Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At...more
12/19/2024
/ Abbreviated New Drug Application (ANDA) ,
Competition ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Policy Statement
Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more
7/3/2024
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Antitrust Provisions ,
Cartels ,
Comment Period ,
EU ,
European Commission ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medicare ,
Monopolization ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Price-Fixing ,
Reverse Payments ,
Settlement Agreements ,
Sherman Act ,
USPTO
Today, as part of the Trump Administration's stated goal to lower drug prices, the Food and Drug Administration (FDA) published a list of pharmaceutical companies that have allegedly refused to sell samples of their drugs to...more