Brief Amici Curiae of 118 Law, Economics, and Business Professors and the American Antitrust Institute in Support of Petitioners
This Supreme Court amicus brief, filed in Federal Trade Commission v.Watson, explains why exclusion-payment settlements, by which brand-namedrug companies pay generic firms to delay entering the market, contravenethe policies of patent law, antitrust law, and the Hatch-Waxman Act. Itaddresses five points.First, the settlements are not consistent with the Hatch-Waxman Act,Congress’s framework for balancing patent and antitrust law in thepharmaceutical industry, which encouraged generics to challenge patents.Second, the settlements are anticompetitive, serving as a form of marketdivision, which is the practical result when brands pay generics to dropchallenges to weak patents and delay entering the market instead.Third, the mere fact of a patent cannot justify the payments. The PatentOffice frequently issues invalid patents, and the patents at the heart ofthese settlements present concern, often covering not the drug’s activeingredient but narrower aspects like the formulation or method of use thatare less innovative and bear more potential for anticompetitive mischief.Patent policy encourages challenges to weak patents, and the proceduralpresumption of validity does not justify the settlements.Fourth, exclusion payments are not needed to settle cases in the publicinterest; history has shown that brands and generics can reach settlementswithout them.Fifth, the most appropriate antitrust framework employs a “quick look”rule-of-reason analysis that treats exclusion payments as presumptivelyunlawful. Such a framework recognizes the potentially severeanticompetitive effects of exclusion-payment settlements while permittingthe settling parties to introduce possible procompetitive justifications,if any, for their agreement.