Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more
8/26/2021
/ Abbreviated New Drug Application (ANDA) ,
CAFC ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Induced Infringement ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On June 21, 2021, the Supreme Court handed down a highly-anticipated decision in United States v. Arthrex, Inc., finding that Administrative Patent Judges (“APJs”)—the judges who sit on Patent Trial and Appeal Board (“PTAB”)...more
7/1/2021
/ Administrative Patent Judges ,
Appointments Clause ,
Constitutional Challenges ,
Director of the USPTO ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
SCOTUS ,
United States v Arthrex Inc
On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and exclusivity-related information for approved drugs listed...more