New federal legislation will take effect this year that will require a reference product sponsor to submit to the FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to...more
4/26/2021
/ Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
IP License ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Purple Book ,
Small and Medium-Sized Enterprises (SMEs)
Welcome to the third issue of the Morgan Lewis Pharma Review, which summarizes key recent cases from the Federal Circuit and district courts that impact the pharma space, including Federal Circuit and district court decisions...more