Intellectual property rights in genes and gene fragments: a registration solution for expressed sequence tags.

Abstract

Out of the Human Genome Project and automated sequencing technology has arisen a controversy over the attempt to obtain patents on fragments of functional genes, known as expressed sequence tags (EST), and the genes themselves. In addition to legal and academic debate over the patent ability of expressed sequence tags, the issue of property rights in these gene fragments raises questions about economics and social policy. The article offers a solution to this debate by proposing a registration stem that, first, avoids the costs of patent prosecution and examination; second, has none of the adverse economic consequences of patenting expressed sequence tags; and, third, recognizes that expressed sequence tags have some value. The article summarizes the science, explains the controversy over ESTs, and outlines a trio of existing models for access to EST sequences. The article continues by analyzing issues of patent law in relation to ESTs and introduces property and economic issues. The article then proposes two possible solutions: limiting to ten the number of ESTs per patent application, as is currently the plan and policy of the PTO; and issuing short-term (ten-year) patents on ESTs alone. This leads to the author explaining, justifying, and defending a registration system that gives less robust property rights than the standard twenty-year patent. Finally, the author addresses some of the philosophical issues pertaining to property rights in genetic material.