A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief

How does the Biologics Price Competition and Innovation Act of 2009 (BPCIA) impact a biosimilar maker’s right to declaratory relief?  In this article, published in Biosimilar Development, Limin Zheng explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.


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