In a potentially critical ruling for the biotechnology industry, the Supreme Court ruled Thursday that naturally-occurring human genes cannot be patented.
The unanimous decision maintained that a DNA segment is a product of nature and not patent eligible merely because it has been isolated.
However, the court ruled that synthetically created DNA, known as complementary DNA or cDNA, is not a product of nature and is patent eligible.
The ruling was seen as a mixed outcome for Myriad Genetics (MYGN), a molecular diagnostic company that had been awarded patents on the BRCA1 and BRCA2 genes.
People with certain mutations of BRCA1 and BRCA2 are at much higher risk of breast and ovarian cancer, and opponents of the patents argued that they granted Myriad a monopoly on the types and cost of testing as well as the availability of second opinions.
"Myriad did not create anything," Justice Clarence Thomas 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."
However, Myriad noted that the court upheld its claims on cDNA and said it has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test.
The American Civil Liberties Union cheered the ruling, with Sandra Park, a staff attorney with the ACLU Women's Rights Project, saying it lifts a major barrier to progress in further understanding how to better treat and prevent diseases.
"In fact, the decision will help, not hinder, the biotechnology industry," Park said. "Most of the industry is focused on using genes as a starting point to create new tools, tests, and therapeutics."
She added, "While all of these applications could be patented, the genes themselves should remain in the public storehouse of knowledge, for scientists at universities and corporations to freely study and use."
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