Waiting on Science: The Stake of Present and Future Patients

Many high-profile stakeholders are engaged in debates about patenting genes, gene sequences, gene fragments, gene products, and methods of manipulating genes: industry representatives who argue that biotechnology as we know it will grind rather than leap unless adequate intellectual property protections are in place; researchers, academic or not, who may or may not have a financial interest in their "invention"; and the public, at least for the portion of genetics research that is supported by federal funding. Some stakeholders have even attended to the investment of particular patient groups whose participation in research provides the fertile ground for the development of the "novel" product (Merz, Magnus et al. 2002, 968-70). The one group that has demanded and yet received little attention as a stakeholder in the debate is, in fact, all of us. Not "all" in the public sense but in the very personal sense. In the sense that most everyone, at some point, will develop a condition that with scientific progress is likely to be ameliorated by the application of genetic technology. We will all be patients soon enough, if we are not already, and it is by this identity that we should discern how we would want gene patenting to proceed. In this sense, genes may not be different because they represent something intrinsic to the human form, but because their proper investigation is intrinsic to the very betterment of the human form.

Rebecca Eisenberg notes that "as an empirical matter" limits on intellectual property protection are unlikely to threaten motivations for and investment in DNA sequencing and related genetics research. But as she astutely points out, depending upon the gauntlet of intellectual property protection, access to sequence information may be stemmed in calculated ways. It is this barrier to innovation that concerns me, on behalf of those would-be patients. It is not only about whether, with license upon license, the tests will be accessible to patients in the economic sense or will price some out of access to treatment (Brody 1996, 7). But with restrictions on research access deriving from ample patent protections, will we even know what scientific breakthroughs we are missing due to scientists forgoing investigations because of a lack of available informational tools (Heller and Eisenberg 1998, 698)? Eisenberg suggests the extreme position: "If the issuance of the patents does not leave the public free to perceive and analyze the information disclosed in patent specifications, the public might be better off withholding patents and allowing others to derive the same information independently." A recent account of the struggle behind hemochromatosis testing actually offers support for the contention that while patents may not even be necessary for rapid test development, adoption of testing is crippled by the existence of patents (Merz, Kriss et al. 2002, 579).

Those investigating the prevalence of secrecy in genetics research note that "The rate of progress in realizing [the genome project's] medical benefits may depend somewhat on the extent to which the results of genetic investigations flow freely among scientists in the field" (Campbell et al. 2002, 474). However, evidence that those performing genetics research are disproportionately inclined to withhold their research information is mounting. In studies by Blumenthal et al. (1997, 1227), 14% of genetics researchers reported refusing other faculty access to research results, compared to 6% among other life- sciences researchers. Fully a fifth of geneticists say that they abandoned a promising line of research for lack of access to colleagues' information. The fact that most of this data reflects researchers' practices prior to issuance of a patent does not mitigate concern that limiting access to genome findings may be an endemic policy in the industry and in the field. The overwhelming sentiment is that data withholding is slowing the rate of genetic progress (73%) (Campbell et al. 2002, 478). The trend is likely driven by the fact that so...