USITC: a powerful forum for biologics patent owners

For manufacturers of biologics and biosimilars, the Biologics Price Competition and Innovation Act (BPCIA) imposes a complex statutory scheme that restricts the timing and control of patent litigation in district court. Biosimilar applicants who find themselves on the receiving end of a potential patent infringement complaint in district court have the advantage of (and have utilised) patent challenges at the Patent Trial and Appeal Board (PTAB).