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CAFC Updates


By July 18, 2022March 7th, 2024No Comments

The Board of Trustees of the Leland Stanford Junior University owns, and CareDx is the exclusive licensee of U.S. Patents  8,703,652, 9,845,497, and  10,329,607, which share the same specification and relate to diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (“cfDNA”). CareDx sued Natera and Eurofins Viracor, Inc. alleging infringement, and both defendants moved to dismiss the complaints for failure to state a claim due to lack of patent-eligible subject matter under § 101. The district court granted the summary judgment motions of ineligibility finding that the asserted claims were directed to the detection of natural phenomena, specifically, the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection. The court concluded that, based on the specification’s numerous admissions, the claims recited only conventional techniques. CareDx appealed.  CareDx argues that the district court did not properly perform step one of the Alice/Mayo analysis because it concluded that step one is essentially the same as step two and centers on conventionality, and that there is no basis in the law for a one-step application of Alice/Mayo. The CAFC points out that their precedent does not limit the conventionality inquiry to step two, and explains that the two stages are plainly related: not only do the two stages involve overlapping scrutiny of the content of the claims, but there can be close questions about when the inquiry should proceed from the first stage to the second. As such, the CAFC rejects CareDx’s effort to draw a bright line between the two steps. Regarding Alice/Mayo step two, CareDx argues that using digital PCR and next-generation sequencing (“NGS”) to identify and measure donor-specific SNPs was an inventive breakthrough and that the patents claim this specific and useful application. However, the CAFC finds that this is not a case involving a method of preparation or a new measurement technique and holds that the asserted claims add nothing inventive because they merely recite standard, well-known techniques in a logical combination to detect natural phenomena. Because the asserted claims are directed to a natural law together with conventional steps to detect or quantify the manifestation of that law, they are ineligible under § 101 and the CAFC affirms the judgment of the district court.

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