SCOTUS hears Amgen v Sandoz biosimilar dispute

The US Supreme Court heard oral arguments from Amgen and Sandoz yesterday in the ongoing battle over a biosimilar version of Amgen’s Neupogen (filgrastim).

The US Court of Appeals for the Federal Circuit, in a previous ruling, decided that it is optional for biosimilar applicants to provide their manufacturing information to the reference product sponsor (RPS) during the ‘patent dance’.

But it also ruled that a biosimilar applicant must wait until its drug has been approved before giving the RPS 180 days’ notice of the biosimilar product’s launch.

According to Kevin Noonan, partner at McDonnell Boehnen Hulbert & Berghoff, the court was receptive to the argument presented by Amgen that the identity of the disputed drug cannot be known until the Food and Drug Administration (FDA) has approved it.

He added: “I think the court realised that it is not efficient to not be able to bring suit without knowing, for example, which disease it treats.

“The court was really trying to just get the parties to walk them through the practicalities of the options.”

Courtenay Brinckerhoff, partner of Foley & Lardner, said: “From the questioning I would not be surprised if they [the Supreme Court] affirm the Federal Circuit on the issue challenged by Sandoz, and confirm that the required 180-day pre-marketing notice only can be given once the biosimilar is approved.”

Noonan added: “I think that Amgen will prevail on the 180-day provision, and Sandoz most likely will on the patent dance.

A spokesperson for Amgen told LSIPR that it believes the Federal Circuit was correct by ruling on the 180-day notice period.

They added: “Any other interpretation would render meaningless the detailed statutory framework Congress established for resolving patent disputes.”

The Supreme Court’s ruling is expected by July this year.

Read the background of the case here.