The American Journal of Bioethics

The concluding sentence in Rebecca Eisenberg's fine article, "How Can You Patent Genes" (2002), is as follows:

The patent system was designed to serve the needs of a bricks-and-mortar world, and it would be foolish to assume that it can meet the challenging needs of the information economy simply by expanding the categories of subject matter that are eligible for patent protection.

This is so eminently reasonable that without knowing anything about patent law, it seems intuitively correct that the system of patent law, even in its most modern iterations, has probably not kept pace with the information or with the genetics age. But what is not so intuitively apparent is what, if anything, should replace the patent system to protect the intellectual effort and the technical expertise that has been invested in discovering the microscopic ordering of base pairs of a natural phenomenon such as the human genome.

On the evening of 12 February 2001, the day when the completion of the human genome map and sequence was formally announced, Francis Collins, the Director of the National Center for Human Genome Research at the National Institutes of Health, gleefully sang "This gene is your gene, this gene is my gene" to the tune of the American patriotic song, "This Land Is Your Land." This was followed by renditions of "Gene Angel" and other modern ballads recast and rephrased to send the message that this genetic information belongs to us all and should be widely available to serve the public good. Maybe Collins has it right and there should be no patenting or privatizing mechanism in place to limit access to or generate royalties from the human genome map and sequence. But the current reality is that we appear to be half in and half out of the patenting system in these matters, and it will be difficult in every case to determine what legal course of action is reasonable, justifiable, and practical.

A clear pivot point or watershed moment in our recent history was the first patent of a biological entity in Diamond v. Chakrabarty (447 U.S. 303 [1980]); but this invention of an organism that could digest oil slicks, had a particular commercial value in and of itself. It could be put to work to accomplish a specific biological or chemical task. The map and sequence of the human genome is a biological given, the underpinning or hard wiring of our biological presence, but in and of itself it accomplishes nothing. It cannot be put to work or made to accomplish a task in the way that the Chakrabarty organism did. So the granting of this first "biological" patent offers little in the way of guidance for the gene patenting question at hand.

Why should anyone profit from the accumulation or use of genetic information, especially in its most generalizable or generic form? One possible reason is that a sizable investment was made to develop the information. But the results of scientific research, most particularly descriptive research, especially when supported with tax dollars, are not meant to pay off in kind, so to speak, with profit as a return on the investment. In addition, from a practical standpoint it is doubtful that attempts to privatize or limit access to this information will ever really succeed. Claims to own or to have patent rights to a portion of the genome or to the location of a specific gene may be successfully sustained in the short term, placing an unusually high cost on drug development in some cases; but eventually the effort to control this flood of information will be futile. The rewards of accruing profits based on patents will most likely go to those who develop innovations in proteomics developed from the genome map and sequence, not for a portion of the genome map...