Patent Infringement in the Context of Follow-On Biologics

Abstract

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. This Article looks at types of strategies industry is likely to use to avoid infringement and how courts are likely to respond to these strategies. This Article focuses 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 that 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.