Federal Circuit hears arguments in Zarxio ‘patent dance’ row

The US Court of Appeals for the Federal Circuit has heard oral arguments in Amgen v Sandoz, a case that should determine whether it is mandatory for biosimilar applicants to engage in the so-called patent dance.

The patent dance refers to patent dispute resolution provisions under the Biologics Price Competition and Innovation Act (BPCIA), which provides a shortened regulatory pathway for biosimilar drugs.

On Wednesday (June 3) circuit Judges Pauline Newman, Alan Lourie and Edward Chen heard the case, which was on appeal from the US District Court for the Northern District of California.

Earlier this year, Sandoz received approval from the US Food and Drug Administration (FDA) to market Zarxio (filgrastim-sndz), a biosimilar version of Amgen’s Neupogen (filgrastim).

Neupogen is an injection used to prevent infection in patients undergoing chemotherapy. Zarxio is the first biosimilar drug to be approved in the US.

Amgen filed for a preliminary injunction at the California district court to stop Sandoz from selling Zarxio. The company argued that Sandoz had broken the law by not adhering to the BPCIA’s patent dance.

The patent dance requires companies seeking to make biosimilar versions of existing biological drugs to notify the reference drug maker within 20 days of the FDA accepting the application for review.

The district court denied that motion and found that it is optional for biosimilar applicants to engage in the patent dance, a decision that Amgen appealed against.

However, last month, the federal circuit issued a preliminary injunction stopping Sandoz from selling Zarxio in the US. The injunction will remain in place until the court clarifies whether Sandoz broke the law by not following provisions of the BPCIA.

The act says: “[The biosimilar] applicant … shall provide to the reference product sponsor a copy of the application … and … may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.”

According to Andrew Williams, a Chicago-based partner at law firm McDonnell Boehnen Hulbert & Berghoff and writing for the Patent Docs blog, Amgen’s position is that the “shall” in this wording takes the meaning of “must” rather than “shall”.

Sandoz argued that the “shall” implies that the biosimilar applicant is not obliged to provide a copy of its application, and only would if it wanted to engage in the patent dance, Williams said.

At the hearing, Chen said that the BPCIA statute created a “choose your own adventure” situation for biosimilar applicants, while Lourie said that the BPCIA should win a “Pulitzer prize for complexity or uncertainty”.

Courtenay Brinckerhoff, a partner at law firm Foley & Lardner in Washington, DC, said in the firm’s PharmaPatents blog that the judges’ questioning seemed to favour Amgen’s position more than Sandoz’s, and that more disputes over the BPCIA’s “complicated requirements” are “sure to come”.

A spokesperson for Amgen told LSIPR: “The appeal presents important issues and we appreciate the court taking the appeal on an expedited briefing schedule. We are confident in the merits of our appeal.”

Sandoz told LSIPR in a statement: “We look forward to a prompt resolution of the appeal procedure following the June 3 hearing. We continue to look forward to launching Zarxio as the first US biosimilar in the near future.”