FDA Releases “Biosimilar Action Plan”

FDA Releases “Biosimilar Action Plan”

On July 18, 2018, FDA released an 11-point plan of action which it contends will “encourage innovation and competition among biologics and the development of biosimilars.” Since passage of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010, FDA has...
PTAB Issues New Guidance on Inter Partes Review

PTAB Issues New Guidance on Inter Partes Review

The Patent Trial and Appeal Board (PTAB) issued a guidance document addressing the impact of the SAS Decision on Inter Partes Reviews. The PTAB’s guidance document outlines new procedures that will be followed in an Inter Partes Review (IPR) as a result of the U.S....