Lexology November 29, 2023
The FTC has been studying the competitive effect of improper listing of patents in the Food and Drug Administration’s (“FDA”) Orange Book as far back as the early 2000s.[i] However, in the last year, the issue has again come to the top of its enforcement agenda, starting with the issuance of an Amicus Curiae brief in November 2022 in Jazz Pharms., Inc. v, Avadel CNS Pharms, arguing that a patent covering a pharmaceutical distribution system does not meet the Orange Book criteria.[ii] This past September, the FTC issued a six-page policy statement, with the goal of putting market participants on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition...
Today's Sponsors
Today's Sponsor