On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more
11/10/2023
/ Competition ,
Enforcement Actions ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Unfair Competition
By now you have seen multiple reports discussing the PTO’s Notice of July 29, 2022, relating to the duties of candor and good faith. Federal Register, Vol. 87, No. 145, July 29, 2022....more
9/16/2022
/ Duty of Candor ,
Food and Drug Administration (FDA) ,
Good Faith ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Orange Book ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
USPTO
Patent holders have the right to exclude others from making, using, selling, or offering to sell an invention—but only during the time a patent is in force....more
FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up of FDA regulation, which would allow it to “responsibly” promote new drug...more