Hastings Science and Technology Law Journal


Jenny M. Alsup


As patents covering brand-name biologics begin to expire, biosimilar manufacturers are preparing to enter the market. Since its enactment in 2010, many have speculated on how the Biologics Price Competition and Innovation Act will influence competition and innovation, and whether the provisions struck the right balance. Now for the first time, the judiciary is interpreting the so-called “patent dance,” the Act’s information exchange and litigation provisions, in decisions that will impact the biosimilar landscape in the years to come. Two cases involving the biologic manufacturers Sandoz and Amgen illustrate the Act’s susceptibility to different interpretations.