On October 18, 2024, the USPTO’s final rule regarding Motion to Amend (“MTA”) practice and procedures in trial proceedings under the America Invents Act became effective. The rule makes permanent several MTA pilot program...more
The United States Patent and Trademark Office ("USPTO") is seeking public input about the need for a statutory experimental use exception in light of the common law jurisprudence. ...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Canada ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Supply Chain
On December 3, 2020, the Patent Trial and Appeal Board (“PTAB”) released data regarding the usage and success rates of its Motion to Amend (“MTA”) Pilot Program (“Pilot”). All PTAB cases instituted on or after March 15, 2019,...more