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In its only precedential patent opinion this week, the Federal Circuit held patents directed to the detection of organ transplant failure to be ineligible under Section 101. 

The patents at issue were all owned by Stanford University and licensed to CareDx.  The patents concern the detection of organ transplant failure.  When a transplanted organ is rejected, the body releases cfDNA.  These increased levels of cfDNA can be detected and then used to diagnose the likelihood of an organ transplant rejection.

Three patents were at issue.  All claims were method claims, and recited some combination of the following 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.

After CareDx sued, Defendants moved to dismiss the lawsuits, arguing ineligibility under Section 101.  A magistrate judge recommended denying the motions.  The district court judge noted that “language in the written description[] of the asserted patent[] suggests that the patented steps are neither new nor unconventional” and that the “specifications raise[d] doubts about the patents’ validity.”  However, the court was concerned about ruling prematurely, and granted limited discovery into whether the patented steps were truly conventional.

On summary judgment, the judge denied the defendants’ motions, finding disputes of fact.  The defendants moved for interlocutory appeal.  Based on the arguments raised in the motion for certification, the judge reconsidered his summary judgment decision and entered summary judgment that all claims were ineligible for patenting.

The Federal Circuit readily agreed with the district court that the claims were ineligible.  The Court found that the case did not involve “a method of preparation or a new measurement technique.”  The court noted that the written description expressly states that the techniques referred to in the claimed steps are “unless otherwise indicated, conventional techniques . . . which are well within the skill in the art.”  The Court also found that “the written description is replete with characterizations of the claimed techniques in terms that confirm their conventionality.” 

The Court also analogized the case to Illumina, Inc. v. Ariosa Diagnostics, Inc., 967 F.3d 1319 (Fed. Cir. 2020).  That case involved the diagnosis of certain fetal characteristics based on detecting cffDNA.  The presence of cffDNA was a natural phenomenon, and the claims-recited similar steps for the diagnosis.  As there, the claims “boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques . . . identifying naturally occurring DNA . . . and then using the natural correlation . . . to identify a potential rejection.” 

The remainder of the opinion concerned CareDx’s procedural arguments, including that the district court’s analysis was faulty because it failed to sufficiently separate its two-step ineligibility analysis, and that the circumstances of the court’s reconsideration and reversal of its summary judgment opinion raised concerns.  The Court readily dismissed these arguments.

The opinion can be found here.

By Nika Aldrich

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This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.