23andMe Patent Creates Controversy

by McDonnell Boehnen Hulbert & Berghoff LLP
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23andMeA patent issued to 23andMe, Inc. last month has created some controversy, and in response, the biotech company, based in Mountain View, California, has posted its side of the story on the 23andMe blog.  The patent, U.S. Patent No. 8,543,339, which is entitled "Gamete donor selection based on genetic calculations," 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.  The patent contains three independent claims, which recite a system, method, and non-transitory computer program product for gamete donor selection:

1.  A system for gamete donor selection comprising:
one or more processors configured to:
    receive a specification including a phenotype of interest that can be present in a hypothetical offspring;
    receive a genotype of a recipient and a plurality of genotypes of a respective plurality of donors;
determine statistical information including probabilities of observing the phenotype of interest resulting from different combinations of the genotype of the recipient and genotypes of the plurality of donors; and
    identify a preferred donor among the plurality of donors, based at least in part on an evaluation of the statistical information determined, including:
        to compare the probabilities of observing the phenotype of interest resulting from different combinations of the genotype of the recipient and the genotypes of the plurality of donors to identify the preferred donor; and
a memory coupled to the processor, configured to provide the processor with instructions.

11.  A method for gamete donor selection, comprising:
    receiving a specification including a phenotype of interest that can be present in a hypothetical offspring;
    receiving a genotype of a recipient and a plurality of genotypes of a respective plurality of donors;
    using one or more computer processors coupled to one or more memories configured to provide the one or more computer processors with instructions to determine statistical information including probabilities of observing the phenotype of interest resulting from different combinations of the genotype of the recipient and genotypes of the plurality of donors; and
identifying a preferred donor among the plurality of donors, based at least in part on the statistical information determined, including:
        comparing the probabilities of observing the phenotype of interest resulting from different combinations of the genotype of the recipient and the genotypes of the plurality of donors to identify the preferred donor.

21.  A non-transitory computer program product for gamete donor selection, the computer program product being embodied in a computer readable storage medium and comprising computer instructions for:
    receiving a specification including a phenotype of interest that can be present in a hypothetical offspring;
    receiving a genotype of a recipient and a plurality of genotypes of a respective plurality of donors;
    determining statistical information including probabilities of observing the phenotype of interest resulting from different combinations of the genotype of the recipient and genotypes of the plurality of donors; and
    identifying a preferred donor among the plurality of donors, based at least in part on an evaluation of the statistical information determined, including:
        comparing the probabilities of observing the phenotype of interest resulting from different combinations of the genotype of the recipient and the genotypes of the plurality of donors to identify the preferred donor.

The detailed description of the '339 patent states that:

The gamete donors and gamete recipient's genetic information such as genome sequences and/or marker information is obtained and stored.  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.

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."  The '339 patent discloses that based on the user specification, a donor selection process is performed, and "the results page shows preferred donors A, B, and C, [wherein] the statistical distributions of the desired genotypes of the hypothetical child resulting from the combinations of the recipient and the donor, as well as an optional score calculated based on the statistical distribution are displayed."

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 last week (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)).

Possibly anticipating a backlash (the Genetics in Medicine commentary was submitted for publication two weeks before the '339 patent issued), 23andMe posted an article on its blog one week after the patent issued.  The article, entitled "A 23andMe Patent," notes that the company had "applied [for the patent] more than five years ago," and that the patent relates to one of the tools 23andMe offers to individuals "as part of their genetic exploration."  The article points out that:

The tool -- Family Traits Inheritance Calculator -- offers an engaging way for you and your partner to see what kind of traits your child might inherit from you.  The Family Trait Inheritance Calculator has also been part of our service since 2009 and is used by our customers as a fun way to look at such things as what eye color their child might have or if their child will be able to perceive bitter taste or be lactose intolerant.

The article indicates that "[w]hen 23andMe applied for the patent (#8543339) it was meant to cover the technology that supports our Family Traits Inheritance Calculator," but acknowledges that "the language of the patent extends beyond the calculator and so we want to be very clear about our technology and our intentions."  In particular, the article explains that:

At the time 23andMe filed the ['339] 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.


The Genetics in Medicine commentary will be discussed in a subsequent post.

 

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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