Will you, won’t you, will you join the dance?

When Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create an abbreviated pathway for biosimilar product approval, it included complicated provisions for resolving patent infringement disputes. In March this year, the US Food and Drug Administration (FDA) approved the first biosimilar product, and the US Court of Appeals for the Federal Circuit then had to decide whether those provisions are mandatory or optional.

On July 21, in Amgen v Sandoz, the federal circuit held that the provisions are optional, although a biosimilar applicant that opts out may be subject to an immediate patent infringement suit. The court also held that biosimilar applicants must give 180 days prior notice of commercial marketing, and cannot do so until the biosimilar product has been approved by the FDA.

The Neupogen biosimilar dispute

In May 2014, Sandoz sought FDA approval of a biosimilar version of Amgen’s Neupogen (filgrastim) product, which is a human granulocyte colony-stimulating factor protein (G-CSF) produced by recombinant DNA technology and used to reduce the chance of infection in certain cancer patients receiving chemotherapy. Although Sandoz notified Amgen of its biosimilar application, it did not provide a copy to Amgen and did not follow any of the other patent provisions of the BPCIA.

Amgen sued Sandoz in the US District Court for the Northern District of California alleging, among other things, violation of California’s unfair competition laws and conversion based on Sandoz’s alleged failure to comply with the BPCIA. The district court ruled in favour of Sandoz, finding no violation of the BPCIA to support Amgen’s state law claims. Although the federal circuit agreed that Sandoz did not have to share its biosimilar application or follow the complicated patent provisions of the BPCIA, it determined that the statute required Sandoz to give 180 days’ pre-marketing notice after its product was approved, so that it could not enter the market until September 2, 2015.

The patent dance

Like the Hatch-Waxman Act, which governs traditional generic drugs, the BPCIA allows a biosimilar applicant to rely on the FDA’s previous approval of a reference product (eg, the original biologic product). Therefore, a biosimilar applicant does not need to provide clinical data demonstrating the safety and efficacy of its product, as long as it submits information demonstrating that its product is ‘biosimilar’ to, or ‘interchangeable’ with, the reference product. Also, like the Hatch-Waxman Act, the BPCIA includes patent dispute resolution procedures, but the similarity ends there.

The BPCIA lays out what the federal circuit characterised as a “unique and elaborate” process, one that many refer to as the ‘biosimilar patent dance’. The process: