The BRCA Gene Patents: Arguments Over Patentability and Social Utility

Abstract

Beginning in 2011, a series of contradictory U.S. court decisions cast doubt on the patentability of Myriad Genetics' BRCA1 and BRCA2, the primary genes responsible for breast and ovarian cancer. Similar legal and political opposition materialized within the European Union, Great Britain, Canada, and the rest of the modern world. Despite years of global debate, the long‐term public policy implications for the BRCA gene patents—and indeed all gene patents—remain unclear. This essay will examine the two primary argument forms that have been presented in the BRCA gene patent debate: “patentability arguments” and “social utility arguments.” Neither line of argument has yielded much in terms of national or international consensus. But both have generated increasingly complex, convoluted, and ultimately irreconcilable debate within and between nations. These endless cycles of legal, political, and scholarly debate cast serious doubt upon the long‐term sustainability of the patent institution as a “one‐size‐fits‐all” funding mechanism for genomic science, the genomic industry, and genomic medicine.