CareDx, Inc. (Stanford Univ.) v. Natera, Inc. and Eurofins Viracor, Inc.

Docket Nos. 2022-1027-8 (https://cafc.uscourts.gov/opinions-orders/22-1027.OPINION.7-18-2022_1979207.pdf)

LOURIE, BRYSON, HUGHES

July 18, 2022

Brief Summary:   Stanford’s claims to detecting organ rejection found ineligible under section 101 (e.g., “applying standard techniques in a standard way to observe natural phenomena does not provide an inventive concept”).

Summary:  Stanford (with CareDx as exclusive licensee) appealed DC summary judgment (SJ) decision finding its US 8,703,652; 9,845,497; and 10,329,607 directed to method for detecting transplant rejection or organ failure by measuring an increase in donor DNA (“cfDNA”) in a patient’s biological sample using high throughput or multiplex sequencing, and/or digital PCR, over time ineligible under section 101.  This FC opinion summarized the claimed methods as having “four steps for detecting a donor’s cfDNA in a transplant recipient: 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.”  CareDx alleged Natera infringed the patents with its kidney transplant rejection tests, and that Eurofins similarly infringed the ‘652 patent.  The DC found the asserted claims ineligible under section 101 because, e.g., the asserted claims were directed to the detection of natural phenomena” and “based on the specification’s numerous admissions, the claims recited only conventional techniques.”  The FC panel reviewed the DC’s grant of SJ de novo under Third Circuit law (SRI Int’l, FC 2019) and its patent ineligibility decision de novo as a question of law (Berkheimer, FC 2018).  The FC panel explained that under Mayo (US 2012), Diehr (US 1981), and Flook (US 1978), “[l]aws of nature and natural phenomena are not patentable, but applications and uses of such laws and phenomena may be patentable”, “[a] claim to otherwise eligible statutory subject matter does not become ineligible by its use of a law of nature or natural phenomenon”, but that “adding ‘conventional steps, specified at a high level of generality,’ to a law of nature or natural phenomenon does not make a claim to the law or phenomenon patentable”, determined using a two-step test of Alice (US 2014 (“examine whether the claims are ‘directed to’ a law of nature or natural phenomenon” and then “whether the limitations of the claim apart from the law of nature or natural phenomenon, considered individually and as an ordered combination, ‘transform the nature of the claim’ into a patent-eligible application”).  CareDx argued the DC did not perform the two-step analysis but instead focused on conventionality and that “using digital PCR and next-generation sequencing (“NGS”) to identify and measure donor-specific SNPs was an inventive breakthrough”.  Natera argued the “asserted claims are directed to detecting natural phenomena” using conventional techniques, citing Athena (FC 2019), Genetic Veterinary (FC 2018), Roche (FC 2018), Cleveland Clinic (FC 2017), and Ariosa (FC 2015).  The FC panel agreed with Natera, writing that “[t]his is not a case involving a method of preparation or a new measurement technique” (Illumina, FC 2020 (eligible new method for detecting fetal cfDNA); “equally as ineligible as those in Ariosa”, “applying standard techniques in a standard way to observe natural phenomena does not provide an inventive concept”).  It also wrote that “our precedent rejects CareDx’s effort to draw a bright line between the two steps” of Alice (Elec. Power, FC 2016).  The DC decision was therefore affirmed.

Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel…

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.