LEAVING ROOM FOR RESEARCH: THE HISTORICAL TREATMENT OF THE COMMON LAW RESEARCH EXEMPTION IN CONGRESS AND THE COURTS, AND ITS RELATIONSHIP TO BIOTECH LAW AND POLICY

Abstract

The recent suit over the validity of gene patents between the American Civil Liberties Union and Myriad Genetics has highlighted the troubling ways in which patents may be interfering with the willingness of scientists and companies to engage in basic biotechnology research on matters of vital importance to human health and disease. Many scholars have argued for a legislative research exemption to protect this sort of research. Theoretically, the common law already contains an exemption to protect certain uses of a patented product from being deemed patent infringement. This Article evaluates the history of the common law research exemption alongside the history of biotechnology policymaking since the 1970s, identifying how confusion over the scope of the judicial research exemption may have led to legislative stagnation on the issue of protecting research. Even during the infancy of biotechnology, members of Congress believed in the existence of a robust research exemption when making policy decisions about whether to create a legislative exemption. Now that the scope of the research exemption has been narrowed significantly by recent Federal Circuit decisions, at a time when the intellectual property regime permits patents on human building blocks as basic as genes, this Article highlights the need for a clear exemption. It also overviews and comments on existing policy solutions scholars have offered to counteract the chilling effect that the lack of a clear exemption might be having on basic research, including research in the biotechnology sector.