Planning to Profit from Designer Babies. Now.
Two prominent groups of scientists, and two major American universities, are trying to patent methods for editing human embryos, with reproductive use clearly intended. Really. Right now.
Heritable genome editing – that is, altering the genes and traits of future children and generations – is prohibited in 70 countries and wildly controversial everywhere. But these people and institutions are laying the groundwork to capitalize on a future they apparently hope to make happen. This summary of what we currently know will be followed by further posts that address the issues in more detail.
One patenting effort is headed by Shoukhrat Mitalipov at Oregon Health & Science University (OHSU), the other by Dietrich Egli at Columbia University in New York. These are not little-known “rogues,” the status typically ascribed to He Jiankui, whose “CRISPR babies” project made him globally notorious and landed him in a Chinese jail. Egli and Mitalipov are prominent scientists, widely published in prestigious journals, who work at major universities.
It is quite possible that their patent applications will not be granted, for reasons briefly discussed below. But the plans for profit are already under way.
The Mitalipov/OHSU team filed for a U.S. patent on “Human Gene Correction” on April 20, 2018. It describes methods of using CRISPR-Cas9 gene editing technology “for correcting a mutant allele of a gene of interest in a primate cell. … The primate cell can be a one-cell embryo and/or a human cell.” An application was initially filed with the World Intellectual Property Organization (WIPO) and published there on October 25, 2018. WIPO does not grant patents but does evaluate applications, essentially to coordinate across jurisdictions. The application entered the US patent system on October 16, 2019 and was published on May 6, 2021
The Egli/Columbia team filed with WIPO on December 10, 2020, for a patent on “Gene Editing to Correct Aneuploidies and Frame Shift Mutations,” which was published on April 4, 2021. From the description:
Aneuploidies due to abnormal chromosome segregation in female meiosis are some of the most frequent problems in human reproduction, resulting in effects such as miscarriage and Down syndrome. … The correction of disease-causing mutations in human embryos could reduce the burden of inherited genetic disorders in the fetus and newborn and improve the efficiency of fertility treatments for couples with disease-causing mutations in lieu of embryo selection.
The clear implication is that the patented process is intended for the assisted reproduction industry and its customers, who would of course pay for the privilege of using it. And it is specifically targeted at Down syndrome, by far the most common condition caused by chromosomal variance – and thus the most lucrative prospective market for fertility entrepreneurs.
The Patent Applicants
Both these teams of scientists have been on our radar for a long time. They are clearly rivals: Egli has critiqued Mitalipov’s embryo editing work on technical grounds, and Mitalipov has rejected the criticism (see their exchange in Nature 1, 2). Both have been deeply involved in the derivation of human embryonic stem cells. Both also have reputations for pushing ethical envelopes. Mitalipov collaborated with Hwang Woo Suk, the disgraced Korean stem cell and cloning scientist, and then became a leading proponent of so-called “3-person IVF” — a controversial technique of nuclear transfer to avoid mitochondrial disease that the FDA would not allow. Egli was also working on mitochondrial replacement and froze embryos that in 2019 he said were “ready for transfer if a legal path could be found.”
Each application names two “inventors.” Mitalipov’s co-inventor is Nuria Marti-Gutierrez, who has worked in his lab since 2012. Egli’s is Nathan Treff, who is notorious for co-founding Genomic Prediction (now rebranded as a clinical laboratory) and Lifeview, which proposes using polygenic analysis of embryos to select those with certain traits, including chromosomal abnormalities, translocations and inversions, cystic fibrosis, thalassemia and Huntington’s disease, as well as “all known monogenic diseases” and a dozen polygenic disorders, including diabetes, coronary artery disease and schizophrenia. Genomic Prediction’s marketing used to include “intellectual disability” and “idiopathic short stature”; Lifeview’s does not, insisting that they “only provide risk scores for polygenic traits related to diseases, not for purely cosmetic traits such as hair color and eye color.” IQ is currently off the table, although Treff’s partner Stephen Hsu has been working on “improving” people’s IQ for a decade. Hsu was removed from his position at Michigan State in 2020 after complaints that he is “a vocal scientific racist and eugenicist.”
The Scientific Elites
In the scientific mainstream, the concept of editing the human germline is hotly debated, with many researchers skeptical or outright opposed. Even those who support it in principle – including most of those with the highest enthusiasm levels – agree that the time is not right, and not close. Several of the most significant groups of elite scientists have been considering this issue in depth:
- The U.S. National Academies and U.K. Royal Society published their latest report, Heritable Human Genome Editing, in September 2020, stating firmly that genome editing technology is not accurate enough to proceed, and that “extensive societal dialogue” is needed before even deciding whether to go ahead. However, the commission that produced the report was mandated to develop a “translational pathway [to] clinical uses” of heritable human genome editing – and it delivered on that directive.
- The International Society for Stem Cell Research (ISSCR), whose guidelines are influential beyond their specific field, has previously recommended prohibiting heritable human genetic modification. We await with interest their latest revision, due imminently, but it would be remarkable if their approach diverged significantly from that of the National Academies.
- The World Health Organization (WHO) is about to publish the Report of an Expert Advisory Committee set up in December 2018 to “examine the scientific, ethical, social and legal challenges associated with Human Genome editing.” Again, it would be quite a surprise if their conclusions gave heritable human genome editing a green light – though even a warning amber would contradict policies in 70 countries around the world.
Guidelines such as these, from scientific organizations and international bodies, do not nullify patent applications; and in most jurisdictions there is no automatic prohibition on patenting something used for an illegal or anti-social purpose. However, the European Patent Office is already prohibited from “patenting processes that could be used to modify human sperm, eggs or embryos.” The U.S. federal government does not at present fund such research; both the Egli and Mitalipov teams use private funds.
The U.S. Patent Office could in principle refuse the patent applications. It would be foolish, however, to rely on that possibility.