In pharmaceutical patent cases, the drug label is often the primary piece of evidence regarding whether generic drug companies induce doctors to infringe brand drug companies’ patents. But a series of recent decisions from the U.S. Court of Appeals for the Federal Circuit has taken this focus on the label too far. Rather than assessing what doctors actually did (or would do) based on a drug label, the Federal Circuit has treated drug labels as if they were patent claims, assessing whether their text merely “contains” a patented method of use. This has yielded a new, problematic doctrinal turn—what we call “infringement by label”—that threatens generics’ ability to enter the market, even when their products would not actually cause doctors to practice any of the brands’ patents. Infringement by label spotlights the Federal Circuit’s misunderstanding of drug labeling at the U.S. Food and Drug Administration (FDA) and a lack of clarity in the court’s case law about the nature of induced patent infringement, the theory of infringement most common in label-focused drug patent litigation. By identifying these deficiencies, this Article aims to return drug patent litigation to its factual and doctrinal moorings. At the same time, we show how the Federal Circuit’s infringement-by-label theory underscores several broader, unresolved questions in patent law—namely, whether the interpretation of drug labels is an issue of law or fact; whether the objects of induced infringement are statements made by the defendant or how such statements are perceived by a direct infringer; and how to construct a hypothetical direct infringer to prove inducement. Answering these questions would improve pharmaceutical patent litigation and clarify how generics can enter the market while being faithful to the FDA’s drug labeling regime.

*Sherkow is Richard W. and Marie L. Corman Professor of Law, College of Law; Professor of Medicine, Carle-Illinois College of Medicine; Professor, European Union Center; Affiliate, Carl R. Woese Institute for Genomic Biology; University of Illinois at Urbana-Champaign. Gugliuzza is Thomas W. Gregory Professor of Law, University of Texas at Austin School of Law. For comments, thanks to Jonas Anderson, Laura Dolbow, Janet Freilich, Jordi Goodman, Michael Goodyear, Cynthia Ho, Tim Holbrook, Mark Janis, Mark Lemley, Mike Meurer, Amy Motomura, Lisa Larrimore Ouellette, Laura Pedraza-Fariña, Nicholson Price, Arti Rai, Greg Reilly, Sean Seymore, Sean Tu, Melissa Wasserman, and Patricia Zettler. This Article benefitted greatly from discussions with the faculty of the George Washington University School of Law as well as presentations at the Patent Scholars Roundtable at Stanford Law School, the Patent Conference at the University of San Diego School of Law, the Health Law Professors Conference at Boston University School of Law, the IP and Innovation Researchers of Asia Conference at Waseda University, and the IP Workshop at the University of Michigan Law School. We are especially indebted to Erika Leitzan for her thoughtful and careful critique of an earlier draft of this Article.