The Actavis Inference: Theory and Practice
51 Pages Posted: 7 Feb 2015 Last revised: 4 Oct 2015
Date Written: February 5, 2015
In FTC v. Actavis, Inc., the Supreme Court considered "reverse payment" settlements of patent infringement litigation. In such a settlement, a patentee pays the alleged infringer to settle, and the alleged infringer agrees not to enter the market for a period of time. The Court held that a reverse payment settlement violates antitrust law if the patentee is paying to avoid competition. The core insight of Actavis is the Actavis Inference: a large and otherwise unexplained payment, combined with delayed entry, supports a reasonable inference of harm to consumers from lessened competition. This paper is an effort to assist courts and counsel in implementing the Actavis Inference. First, we evaluate a variety of fact patterns that have arisen in the district courts since Actavis, including payment that takes a form other than cash. For example, a branded drug maker may promise not to offer an authorized generic drug. As we explain, under Actavis, such agreements are especially likely to violate antitrust law. We also consider how much detail a plaintiff must offer in its initial complaint to comply with federal pleading requirements.
Second, we demonstrate that the Actavis Inference fully applies when multiple generic firms, rather than just one, threaten to enter the market. Our economic model shows that the Actavis Inference becomes stronger and more important in the presence of multiple generic firms. Our analysis demonstrates that the contrary conclusions reached in a recent paper by Bruce Kobayashi, Joshua Wright, Douglas Ginsburg, and Joanna Tsai (KWGT) are incorrect, inconsistent with KWGT’s own analysis, or irrelevant to a faithful implementation of Actavis.
Third, we clarify the reasons not to litigate the patent in the antitrust case. Thanks to the Actavis Inference, a trial court need not determine patent validity or infringement in order to assess the legality of the settlement. The antitrust question depends upon the ex ante prospects in patent litigation and not ex post litigation of the patent by a patent court or by the antitrust court considering the settlement. Litigating the patent is thus of limited probative value and not dispositive regarding a potential antitrust violation.
Keywords: Actavis, antitrust, drugs, FTC, Hatch-Waxman, innovation, patent, Paragraph IV, pay for delay, pharmaceuticals, regulation, reverse payment, settlement
JEL Classification: K21, L40, L41, L50
Suggested Citation: Suggested Citation