With this post the GLR introduces a new Contributing Writer, Jonathan Webber. Jonathan is a web editor at Robinson, Bradshaw & Hinson, the law firm that sponsors the GLR. His duties include copy-editing the GLR. That exposure, together with his background in anthropology—he came to RBH with a degree in anthropology and experience as both a field archaeologist and cultural educator for a state park system—has sparked his interest in some of the cultural and ethical issues that genomics raises. In this first post he brings his perspective to bear on the implications of 23andMe’s “designer babies” patent, and we look forward to more of his insight in the future.
By the way, some readers may detect a growing anthropological conspiracy: I’m an anthropologist, as is Contributing Editor Jen Wagner, and now Jonathan. Yes, we’re taking over.
The September 24, 2013 grant of a patent to 23andMe for “gamete donor selection based on genetic calculations” has stirred another round of controversy about “designer babies.” Predictably, the press and blogosphere lit up with condemnations of both 23andMe and the United States Patent and Trademark Office. Karen Kaplan of the Los Angeles Times writes that the patent itself is “even more repulsive than the idea of using DNA tests to help people create designer babies.” Dov Fox of the University of San Diego School of Law suggests that “Congress should consider amending the patent law to appoint ‘ethics representatives’ to the PTO.” Sigrid Sterckx, et al., writing in Genetics in Medicine, note that the PTO did not “question whether techniques for facilitating the ‘design’ of future human babies were appropriate subject matter for a patent.”
So, while some ire has been and will be directed at 23andMe itself, commentators are also raising larger questions about patent eligibility and the patent application process.
We should note that the original provisional patent application was filed in late 2008. In the patent, 23andMe suggests that the process could be applied in both therapeutic fertility medicine and non-therapeutic donor selection (sex, skin tone, eye color, athleticism). Describing such a clinical use in the patent, 23andMe says:
In some embodiments, the recipient is allowed to make a specification of one or more phenotypes of interest in the hypothetical offspring. Statistical information pertaining to the likelihood of observing phenotypes of interest are determined, based on the genotype of the recipient and the genotypes of different donors. For example, probabilities of the phenotypes of interest in the hypothetical offspring resulting from different recipient-donor combinations are computed. Based on the statistical information, one or more preferred donors are identified and optionally selected by the recipient. In some embodiments, the recipient is allowed to make further inquiries about additional phenotypes in the hypothetical offspring with a particular selected donor.
Between the time of the filing and the present, some fertility clinics advertising donor selection services for non-therapeutic purposes (despite the fact that the scientific community doubted at the time that any guarantees could be made that such services would be solely non-therapeutic) found themselves on the PR defensive and backed off on such services for the time being. Through its blog, 23andMe states that it has no plans to implement its patent in this manner:
At the time 23andMe filed the patent, there was consideration that the technology could have potential applications for fertility clinics so language specific to the fertility treatment process was included in the patent. But much has evolved in that time, including 23andMe’s strategic focus. The company never pursued the concepts discussed in the patent beyond our Family Traits Inheritance Calculator, nor do we have any plans to do so.
Until the 23andMe patent, the donor selection process had been little more than a rough effort to control the workings of chance. For example, sperm banks keep profiles of donors in order for recipients to “find a good match,” but there is not a lot of certainty that the resulting child will carry the stellar traits advertised. This patent represents a sort of breakthrough in the science and a new frontier in patentability. The patent office said, in effect, “We think this is patentable subject matter and that the invention is both novel and nonobvious—and therefore we have no basis to deny the patent.”
Never content with Nature’s provisions, our species is a tinkerer. This is not new; we have tinkered since we deemed our bare hands insufficient and broke rocks to make tools. We picked up the pace when we replaced hunting and gathering with husbandry and harvesting. We did quite well on that front for the, roughly, ten millennia before genetic science unlocked the secrets of life in the genome.
This drive for mastery over nature is the drive to impose human-conceived order on the perceived chaos of nature—to reduce the role of chance. So, to wrest control from capricious luck, we molded the land to our purposes. We adapted to every environment on Earth, and if we did not find it to our liking, we altered it. But more than that, we created identities as peoples. We created rules, rituals and regulations to impose yet more order over what we perceived as the chaotic forces of nature at work on our domestic(ated) communities. Our contemporary moral and legal systems are the result of these efforts to date. Our scientific achievements are the result of our efforts to understand it all.
And so we stand today at the point where some degree of mastery over the genetic future of the human species seems to be a possibility. That’s a pretty heady notion. Those who find repulsive the idea of manipulating the genes of a zygote for non-therapeutic purposes are probably on the right track in pursuing greater government regulation of genetic science’s applications to donor selection. The technology is inevitable, and in an unregulated environment, it is up to the patent-holder to decide whether to exploit the patent commercially or not. If they are not “preventive patent-holders” — that is, sitting on patents with the express intention of preventing the use of the patented technology — whether they choose to exploit the patent will depend on the costs and benefits. Would media and public condemnation be enough to stop a company from providing a service for which there is an express market demand?
At Inventing Patents, Andrew Chadeayne asks:
[W]hat is going to happen with the patented technology? Despite issuing a press release stating that the company would never enter the designer baby market itself, the company did not say anything about licensing or selling the technology to another entity. I suspect that the market for designing a healthy baby with desired physical attributes could be quite lucrative. 23andMe says that they “want to be very clear about our technology and intentions.” In particular, aside from spending 6 years drafting and prosecuting a US Patent application, they have “never pursued” the designer baby market, “nor do [they] have any plans to do so….”
Do those statements include selling or licensing the technology to other companies?
There are a significant number of prospective parents who want to do more than just roll the dice on their offspring. Surely it is inevitable that some will want to avail themselves of such services. In one survey, nearly thirteen percent of respondents indicated that, if such a service were available, they would genetically select for children with high intelligence; ten percent would select for athletic prowess
A recent New York Magazine article asked whether ethical parenting is possible in New York City. With the pressure to compete for spaces in kindergartens and prep schools, parents spend small fortunes on test preparation and give their children drugs off-label on test days. In a 2009 poll by the Josephson Institute of Ethics, a majority of young persons aged 17 and under said that it was necessary to cheat or break the rules to get ahead in society, so the pressure is apparently producing an ethos of “by any means necessary.”
The new eugenics seeks to make reproductive decision-making an individualistic enterprise in two senses: first genetic choices are made by individual families rather than by groups of state officials or relevant experts; second, they are made for individual offspring rather than for inclusive gene pools. [Emphasis in original]
Freed from the coercive power of the state and its excesses, proponents of free-market eugenics such as Ronald Dworkin and Gregory Stock ask, why object to the voluntary improvement of our offspring? (Voluntary, that is, on the part of the parents, not the children, but then, what choice do the children ever have?) Genomics pioneer (and the “Caligula of biology”) James Watson has argued that “stupidity” is a disability worth eliminating from society through human genomic science. How different is this from hiring high-dollar private SAT tutors and athletic coaches? If there is a market for designer babies, they ask, should it not be the parents’ choice?
Millennial American culture has seen both a rise in the ideology of meritocracy and a decline in social mobility. If a market exists for designer babies, this market is likely to be affluent. Poor people need not apply. In the contemporary cultural and economic climate, the government is unlikely to subsidize access to voluntary genomic selection for poor people any time soon. This raises the troubling issue of a genetic caste system.
So we have those who are willing to pay for designer babies and a company that has a patented process that has the potential to provide them. Holding them at bay (for the moment) are public opinion and the choice of a patent-holder to refrain from offering its process to consumers. Will this be enough to hold a potentially high-ticket designer baby market off for much longer? If legislation attempts to prohibit such a market, will such services be offered abroad? Or could it be available on the black market, like off-label medications for use on test day?
Humans have undergone an epic, epochal, journey to arrive in this place today. The decisions we make now about who we are, who we want to be, and what role luck should have in the whole process for different people will affect—perhaps even determine—who we will be in ten millennia.
But, as we stand on the brink of genetic self-determination, we find ourselves deeply divided along ideological and tribal lines, and the accompanying value systems are implicated in these choices. Each tribe will have its own values and traits it considers desirable. Imagine the genetic legacy of a particular era’s ideals of beauty or of physical and mental prowess. Our species would no longer reflect the random mutations of nature and adaptations to environment. Where our species in concerned, the two fundamental principles of our evolution—natural selection and random mutation—would be thwarted. We would become expressions of ideals. Some might say this has always been, as we choose mates and reproduce within or outside our respective groups. But now ‘ideal’ children—in the literal sense, designed and ordered based on the parents’ personal ideals of beauty and success—may possibly be created without regard to their parents’ genetic heritage.
We must ask the questions: for whom and for what does this technology exist? And what are the long-term consequences for our future as a species? Surely, the application of genomic science to donor selection for non-therapeutic purposes is inevitable. The potential market and the know-how are both there. If decisions about the limitations of reproductive technology are not made by law, they will be made by the market. How we will handle it is anyone’s guess. All I know is that I wish I could live to see us in ten thousand years. If there were a genetic enhancement to make that possible, say, a technology for editing the genes of living humans, I might just be in the market.