Federal Circuit denies rehearing in ‘patent dance’ case

The US Court of Appeals for the Federal Circuit has declined to hear the Amgen v Sandoz ‘patent dance’ dispute en banc.

Amgen had appealed against the federal circuit’s July ruling which said that the so-called ‘patent dance’ is optional under provisions set out in the Biologics Price Competition and Innovation Act (BPCIA).

Sandoz unsuccessfully appealed against part of the ruling which said that a biosimilar applicant must give 180-days pre-marketing notice after the biosimilar application has been approved by the US Food and Drug Administration (FDA).

The dispute centred on Novartis-owned Sandoz’s attempt to market a biosimilar version of Amgen’s Neupogen (filgrastim) drug.

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

The BPCIA provides both a shortened regulatory pathway for biosimilar drugs and a mechanism, known as the ‘patent dance’, which allows parties to address any patent claims while the applied-for drug is being approved.

Last year, Sandoz informed Amgen that it had filed an application with the FDA to make a generic version of Neupogen. The FDA approved Sandoz’s application in March making Zarxio the first biosimilar to be approved in the US.

But Sandoz stopped short of providing Amgen with a copy of the FDA application or any other information that described the process or processes used to manufacture Zarxio. Sandoz argued that it was not mandatory to do so under the BPCIA.

Amgen subsequently sued Sandoz at the US District Court for the Northern District of California last year claiming that the BPCIA required them to provide details.

In March, the district court ruled that the ‘patent dance’ was optional and therefore Sandoz’s actions were not unlawful.  In a unanimous verdict, the federal circuit upheld the district court’s judgement.