Supreme Court to Decide if Human Genes Are Patentable

Photo: Courtesy of U.S. Supreme Court

The Supreme Court announced Friday it would review a case testing whether human genes may be patented, in a dispute weighing patents associated with human genes known to detect early signs of breast and ovarian cancer.

A 2009 lawsuit filed by the American Civil Liberties Union claimed among other things the First Amendment is at stake because the patents are so broad they bar scientists from examining and comparing the BRCA1 and BRCA2 genes at the center of the dispute. In short, the patents issued more than a decade ago cover any new scientific methods of looking at these human genes that might be developed by others.

The ACLU, representing dozens of patients and researchers, said the case challenges the legality and constitutionality of granting patents covering the most basic element of every person’s individuality. The civil rights group maintains that, “What is patented is the abstract idea that nature has made the two genes different in a manner that increases that person’s risk of cancer.”

The patents at issue gave Myriad Genetics, the defendant in the case, a virtual monopoly on such predictive testing for breast and ovarian cancer, according to the suit. Women who fear they may be at an increased risk are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder, which charges about $3,000 per test or more.

Myriad, which had issued a cease-and-desist order to Yale University scientists researching the genes, has maintained that its patents are valid and enforceable, a statement a federal appeals court agreed with in August.

About 10 percent of women with breast cancer are likely to have a mutation inherited from their parents in the genes at issue, according to the suit.

Patents for exclusive genetic testing have also been issued for a host of genes, including those related to cystic fibrosis, heart arrhythmias and hemochromatosis.

The Patent and Trademark Office first issued a patent for a human gene in 1982 to the Regents of the University of California in connection to a hormone promoting breast development during pregnancy.