Partner Mark Ford and Associate Kristen Parnigoni authored an article in the November 2024 issue of Concurrences.
Abstract: The Federal Trade Commission has recently increased its scrutiny of pharmaceutical companies’ patent listings in the Orange Book, challenging hundreds of device and delivery system patents through warning letters and policy statements over the last year. This enforcement shift coincides with significant judicial developments in the First and Second Circuits that changed the landscape for proving and defending antitrust claims based on alleged improper Orange Book listings. Standards now place the burden on pharmaceutical companies to prove their good faith in listing patents as an affirmative defense, rather than requiring antitrust plaintiffs to demonstrate bad faith. This article examines this convergence of regulatory and judicial developments against the backdrop of the Hatch-Waxman Act’s framework for generic drug approval and the recent Orange Book Transparency Act of 2020. Further, it discusses the practical implications of this emerging standard, including challenges related to privilege waivers and proving causation of competitive harm, while raising questions about how courts in other circuits may approach these issues.
