The Supreme Court’s interpretation of the biosimilars statute and the value of certainty

October 25, 2017

In June, the United States Supreme Court interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the first time in the first litigation under the statute. The Court held unanimously in Sandoz v. Amgen that provisions of the BPCIA requiring disclosure allowing innovators to assess whether their patents are infringed are not enforceable under federal law. The ruling also allows biosimilar makers to provide notice of first commercial marketing, long before approval or marketing of the biosimilar.

The Supreme Court’s decision undoubtedly introduces uncertainty into provisions that many viewed as necessary and enforceable. But due to the value of certainty for both biosimilar makers and innovators alike in resolving patent disputes for blockbuster biologics, the impact of the Court’s decision may ultimately be modest.

To continue reading Irena Royzman and Nathan Monroe-Yavneh's article from Nature Biotechnology, please click here.