Brief of 11 Professors as Amici Curiae in Support of Amgen in Amgen v. Sandoz

Abstract

The Federal Circuit ruled in Amgen v. Sandoz that the premarket information exchange process in the Biologics Price Competition and Innovation Act (sometimes known as the “patent dance”) — which begins when a biosimilar applicant complies with section 351(l)(2)(A) of the Public Health Service Act (the applicant “shall provide” a copy of its marketing application) — is optional for biosimilar applicants. This amicus brief explains why the discovery and development of new biological medicines is expensive, time-consuming, and risky. It notes that the United States has led the world for decades in the development of important new biologics for serious and life–threatening diseases, and it explains that this innovation is made possible by robust patent protection. The brief then describes the importance of permitting patent enforcement prior to market launch of infringing medicines. It also explains that the Federal Circuit misunderstood the purpose of the artificial act of infringement where biosimilar applicants fail to comply, because the court failed to take account of the difference (particularly in FDA’s role) between this statute and the Hatch-Waxman generic drug statute. Finally, the brief describes the process culminating in enactment of the BPCIA, noting the many arguments and proposals to make the premarket information exchange and patent litigation processes optional. As Sandoz noted publicly right after enactment, Congress chose instead to make participation mandatory.