Yesterday, the U.S. Supreme Court held 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.” The Court’s ruling decided the question: “Are human genes patentable?” We have been blogging on this issue for some time now, see for example here, our blog on the oral arguments at the Supreme Court with links to some previous blogs.
Myriad concerns the “discover[y of] the precise location and sequence of what are known as the BRCA1 and BRCA2 genes.” Specifically, Myriad discovered that “[m]utations in these genes can dramatically increase an individual’s risk of developing breast and ovarian cancer.” Myriad subsequently obtained a patent including such claims as “[a]n isolated DNA coding for a BRCA1 polypeptide” that included a specific amino acid sequence. The isolated DNA existed in nature before Myriad found them, the Court noted, and Myriad’s principle contribution involved determining the precise location and genetic sequence of these polypeptides. The Court said that finding the location of the genes does not make the genes themselves patentable, nor does the extensive effort involved in discovering them. Additionally, the Court found that isolating certain DNA from the human genome by severing chemical bonds would be not enough to render the matter patent eligible, because the “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.” As a result, the Court held the claims invalid since “genes and the information they encode are not patent eligible under [35 U.S.C.] § 101 simply because they have been isolated from the surrounding genetic material.”
Another issue was whether the cDNA sequence claimed in the patent (as opposed to the full DNA sequence) would be patent-eligible. Here, the Court said that “cDNA cannot be isolated from nature, but instead must be created in the laboratory.” The Court noted that “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” So, even though “cDNA retains the naturally occurring exons of DNA,  it is distinct from the DNA from which it was derived.” For this reason, the Court concluded, “cDNA is not a ‘product of nature’ and is patent eligible under § 101, except insofar as . . . a short strand of cDNA may be indistinguishable from natural DNA.”