Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in CareDx, Inc., The Board of Trustees of the Leland Stanford Junior University v. Natera, Inc. & Eurofins Viracor, Inc., Nos. 2022-1027, -1028 (July 18, 2022), affirming a district court’s decision that certain patents owned by Stanford and licensed to CareDx are ineligible for patent under 35 U.S.C. § 101.
CareDx sued Natera and Eurofins, asserting their organ transplant rejection tests infringed three patents owned by Stanford and exclusively licensed to CareDx. The asserted patents address methods for diagnosing the likelihood of an organ transplant rejection by detecting levels of a donor’s cell-free DNA (“cfDNA”) in a recipient’s body. The representative claims include four steps:
“1. obtaining” or “providing” a “sample” from the recipient that contains cfDNA;
2. “genotyping” the transplant donor and/or recipient to develop “polymorphism” or “SNP” “profiles”;
3. “sequencing” the cfDNA from the sample using “multiplex” or “high-throughput” sequencing; or performing “digital PCR”; and
4. “determining” or “quantifying” the amount of donor cfDNA.”
Natera and Eurofins both moved to dismiss the suits against them asserting patent ineligibility under § 101. The district court denied the motion so the parties could conduct limited discovery to develop the record on conventionality. After the limited discovery period, Natera and Eurofins moved for summary judgment of ineligibility, which was ultimately granted based on the district court’s determination that the claims were directed to the detection of natural phenomena and recited only conventional techniques. CareDx appealed.
The Federal Circuit affirmed. At the Alice/Mayo step one inquiry, the Court held this “is not a case involving a method of preparation or a new measurement technique.” The Court explained that the specifications of the patents made it clear that the claims “merely recite the conventional use of existing techniques to detect naturally occurring cfDNA.” Accordingly, the claims are not directed to improved laboratory techniques, but to natural phenomena. The Court rejected CareDx’s assertion that the district court erred by considering the conventionality of the laboratory techniques at step one of the Alice/Mayo inquiry, noting that “many of our opinions make clear that the two stages involve overlapping scrutiny . . . .” Regarding Alice/Mayo step two, the Court agreed with the district court that the asserted claims add nothing inventive and that the conclusion of conventionality was well supported by admissions in the specifications of the patents themselves.