Bioethicists "Urge Maximal Transparency" in Response to 23andMe Patent

by McDonnell Boehnen Hulbert & Berghoff LLP

23andMeLast week, we discussed a patent, recently issued to 23andMe, Inc., that has created some controversy.  The patent, U.S. Patent No. 8,543,339, is directed to a system for identifying a preferred gamete donor from among the plurality of donors based on a phenotype of interest, the genotype of a recipient, and the genotypes of the donors.  According to the '339 patent, one embodiment of the invention is disclosed in Figure 4 (below), which shows "a user interface for making [a] user specification and displaying the results," in which "the recipient has specified that she prefers low risk of colorectal cancer and congenital heart defects equally, and to a lesser degree she also prefers green eye color."

2013-10-08 FIG4In the wake of the '339 patent's issuance, 23andMe has been criticized for its efforts to secure patent protection on a method of creating "designer babies."  A commentary regarding the "controversial patent" appeared in the journal Genetics in Medicine earlier this month (Sterckx et al., "I prefer a child with . . .": designer babies, another controversial patent in the arena of direct-to-consumer genomics," Genetics in Medicine (October 3, 2013)).  The article, authored in part by several bio- or medical ethicists and a patent attorney, notes that when "[t]aken out of 'patentese,' what 23andMe is claiming [in the '339 patent] is a method by which prospective donors of ova and/or sperm may be selected so as to increase the likelihood of producing a human baby with characteristics desired by the prospective parents."  The article focuses on two figures from the patent -- Figures 4 and 6 -- and particularly points to the alternative choices presented in Figure 4 (above) after the phrase "I prefer a child with:".

The article initially calls into question the U.S. examination process, noting that "at no stage during the examination of the patent application did the patent office Examiner question whether techniques for facilitating the 'design' of future human babies were appropriate subject matter for a patent."  However, the authors then acknowledge that "[i]t might be argued that this is not surprising [because] unlike the patent law operating across Europe (the European Patent Convention, or EPC), US patent law contains no explicit clause excluding from patent-eligibility inventions that contravene morality."  Then again, the authors suggest that "the utility requirement of US patent law includes a morality aspect which, admittedly, is very rarely applied by the US Patent and Trademark Office," and point out this aspect of the utility requirement was invoked when the Office rejected an application directed to human/animal chimeras that was filed by Stuart Newman and Jeremy Rifkin in 1997.

According to the authors, "it is clear that selecting children in ways such as those patented by 23andMe is hugely ethically controversial."  While the authors concede that "[t]he use of preimplantation genetic diagnosis to avoid implantation of embryos bearing serious genetic abnormalities is by Genetics in Medicinenow becoming commonplace," they argue that the use of "a computerized process for selecting gamete donors to achieve a baby with a 'phenotype of interest' that the prospective parent 'desires in his/her hypothetical offspring,' as 23andMe puts it, seems to have much broader implications."

The article concludes by stating that 23andMe's pursuit of the '339 patent, following the "uproar" that greeted the company's announcement in 2012 that it had been granted a patent on a test for determining the propensity to develop Parkinson disease, was "surprising."  In particular, the authors wonder why 23andMe, following its past experience, would have pursued the '339 patent "with no apparent public discussion."  Noting that "[p]ublic trust is central to the continuing success of human genetics research in general and biobank-based research in particular," the authors "urge maximal transparency by all engaged in human genetics research."


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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