The BPCIA And Declaratory Judgment The Real Dance Partners
The BPCIA And Declaratory Judgment: The Real Dance Partners? By Candace Polster, Christopher Betti, Ph.D., and Richard Martin, Ph.D., Morgan Lewis Congress enacted the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 to provide an abbreviated approval pathway for generic (“biosimilar”) versions of biologic drugs. Similar to the landmark 1984 Hatch-Waxman Act governing small molecule generics, the BPCIA includes a framework for resolving patent disputes that attempts to streamline the dispute resolution process while balancing the interests of the innovator, or refere...
Source: lifescienceleader.com