Supreme Court Decision Renders Patent Ineligible Isolated DNA

The predictions of those that attended the oral argument before the Supreme Court for Association for Molecular Pathology et al. v. Myriad Genetics were correct - despite two Federal Circuit decisions to the contrary and the USPTO's years of issuing patents with claims to isolated DNA, the Supreme Court held that such claims are not patentable subject matter. In an essentially unanimous decision, the Court held that patent claims assigned to Myriad directed to isolated DNA for a BRCA1 or BRCA2 gene (genes in which certain mutations increase and individual's risk for breast cancer) were not patent eligible subject matter. In its decision, the Court held that the act of isolating the DNA from how it exists in nature does not lend subject matter eligibility to what the Court held exists in nature (the genetic information encoded in the BRCA1 and BRCA2 genes), soundly rejecting arguments that the chemical changes to DNA for it to exist outside of nature render such isolated DNA subject matter eligible. In its decision, the Court determined not to defer to the USPTO's past practice of issuing patents with claims directed to isolated DNA.

Somewhat dampening the significant impact of this opinion is the Court's determination that cDNA (the complementary DNA to messenger RNA that contains only exons and thus does not exist in nature) is subject matter eligible. DNA with a nucleotide sequence that is altered from how it exists in nature was also considered subject matter eligible, as would be any innovative methods used to isolate DNA or new applications of knowledge about the BRCA1 and BRCA2 genes. As the opinion concluded, the Court held: "genes and the information that they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material."