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

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."

Comments

[Skeptical]

http://www.uspto.gov/aia_implementation/human-organism-memo.pdf

Does not apply? What does "directed to" mean? It cannot mean the same as "encompass."

[Paulanne Chelf]

My recollection is that, after initially opining that they would not grant claims to "monsters", a subsequent statement from the USPTO in the Newman/Rifkin application backtracked, and said the Office would examine the application on the merits, as with all applications. It seems likely that the Examiner's supervisor pointed out the lack of a moral ground for rejection in US patent law...

[Mollie Roth]

Is this issue of ethics not merely one of degree, and one that we have been slowly and inexorably moving toward from the very first test tube baby? Prospective parents do not walk into donor offices and simply take what is available nor are donated sperm and/or ova assigned on a random basis. Prospective parents already have access to significant amounts of information about the donors - age, education, height, hair and eye color and on and on - from which they make a decision about which is best to "design" their baby. Based on basic Mendelian genetics, these parents are placing bets on their ability to achieve the child they want, at least with regard to the simpler phenotypic issues of inheritance. By incorporating genetics into the review process, they are only increasing their positive odds.

[Skeptical]

One of degree?

If a certain German dictator had not included in his designs for a master race the genocide of the 'less desirable,' would his Aryan aim be any more palatable?

Does 'degree' even matter when it comes to the patent world? Where does 'degree' come into the phrase "directed to?'

Mollie, there is a difference between what scientists may attempt and what the patent world condones. Patent law is not meant to proscribe what a scientist may attempt to do - it just will not reward all scientific efforts. The issue of ethics is not one of degree in the patent world.

After all, what attempt to legislate morality has ever worked in the history of mankind? Just as we have always had laws, we have had criminals who break those laws.

Human nature, being what it is...

[Skeptical]

A glowing review of the founder of 23andMe Anne Wojcicki is featured in the magazine FastCompany.

Without (necessarily) casting aspersions, my admittedly cynical mind picked up on a number of tidbits: 1%'er, deep money connections to Russia, embedded with Big Data, and China housing the data store...

Am I one to blindly give my trust (and my code) away? Color me...