Amgen dealt blow as FDA rules 'patent dance' optional

The US Food and Drug Administration (FDA) has denied Amgen’s petition asking that the so-called patent dance between a biosimilar maker and the product’s innovator be a mandatory requirement.

Amgen’s petition centred on the The Biosimilars Price Competition and Innovation Act (BPCIA), a shortened regulatory pathway for biosimilar products.

The act introduced the patent dance, a process in which the biosimilar maker may provide a copy of its FDA biosimilar application to the reference drug maker in order to negotiate which patents would be subject to infringement litigation.

Last July, generic drug maker Sandoz sent an application to the FDA seeking approval to market Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim).

Neupogen is an injection that protects against infection in cancer patients receiving chemotherapy.

But Sandoz did not notify Amgen of its application. Amgen responded by filing a lawsuit against Sandoz at the US District Court for the Northern District of California last October, accusing it of unlawfully refusing to engage in the 'patent dance'.

It had asked for a preliminary injunction stopping Sandoz from marketing Zarxio, which was refused earlier this month (March 19).

Last October, Amgen also filed its petition with the FDA.

In its filing, it argued that not complying with the certification “vitiates the entire scheme that Congress created”.

Momenta Pharmaceuticals, which opposed the petition, argued that the information exchanges of the “patent dance” are not mandatory.

Citing Momenta’s comment, the FDA took the view that the “patent dance” is an “optional method of resolving patent disputes”, and last Wednesday (March 25) denied Amgen’s petition.

The FDA approved Zarxio earlier this month.