In Association for Molecular Pathology v Myriad Genetics Inc the US Supreme Court overturned in-part the Court of Appeals finding that both isolated DNA and complementary DNA (cDNA) are patent eligible.
Scientists can synthetically create strands of nucleotides known as complementary DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns. It is also known that mutations of BRCA1 and BRCA2 genes can dramatically increase the risk of breast and ovarian cancer. If valid, Myriad’s patents would give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes, and would give Myriad the exclusive right to synthetically create BRCA cDNA.
The Court of Appeals for the Federal Circuit (CAFC) initially reversed, but on remand in light of the Supreme Court’s Mayo Collaborative Services v Prometheus Laboratories decision on patentability, the CAFC found both isolated DNA and cDNA patent eligible.
The Supreme Court reversed this finding in respect of isolated DNA, holding that isolated DNA is still a product of nature and not patent eligible merely because it has been isolated. Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the patentability inquiry.
Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, the claims focus on the genetic information encoded in the BRCA1 and BRCA2 genes.
However, the Supreme Court held that cDNA is patent eligible because it is not naturally occurring - it is not a product of nature. Something new is created when the introns are removed, leaving only exons – even if the order of the exons is dictated by nature.
The Supreme Court also clarified that this case does not involve a consideration of the patentability of method claims, new applications of knowledge about the BRCA1 and BRCA2 genes, or DNA in which the order of the naturally occurring nucleotides has been altered.
The USPTO has subsequently issued a provisional memorandum to patent examiners asking them to reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter.
