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
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
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