The Federal Circuit recently held that a claim of U.S. Patent No. 5,612,179, reciting “methods of detecting genetic variations” was directed to unpatentable subject matter under 35 U.S.C. § 101. Genetic Technologies Ltd. V. Merial, LLC, Nos. 2015-1202, 2015-1203 (Fed. Cir. April 8, 2016). Anytime the Federal Circuit weighs in on Section 101 patent-eligibility, those of us in the patent bar scramble to comprehend the potential impact to pending patent applications and issued patents alike. For those of us who practice in the computer area, the question arises: how are we informed, or are we informed, by a holding concerning patent claims directed to genetic analysis?
The answer, I believe, is that cases such as Genetic Technologies, while providing little specific guidance, do serve as a strong guidepost illustrating the susceptibility of broad and seemingly abstract claims under the patent-eligibility rubric of Mayo and Alice. And if you are looking for specific practice tips, this case illustrates the importance of prior art in the patent-eligibility analysis, and, if you are patent applicant or owner, the importance of distinctions from the prior art being something that cannot be characterized as a “mental step.”
Independent claim 1 of the ’179 patent is directed to a “method for detection of at least one coding region allele of a multi-allelic genetic locus.” The claim is short, and presumably broad. It was, the court said, “quite similar to the claims invalidated in Mayo itself.” Applying the first part of the Mayo/Alice two-part patent-eligibility test, the court found that the claim was “directed to a natural law—the principle that certain non-coding and coding sequences are in linkage disequilibrium with one another.”
The court then turned to the second part of the patent-eligibility test, the question of whether the claim recited an additional innovation to overcome the recitation of a natural law. This is where those of us in the computer arts may draw some lessons. The court analyzed the steps of claim 1 of the ’179 patent, and explained how they were found in the prior art. Even more interesting was the court’s analysis with respect to the feature “to detect the allele,” which the patent owner argued was “significantly more” than the claimed natural law. The court disagreed, explaining that the term “is a mental process step, one that provides claim 1 with a purpose but does not create the requisite inventive concept.” The court reasoned that the step “merely sets forth a routine comparison that can be performed in the human mind.” The only alleged point of novelty was a “newly discovered natural law.”
In other words, whatever your practice area, the Genetic Technologies case reinforces that patent claims drawn strictly to data processing, analysis, or steps that arguably could be carried out in the human mind, are susceptible to patent-eligibility challenges. Some district courts have recently found patent-eligibility of claims that were directed to data processing, i.e., analyzing and/or providing information. Without saying that these decisions are outliers, one can point to Genetic Technologies has an exemplar of the trend to find patent-ineligibility of claims whose only purported novelty lies in analyzing data. One has to doubt that Genetic Technologies would have come out differently in the data analysis been in a computer as opposed to “mental steps.”