In a recent decision, the Federal Circuit found that claims to synthetic primers are not patent eligible.
Myriad Genetics, Inc., along with its partners, discovered that people with certain mutations in the BRCA-1 or BRAC-2 genes are significantly more likely to develop certain cancers, including breast cancer. The case, In re BRCA-1-and BRCA-2-Based Heredity Cancer Test Patent Litigation, is the latest attempt by Myriad to enforce its patents covering genetic testing for the breast cancer genes BRCA-1 and BRCA-2.
The claims at issue are directed to synthetic primers, small pieces of DNA sequence used to amplify a specific gene by binding to a specific sequence of that gene. In this case, the claimed primers are used to isolate the BRCA-1 or BRCA-2 gene. The Federal Circuit found that the fact that the primers are made synthetically does not make the claims patent eligible explaining that “neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”
In 2013, the Supreme Court decided AMP v. Myriad, finding that Myriad’s claims directed to isolated DNA are invalid because they are directed to patent-ineligible subject matter. Specifically, the Supreme Court held that isolated DNA strands are naturally occurring. However, the Supreme Court held that Myriad’s claims to cDNA (synthetically created DNA molecules containing only the coding sequence) are directed to patent eligible subject matter because these synthetic DNA molecules do not exist in nature.
After the 2013 Supreme Court decision, generic competitors entered the market offering tests designed to detect susceptibility to certain cancers, including susceptibility to breast cancer due to mutations in the BRCA-1 and BRCA-2 genes. Myriad filed an infringement suit against some of these competitors, including Ambry Genetics, Corp., asserting claims from the same patents involved in the previous litigation that had not been considered by either the Supreme Court or the Federal Circuit.
Myriad argued that the asserted claims are patent eligible because single-stranded DNA does not exist in the human body and, thus, the claimed synthetic primers are not naturally occurring. The Federal Circuit, quoting the Supreme Court’s 2013 decision, rejected this argument because “separating [DNA] from its surrounding genetic material is not an act of invention.”
This holding may have important implications for obtaining and enforcing patents in the biological and chemical fields.