Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more
8/27/2025
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patient Access ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
Stays
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
12/20/2023
/ Bayh-Dole Act ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health and Safety ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
March-in Rights ,
NIST ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs