information exchange and patent dance rulings, while Sandoz wanted a redo of the decision on the 180-day notice requirement.

In its petition, Sandoz asked the Supreme Court to consider whether notice of commercial marketing given before US Food and Drug Administration (FDA) approval can be effective, and whether the Federal Circuit was correct to treat Section 262(l)(8)(A) of the BPCIA as a standalone requirement and create an injunctive remedy that delays all biosimilars by 180 days after approval.

Courtenay Brinckerhoff, partner at Foley & Lardner, called Sandoz’s petition to the Supreme Court unsurprising and said the Supreme Court “may be inclined to grant cert, since this is the first decision interpreting this aspect of the BPCIA”.

She added: “The decision postpones the market entry of approved biosimilar products, in effect delaying the availability of less expensive biosimilar products that the BPCIA was enacted to provide.”

Author: Tammy Facey

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