Court Declares Human Genes Cannot Be Patented


By Paul Johnson

Washington DC (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 -- BRCA1 and BRCA2, 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 were pleased with the ruling with the stock soaring as much as 9% before settling back. It was up more than 3% in midday trading.
Myriad had no initial reaction to the decision.
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.
The issue has deeply divided the scientific and business communities.
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.
Outside the court during oral arguments in April, several protesters held signs, such as "Your corporate greed is killing my friends" and "My genes are not property."
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.
Court backs Obama administration position
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 American Civil Liberties Union said the decision represents a major shift in patent law and overturns established policy.
"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, senior staff attorney with the ACLU Women's Rights Project. "Myriad did not invent the BRCA genes and should not control them. 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."
Dr. Harry Ostrer, director of genetic and genomic testing at Montefiore Medical Center in New York, said the decision will not undermine the genetically engineered drug industry and expects the costs of tests to fall.

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