In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...more
6/18/2024
/ Abbreviated New Drug Application (ANDA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Medical Devices ,
Orange Book ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Written Description of Therapeutic Efficacy -
In two 2019 rulings, the Federal Circuit invoked the “written description requirement” of 35 U.S.C. § 112 to require evidentiary support for therapeutic efficacy. Now that the...more
2/24/2021
/ Appeals ,
Copyright ,
Defend Trade Secrets Act (DTSA) ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Misappropriation ,
Patent-Eligible Subject Matter ,
Pharmaceutical Patents ,
Section 101 ,
Social Media ,
Trade Secrets ,
USPTO ,
Written Descriptions