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The various research efforts that comprise the Human Genome Project will inevitably both draw on and yield a multitude of patentable inventions. The broad subject matter of the patent laws potentially reaches every phase of the Genome Project, from the discovery of new research technologies, such as techniques and equipment for DNA sequencing, through the ultimate development of new products, such as screening tests for genetically transmitted diseases. Even bits and pieces of the human genome itself may be, and sometimes have been, patented.' Nor does the fact that the public is paying for the Genome Project through federal funding mean that the public may freely enjoy the fruits of that research. Quite the contrary, existing law not only permits, but affirmatively encourages, patenting and private commercial exploitation of inventions made in the course of the Genome Project.

Nonetheless, the prospect of private ownership of knowledge emanating from the Genome Project has provoked controversy. The National Research Council Committee on Mapping and Sequencing the Human Genome concluded in its 1988 study that "human genome sequences should be a public trust" not subject to the intellectual property laws,2 while the Office of Technology Assessment's 1988 report on the Genome Project suggested that federal agencies and Congress should instead promote early filing of patent applications followed by prompt release of data. 3 By early 1992, the controversy had focused on the filing by the National Institutes of Health (NIH) of patent applications on some 2,375 partial cDNA sequences identified in its laboratories, along with the as-yet unidentified full genes and gene products to which they correspond.

Given the magnitude of resources invested in the Human Genome Project in both the public and private sectors and the tremendous potential benefits to be reaped from this research, the role of the patent laws in this area deserves careful thought. Ideally, patent law should promote the progress of researc and product development and the dissemination of research results. This chapter clarifies some of the implications of patent law for the Genome Project, with a view to identifying problems that might interfere with the smooth operation of the patent system in this context.


Reproduced by permission of Oxford University Press.