Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
As discussed last month, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in FDA’s Orange Book for a variety of products was improper. Shortly thereafter, the FTC began...more
FTC recently placed improper Orange Book patent listings squarely in its crosshairs. In its September 2023 policy statement, FTC announced that it would “scrutinize improper Orange Book listings” and “use its full legal...more