Thursday. June 13, 2013. The Supreme Court of the United States has ruled that isolated human genes cannot be patented.
[see, Association for Molecular Pathology, Et Al. v. Myriad Genetics, Inc., Et al., Supreme Court of the United States (SCOTUS), 569 U.S. ____ (2013), No. 12-398, Argued April 15, 2013, Decided June 13, 2013, Certiorari to the United States Court of Appeals for the Federal Circuit]
The opinion by the Court was unanimous, and it was written by Justice Clarence Thomas.
SCOTUS struck down patents on isolated DNA associated with an increased risk of breast and ovarian cancer. At issue in the case was whether isolated genes are “human-made inventions” that can be patented, or “products of nature” that may not be patented.
“We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Thomas wrote.
Myriad Genetics had obtained the patents after discovering the precise location and sequence of two genes known as BRCA1 and BRCA2. Those who have mutations in those genes have a much greater risk of breast and ovarian cancer. Indeed, actress Angelina Jolie opted to have a double mastectomy after discovering a defect in her BRCA1 gene. Critics say patents drive up the costs of such tests.
Despite the importance of Myriad's discovery, the company was not entitled to a patent, Thomas said.
"Myriad did not create anything," he wrote. "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 court did find, however, that synthetically created DNA is patent eligible because it is not naturally occurring. Such DNA is also known as complementary DNA or cDNA.
Justice Antonin Scalia joined all of Thomas' opinion except for portions that are "going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief."
The American Civil Liberties Union and the Public Patent Foundation had filed the suit challenging the patents. The groups had argued the patents obtained by Myriad Genetics allowed the company to control the cost of gene tests that are crucial to women making medical decisions.
Scientists can provide genetic testing without relying on cDNA, according to the ACLU. A press release quotes Sandra Park, senior staff attorney with the ACLU Women's Rights Project. "Today, the court struck down a major barrier to patient care and medical innovation," Park said. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."
Myriad Genetics issued a press release pointing to a section of Thomas' opinion in which he noted that none of Myriad's "method claims" were before the court. "Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes," Thomas wrote, "it could possibly have sought a method patent."
[SCOTUSblog/Tom Goldstein/6-13-2013; www.abajournal.com/news/article/isolated human genes cannot be patented]
SCOTUS SYLLABUS
Each human gene is encoded as deoxyribonucleic acid (DNA), which takes the shape of a "double helix." Each "cross-bar" in that helix consists of two chemically joined nucleotides. Sequences of DNA nucleotides contain the information necessary to create strings of amino acids used to build proteins in the body. The nucleotides that code for amino acids are "exons," and those that do not are "introns." Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns.
Respondent Myriad Genetics, Inc. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes’ typical nucleotide sequence, which, in turn, enabled it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient’s cancer risk. 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. Petitioners filed suit, seeking a declaration that Myriad’s patents are invalid under 35 U. S. C. §101. As relevant here, the District Court granted summary judgment to petitioners, concluding that Myriad’s claims were invalid because they covered products of nature. The Federal Circuit initially reversed, but on remand in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S. ___, the Circuit found both isolated DNA and cDNA patent eligible.
Held: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA ispatent eligible because it is not naturally occurring. Pp. 10–18.
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