MoFo secured a significant victory on behalf of client Sandoz Inc. in a case interpreting the ACA’s Biologics Price Competition and Innovation Act. The case Amgen Inc. et al. v. Sandoz Inc. et al., filed last October by Amgen, sought to delay Sandoz’s launch of its biosimilar filgrastim drug Zarxio®, which can help prevent infections in cancer patients. This high-profile dispute was closely watched by the business community. It is the first case to decide two key issues with regard to how the BPCIA enables the biosimilar applicant and reference product sponsor to resolve patent disputes. On March 19, 2015, the federal district court ruled in Sandoz’s favor on all issues before the court, adopting Sandoz’s interpretation of the BPCIA in all respects. The court also denied Amgen’s motions urging a contrary interpretation and seeking a preliminary injunction. The decision permits Sandoz to launch the first biosimilar product in the United States, which obtained FDA approval on March 6, 2015. That approval garnered widespread media coverage, including front page news in The Wall Street Journal.
This victory for Sandoz will pave the way for the biosimilar industry, which is expected to play a major role in the evolution of healthcare in this country.