Court: Human Genes Cannot be Patented

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By CNN Staff

(CNN) — The Supreme Court unanimously ruled Thursday that human genes cannot be patented.

But in something of a compromise decision, all nine justices said while the naturally occurring isolated biological material itself is not patentable, a synthetic version of the gene material may be patented.

“Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material,” said Justice Clarence Thomas for the 9-0 court decision.

The case involves Utah-based company Myriad Genetics, which was sued over its claim of patents relating to two types of biological material that it identified — BCRA-1 and BCRA-2, whose mutations are linked to increased hereditary risk for breast and ovarian cancer.

Since Myriad owns the patent on breast cancer genes, it is the only company that can perform tests for potential abnormalities.

Investors in Myriad appear pleased with the ruling with the stock up 6%, and has been up as much as 9%.

At issue is whether “products of nature” can be treated the same as “human-made” inventions, allowing them to be held as the exclusive intellectual property of individuals and companies.

On one side, scientists and companies argue patents encourage medical innovation and investment that saves lives. On the other, patient rights groups and civil libertarians counter the patent holders are “holding hostage” the diagnostic care and access of information available to high-risk patients.

The issue gained greater public attention when actress Angelina Jolie announced last month she had undergone a double mastectomy after taking the BRCA tests from Myriad.

The high court has long allowed patent protection for the creation of a new process or use for natural products. Whether “isolating” or “extracting” genes themselves qualifies for such protection became the issue.

The justices took the position offered by the Obama administration — DNA itself is not patentable but so-called “cDNA” can be. Complementary DNA is artificially synthesized from the genetic template, and engineered to produce gene clones.

Use of this protein-isolating procedure, known as “tagging,” is especially important in mapping and cataloguing the vast human genome.

The federal government had suggested Congress could create exceptions in the genetic or bio-tech testing arena, over so-called “use” patents for specific procedures.

But the justices decided that was not the case in the current dispute.

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

But Thomas said, “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.”

The case is Association for Molecular Pathology v. Myriad Genetics (12-398).