Supreme Court Gene Patent Case: Unanimous Decision Allows Companies To Patent Synthetic Gene Material, But Not Human Genes

Supreme Court
In a historic gene patent case, the Supreme Court unanimously ruled in Thursday that human genes cannot be patented. Matt Wade/Wiki Commons

Thursday morning, the U.S. Supreme Court unanimously ruled that human genes cannot be patented, saying that DNA is "a product of nature and not patent eligible merely because it has been isolated." The Court did offer what many consider a compromise to the biotechnology industry by permitting synthetically produced genetic material to be patented.

The case involved Myriad Genetics, a Utah-based molecular diagnostic company that was given patents for isolating the BRCA1 and BRCA2 genes. People who have these genes are at higher risk for breast and ovarian cancer. Just last month, actress Angelina Jolie made headlines when she revealed that she had a double mastectomy after testing positive for the BRCA2 gene. Myriad market tests, like the one Jolie took to assess disease risk, guide treatment decisions and assess risk of disease progression and reoccurrence.

The issue in the case was whether genes could be treated the same as human inventions under patent law, allowing them to be exclusively used by one company for testing and research. Patient advocacy groups argued that the exclusive use of certain genes by one company prevented more widespread research by other companies that could create a cure. Doctors, researchers, and patients alike challenged the patents because they hindered research. Privacy advocates even argued that Myriad's patents prohibited women scientists from evaluating their own genes. But Myriad, who owned the patent on breast cancer genes, said that it isolated the genes, so it should be allowed exclusive access to tests for abnormalities and treatment.

"Myriad did not create anything," wrote Justice Clarence Thomas in the decision. "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."

This could prove to be one of the most significant decisions on the Supreme Court's calendar this year. The court's ruling will have a profound impact on the course of scientific research and medical testing. Businesses who were previously willing to invest in the expensive task of isolating genes may not be as apt to do so, now that more companies, researchers, and institutions will be able to have their hands in the research. But since this decision just came down, diagnostic testing companies will have a long way to go before catching up with Myriad.

According to USA Today, the U.S. Patent and Trademark Office has granted more than 40,000 patents linked to genetic material. Myriad, armed with many of those patents, has tested over one million women for mutations. Although Myriad will not continue to keep a monopoly over these genes, the court did leave room for patents of synthetic genetic material. Myriad's investors were apparently pleased with the result, as the stock has been up as much as nine percent since the ruling.

As Justice Thomas diplomatically pointed out, "groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent law] inquiry."

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