By Donald Zuhn —

Last 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."

In 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 now 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."