On 13 June 2013, the long awaited opinion of the Supreme Court of the United States in the case on whether human DNA is patentable was issued and, the last line of the opinion summarizes, “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.”
More specifically, the Supreme Court unanimously held that isolated DNA is not patentable because it is a product of nature, but did find cDNA to be patent eligible. The Court was also careful to note several areas that the opinion did not cover. Justice Thomas wrote the opinion of the Court, with Justice Scalia filing a concurring opinion, available here. Additionally background, including KEI’s several amicus briefs in the case, recap of oral arguments at the Supreme Court and Federal Circuit, and two prior Federal Circuit opinions are available here. Ultimately, this case could have implications not only for those seeking diagnostic testing on the BRCA1 and BRCA2 genes, but also for other testing on genes for which USPTO has granted patents and on personalized medicine.
Justice Thomas’ Opinion for a Unanimous Court
After briefly going through an explanation of what genes are, the use of DNA, mRNA and cDNA, Justice Thomas turns to the specifics of the case. The Court notes that mutations on the BRCA1 and BRCA2 genes “dramatically increase an individual’s risk of developing breast and ovarian cancer. The average American woman has a 12- to 13-percent risk fo developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer.” After identifying and locating the BRCA1 and BRCA2 genes, Myriad was able to develop diagnostic tests to detect the mutations and assess an individuals’ risk of cancer. Myriad sought and received several patents on claims on these genes. Justice Thomas notes that “Myriad’s patents would, if valid, give it the exclusive
right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.” The breaking of the covalent bonds is what the Federal Circuit based its opinion on when it upheld Myriad’s genes.
The Court noted that “isolation is necessary to conduct genetic testing” and that entities other than Myriad provided BRCA testing until Myriad Genetics sent cease-and-desist letters and filed patent infringement suits. As a result of its patents, Myriad became the sole provider of genetic testing for the BRCA1 and BRCA2 genes.
The Court then detailed the three separate opinions of the Federal Circuit which twice held, by a 2-1 vote and in an extremely fractured opinion upheld the patentability of Myriad’s genes. Review of the Federal Circuit’s opinion is available here. The Court did note that while there were three separate opinions regarding patent eligibility of isolated DNA, that all three judges agreed with regard to the eligibility of cDNA.
In reversing the Federal Circuit and holding that isolated DNA is not patent eligible, the Court emphasized that laws of nature have long been excluded from patent eligibility because they represent basic tools:
. . .without this exception, there would be considerable danger that the grant of patents would “tie up” the use of such tools and thereby “inhibit future innovation premised upon them.” Id., at ___ (slip op., at 17). This would be at odds with the very point of patents, which exist to promote creation. Diamond v. Chakrabarty, 447 U. S. 303, 309 (1980) (Products of nature are not created, and “‘manifestations . . . of nature [are] free to all men and reserved exclusively to none’”). . . 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.”.
While recognizing the importance of the discovery of the isolated BRCA genes, the Court noted that the significance of a finding is not enough to create patentability or circumvent the long-standing exclusions from patentability:
In this case, by contrast, Myriad did not create anything. 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. . . 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.
The Court expressly rejected the Federal Circuit’s line of reasoning regarding upholding the claims on the basis of the breaking of covalent bonds. In Judge Lourie’s opinion in the Federal Circuit, he asserted that breaking of covalent bonds was sufficient to make the isolated DNA an invention rather than a product of nature. The Supreme Court dismisses this reasoning, noting that Myriad’s concerns are founded on the genetic sequence, not the specific composition of the molecule:
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. 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.
Finally, the Court rejects the proposition that USPTO’s practice in awarding gene patents is entitled to deference. In part, the Court noted that Congress has not endorsed these practices in subsequent legislation. Additionally, the fact that the Solicitor General took the position that isolated DNA is not patent eligible undercut any deference to the USPTO.
In upholding the cDNA claims in a brief, one-paragraph section of the opinion, the Court writes that even though
“[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” Id., at 51. 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.
After issuing its opinion that isolated DNA not patent eligible, but upholding cDNA, the Court takes care to detail what the opinion does not cover. It reminds that no method claims were before the Court in this case (the Federal Circuit rejected the majority of Myriad’s particular method claims-at-issue) and that, “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.” Myriad was unable to do so, because the methods for isolating the DNA were well-understood and practiced at the time of the discovery.
Additionally, the Court, citing the lower court’s dissenting opinion, notes “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.”
Finally, the Court takes care to state that “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.”
Justice Scalia’s Concurring Opinion
Justice Scalia’s short concurrence notes only that he is unable to join in the portions of the opinion that goes into detail of molecular biology because he is unable to affirm such details on his own knowledge. The entirety of the concurrence is reprinted below:
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.