Genetic Technologies Ltd. v. Merial LLC, Bristol-Myers Squibb Company


Docket No. 2015-1202, -1203

PROST, DYK, TARANTO
April 8, 2016

Brief Summary: DC decision finding claims to method for amplifying and analyzing DNA sequences invalid under § 101 affirmed under the two-step Alice/Mayo test.

Summary: GTG appealed DC grant of Merial/BMS’s motion to dismiss for failure to state a claim (“Rule 12(b)(6)”) and judgment that claims 1-25 and 33-36 of US 5,612,179 directed to “[a] method for detection of at least one coding region allele of a multi-allelic genetic locus” by amplifying genomic DNA “to produce an amplified DNA sequence characteristic of [an] allele” and “analyzing the DNA sequence to detect the allele” are ineligible for patenting under § 101. The FC opinion explained the “now well-established two-step test for patent eligibility under § 101” (Alice, US 2014): 1) “determine whether the claims are directed to” “laws of nature, natural phenomena, and abstract ideas”; and, 2) “a search for an inventive concept-i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.” On the first question, the panel found that claim 1 is directed to a law of nature: “the relationship between non-coding and coding sequences in linkage disequilibrium and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences”. It summarized claim 1 “[i]n somewhat plainer terms” as covering “a method of detecting a coding region of a person’s genome by amplifying and analyzing a linked non-coding region of that person’s genome” (“any comparison, for any purpose, of any non-coding region sequence known to be linked with a coding region allele at a multi-allelic locus”, scope not limted “to methods of detecting any particular alleles linked to any particular non-coding sequences”). The panel concluded “[c]laim 1 broadly covers essentially all applications, via standard experimental techniques, of the law of linkage disqequilibrium to the problem of detecting coding sequences of DNA” and “[l]inkage disequilibrium is indisputably a universal, inherent feature of human DNA”. It compared this case favorably to Mayo (US 2012), in which “the claims were necessarily directed to an underlying law of nature or natural phenomenon, even if implementation of the method involves substantial human labor and ingenuity” and Ariosa (FC 2015) (“the invention there did not purport to ‘create[] or alter][] any of the genetic information encoded in the cffDNA”). In the second step of the analysis, the FC panel concluded neither the “amplifying” or “analyzing” steps were anything other than “routine and conventional” and do not “provide sufficient inventive concept to render claim 1 patent eligible” (and rejecting in fn 3 “GTG’s arguments that claim 1 is inventive because it involves analysis of man-made amplified DNA”). The step of detecting the allele was concluded to be a “mental process step, one that provides claim 1 with a purpose but does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind” (Cybersource, FC 2011). Thus, the DC decision was affirmed.

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