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
Unenforceability of a patent for a drug formulation was affirmed by the US Court of Appeals for the Federal Circuit earlier this month in Belcher Pharmaceuticals, LLC v. Hospira, Inc., Appeal No. 2020-1799 (Fed. Circ. Sept....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