On December 7, the Biden administration announced a proposed framework for determining whether the government may exercise its march-in rights to license pharmaceutical patents to third parties if it determines that the price...more
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
Fish and Richardson has obtained the first appellate reversal of a Post-Grant Review (PGR) proceeding at the United States Court of Appeals for the Federal Circuit since the proceedings were first implemented in...more
On October 27, the PTAB issued a Final Written Decision in an IPR challenging claims 1-8 of US Patent 8,337,856, directed to immunoconjugates comprising an anti-ErbB antibody, such as the humanized anti-ErbB2 antibody known...more