We're pleased to introduce Sidebars! This limited podcast series by Kilpatrick Townsend's biopharma team showcases today's leading women in the patent bar. Each of the episodes is a candid conversation between groundbreaking...more
Approval Processes -
The regulatory approval pathway for a new “biological product” submitted as a Biologics License Application (BLA) under the Biologics Price Competition and Innovation Act (BPCIA), is now separate from...more
On January 13, we originally posted on this topic. An update was posted on February 5. This post provides the most recent update on this matter.
Yesterday, the Federal Circuit granted Teva’s petition for en banc rehearing....more
On January 8, 2021, the Supreme Court granted a petition for a writ of certiorari filed by Minerva Surgical, Inc. on September 30, 2020. The question presented is “whether a defendant in a patent infringement action who...more
Statutory Basis For Label Carve-Outs -
Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use...more