Orange Book Listing Strategy and Emerging Antitrust Risk

Orange Book listing decisions are coming under increasing scrutiny from both regulators and the courts, placing them at the centre of Hatch-Waxman disputes and a growing wave of antitrust litigation. As challenges over whether certain patents were appropriately listed increase, innovator companies must strike a careful balance between maximising lifecycle protection and avoiding competition law exposure. This session will explore how Orange Book strategy is evolving in response to heightened regulatory oversight and antitrust theories.

• Examine how companies determine which patents meet FDA criteria for Orange Book listing.
• Analyse recent cases and disputes where Orange Book listings have been contested.
• Explore how plaintiffs and regulators are framing Orange Book conduct as anticompetitive, including claims tied to sham listings, monopolisation, and misuse of the Hatch-Waxman framework.
• Review the increasing role of the FTC, including warning letters, enforcement actions, and policy statements, alongside the rise in private antitrust litigation targeting listing practices.