The U.S. Supreme court recently delivered a unanimous opinion in Sandoz v. Amgen. This complicated case centers on Biosimilars, which are generic versions of biologic drugs, and the dance of patent litigation that can ensue when a generic manufacturer seeks approval for a product under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The BPCIA provides an abbreviated pathway for obtaining FDA approval of the generic form of an already approved reference biological product.
Under the BPCIA, a generic manufacturer must notify the originator at least 180 days before launch of their product. In its decision, the Supreme Court held that notice of commercial marketing by a generic manufacturer does not have to wait until approval of the biosimilar.
This is significant, because otherwise, a biosimilar manufacturer could not enter the market upon approval, but would have to delay their marketing by 180 days.
The Court also dealt with the question of whether an injunction is available under federal law to force compliance of the generic manufacturer with certain disclosure requirements under the BPCIA. The Court ruled there is no cause of action under federal law, the only option being to sue for patent infringement at that juncture, but left open the question whether compliance can be compelled under state law.
The case has now been remanded for further ruling by the Federal Circuit.