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It’s All Relative: Federal Circuit Upholds Invalidity of 23andMe’s Genetic Ancestry Testing Patent For Claiming a Rule of Nature

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23andMe, Inc. v. DNA, LLC et al., Appeal No. 2019-1222 (Fed. Cir. Jan. 9, 2020)

The Federal Circuit has denied a petition for rehearing en banc brought by 23andMe, leaving in place the court’s earlier ruling on October 4, 2019, that the company’s patent, which describes a method for identifying the degree of relationship between two individuals based on their DNA samples, was invalid for claiming a rule of nature.

23andMe’s patent, U.S. Patent No. 8,463,554 (“Finding relatives in a database”), covers a method of comparing two individuals’ recombinable DNA sequence information—rather than the whole genome—in order to determine a relative relationship. According to 23andMe, the ‘554 patent explains that only relatives will share long stretches of genome regions where their recombinable DNA is completely or nearly identical. 23andMe sued Ancestry in the U.S. District Court for the Northern District of California, alleging that it was infringing the ‘554 patent with its AncestryDNA kits, which feature services to identify relatives who share parts of their DNA.

Ancestry moved to dismiss 23andMe’s claim for patent infringement, arguing that that the ‘554 patent is directed to unpatentable subject matter under the U.S. Supreme Court’s Alice and Mayo decisions. According to Ancestry, the ‘554 patent “claims an abstract idea (determining a relative relationship by comparing similarities between DNA), and a law of nature (people who share similar DNA are related),” making it subject-matter ineligible under § 101.

Judge Edward Chen granted Ancestry’s request to dismiss the patent infringement claim. The district court explained that “[t]he ‘554 patent claims at issue are ‘directed to’ a law of nature because the focus of the claims is a correlation that exists in nature—i.e., the more recombinable DNA information that is shared between two people, the closer the degree of relationship.” The court rejected 23andMe’s argument that the focus of the claims is not a law of nature but rather “a new and useful way to identify a relative and the degree of relative relatedness, based on a specific selection and characterization of recombinable DNA.” According to the court, 23andMe was essentially arguing that its invention was a new and useful way of detecting a relative relationship based on DNA patterns which occur in nature, and where a claim’s focus is detecting a law of nature or natural phenomenon, that meets the “directed to” standard at Alice step one. The district court further held that the claims at issue do not contain an inventive concept under Alice step two. The court rejected 23andMe’s argument that the claims disclose a new and useful technique for detecting a relative relationship, explaining that “ultimately the only means of detecting a relative relationship is comparing the recombinable DNA information,” and “an instruction to undertake a simple comparison step does not represent an unconventional, inventive application sufficient to make [a] claim patent-eligible.”

On appeal, Circuit Judges Prost, Wallach, and Hughes summarily affirmed the district court’s ruling. 23andMe petitioned for rehearing by the full court, contending that “[i]f permitted to stand, the panel’s affirmance of the district court’s invalidation of 23andMe’s dependent Claim 12 may well serve as a death knell for the patent eligibility of DNA based method claims that employ unconventional and new techniques.” The petition was denied on January 9, 2020. Thus, the district court’s invalidity ruling currently stands.

Implications for Patent Law Litigation

Though the Federal Circuit’s affirmance of the district court decision pursuant to Federal Circuit Rule 36 is not precedential, it is important to thoroughly consider the issue of patent eligibility of DNA based method claims both during patent prosecution and in developing patent infringement litigation strategies.