On June 13, 2013, in a seminal case on the patentability of the genetic code, the U.S. Supreme Court unanimously held that “naturally occurring DNA … is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.” See Association for Molecular Pathology v. Myriad Genetics Inc. (2013).
While the Myriad decision is anticipated to bring a sea change in how patent claims covering genetic material are drafted, it is important to note what the case does and does not effect:
- The decision only directly impacts claims directed to compositions of matter; not method claims directed to the use of isolated genes.
- The Court in Myriad did not consider the patentability of DNA in which the order of naturally occurring nucleotides has been changed.
- The Court’s holding that cDNA is patent eligible was limited to the context of patentable subject matter under section 101 of the Patent Act. The Court expressed “no opinion whether cDNA satisfies the other statutory requirements of patentability,” signaling that claims drawn to cDNA could ultimately be found unpatentable on grounds of obviousness.
Although the long-term impact of the Myriad decision is unclear, the Court’s holding is sufficiently narrow so that the immediate impact is to provide scientists greater freedom to experiment with genetic material while continuing to provide options for the protection of biotechnological inventions. We will closely monitor how the lower federal courts interpret and apply this case in the future.