Biosimilars Action Plan – FDA Seeks to Create a Dynamic Biologics Market

Biosimilar

Last week, the U.S. Food & Drug Administration (“FDA”) released a Biosimilars Action Plan (“BAP”) with the objective of promoting innovation, competition and affordability of biologics and biosimilar products.  Characterizing the BAP as “an important piece of the Administration’s bold Blueprint to Lower Drug Prices,” the FDA underscored the need for a competitive market for…

State University’s Filing of Patent Infringement Action Waives Sovereign Immunity to IPR Proceedings

Inter partes review, PTAB, Sovereign immunity

The Patent Trial and Appeal Board (“PTAB”) recently held that sovereign immunity under the Eleventh Amendment is waived in the context of inter partes review (“IPR”) by a state’s filing of a patent litigation in federal court.  Ericsson Inc. v. Regents of the University of Minnesota, IPR2017-01186, Paper No. 14. The PTAB first addressed whether…