Rebecca S. Eisenberg
University of Michigan Law School, Ann Arbor, MI 48109
Intellectual property issues have been uncommonly salient in the recent history of advances in genomics. Beginning with the filing of patent applications by NIH on the first batch of expressed sequence tags (ESTs) from the laboratory of Dr. Craig Venter, each new development has been met with speculation about its strategic significance from an intellectual property perspective. Are ESTs of unknown function patentable, or is further work necessary before they satisfy patent law standards? Will patents on such fragments promote commercial investment in product development, or will they interfere with scientific communication and collaboration and retard the overall research effort? Without patent rights, how may the owners of private cDNA sequence databases earn a return on their investment while still permitting other investigators to obtain access to the information on reasonable terms? What are the rights of those who contribute resources such as cDNA libraries that are used to create the databases, and of those who identify sequences of interest out of the morass of information in the databases by formulating appropriate queries? Will the disclosure of ESTs in the public domain preclude patenting of subsequently characterized full-length genes and gene products? And why would a commercial firm invest its own resources in generating an EST database for the public domain?
Two factors have contributed to the fascination with intellectual property in this setting. First is a perception that some pioneers in genomics have sought to claim intellectual property rights that reach beyond their actual achievements to cover future discoveries yet to be made by others. For example, the controversial NIH patent applications claimed rights not only in the ESTs that were actually set forth in the specifications, but also in the full-length cDNAs that might be obtained by using the ESTs as probes, as well as in other, undisclosed fragments of those genes. More recently, private owners of cDNA sequence databases have set as a condition for access agreement to offer the database owners licenses to any resulting intellectual property. These efforts to claim rights to the future discoveries of others raise issues about the fairness and efficiency of the law in allocating rewards and incentives along the path of cumulative innovation.
Second is the counterintuitive alignment of interests in the debate. It was a public institution, NIH, that initially favored patenting discoveries that some representatives of industry thought should remain unpatented, and it was a major pharmaceutical firm, Merck & Co., that ultimately took upon itself the quasi-governmental function of sponsoring a university-based effort to place comparable information in the public domain. These topsyturvy positions in the public and private sectors raise intriguing questions about the proper roles of government and industry in genomics research, and about who stands to benefit (and who stands to lose) from the private appropriation of genomic information.
Supported by a grant from the Director, Office of Energy Research, Office of Health and Environmental Research of the U.S. Department of Energy under contract DE-FG02-94ER61792.
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