Patent Infringement in the Context of Follow-on Biologics

This article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk to develop the product. I look at types of strategies industry is likely to use to avoid infringement and how courts are likely to respond to these strategies. I focus predominantly on the doctrine of equivalents, both because it will be particularly important in suits concerning follow-on biologics (it is nearly impossible to make a follow-on biologic identical to the reference drug) and because it represents the outer limits of the scope of a patent, and thus the most difficult cases. The article is important for courts who must create a coherent body of law where no precedent yet exists, for industry members trying to predict how their products will be received and for policy makers who seek to understand the nature of infringement suits and shape this body of law in a direction that makes sense for all parties involved. * Associate, Covington & Burling, LLP, Washington, D.C. This paper contains my views only and does not reflect the views of Covington & Burling or any of its clients. I am a John M. Olin Fellow in Law and Economics at Harvard Law School and I acknowledge support from the School’s John M. Olin Center for Law, Economics and Business. The article won the Irving Oberman Memorial Prize for Intellectual Property. For their edits and advice, I thank Julie Cohen, Rochelle Cooper Dreyfuss, Robin Feldman, Peter Barton Hutt, Bryan Laulicht, Benjamin Roin, Steven Shavell, Robert Sitkoff and Henry Smith. 2 Patent Infringement in the Context of Follow-on Biologics Table of