Over the last eight months, the US Federal Trade Commission (FTC) has focused on what it characterizes as “improper” Orange Book listings and the impacts of such listings on generic entry....more
The US Federal Trade Commission (FTC) sent letters on November 7, 2023, accusing 10 companies of improperly listing drug delivery device patents in the US Food and Drug Administration (FDA) Orange Book, stating that the FTC...more
The US Federal Trade Commission (FTC) recently issued a policy statement “to put market participants on notice that the FTC intends to scrutinize improper Orange Book listings” and take “actions against companies and...more
The US Court of Appeals for the Federal Circuit’s recent decision in In re Cellect confirmed that, when considering whether a reference patent invalidates for obviousness-type double patenting (ODP) a patent having a term...more
The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing requirements of existing FDA regulations....more
Signed into law on December 27, 2020, the Biological Product Patent Transparency Act (42 U.S.C. § 262(k)(9)) requires biological reference product sponsors to provide to the US Food and Drug Administration within 30 days of...more