As previously reported on March 31, 2021, AbbVie Inc. has petitioned the U.S. Supreme Court for a writ of certiorari to review the Third Circuit’s ruling determining the biopharma company’s patent infringement suit was a sham...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
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