On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more
Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more
1/26/2023
/ Biosimilars ,
Canada ,
Double Patent ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Obviousness-Type Double Patenting (ODP) ,
Patent Litigation ,
Patent Portfolios ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
UK ,
USPTO
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year...
President Biden Signs Orange Book Transparency Act -
In January, we reported that President Biden...more
12/31/2021
/ Biden Administration ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Guidance Update ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Orange Book ,
Patent Applications ,
Patent Examinations ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book ,
Statutory Requirements ,
Transparency ,
USPTO