The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
6/14/2024
/ Abbreviated New Drug Application (ANDA) ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Life Sciences ,
Medicare Modernization Act ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
USPTO
In its recent en banc decision issued in LQK v. GM Global, the Federal Circuit overruled the Rosen-Durling test for design patent obviousness, jettisoning decades-old precedent and loosely outlining a design patent...more
In prior posts for this series, we have discussed areas of law where Commissioners have voiced their dissent and demonstrated a clear divide among the decision-makers. But when it comes to Standard Essential Patents (SEPs),...more