Amgen loses bid to delay Neupogen biosimilar entry

A judge at the US District Court for the Northern District of California has denied Amgen’s attempt to block entry of a biosimilar version of its drug Neupogen (filgrastim).

Neupogen is an injection that prevents against infection in patients undergoing chemotherapy.

Earlier this month, the US Food and Drug Administration (FDA) approved Sandoz’s biosimilar version of Neupogen, called Zarxio. Zarxio was the first biosimilar to be approved in the US and earlier under the Biologics Price Competition and Innovation Act (BPCIA).

The BPCIA is an abbreviated regulatory pathway for companies seeking FDA approval for biosimilar drugs. It introduced a process that has been referred to as the “patent dance” in which the biosimilar applicant provides the company that made the drug with a copy of its application, and the parties then negotiate which patents would be subject to infringement litigation.

Sandoz had applied for the FDA’s approval to market Zarxio as a biosimilar version of Neupogen in July 2014. However, it had not provided Amgen with a copy of its application, denying it the “patent dance” and opportunity to negotiate.

Amgen said that Sandoz had acted unlawfully by not complying with the BPCIA, and that it was in breach of California’s Unfair Competition Law (UCL). It also accused Sandoz of infringing US patent 6,162,427.

It requested a preliminary injunction to stop Sandoz from selling Zarxio until the court had issued a disposition on the case’s merits.

Sandoz filed a counterclaim for declaratory judgment that finds its conduct is permissible, and for non-infringement and invalidity of the ‘427 patent.

Judge Richard Seeborg on Thursday (March 19) said that “there is no dispute” that Sandoz did not engage in the BPCIA’s “patent dance”, though he found that its decision not to do so was within its rights.

Seeborg denied Amgen’s motion for a preliminary injunction, and dismissed its claims under the UCL. He allowed Sandoz’s counterclaims to advance.

A spokesperson for Amgen told LSIPR: “We are disappointed in the district court’s decision and will seek review by the appeals court.”

Sandoz did not respond to a request for comment.