The Biological Product Patent Transparency Act (“BPPT”) – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the...more
4/8/2021
/ Abbreviated New Drug Application (ANDA) ,
aBLA ,
Antitrust Violations ,
BPCIA ,
Consolidated Appropriations Act (CAA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Orange Book ,
Patent Trial and Appeal Board ,
Purple Book ,
Transparency
On March 13, 2020, the U.S. Court of Appeals for the D.C. Circuit affirmed the D.C. District Court’s 2018 summary judgment ruling in favor of Eagle Pharmaceuticals and against the FDA, finding that (1) the Orphan Drug Act...more