A naturally occurring DNA segment is not eligible for a patent simply because it has been isolated, the Supreme Court of the United States ruled June 13. DNA that is not a product of nature may be patent eligible, however.
The ruling came in Association for Molecular Pathology, et al. v. Myriad Genetics Inc., et al., 12-398, in which Myriad Genetics Inc. filed several patents after discovering the precise location and sequence of what are known as BRCA1 and BRCA2 genes. Mutations in these genes can significantly increase a person’s risk of developing breast and ovarian cancer.
Other organizations offered BRCA testing after Myriad discovered the genes, but the company asserted that testing infringed on its patents.
The United States Court of Appeals for the Federal Circuit held both isolated DNA and cDNA – which is an exons-only molecule that is created in a lab – are patent eligible. Two of the three judges on the panel held that the act of isolating DNA allows a company to obtain a patent.
The question in this case is whether Myriad’s discovery of the location and genetic sequences of the genes render it patentable under 35 U.S.C. Section 101. “In this case … Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention,” the opinion states, delivered by Associate Justice Clarence Thomas. All of the justices joined, with Associate Justice Antonin Scalia joining in part.
“The court said that you can’t get a patent on a DNA sequence that has been isolated from its surrounding material because it’s a ‘product of nature,’ but you can potentially get a patent on a DNA sequence that has been altered in the lab,” explained Mark D. Janis, director of the Center for Intellectual Property Research at Indiana University Maurer School of Law.
Thomas noted what was not implicated by this decision. There are no method claims before the court; the processes used by Myriad to isolate the DNA were well understood and widely used. The case doesn’t involve patents on new applications of knowledge about these genes. And the court did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.
“We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”
In a statement issued after the decision, Peter D. Meldrum, president and CEO of Myriad Genetics Inc. said, “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward. More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall healthcare costs.”
Janis believes the impact of the decision will be modest.
“There are many alternative ways to claim biotechnology inventions, and the court’s decision is directed only to one of those strategies,” he said. “In the long term, I think it will be viewed largely as a symbolic gesture by the court – a reminder that at least some subject matter does lie in the zone of ineligible products of nature. I do not think it will be regarded as a particularly memorable exposition of patent law principles.”•