SCOTUS: Genes (in their Natural State) Not Patentable

The Supreme Court today issued its much-awaited decision in the Myriad Technologies case.  At issue in the case were Myriad’s patents on  the BRCA1 and BRCA2 genes — genes which are important genetic markers for determining susceptibility to breast cancer.  Myriad discovered “the precise location” of the two genes (on chromosomes 17 and 13), and sequenced the two genes to determine the precise nucleotide pattern in each.  That information, in turn, enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer.  Because of the patents, Myriad claimed the “exclusive right to isolate an individual’s BRCA1 and BRCA2 genes” — that is, the exclusive right to perform these diagnostic tests, because isolating the gene in any individual constituted an  infringement of their patent.

Myriad also had patents covering the so-called “cDNA” — composite DNA.  These are nucleotide strands derived from the genes, but not identical to them; the cDNA for the BRCA1 gene consists of only those portions of the gene  (the “exons”) that are used during the process of protein production, and it omits the non-coding portions of the original gene (“introns”).

The Court (9-0, opinion by Thomas) invalidated Myriad’s patents on the genes themselves, because Myriad had not “created” anything but had rather  “discovered” the naturally-occurring characteristics (location and sequence) of the genes in question:

It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. . . . To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.

The cDNA, however, is patentable, because it does not exist as such in nature, and is therefore the product of human invention:

cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. Petitioners concede that cDNA differs from natural DNA in that “the non-coding regions have been removed.” They nevertheless argue that cDNA is not patent eligible because “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” That may be so, but the lab technician unquestionably creates something new when cDNA is made. 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 [of the Patent Act].

All well and good.  I think the Court got it right on this one — I have never understood the contortions that were required to allow naturally-occurring genetic material, without alteration in its composition, to be patented, and I’m glad the Court shares that view.

There was only one Justice writing separately — Justice Scalia, whose opinion concurring in part and concurring in the judgment reads in its entirety as follows:

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.

I don’t mean to pick on Justice Scalia, but I’m genuinely confused by this.  On the one hand, this case is all about  “fine details of molecular biology,” like it or not; the differences between cDNA and ordinary DNA are details of molecular biology and are at the heart of the case.  Why is this case different from one where, say, the Court has to understand the intricacies of inter-bank money transfer practices and processes in order to render its decision – I’ve never seen Justice Scalia distance himself from the “details” of those (very complicated) matters.

And more troubling:  does this mean that in all of the other opinions to which Justice Scalia lent his name he was “affirm[ing] the details on my own knowledge or even my own belief”??  Here’s some language from an earlier patent case this term, Bowman v. Monsanto, from Justice Kagan’s opinion for the Court (which Scalia joined without additional comment):

Respondent Monsanto invented a genetic modification that enables soybean plants to survive exposure to glyphosate, the active ingredient in many herbicides (including Monsanto’s own Roundup). Monsanto markets soybean seed containing this altered genetic material as Roundup Ready seed. Farmers planting that seed can use a glyphosatebased herbicide to kill weeds without damaging their crops. Two patents issued to Monsanto cover various aspects of its Roundup Ready technology, including a seed incorporating the genetic alteration. . . . Because glyphosate resistance comes from the seed’s genetic material, that trait is passed on from the planted seed to the harvested soybeans: Indeed, a single Roundup Ready seed can grow a plant containing dozens of genetically identical beans, each of which, if replanted, can grow another such plant—and so on and so on.

Inamsuch as Scalia didn’t qualify his position in that case, is he “affirming” all of those details?  On what basis?  And if so, what makes molecular biology different from seed biology?  I don’t get it.



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