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
The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators. In the broadest reading, some see the majority opinion as rendering any...more
The U.S. Court of Appeals for the Federal Circuit’s New Year’s eve opinion in Ball Metal v. Crown Packaging, though nonprecedential, raises important considerations for pharmaceutical and biologics patents – where patent...more
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
On August 9, 2019, the Federal Circuit issued a public opinion in Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH & Co. KG, finding claims directed to methods for detecting a genetic marker for a canine hereditary disease...more
8/14/2019
/ Alice Corporation ,
Corporate Counsel ,
Diagnostic Method ,
Diagnostic Tests ,
DNA ,
Dogs ,
Genetic Materials ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents
On January 11, 2019, the U.S. Court of Appeals for the Federal Circuit issued a precedential opinion affirming the decision of the Patent Trial and Appeal Board (“PTAB”) in an inter partes review proceeding (“IPR”) finding...more