A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. On the other hand, cDNA is patent eligible because it is not naturally occurring.
Background / Facts: The patents here are directed to human genes now known as BRCA1 and BRCA2 that are associated with a predisposition to breast and ovarian cancers. Myriad was able to identify and isolate these genes, and thereby provide associated diagnostic testing services to women. The claims attempt to directly capture these naturally occurring segments of DNA as isolated from the rest of the human genome as well as a synthetically created version known as complementary DNA (cDNA), which contains the same protein-coding information found in a corresponding segment of natural DNA but omits the portions within the DNA segment that do not specifically code for proteins.
Issue(s): Whether a naturally occurring segment of DNA is patent eligible under 35 U.S.C. § 101 by virtue of its isolation from the rest of the human genome and whether synthetically created cDNA is patent eligible under 35 U.S.C. § 101 by virtue of its artificially induced differences from natural DNA.
Holding(s): No for natural DNA; yes for cDNA. A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring. In departing from the Federal Circuit opinion below, the Supreme Court held that Myriad’s claims were not saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally 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.”