Breaking: SCOTUS releases Myriad decision (gene patent case)

Full text of decision here (pdf), more thoughts from me later…

Background on Association for Molecular Pathology v. Myriad Genetics, Inc. (SCOTUSblog)

From the opinion (Justice Thomas writing for the unanimous decision, with Justice Scalia concurring, in part, and writing a concurring opinion):

“For the reasons that follow, we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.” (p. 1)

“The central dispute among the panel members was whether the act of isolating DNA—separating a specific gene or sequence of nucleotides from the rest of the chromosome—is an inventive act that entitles the individual who first isolates it to a patent.” (p. 8)

“The rule against patents on naturally occurring things is not without limits, however, for “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” and “too broad an interpretation of this exclusionary principle could eviscerate patent law.” 566 U. S., at ___ (slip op., at 2). As we have recognized before, patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.” Id., at ___ (slip op., at 23). We must apply this well-established standard to determine whether Myriad’s patents claim any “new and useful . . . composition of matter,” §101, or instead claim naturally occurring phenomena.” (p. 11)

“It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes” (pp. 11-12)

“Many of Myriad’s patent descriptions simply detail the “iterative process” of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought.” (p. 14)

“If the patents depended upon the creation of a unique molecule, then a would-be infringer could
arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ’282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with
the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.” (p. 15)

“cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” (p. 16)

“cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which
it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101” (p. 17)

And finally, Justice Scalia’s concurring opinion, in its entirety:

“I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied
the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.” (p. 1)

About Adam Van Arsdale

I am biological anthropologist with a specialization in paleoanthropology. My research focuses on the pattern of evolutionary change in humans over the past two million years, with an emphasis on the early evolution and dispersal of our genus, Homo. My work spans a number of areas including comparative anatomy, genetics and demography.
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