Supreme Court reaches double decision in gene-patenting case

National Constitution Center

A unanimous Supreme Court said on Thursday that companies can’t patent human genes that occur naturally, but they can patent synthetic genes created after the extraction of genetic materials from a person’s body.

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The decision, written by Justice Clarence Thomas, is a mixed one. Myriad Genetics, a company that invested a huge amount of money patenting genes used to detect breast cancer, had two types of patents at stake in the case.

One patent involves the process of isolating DNA from a cell that includes markers called BRCA1 and BRCA2. A second patent is related to the creation of complementary DNA, or cDNA, a synthetic product that is used in tests to detect breast cancer.

Related Links: Case details on SCOTUSblog | Case details on Cornell Legal Information Institute

“Myriad did not create anything,” Thomas said. “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.”

“We merely hold that genes and the information they encode are not patent eligible … simply because they have been isolated from the surrounding genetic material,” Thomas said.

Myriad claims its patent was justified because of the time and money it put into finding the two BRCA2 genes. Each gene contains a few thousand nucleotides, on chromosomes containing tens of millions of nucleotides.

Part of the patent involves the process of creating synthetic genes that only contained the BRCA material, and not the millions of other nucleotides.

One consequence of the decision is that companies deciding to undertake the considerable costs of genetic research may not have the incentive to do so.

But the decision also offers patent protection for cDNA and other synthetic products derived from genetic materials.

The American Civil Liberties Union and the Public Patent Foundation had filed the suit challenging the patents. The ACLU said on Thursday that scientists can provide genetic testing without relying on cDNA.

“Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park, a senior staff attorney with the ACLU Women’s Rights Project. “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.”

The Myriad case attracted additional attention after actress Angelina Jolie made global headlines in April when she announced that she underwent a double mastectomy after BRCA tests revealed she was at a high risk of developing breast and ovarian cancer.

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