Technique to Determine Transplant Rejection Found Ineligible for Patenting

Patents undone by their own discussion of conventional analysis techniques

Stanford and CareDX (“Stanford”) obtained patents to detect whether an organ transplant was failing and sued companies using the technique. The companies responded by filing for summary judgment that the patents’ claims were ineligible. Stanford provided an expert declaration in attempt to show a genuine issue of material fact to defeat the summary judgment motion and sought the opportunity to present its case to a jury. The district court granted the summary judgment motion, and the Federal Circuit affirmed.

Stanford’s claims were found to be indistinguishable from other diagnostic method claims the Supreme Court and the Federal Circuit found ineligible. The Federal Circuit stated that the claims boil down to collecting a bodily sample, analyzing the level of what was found in the sample “using conventional techniques, including PCR,” identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened levels and transplant health to identify a potential rejection, none of which was inventive.

Stanford’s contention that its invention lay in the particular analysis techniques used was discounted because the analysis techniques themselves were “conventional” based on statements in the specification. Thus, the Federal Circuit felt the claims did not recite an inventive concept because they were merely applying standard techniques in a standard way to observe natural phenomena. This type of reasoning highlights tension between patent ineligibility and other patent validity doctrines, as a new use of an existing technique may show novelty and can be nonobvious.

On the issue of evidence to defeat a summary judgment motion, the Federal Circuit held that the expert declaration and extrinsic evidence did not create a genuine issue of material fact due to the explicit contradiction between Stanford’s extrinsic evidence and the numerous admissions of conventionality of the analysis techniques in the intrinsic record.