On October 2nd, the Court of Appeals for the Federal Circuit (CAFC) will hear arguments in the 23andMe v. Ancestry.com dispute regarding whether 23andMe’s patent claims, which are directed to hybrid technologies, are eligible for patenting (i.e., directed to statutory subject matter) under 35 U.S.C. § 101. The outcome of that case could have far reaching implications for patenting hybrid technologies, such as digital-health innovations which is a rapidly expanding area of technology.
To help explain why this is so significant a short primer on section 101 is helpful. In the United States inventors can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Although this initial threshold is relatively easy to overcome, courts have added hurdles to obtaining a patent. These include a bar against obtaining patents on (1) laws of nature or (2) abstract ideas, among others. At the same time, courts have struggled to articulate tests for these limits.
Courts have typically applied the “law of nature” analysis to patents related to biomedical technologies, while applying the “abstract idea” analysis for patents directed to software or computer-based technologies. Despite the convergence of electrical and biomedical innovations, courts have not typically analysed the eligibility of patents covering inventions with a foot in both worlds.
As described in the patent, 23andMe’s technology is premised on the recognition that because recombinable DNA includes mutations that occur from generation to generation such that only relatives will share long stretches of recombinable DNA that is identical or nearly identical, the existence of those stretches of DNA can identify related individuals. The patent refers to these stretches as “Identical By Descent” or “IBD” regions. The patented technology includes sequencing the entire genome of an individual to determine IBD regions or, in some cases, identifying certain markers that tend to vary in different individuals as the basis of the IBD regions. 23andMe’s patented process makes use of computerised computations to determine a predicted degree of relationship between individuals based on the IBD regions
At the district court, Ancestry.com argued both that the 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).” Ancestry.com, therefore, challenged both the software component, the determination of a relative relationship, and the biological component, the nature of shared recombinable DNA sequences, of the technology.
The court analysed previous rulings in each of these relatively independent areas of analysis. First, the court examined cases related to laws of nature finding that these cases generally hold that inventions that cover naturally occurring phenomena or simple observations of natural phenomena are not eligible for patent protection. Second, the court considered cases involving patents alleged to be directed to abstract ideas. These cases focused on determinations that patents were not covering an abstract idea itself, but rather new and novel ways of using the abstract idea to achieve some other result. The court admitted that the 23andMe patent could stand or fall based on which line of cases were most applicable to the technology.
Despite the use of computerised computations, the court determined that the claims more closely resembled biomedical technology, thereby evaluating whether the claims were directed to a law of nature. Under that evaluation, the court ultimately invalidated the patent.
On appeal, the Federal Circuit will, for the first time, address how current law on patent subject matter eligibility applies to hybrid technologies. The parties have asked the CAFC to consider whether the district court’s analysis was correct. In written arguments, 23andMe relies on both the law of nature and abstract idea precedent in arguing that its claims are eligible for a patent. Ancestry.com, in its written arguments, reiterated its position that the patent should be invalidated as either a law of nature or an abstract idea. As a result, the Federal Circuit may take this opportunity to revisit the district court’s analysis and provide guidance on addressing technologies that simultaneously invoke previously separate lines of analysis.
The lower court’s ruling can provide some instructive clues for drafting claims covering hybrid inventions. Companies may be inclined to draft claims in a way that squarely positions hybrid technologies as either electrical or biomedical technology depending on which line of cases provides better support securing a patent.
But those seeking patents on hybrid technologies should be aware that the Federal Circuit could provide important guidance on how lower courts will analyse those patent claims. The guidance from the district court may not survive the CAFC’s scrutiny. Additionally, the Federal Circuit may provide new tests or methods for analysing these types of patents. The oral argument, scheduled for this week, could provide insight into how the Federal Circuit might ultimately decide and how companies developing hybrid technologies should protect their innovations.