On June 3, 2015, the Federal Circuit heard oral arguments in Amgen v. Sandoz regarding the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). As reflected in Judge Lourie’s comments, this case requires the court to interpret a statue that should win “a Pulitzer Prize for complexity.”

The Neupogen® // Zarxio™ Biosimilar Dispute

Sandoz’ Zarxio™ (filgrastim-sndz) product is the first product approved under the BPCIA, and was approved as a biosimilar of Amgen’s Neupogen® (filgrastim) product. Under § 262(l)(2)(A), once the FDA notified Sandoz that its biosimilar application had been accepted for review, Sandoz had 20 days to provide Amgen with a copy of its biosimilar application and other information describing how its product is made. As set forth in the district court’s order, Sandoz did not provide Amgen a copy of its application within the 20 day period, and did not follow any of the other patent dispute resolution procedures of the statute. Amgen sued Sandoz asserting various state law claims arising out of Sandoz’ failure to follow § 262(l) and infringement of U.S. Patent 6,162,427.

As explained in this article, the district court held that the patent dispute resolution provisions of the BPCIA are optional.

The Oral Arguments

Judges Newman, Lourie and Chen are hearing the Federal Circuit appeal.

The judges spent considerable time trying to understand the patent infringement provisions of the BPCIA, including those embodied in 35 USC § 271(e)(2)(C). For example, the judges struggled with language that seems to make filing a biosimilar application an act of infringement, even though the infringed patents are not identified until the procedures of 42 USC § 262(l) have been followed (or not). The judges also questioned whether other instances of the term “shall” in the statute are mandatory, such as § 262(l)(6), which provides that “the reference product sponsor shall bring an action for patent infringement” on the agreed-upon patents. The judges considered the framework of the BCPIA as a whole, and the impact on the reference product sponsor if the patent dispute resolution and/or notice provisions are as optional as the district court found.

While predicting a Federal Circuit decision based on the oral arguments always is of dubious value, the judges’ questioning seemed to favor Amgen’s position more than it favored Sandoz’ position. For example, Judge Chen stated that he doubted that the statute merely created a “choose your own adventure” framework for the biosimilar applicant.

One of Judge Lourie’s final comments garnered laughter from the courtroom:

If the purpose of the statute is to avoid litigation, it’s already failed.

Indeed, regardless of how the court decides this case, more disputes over the complicated requirements of the BPCIA are sure to come.