US Supreme Court Rules Isolated Human Genes Unpatentable
On Thursday, June 13, 2013, the United States Supreme Court posted, in a 9-0 count, that isolated human genes do not qualify as patentable subject matter.
Myriad Genetics, a biotech company, owns patents for the BRCA1 and BRCA2 genes, mutations of which help to increase the risk for particular breast and ovarian cancers. The question at hand is whether or not these genes, which are naturally occurring segments of DNA, are eligible for a patent under Section 101 of the Patent Act, which states that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title” 35 U.S.C. §101.
The case in question, Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, discusses Myriad’s ability to control testing for the genes due to the fact that they own the gene patents. The American Civil Liberties Union, who filed the suit against Myriad in 2009, posted on their website about why they believe genes should not be patentable material. The ACLU claims that by having gene patents, testing for patients is monopolized since the company who owns the patents can then control who administers the tests, as well as how much the tests cost.
Myriad has defended its rights to the gene patents and has also posted on their website about gene patenting and the myths they say revolve around it. The American Intellectual Property Law Association filed an amicus brief also stating that isolated DNA (which includes the BRCA1 and BRCA2 genes) should be allowed as patentable material.
The Supreme Court decision, written by Justice Clarence Thomas, states that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.” The opinion goes on to state that “Myriad did not create or alter either the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA”, and that “finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible.”
Though isolated human genes are ineligible for patentability, cDNA, which the opinion states is not a “product of nature”, is indeed eligible. Justice Thomas goes on to write that “the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.” This means that while isolated human genes no longer have patent eligibility, Myriad and other biotech companies may continue to patent products that have been synthetically altered.
A transcript of the hearing can be found here. The audio of the hearing can be found here.
Audrey Nicolson
Law Clerk
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