In a unanimous decision Thursday morning, the Supreme Court of the United States held that naturally occurring DNA within the human body cannot be patented, though synthetic copies
of those genes can be. This is, apparently, a big deal, and I'll do my best to explain.
The Patent Act's §101 allows inventors to patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement." As Lyle Denniston explained, Myriad Genetics had isolated two genes with known genetic mutations that suggest a significantly higher risk of cancer in women—particularly, breast and ovarian cancer—BRCA1 (which Angelina Jolie discovered she had) and BRCA2. Myriad claimed a patent on the genes as a “product of human ingenuity," saying that it was able to do something no one else could requiring “an enormous amount of human judgment, including how to define the beginning and end of these genes," such that Myriad's isolating the gene makes that isolated gene its own, patentable creation.
After it isolated the gene, other medical facilities started testing patients for BRCA1 and BRCA2 as well. Myriad sued the University of Pennsylvania’s Genetic Diagnostic Laboratory, Dr. Harry Ostrer, and others for providing such genetic testing services to women as a violation of its patent, leading to the current fracas. The ACLU took on the case, arguing on their behalf that Myriad hadn't created anything, since genes are genes occurring in nature, and you can't patent nature. Or as Dr. James Watson, who co-discovered DNA in the first place argued in his amicus brief,
Life's instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts.
Dr. Watson goes onto argue that the innovations needing patent protection (and thus financial incentives) aren't patents on the isolated genes themselves, but rather on the procedures and technologies using the genes.
Now here's the sentence you'd never thought you'd read: Justice Thomas wrote for a unanimous Court, mostly granting victory to the ACLU. Why? Flip below the fold, and you'll also see some uncharacteristic modesty from Justice Scalia.
The Court explains:
Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry. In Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127 (1948), this Court considered a composition patent that claimed a mixture of naturally occurring strains of bacteria that helped leguminous plants take nitrogen from the air and fix it in the soil. The ability of the bacteria to fix nitrogen was well known, and farmers commonly “inoculated” their crops with them to improve soil nitrogen levels. But farmers could not use the same inoculant for all crops, both because plants use different bacteria and because certain bacteria inhibit each other. Upon learning that several nitrogen-fixing bacteria did not inhibit each other, however, the patent applicant combined them into a single inoculant and obtained a patent. The Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. Id., at 132 (“There is no way in which we could call [the bacteria mixture a product of invention] unless we borrowed invention from the discovery of the natural principle itself”). His patent claim thus fell squarely within the law of nature exception. So do Myriad’s. Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes “new . . . composition[s] of matter,” §101, that are patent eligible.
Indeed, Myriad’s patent descriptions highlight the problem with its claims. For example, a section of the ’282 patent’s Detailed Description of the Invention indicates that Myriad found the location of a gene associated with increased risk of breast cancer and identified mutations of that gene that increase the risk. In subsequent language Myriad explains that the location of the gene was unknown until Myriad found it among the approximately eight million nucleotide pairs contained in a subpart of chromosome 17. The ’473 and ’492 patents contain similar language as well. 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. Myriad seeks to import these extensive research efforts into the §101 patent-eligibility inquiry. But extensive effort alone is insufficient to satisfy the demands of §101.
Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. ...
However, the Court unanimously found, Myriad could patent its synthetically created exons-only strands of nucleotides known as
composite complementary DNA (cDNA). cDNA, as Justice Thomas explains, contains only the exons that occur in DNA, omitting the intervening introns. The ACLU had argued against patenting cDNA as well, claiming that if DNA was a newspaper the cDNA was just the same newspaper without ad clutter, but the Court disagreed, concisely:
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, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.
(Though, in a footnote, the Court notes that "We express no opinion whether cDNA satisfies the other statutory requirements of patentability.")
So, what does this mean? Justice Thomas explains what it doesn't mean, and this conclusion is worth quoting in full:
It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents “were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach," and are not at issue in this case.
Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.”
Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.
Are you lost? So was Justice Scalia, who concurs 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.
What might this mean? If Myriad Genetics can no longer patent this genetic testing, it no longer has a monopoly on testing. More facilities can perform the BRCA1/BRCA2 test. Prices fall. Fewer women die of cancer. This is a good day.
Congresswoman Debbie Wasserman Schultz just tweeted:
See also mconvente's diary.
