Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists\u27 ability to continue and expand research into the human genome to improve patients\u27 access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass\u27n for Molecular Pathology v. U.S. Patent & Trademark Office. Both sides have legitimate concerns. Given the unique nature of DNA, patents that broadly cover genetic materials and prevent their use (except by the license of the patentee) create insurmountable roadblocks for future research. However, denying exclusive rights to the fruits of laborious and costly research will remove the necessary incentives for investment in these endeavors, thus delaying scientific and medical discoveries. To remedy these problems, this Article proposes a non-patent exclusivity system administered by the Food and Drug Administration. Under such a system, the innovators who bring new therapeutic or diagnostic products to market would receive exclusive rights to market their products for a limited time. This regime would provide sufficient market-based incentives to continue with the research and investment in this area. At the same time, because genetic sequences would no longer be broadly protected by patents, the public would be able to access these basic research tools without fear of infringement litigation. This approach addresses the concerns of both sides to the debate and leads to a cheaper, more predictable, and easier to administer system of exclusive rights