By: Katherine Rubino

On October 2nd, 2019 oral arguments commenced at the Court of Appeals for the Federal Circuit (CAFC) in the case of 23andMe, Inc. v. DNA, LLC. This case centers around technology directed at ever popular DNA testing kits available for consumers to use at home in attempts to find long lost relatives.

This case commenced last year when 23andMe, Inc. (“23”) filed suit against DNA, LLC, et al (“Ancestry”) for patent infringement, unfair and deceptive advertising, and trademark infringement. Ancestry filed a motion to dismiss all claims, and on September 23rd, 2018, the U.S. District Court for the Northern District of California determined that 23’s patent entitled “Finding relatives in a database” (Patent 8,463,554) was directed at patent-ineligible concepts and as such was rendered invalid. The ‘554 patent is unique in that it contains a hybrid invention containing a novel biotechnology component and a novel software component.

23’s patent at issue (‘554), describes a three step process to determine the degree of relationship between two deoxyribonucleic acid samples. The patent describes a process where recombinable DNA of a first user is compared to recombinable DNA of a second user. The two DNA sequences are used to calculate a predicted degree of relationship between the first user and the second user, and if the degree of relationship meets a threshold value, the first user is notified about a relative relationship with the second user.

The ‘554 patent determines a degree of relationship between a first user and a second user  by locating “identical by descent” (IBD) regions of DNA, which have nearly identical genetic sequences. IBD regions form when genetic information has been inherited from a common ancestor without any intervening recombination. IBD regions function under the presumption that any given pair of individuals are related through many common ancestors, though many of these relationships are too distance to result in detectable IBD segments.

Ancestry argued that the ‘554 patent was directed at patent-ineligible concepts under 35 U.S.C. ⸹101 for being directed at a law of nature and for being directed towards an abstract idea. The District Court applied the two-part Alice test to determine if the ‘554 patent was directed to a law of nature. The Alice test was developed from Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014) and analyzes whether claims are directed towards patent-ineligible ideas such as laws of nature, abstract ideas, and natural phenomenon. Part one of the Alice test determines if a patent is directed to a patent-ineligible concept. If the answer to part one is no, then the claim is patent eligible. If the answer to part one of the Alice test is yes, then a claim is directed towards a patent-ineligible concept and part two of the Alice test must be analyzed. Part two of Alice determines whether a claim contains an “inventive concept” sufficient to transform a claimed abstract idea into a patent-eligible application. The court in Alice clarified the idea of an inventive concept by specifying that an abstract idea must include “additional features” that ensure that a claim is doing more than simply monopolizing an abstract idea.

In regards to the first argument regarding a law of nature, the District Court found that under part one of the Alice test, the ‘544 patent was directed towards a patent-ineligible concept because the claims in the ‘544 patent were directed towards a law of nature, specifically people who share similar DNA sequences are related. Under part two of the Alice test, the District Court found that the ‘544 patent did not have enough of an inventive concept to distinguish it from purely natural phenomenon.  The District Court found that there were not enough improvements or alterations to pass part two of the Alice test.

With reference to Ancestry’s second argument relating to an abstract idea, the District Court analyzed the software component of 23’s invention. The District Court found that even though 23 was using computerized calculations, the claims more closely reflected biomedical technology, and therefore analyzing the claims as an abstract idea was inappropriate. Instead, the claims had to be analyzed as being directed to a law of nature, and as such were invalid.

Earlier this year, 23 appealed the decision from the District Court to the CAFC, whereby oral arguments commenced last week. This case is monumental in that for the first time, the CAFC will address how ⸹101 is to be applied to mixed hybrid inventions. This is a very common feature in the medtech space, as many novel inventions contain both a device component and a software component. Inventors active in this space should take note, as the CAFC may provide guidance as to how lower courts may interpret claims directed at such hybrid inventions. For now we must continue to wait, as a  decision is anticipated to be issued in early spring next year.