The U.S. Supreme Court has determined that while human genes and the information they encode are not patent eligible, despite the effort required to isolate them, a synthetically created DNA strand—complementary DNA—that is not naturally occurring may be patent eligible. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S., decided June 13, 2013). Details about the Federal Circuit decision that the Court affirmed in part and reversed in part appear in Issue 41 of this Bulletin.
According to the Court, “Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13.” Because the location and order of the nucleotides existed in nature before Myriad found them, the Court determined that certain of its patents did not satisfy the Patent Act’s § 101 inquiry. At stake in the litigation was Myriad’s exclusive right to isolate these genes and develop medical tests useful for detecting mutations that “dramatically increase the risk of breast and ovarian cancer.”