Paying for Delay: Pharmaceutical Patent Settlement as a Regulatory Design Problem
68 Pages Posted: 21 Oct 2006 Last revised: 28 Dec 2013
Over the past decade, drug makers have settled patent litigation by making large payments to potential rivals who, in turn, abandon suits that (if successful) would increase competition. Because such "pay-for-delay" settlements postpone the possibility of competitive entry, they have attracted the attention of antitrust enforcement authorities, courts, and commentators. Pay-for-delay settlements not only constitute a problem of immense practical importance in antitrust enforcement, but also pose a general dilemma about the proper balance between innovation and consumer access.
This Article examines the pay-for-delay dilemma as a problem in regulatory design. A full analysis of the relevant industry-specific regulatory statute, the Hatch-Waxman Act, yields two conclusions. First, certain features of the Act widen, often by subtle means, the potential for anticompetitive harm from pay-for-delay settlements. Second, the Act reflects a congressional judgment favoring litigated challenges, contrary to arguments employed to justify these settlements. These results support the further conclusion that pay-for-delay settlements are properly condemned as unreasonable restraints of trade. This analysis illustrates two mechanisms by which an industry-specific regulatory regime shapes the scope of antitrust liability: by creating (or limiting) opportunities for anticompetitive conduct as a practical economic matter, and by guiding as a legal matter the vigor of antitrust enforcement in addressing that conduct.
Keywords: agency, antitrust, Cipro, drug, exclusion payment, FTC, Federal Trade Commission, generic drugs, Hatch-Waxman, paragraph IV, patent, pay for delay, pharmaceutical, regulation, reverse payment, Schering, settlement, Sherman Act, tamoxifen
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