Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags

Abstract

Although it is well accepted in United States law that genes are patentable, there is intense controversy over the patentability of the gene fragments known as expressed sequence tags (ESTs). There is division on this issue within and among the scientific community, the Patent and Trademark Office, and legal scholars. Professor Richard A. Epstein takes the position that ESTs belong in the public domain, whereas Professor Rebecca S. Eisenberg seems partly sympathetic to patenting ESTs in a 1996 article though less sympathetic in a 1998 article with Professor Michael A. Heller. In contrast, we try to provide the most sensible solution for intellectual property rights in expressed sequence tags, namely, a registration system that provides for three phases with different levels of exclusivity and protection. Phase One gives a registrant five years of exclusive protection, including the power to license work by others on its EST. Phase Two provides a registrant with inexclusive protection and the right to a governmentally determined royalty if others develop a commercial product within that time. Phase Three begins fifteen years after registration; the EST now enters the public domain and the former owner of the EST now receives no licensing fees or royalties. This position is superior to the no-patent position of Professor Epstein and the patent position of John J. Doll of the United States Patent and Trademark Office. We support this contention by a detailed examination of the law and economics of the patentability of genetic sequences. Our Article deals with property rights in genes and gene fragments in an integrated way on multiple levels. The levels, in ascending order of generality, are as follows. First is analysis, informed by the real-world practice of biotechnological research and product development, of the Patent Act and relevant decisions on patents pertaining to genetic material. Second is contact with and appraisal of the works of some of the most prominent scholars who have written on this topic. Third is philosophical discussion of the justifiability of property rights in the molecular building blocks of life. Only by integrating discussion from each of these levels is it possible to reach an adequately justified position on property rights in genes and gene fragments.

JEL Classification: O34