The Two Meanings of How and the Gene Patenting Debate

"How Can You Patent Genes," the title of Rebecca Eisenberg's (2002) paper, summarizes, I suspect unintentionally, the entire debate about gene patents. She says that in 15 years of giving talks on genetics and the law, "how can you patent DNA sequences?" is the most frequently and persistently asked question. There are two readings of this question, each corresponding to an entire family of claims in public-policy-oriented bioethics (which I will call "public bioethics").

Public bioethics has traditionally been split between those who ask what Jurgen Habermas has called "substantively rational" and "formally rational" questions (Evans 2002). A "substantively rational" question is about the ends or values we should pursue with means such as genetic science. A "formally rational" question assumes a particular end or value and seeks to determine the most efficacious means to achieve this end.

We are told that the audiences who raise the question expressed in Eisenberg's title are "widely varying." I suspect that if this includes laypersons, unschooled in bioethics or law, they ask the substantively rational question of "How can you patent genes?"—as in "how can you consider doing that, given what our values are?" Eisenberg assumes that they are asking the formally rational question, "how can you patent genes?" as in, "how do you best go about patenting genes, given the assumed goal of maximizing biomedical inventiveness?"

Ideally, we should not have a debate about the second question without a preceding, or at least concurrent, debate about the first question. That is, we should not debate what the most efficacious means are until we can answer: efficacious means toward what end? The first debate has not occurred. Eisenberg's paper, like many other analyses in public bioethics (Evans 2002), seems to have put the "cart" of patent law before the "horse" of our societal goals, although her analyses of how to design the best cart possible are insightful.

With this distinction in mind, we can revisit Eisenberg's central question: "what accounts for this persistent lack of clarity about how patent law applies" to genetic technology? Within the realm of designing a more efficacious means toward the end assumed by patent law, Professor Eisenberg's explanation seems sound. However, from the other interpretation of the title of her paper, and of the debate more generally, I suspect that what accounts for the lack of clarity is the public's unwillingness to accept the means of patent law because it promotes goals they disapprove of.

What are society's goals for genetics? First, there is probably consensus about one goal—promoting human health—which is clearly Eisenberg's goal. It is also obviously a worthy goal. However, if we don't consider what the other goals might be, we will never know whether the proposed means—a more fine-tuned patent system—will maximize all of our goals in genetic science. What goals does the public hold that are violated by the means of patent law as applied to genes?

One possibility is the goal of having the public retain a view of human beings as special compared to what are considered objects. This is the view expressed by religious leaders who opposed patenting in a statement in 1995—the only organized public debate on gene patenting of which I am aware (Evans 2001). I realize that many readers will give up at this point, not wanting to contemplate a concept so difficult to define and measure. But, I would argue that this is what the public is probably concerned about, and therefore it is up to us to figure out this concern and be guided by it.

Mark Hanson (2001) claims, and I agree, that the religious leaders were not concerned about the technical definition of ownership but rather about "the law's expressive power in relation to a...